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Transgender Women and Prostate Cancer: It’s Complicated
The Veterans Health Administration (VHA) provides care for about 10,000 transgender women, and clinicians must understand their distinctive needs for prostate cancer screening, a urologist told cancer specialists during a presentation at the 2024 annual meeting of the Association of VA Hematology/Oncology in Atlanta.
Even if they’ve undergone gender reassignment surgery, “all transgender women still have a prostate, so therefore they remain at risk of prostate cancer and could still be considered for prostate cancer screening,” said Farnoosh Nik-Ahd, MD, a resident physician at the University of California San Francisco. However, “clinicians and patients may not be aware of prostate cancer risk, so that they may not think [of screening] transgender women.”
Nik-Ahd also noted another complication: The results of prostate screening tests may be misleading in this population.
Transgender women were born biologically male but now identify as female. These individuals may have undergone gender reassignment surgery to remove male genitalia, but the procedures do not remove the prostate. They also might be taking estrogen therapy. “Prostate cancer is a hormonally driven cancer, and the exact impact of gender-affirming hormones on prostate cancer risk and development is unknown,” Nik-Ahd said.
In a 2023 study in JAMA, Nik-Ahd and colleagues identified 155 cases of prostate cancer in transgender women within the VHA (about 14 cases per year) from 2000 to 2022. Of these patients, 116 had never used estrogen, while 17 had used it previously and 22 used it at diagnosis.
The median age of patients was 61 years, 88% identified as White, and the median prostate-specific antigen (PSA) was 6.8 ng/mL. “Given estimates of 10,000 transgender women in the US Department of Veterans Affairs, 33 cases per year would be expected. Instead, only about 14 per year were observed,” the researchers wrote. “Lower rates may stem from less PSA screening owing to barriers including lack of prostate cancer risk awareness or stigma, the suppressive effects of estrogen on prostate cancer development, or prostate cancers being missed in transgender women because of misinterpretation of ‘normal’ PSA levels among those receiving gender-affirming hormone therapies.”
In the presentation, Nik-Ahd said, “PSA density, which is a marker of prostate cancer aggressiveness, was highest in transgender women who were actively on estrogen.”
She noted, “the existing thyrotropin reference ranges, which is what we use to interpret PSA values, are all based on data from cisgender men.” The ranges would be expected to be far lower in transgender women who are taking estrogen, potentially throwing off screening tests, she said, and “ultimately missing clinically significant prostate cancer.”
In the larger picture, there are no specific guidelines about PSA screening in transgender women, she said.
A recent study published in JAMA by Nik-Ahd and colleagues examined PSA levels in 210 transgender women (mean age 60 years) treated within the VHA from 2000 to 2023. All were aged 40 to 80 years, had received estrogen for at least 6 months (mean duration 4.7 years), and didn’t have prostate cancer diagnoses.
“Median (IQR) PSA was 0.02 (0-0.2) ng/mL and the 95th percentile value was 0.6 ng/mL,” the report found. “PSAs were undetectable in 36% of patients (23% and 49% of PSAs in patients without and with orchiectomy, respectively).”
The researchers write that “the historic cut point of 4 ng/mL, often used as a threshold for further evaluation, is likely far too high a threshold for this population.”
Nik-Ahd noted, “clinicians should interpret PSA values in transgender women on estrogen with extreme caution. In this population, normal might actually not be normal, and a value that is considered normal might be very abnormal for somebody who is on estrogen. If you're unsure of whether a PSA value is appropriate for a transgender woman on estrogen, refer that patient to a urologist so they can undergo further evaluation.”
Farnoosh Nik-Ahd discloses consulting for Janssen.
The Veterans Health Administration (VHA) provides care for about 10,000 transgender women, and clinicians must understand their distinctive needs for prostate cancer screening, a urologist told cancer specialists during a presentation at the 2024 annual meeting of the Association of VA Hematology/Oncology in Atlanta.
Even if they’ve undergone gender reassignment surgery, “all transgender women still have a prostate, so therefore they remain at risk of prostate cancer and could still be considered for prostate cancer screening,” said Farnoosh Nik-Ahd, MD, a resident physician at the University of California San Francisco. However, “clinicians and patients may not be aware of prostate cancer risk, so that they may not think [of screening] transgender women.”
Nik-Ahd also noted another complication: The results of prostate screening tests may be misleading in this population.
Transgender women were born biologically male but now identify as female. These individuals may have undergone gender reassignment surgery to remove male genitalia, but the procedures do not remove the prostate. They also might be taking estrogen therapy. “Prostate cancer is a hormonally driven cancer, and the exact impact of gender-affirming hormones on prostate cancer risk and development is unknown,” Nik-Ahd said.
In a 2023 study in JAMA, Nik-Ahd and colleagues identified 155 cases of prostate cancer in transgender women within the VHA (about 14 cases per year) from 2000 to 2022. Of these patients, 116 had never used estrogen, while 17 had used it previously and 22 used it at diagnosis.
The median age of patients was 61 years, 88% identified as White, and the median prostate-specific antigen (PSA) was 6.8 ng/mL. “Given estimates of 10,000 transgender women in the US Department of Veterans Affairs, 33 cases per year would be expected. Instead, only about 14 per year were observed,” the researchers wrote. “Lower rates may stem from less PSA screening owing to barriers including lack of prostate cancer risk awareness or stigma, the suppressive effects of estrogen on prostate cancer development, or prostate cancers being missed in transgender women because of misinterpretation of ‘normal’ PSA levels among those receiving gender-affirming hormone therapies.”
In the presentation, Nik-Ahd said, “PSA density, which is a marker of prostate cancer aggressiveness, was highest in transgender women who were actively on estrogen.”
She noted, “the existing thyrotropin reference ranges, which is what we use to interpret PSA values, are all based on data from cisgender men.” The ranges would be expected to be far lower in transgender women who are taking estrogen, potentially throwing off screening tests, she said, and “ultimately missing clinically significant prostate cancer.”
In the larger picture, there are no specific guidelines about PSA screening in transgender women, she said.
A recent study published in JAMA by Nik-Ahd and colleagues examined PSA levels in 210 transgender women (mean age 60 years) treated within the VHA from 2000 to 2023. All were aged 40 to 80 years, had received estrogen for at least 6 months (mean duration 4.7 years), and didn’t have prostate cancer diagnoses.
“Median (IQR) PSA was 0.02 (0-0.2) ng/mL and the 95th percentile value was 0.6 ng/mL,” the report found. “PSAs were undetectable in 36% of patients (23% and 49% of PSAs in patients without and with orchiectomy, respectively).”
The researchers write that “the historic cut point of 4 ng/mL, often used as a threshold for further evaluation, is likely far too high a threshold for this population.”
Nik-Ahd noted, “clinicians should interpret PSA values in transgender women on estrogen with extreme caution. In this population, normal might actually not be normal, and a value that is considered normal might be very abnormal for somebody who is on estrogen. If you're unsure of whether a PSA value is appropriate for a transgender woman on estrogen, refer that patient to a urologist so they can undergo further evaluation.”
Farnoosh Nik-Ahd discloses consulting for Janssen.
The Veterans Health Administration (VHA) provides care for about 10,000 transgender women, and clinicians must understand their distinctive needs for prostate cancer screening, a urologist told cancer specialists during a presentation at the 2024 annual meeting of the Association of VA Hematology/Oncology in Atlanta.
Even if they’ve undergone gender reassignment surgery, “all transgender women still have a prostate, so therefore they remain at risk of prostate cancer and could still be considered for prostate cancer screening,” said Farnoosh Nik-Ahd, MD, a resident physician at the University of California San Francisco. However, “clinicians and patients may not be aware of prostate cancer risk, so that they may not think [of screening] transgender women.”
Nik-Ahd also noted another complication: The results of prostate screening tests may be misleading in this population.
Transgender women were born biologically male but now identify as female. These individuals may have undergone gender reassignment surgery to remove male genitalia, but the procedures do not remove the prostate. They also might be taking estrogen therapy. “Prostate cancer is a hormonally driven cancer, and the exact impact of gender-affirming hormones on prostate cancer risk and development is unknown,” Nik-Ahd said.
In a 2023 study in JAMA, Nik-Ahd and colleagues identified 155 cases of prostate cancer in transgender women within the VHA (about 14 cases per year) from 2000 to 2022. Of these patients, 116 had never used estrogen, while 17 had used it previously and 22 used it at diagnosis.
The median age of patients was 61 years, 88% identified as White, and the median prostate-specific antigen (PSA) was 6.8 ng/mL. “Given estimates of 10,000 transgender women in the US Department of Veterans Affairs, 33 cases per year would be expected. Instead, only about 14 per year were observed,” the researchers wrote. “Lower rates may stem from less PSA screening owing to barriers including lack of prostate cancer risk awareness or stigma, the suppressive effects of estrogen on prostate cancer development, or prostate cancers being missed in transgender women because of misinterpretation of ‘normal’ PSA levels among those receiving gender-affirming hormone therapies.”
In the presentation, Nik-Ahd said, “PSA density, which is a marker of prostate cancer aggressiveness, was highest in transgender women who were actively on estrogen.”
She noted, “the existing thyrotropin reference ranges, which is what we use to interpret PSA values, are all based on data from cisgender men.” The ranges would be expected to be far lower in transgender women who are taking estrogen, potentially throwing off screening tests, she said, and “ultimately missing clinically significant prostate cancer.”
In the larger picture, there are no specific guidelines about PSA screening in transgender women, she said.
A recent study published in JAMA by Nik-Ahd and colleagues examined PSA levels in 210 transgender women (mean age 60 years) treated within the VHA from 2000 to 2023. All were aged 40 to 80 years, had received estrogen for at least 6 months (mean duration 4.7 years), and didn’t have prostate cancer diagnoses.
“Median (IQR) PSA was 0.02 (0-0.2) ng/mL and the 95th percentile value was 0.6 ng/mL,” the report found. “PSAs were undetectable in 36% of patients (23% and 49% of PSAs in patients without and with orchiectomy, respectively).”
The researchers write that “the historic cut point of 4 ng/mL, often used as a threshold for further evaluation, is likely far too high a threshold for this population.”
Nik-Ahd noted, “clinicians should interpret PSA values in transgender women on estrogen with extreme caution. In this population, normal might actually not be normal, and a value that is considered normal might be very abnormal for somebody who is on estrogen. If you're unsure of whether a PSA value is appropriate for a transgender woman on estrogen, refer that patient to a urologist so they can undergo further evaluation.”
Farnoosh Nik-Ahd discloses consulting for Janssen.
The OCTAGON Project: A Novel VA-Based Telehealth Intervention for Oral Chemotherapy Monitoring
Background
Many Veterans with cancer experience substantial side effects related to their chemotherapy treatments resulting in impaired quality of life. Prompt management of such symptoms can improve adherence to therapy and potentially clinical outcomes. Previous studies in cancer patients have shown that mobile apps can improve symptom management and quality of life, though there are limited studies using oncology-focused apps in the VA population. The VA Annie App is an optimal platform for Veterans since it relies primarily on SMS-based texting and not on internet capabilities. This would address several well-known barriers to Veterans’ care access (limited internet connectivity, transportation) and enhance symptom reporting between infrequent provider visits. Providers can securely collect app responses within the VA system and there is already considerable VA developer experience with designing complex protocols. The OCTAGON project (Optimizing Cancer Care with Telehealth Assessment for Goal-Oriented Needs) will have the following goals: 1) To develop Annie App protocols to assist in management of cancer and/or chemotherapy-related symptoms (OCTAGON intervention), 2) To examine initial acceptability, feasibility, and Veteran-reported outcomes, 3) To explore short term effects on the utilization of VA encounters.
Methods
All patients who are primarily being managed at the VA Ann Arbor for their cancer therapy and are receiving one of the following therapies are considered eligible: EGFR inhibitors (lung cancer), antiandrogen therapies (prostate cancer), BTK inhibitors (lymphoma).
Discussion
Drug-specific protocols will be developed in conjunction with clinical pharmacists with experience in outpatient oral chemotherapy toxicity monitoring. Questions will have either a Yes/No, or numerical response. Interventions will be administered weekly for the first 3 months after enrollment, then decrease to monthly for a total of 6 months on protocol. Patients will be directed to contact their providers with any significant changes in tolerability. Planned data collected will include intervention question responses, adverse events, demographics, diagnosis, disease response, hospitalizations, treatment dose reductions or interruptions, provider and staff utilization. Survey responses to assess treatment acceptability (Treatment Acceptability/Adherence Scale), usability (System Usability Scale), general health (PROMIS-GH), and patient satisfaction will also be collected. Funding: VA Telehealth Research and Innovation for Veterans with Cancer (THRIVE).
Background
Many Veterans with cancer experience substantial side effects related to their chemotherapy treatments resulting in impaired quality of life. Prompt management of such symptoms can improve adherence to therapy and potentially clinical outcomes. Previous studies in cancer patients have shown that mobile apps can improve symptom management and quality of life, though there are limited studies using oncology-focused apps in the VA population. The VA Annie App is an optimal platform for Veterans since it relies primarily on SMS-based texting and not on internet capabilities. This would address several well-known barriers to Veterans’ care access (limited internet connectivity, transportation) and enhance symptom reporting between infrequent provider visits. Providers can securely collect app responses within the VA system and there is already considerable VA developer experience with designing complex protocols. The OCTAGON project (Optimizing Cancer Care with Telehealth Assessment for Goal-Oriented Needs) will have the following goals: 1) To develop Annie App protocols to assist in management of cancer and/or chemotherapy-related symptoms (OCTAGON intervention), 2) To examine initial acceptability, feasibility, and Veteran-reported outcomes, 3) To explore short term effects on the utilization of VA encounters.
Methods
All patients who are primarily being managed at the VA Ann Arbor for their cancer therapy and are receiving one of the following therapies are considered eligible: EGFR inhibitors (lung cancer), antiandrogen therapies (prostate cancer), BTK inhibitors (lymphoma).
Discussion
Drug-specific protocols will be developed in conjunction with clinical pharmacists with experience in outpatient oral chemotherapy toxicity monitoring. Questions will have either a Yes/No, or numerical response. Interventions will be administered weekly for the first 3 months after enrollment, then decrease to monthly for a total of 6 months on protocol. Patients will be directed to contact their providers with any significant changes in tolerability. Planned data collected will include intervention question responses, adverse events, demographics, diagnosis, disease response, hospitalizations, treatment dose reductions or interruptions, provider and staff utilization. Survey responses to assess treatment acceptability (Treatment Acceptability/Adherence Scale), usability (System Usability Scale), general health (PROMIS-GH), and patient satisfaction will also be collected. Funding: VA Telehealth Research and Innovation for Veterans with Cancer (THRIVE).
Background
Many Veterans with cancer experience substantial side effects related to their chemotherapy treatments resulting in impaired quality of life. Prompt management of such symptoms can improve adherence to therapy and potentially clinical outcomes. Previous studies in cancer patients have shown that mobile apps can improve symptom management and quality of life, though there are limited studies using oncology-focused apps in the VA population. The VA Annie App is an optimal platform for Veterans since it relies primarily on SMS-based texting and not on internet capabilities. This would address several well-known barriers to Veterans’ care access (limited internet connectivity, transportation) and enhance symptom reporting between infrequent provider visits. Providers can securely collect app responses within the VA system and there is already considerable VA developer experience with designing complex protocols. The OCTAGON project (Optimizing Cancer Care with Telehealth Assessment for Goal-Oriented Needs) will have the following goals: 1) To develop Annie App protocols to assist in management of cancer and/or chemotherapy-related symptoms (OCTAGON intervention), 2) To examine initial acceptability, feasibility, and Veteran-reported outcomes, 3) To explore short term effects on the utilization of VA encounters.
Methods
All patients who are primarily being managed at the VA Ann Arbor for their cancer therapy and are receiving one of the following therapies are considered eligible: EGFR inhibitors (lung cancer), antiandrogen therapies (prostate cancer), BTK inhibitors (lymphoma).
Discussion
Drug-specific protocols will be developed in conjunction with clinical pharmacists with experience in outpatient oral chemotherapy toxicity monitoring. Questions will have either a Yes/No, or numerical response. Interventions will be administered weekly for the first 3 months after enrollment, then decrease to monthly for a total of 6 months on protocol. Patients will be directed to contact their providers with any significant changes in tolerability. Planned data collected will include intervention question responses, adverse events, demographics, diagnosis, disease response, hospitalizations, treatment dose reductions or interruptions, provider and staff utilization. Survey responses to assess treatment acceptability (Treatment Acceptability/Adherence Scale), usability (System Usability Scale), general health (PROMIS-GH), and patient satisfaction will also be collected. Funding: VA Telehealth Research and Innovation for Veterans with Cancer (THRIVE).
Whole Health Oncology—Just Do It: Making Whole Person Cancer Care Routine and Regular at the Dayton VA Medical Center (DVAMC)
Background
VA Whole Health (WH) is an approach that empowers and equips people to take charge of their health and well-being. In 2020, 18 WH Flagship sites demonstrated reduced opiate use and smaller increases in pharmacy costs as well as favorable veteran self-reported measures. VA mandated WH integration into mental health and primary care. Purose: To incorporate WH within Dayton VA cancer care, using the Personal Health Inventory (PHI) as an intake tool, a tumor-agnostic WH oncology clinic was established.
Methods
Led by an oncologist, a referral-based clinic opened in 2021. Pre-work included EHR items (stop codes/templates), staff training and leverage of mental health integration. VA’s generic PHI was utilized until an oncology-specific PHI was developed by leaders in the field.(3-5) Clinic data was tracked.
Results
170 visits offered (June 2021-May 2024). 32 referrals received (one without cancer; deaths: two pre-intake/five post-intake); 70 appointments occurred among 30 veterans (30 intake/40 follow-up) for 41% fill rate (up 5% from 1st six months). 96% PHI completion rate. Referral sources: fellows (43%), attendings (17%), PCP (3%), Survivorship Clinic (3%), self-referral (33%)--40% of these from cancer support group members. Cancer types (one dual-diagnosis; total >100%): 24% breast, 17% prostate, 17% NSCLC, 10% NHL, 10% pancreatic, 7% Head/Neck, 7% SCLC, 3% each colon/esophageal/kidney. Cancer Stages represented: I (10%), II (20%), III (23%) and IV (47%). Participant info: Age range (36-85); 69% male and 31% female with 86% on active cancer therapy (hormonal, immune-, chemo- or chemoradiation). Supplements were discussed at 26% of visits and referrals ordered at 27% (4-massage therapy, 1-acupuncture, 1-chiropractic, 2-health coaching, 1-cardiology, 1-lymphedema therapy, 1-social work, 1-survivorship clinic, 1-yoga, 1-diabetes education, 1-ENT, 1-nutrition, 1-pathology, 1-pulmonary, 1-prosthetics).
Conclusions
WH within cancer care is feasible for veterans on active treatment (all types/stages) and at a non-Flagship/unfunded site. Veterans gain introduction to WH through the PHI and Complementary-Integrative Health referrals (VA Directive 1137). Cancer support group attendance prompts WH clinic self-referrals. Next steps at DVAMC are to offer mind-body approaches such as virtual reality experiences in the infusion room and VA CALM sessions via asynchronous online delivery; funding would support WH evolution in oncology.
Background
VA Whole Health (WH) is an approach that empowers and equips people to take charge of their health and well-being. In 2020, 18 WH Flagship sites demonstrated reduced opiate use and smaller increases in pharmacy costs as well as favorable veteran self-reported measures. VA mandated WH integration into mental health and primary care. Purose: To incorporate WH within Dayton VA cancer care, using the Personal Health Inventory (PHI) as an intake tool, a tumor-agnostic WH oncology clinic was established.
Methods
Led by an oncologist, a referral-based clinic opened in 2021. Pre-work included EHR items (stop codes/templates), staff training and leverage of mental health integration. VA’s generic PHI was utilized until an oncology-specific PHI was developed by leaders in the field.(3-5) Clinic data was tracked.
Results
170 visits offered (June 2021-May 2024). 32 referrals received (one without cancer; deaths: two pre-intake/five post-intake); 70 appointments occurred among 30 veterans (30 intake/40 follow-up) for 41% fill rate (up 5% from 1st six months). 96% PHI completion rate. Referral sources: fellows (43%), attendings (17%), PCP (3%), Survivorship Clinic (3%), self-referral (33%)--40% of these from cancer support group members. Cancer types (one dual-diagnosis; total >100%): 24% breast, 17% prostate, 17% NSCLC, 10% NHL, 10% pancreatic, 7% Head/Neck, 7% SCLC, 3% each colon/esophageal/kidney. Cancer Stages represented: I (10%), II (20%), III (23%) and IV (47%). Participant info: Age range (36-85); 69% male and 31% female with 86% on active cancer therapy (hormonal, immune-, chemo- or chemoradiation). Supplements were discussed at 26% of visits and referrals ordered at 27% (4-massage therapy, 1-acupuncture, 1-chiropractic, 2-health coaching, 1-cardiology, 1-lymphedema therapy, 1-social work, 1-survivorship clinic, 1-yoga, 1-diabetes education, 1-ENT, 1-nutrition, 1-pathology, 1-pulmonary, 1-prosthetics).
Conclusions
WH within cancer care is feasible for veterans on active treatment (all types/stages) and at a non-Flagship/unfunded site. Veterans gain introduction to WH through the PHI and Complementary-Integrative Health referrals (VA Directive 1137). Cancer support group attendance prompts WH clinic self-referrals. Next steps at DVAMC are to offer mind-body approaches such as virtual reality experiences in the infusion room and VA CALM sessions via asynchronous online delivery; funding would support WH evolution in oncology.
Background
VA Whole Health (WH) is an approach that empowers and equips people to take charge of their health and well-being. In 2020, 18 WH Flagship sites demonstrated reduced opiate use and smaller increases in pharmacy costs as well as favorable veteran self-reported measures. VA mandated WH integration into mental health and primary care. Purose: To incorporate WH within Dayton VA cancer care, using the Personal Health Inventory (PHI) as an intake tool, a tumor-agnostic WH oncology clinic was established.
Methods
Led by an oncologist, a referral-based clinic opened in 2021. Pre-work included EHR items (stop codes/templates), staff training and leverage of mental health integration. VA’s generic PHI was utilized until an oncology-specific PHI was developed by leaders in the field.(3-5) Clinic data was tracked.
Results
170 visits offered (June 2021-May 2024). 32 referrals received (one without cancer; deaths: two pre-intake/five post-intake); 70 appointments occurred among 30 veterans (30 intake/40 follow-up) for 41% fill rate (up 5% from 1st six months). 96% PHI completion rate. Referral sources: fellows (43%), attendings (17%), PCP (3%), Survivorship Clinic (3%), self-referral (33%)--40% of these from cancer support group members. Cancer types (one dual-diagnosis; total >100%): 24% breast, 17% prostate, 17% NSCLC, 10% NHL, 10% pancreatic, 7% Head/Neck, 7% SCLC, 3% each colon/esophageal/kidney. Cancer Stages represented: I (10%), II (20%), III (23%) and IV (47%). Participant info: Age range (36-85); 69% male and 31% female with 86% on active cancer therapy (hormonal, immune-, chemo- or chemoradiation). Supplements were discussed at 26% of visits and referrals ordered at 27% (4-massage therapy, 1-acupuncture, 1-chiropractic, 2-health coaching, 1-cardiology, 1-lymphedema therapy, 1-social work, 1-survivorship clinic, 1-yoga, 1-diabetes education, 1-ENT, 1-nutrition, 1-pathology, 1-pulmonary, 1-prosthetics).
Conclusions
WH within cancer care is feasible for veterans on active treatment (all types/stages) and at a non-Flagship/unfunded site. Veterans gain introduction to WH through the PHI and Complementary-Integrative Health referrals (VA Directive 1137). Cancer support group attendance prompts WH clinic self-referrals. Next steps at DVAMC are to offer mind-body approaches such as virtual reality experiences in the infusion room and VA CALM sessions via asynchronous online delivery; funding would support WH evolution in oncology.
A Phase II Study With Androgen Deprivation Therapy and Up-Front Radiotherapy in High-Intermediate and High-Risk Prostate Cancer With Stereotactic Body Radiation Therapy to Pelvic Nodes and Concomitant Prostate Boost by Simultaneous Integrated Boost
Background
The adoption of Stereotactic Body Radiation Therapy (SBRT) for prostate cancer has allowed treatment to be completed in less than 2 weeks, but has predominantly been given to the prostate only. Currently, very few prospective studies have compared delivery of SBRT versus hypofractionated radiotherapy (HFX) when giving concurrent pelvic radiation. The aim of the study is to evaluate the tolerance and efficacy of pelvic node radiotherapy and SIB to the prostate in prostate patients requiring nodal irradiation.
Methods
A total of 58 patients were irradiated with SBRT and initiated ADT therapy between 2014 and 2023. 57 patients were treated with 7.5 Gy to the prostate and 1 to 7.25 Gy. All patients were treated with 5 Gy x 5 fraction to the pelvis. This group was compared to a preselected historical cohort of 65 HFX patients with 57 of these patients treated with 67.5/50 Gy in 25 fractions, 1 with patient 67.5/45 Gy in 25 fractions, and 6 patients with 60/44-46 Gy in 20 fractions. Patients were evaluated for GU and GI toxicities according to Radiation Therapy Oncology Group Toxicity criteria at one year post radiation therapy.
Results
There were 31 grade 0 (53.4%), 1 grade 1 (1.7%), 25 grade 2 (43.1%), 1 grade 3 (1.7%) events in the SBRT group and 29 GU grade 0 (44.6%), 3 grade 1 (4.6%), and 33 grade 2 (50.8%) GU toxicities in the HFX group with no significant difference between the groups (p=0.464). There were 55 grade 0 (94.8%), 1 grade 1 (1.7%), and 2 grade 2 (3.4%) GI toxicities in the SBRT group and 59 grade 0 (90.8%), 1 grade 1 (1.5%), and 5 grade 2 (7.7%) events in the HFX group with no significant difference between the groups (p=0.381).
Conclusions
This prospective study provides data to support the use of concurrent pelvic radiation with SBRT to the prostate. Our findings suggest there is no difference in toxicity between HFX and 25 Gy pelvic radiation (5 Gy/5 fractions) concurrent with SBRT to the prostate, therefore it appears to be a safe and convenient option for veterans with prostate cancer.
Background
The adoption of Stereotactic Body Radiation Therapy (SBRT) for prostate cancer has allowed treatment to be completed in less than 2 weeks, but has predominantly been given to the prostate only. Currently, very few prospective studies have compared delivery of SBRT versus hypofractionated radiotherapy (HFX) when giving concurrent pelvic radiation. The aim of the study is to evaluate the tolerance and efficacy of pelvic node radiotherapy and SIB to the prostate in prostate patients requiring nodal irradiation.
Methods
A total of 58 patients were irradiated with SBRT and initiated ADT therapy between 2014 and 2023. 57 patients were treated with 7.5 Gy to the prostate and 1 to 7.25 Gy. All patients were treated with 5 Gy x 5 fraction to the pelvis. This group was compared to a preselected historical cohort of 65 HFX patients with 57 of these patients treated with 67.5/50 Gy in 25 fractions, 1 with patient 67.5/45 Gy in 25 fractions, and 6 patients with 60/44-46 Gy in 20 fractions. Patients were evaluated for GU and GI toxicities according to Radiation Therapy Oncology Group Toxicity criteria at one year post radiation therapy.
Results
There were 31 grade 0 (53.4%), 1 grade 1 (1.7%), 25 grade 2 (43.1%), 1 grade 3 (1.7%) events in the SBRT group and 29 GU grade 0 (44.6%), 3 grade 1 (4.6%), and 33 grade 2 (50.8%) GU toxicities in the HFX group with no significant difference between the groups (p=0.464). There were 55 grade 0 (94.8%), 1 grade 1 (1.7%), and 2 grade 2 (3.4%) GI toxicities in the SBRT group and 59 grade 0 (90.8%), 1 grade 1 (1.5%), and 5 grade 2 (7.7%) events in the HFX group with no significant difference between the groups (p=0.381).
Conclusions
This prospective study provides data to support the use of concurrent pelvic radiation with SBRT to the prostate. Our findings suggest there is no difference in toxicity between HFX and 25 Gy pelvic radiation (5 Gy/5 fractions) concurrent with SBRT to the prostate, therefore it appears to be a safe and convenient option for veterans with prostate cancer.
Background
The adoption of Stereotactic Body Radiation Therapy (SBRT) for prostate cancer has allowed treatment to be completed in less than 2 weeks, but has predominantly been given to the prostate only. Currently, very few prospective studies have compared delivery of SBRT versus hypofractionated radiotherapy (HFX) when giving concurrent pelvic radiation. The aim of the study is to evaluate the tolerance and efficacy of pelvic node radiotherapy and SIB to the prostate in prostate patients requiring nodal irradiation.
Methods
A total of 58 patients were irradiated with SBRT and initiated ADT therapy between 2014 and 2023. 57 patients were treated with 7.5 Gy to the prostate and 1 to 7.25 Gy. All patients were treated with 5 Gy x 5 fraction to the pelvis. This group was compared to a preselected historical cohort of 65 HFX patients with 57 of these patients treated with 67.5/50 Gy in 25 fractions, 1 with patient 67.5/45 Gy in 25 fractions, and 6 patients with 60/44-46 Gy in 20 fractions. Patients were evaluated for GU and GI toxicities according to Radiation Therapy Oncology Group Toxicity criteria at one year post radiation therapy.
Results
There were 31 grade 0 (53.4%), 1 grade 1 (1.7%), 25 grade 2 (43.1%), 1 grade 3 (1.7%) events in the SBRT group and 29 GU grade 0 (44.6%), 3 grade 1 (4.6%), and 33 grade 2 (50.8%) GU toxicities in the HFX group with no significant difference between the groups (p=0.464). There were 55 grade 0 (94.8%), 1 grade 1 (1.7%), and 2 grade 2 (3.4%) GI toxicities in the SBRT group and 59 grade 0 (90.8%), 1 grade 1 (1.5%), and 5 grade 2 (7.7%) events in the HFX group with no significant difference between the groups (p=0.381).
Conclusions
This prospective study provides data to support the use of concurrent pelvic radiation with SBRT to the prostate. Our findings suggest there is no difference in toxicity between HFX and 25 Gy pelvic radiation (5 Gy/5 fractions) concurrent with SBRT to the prostate, therefore it appears to be a safe and convenient option for veterans with prostate cancer.
Do We Need More Screen Time? Patterns of Telehealth Utilization for Patients With Prostate Cancer in the Veterans Health Administration (VHA)
Background
Prostate cancer is the most common cancer in the VHA. Telehealth use has increased and has the potential to improve access for patients. We examined patterns of care for VHA patients with prostate cancer, including whether visits were in person, by telephone or by video.
Methods
Using the VHA Corporate Data Warehouse, we extracted data on all incident cases of prostate cancer from 1/1/2016-1/31/2023 with sufficient information (Gleason score, prostate-specific antigen [PSA], and tumor stage) to categorize into National Comprehensive Cancer Network (NCCN) risk strata. We excluded patients who died within 1 year of diagnosis and those with no evidence of PSA testing, prostate biopsy or treatment within 2 years. We categorized all outpatient visits related to a person’s Urology- and Medical Oncology based care – including the visit modality – based on administrative visit stop codes. We defined ‘during COVID’ as visits after 3/11/2020. We calculated the percent of visits performed by modality in each year after diagnosis.
Results
Among the 60,381 men with prostate cancer, 61% were White, 33% Black; 5% Hispanic; 32% rural. For NCCN category, 30% had high risk prostate cancer, which increased with age, 50% had intermediate risk and 20% had low risk. Prior to COVID, for visits to Urology within the first year after diagnosis, 79% were in person, 20% were by telephone and 0.1% were by video. Visits to Oncology within the first year after diagnosis were similar—82% in person, 16% by phone and 0.3% by video.
Discussion
During the COVID period, video visits increased significantly but remained a small proportion, accounting for only 2% of visits for both Urology and Oncology. Video visits increased during the COVID-19 pandemic but remained rare. Across many diseases and conditions, the quality of care for video visits has been at least as good as for in-person care.
Conclusions
There is a missed opportunity to provide care by video within VHA for patients with prostate cancer, particularly given that about 1/3 of patients are from rural areas. Future analyses will examine barriers to video telehealth and the impact of video visits on quality and equity of prostate cancer care.
Background
Prostate cancer is the most common cancer in the VHA. Telehealth use has increased and has the potential to improve access for patients. We examined patterns of care for VHA patients with prostate cancer, including whether visits were in person, by telephone or by video.
Methods
Using the VHA Corporate Data Warehouse, we extracted data on all incident cases of prostate cancer from 1/1/2016-1/31/2023 with sufficient information (Gleason score, prostate-specific antigen [PSA], and tumor stage) to categorize into National Comprehensive Cancer Network (NCCN) risk strata. We excluded patients who died within 1 year of diagnosis and those with no evidence of PSA testing, prostate biopsy or treatment within 2 years. We categorized all outpatient visits related to a person’s Urology- and Medical Oncology based care – including the visit modality – based on administrative visit stop codes. We defined ‘during COVID’ as visits after 3/11/2020. We calculated the percent of visits performed by modality in each year after diagnosis.
Results
Among the 60,381 men with prostate cancer, 61% were White, 33% Black; 5% Hispanic; 32% rural. For NCCN category, 30% had high risk prostate cancer, which increased with age, 50% had intermediate risk and 20% had low risk. Prior to COVID, for visits to Urology within the first year after diagnosis, 79% were in person, 20% were by telephone and 0.1% were by video. Visits to Oncology within the first year after diagnosis were similar—82% in person, 16% by phone and 0.3% by video.
Discussion
During the COVID period, video visits increased significantly but remained a small proportion, accounting for only 2% of visits for both Urology and Oncology. Video visits increased during the COVID-19 pandemic but remained rare. Across many diseases and conditions, the quality of care for video visits has been at least as good as for in-person care.
Conclusions
There is a missed opportunity to provide care by video within VHA for patients with prostate cancer, particularly given that about 1/3 of patients are from rural areas. Future analyses will examine barriers to video telehealth and the impact of video visits on quality and equity of prostate cancer care.
Background
Prostate cancer is the most common cancer in the VHA. Telehealth use has increased and has the potential to improve access for patients. We examined patterns of care for VHA patients with prostate cancer, including whether visits were in person, by telephone or by video.
Methods
Using the VHA Corporate Data Warehouse, we extracted data on all incident cases of prostate cancer from 1/1/2016-1/31/2023 with sufficient information (Gleason score, prostate-specific antigen [PSA], and tumor stage) to categorize into National Comprehensive Cancer Network (NCCN) risk strata. We excluded patients who died within 1 year of diagnosis and those with no evidence of PSA testing, prostate biopsy or treatment within 2 years. We categorized all outpatient visits related to a person’s Urology- and Medical Oncology based care – including the visit modality – based on administrative visit stop codes. We defined ‘during COVID’ as visits after 3/11/2020. We calculated the percent of visits performed by modality in each year after diagnosis.
Results
Among the 60,381 men with prostate cancer, 61% were White, 33% Black; 5% Hispanic; 32% rural. For NCCN category, 30% had high risk prostate cancer, which increased with age, 50% had intermediate risk and 20% had low risk. Prior to COVID, for visits to Urology within the first year after diagnosis, 79% were in person, 20% were by telephone and 0.1% were by video. Visits to Oncology within the first year after diagnosis were similar—82% in person, 16% by phone and 0.3% by video.
Discussion
During the COVID period, video visits increased significantly but remained a small proportion, accounting for only 2% of visits for both Urology and Oncology. Video visits increased during the COVID-19 pandemic but remained rare. Across many diseases and conditions, the quality of care for video visits has been at least as good as for in-person care.
Conclusions
There is a missed opportunity to provide care by video within VHA for patients with prostate cancer, particularly given that about 1/3 of patients are from rural areas. Future analyses will examine barriers to video telehealth and the impact of video visits on quality and equity of prostate cancer care.
Metastatic Prostate Cancer Presenting as Pleural and Pericardial Metastases: A Case Report and Literature Review
Background
Metastatic prostate cancer typically manifests with metastases to the lungs, bones, and adrenal glands. Here, we report a unique case where the initial presentation involved pleural nodules, subsequently leading to the discovery of pleural and pericardial metastases.
Case Presentation
Our patient, a 73-year-old male with a history of active tobacco use disorder, COPD, and right shoulder melanoma (2004), initially presented to his primary care physician for a routine visit. Following a Low Dose Chest CT scan (LDCT), numerous new pleural nodules were identified. Physical examination revealed small nevi and skin tags, but no malignant characteristics. Initial concerns centered on the potential recurrence of malignant melanoma with pleural metastases or an inflammatory condition. Subsequent PET scan results raised significant suspicion of malignancy. PSA was 2.41. Pleuroscopy biopsies revealed invasive nonsmall cell carcinoma, positive for NKX31 and MOC31, but negative for S100, PSA, and synaptophysin. This pattern strongly suggests metastatic prostate cancer despite the absence of PSA staining. (Stage IV B: cTxcN1cM1c). A subsequent PSMA PET highlighted extensive metastatic involvement in the pericardium, posterior and mediastinal pleura, mediastinum, and ribs. Treatment commenced with Degarelix followed by the standard regimen of Docetaxel, Abiraterone, and prednisone. Genetic counseling and palliative care services were additionally recommended.
Discussion
Prostate cancer typically spreads to bones, lungs, liver, and adrenal glands. Rarely, it appears in sites like pericardium and pleura. Pleural metastases are usually found postmortem; clinical diagnosis is rare. Pericardial metastases are exceptionally uncommon, with few documented cases. The precise mechanism of metastatic dissemination remains uncertain, with theories suggesting spread through the vertebral-venous plexus or via the vena cava to distant organs. Treatment approaches vary based on symptomatic effusions, ranging from pericardiocentesis, thoracocentesis to chemotherapy, radiotherapy, and hormone therapy. Studies have shown systemic docetaxel to be effective in managing pleural and pericardial symptoms. Despite their rarity, healthcare providers should consider these possibilities when encountering pleural thickening or pericardial abnormalities on imaging studies.
Conclusions
Pleural and pericardial metastases represent uncommon occurrences in prostate cancer. Continued research efforts can facilitate early detection of metastatic disease, enabling more effective and precisely targeted management strategies when symptoms manifest.
Background
Metastatic prostate cancer typically manifests with metastases to the lungs, bones, and adrenal glands. Here, we report a unique case where the initial presentation involved pleural nodules, subsequently leading to the discovery of pleural and pericardial metastases.
Case Presentation
Our patient, a 73-year-old male with a history of active tobacco use disorder, COPD, and right shoulder melanoma (2004), initially presented to his primary care physician for a routine visit. Following a Low Dose Chest CT scan (LDCT), numerous new pleural nodules were identified. Physical examination revealed small nevi and skin tags, but no malignant characteristics. Initial concerns centered on the potential recurrence of malignant melanoma with pleural metastases or an inflammatory condition. Subsequent PET scan results raised significant suspicion of malignancy. PSA was 2.41. Pleuroscopy biopsies revealed invasive nonsmall cell carcinoma, positive for NKX31 and MOC31, but negative for S100, PSA, and synaptophysin. This pattern strongly suggests metastatic prostate cancer despite the absence of PSA staining. (Stage IV B: cTxcN1cM1c). A subsequent PSMA PET highlighted extensive metastatic involvement in the pericardium, posterior and mediastinal pleura, mediastinum, and ribs. Treatment commenced with Degarelix followed by the standard regimen of Docetaxel, Abiraterone, and prednisone. Genetic counseling and palliative care services were additionally recommended.
Discussion
Prostate cancer typically spreads to bones, lungs, liver, and adrenal glands. Rarely, it appears in sites like pericardium and pleura. Pleural metastases are usually found postmortem; clinical diagnosis is rare. Pericardial metastases are exceptionally uncommon, with few documented cases. The precise mechanism of metastatic dissemination remains uncertain, with theories suggesting spread through the vertebral-venous plexus or via the vena cava to distant organs. Treatment approaches vary based on symptomatic effusions, ranging from pericardiocentesis, thoracocentesis to chemotherapy, radiotherapy, and hormone therapy. Studies have shown systemic docetaxel to be effective in managing pleural and pericardial symptoms. Despite their rarity, healthcare providers should consider these possibilities when encountering pleural thickening or pericardial abnormalities on imaging studies.
Conclusions
Pleural and pericardial metastases represent uncommon occurrences in prostate cancer. Continued research efforts can facilitate early detection of metastatic disease, enabling more effective and precisely targeted management strategies when symptoms manifest.
Background
Metastatic prostate cancer typically manifests with metastases to the lungs, bones, and adrenal glands. Here, we report a unique case where the initial presentation involved pleural nodules, subsequently leading to the discovery of pleural and pericardial metastases.
Case Presentation
Our patient, a 73-year-old male with a history of active tobacco use disorder, COPD, and right shoulder melanoma (2004), initially presented to his primary care physician for a routine visit. Following a Low Dose Chest CT scan (LDCT), numerous new pleural nodules were identified. Physical examination revealed small nevi and skin tags, but no malignant characteristics. Initial concerns centered on the potential recurrence of malignant melanoma with pleural metastases or an inflammatory condition. Subsequent PET scan results raised significant suspicion of malignancy. PSA was 2.41. Pleuroscopy biopsies revealed invasive nonsmall cell carcinoma, positive for NKX31 and MOC31, but negative for S100, PSA, and synaptophysin. This pattern strongly suggests metastatic prostate cancer despite the absence of PSA staining. (Stage IV B: cTxcN1cM1c). A subsequent PSMA PET highlighted extensive metastatic involvement in the pericardium, posterior and mediastinal pleura, mediastinum, and ribs. Treatment commenced with Degarelix followed by the standard regimen of Docetaxel, Abiraterone, and prednisone. Genetic counseling and palliative care services were additionally recommended.
Discussion
Prostate cancer typically spreads to bones, lungs, liver, and adrenal glands. Rarely, it appears in sites like pericardium and pleura. Pleural metastases are usually found postmortem; clinical diagnosis is rare. Pericardial metastases are exceptionally uncommon, with few documented cases. The precise mechanism of metastatic dissemination remains uncertain, with theories suggesting spread through the vertebral-venous plexus or via the vena cava to distant organs. Treatment approaches vary based on symptomatic effusions, ranging from pericardiocentesis, thoracocentesis to chemotherapy, radiotherapy, and hormone therapy. Studies have shown systemic docetaxel to be effective in managing pleural and pericardial symptoms. Despite their rarity, healthcare providers should consider these possibilities when encountering pleural thickening or pericardial abnormalities on imaging studies.
Conclusions
Pleural and pericardial metastases represent uncommon occurrences in prostate cancer. Continued research efforts can facilitate early detection of metastatic disease, enabling more effective and precisely targeted management strategies when symptoms manifest.
Creating a Urology Prostate Cancer Note, a National Oncology and Surgery Office Collaboration for Prostate Cancer Clinical Pathway Utilization
Background
Prostate cancer is the most common non-cutaneous malignancy diagnosis within the Department of Veterans Affairs (VA). The Prostate Cancer Clinical Pathways (PCCP) were developed to enable providers to treat all Veterans with prostate cancer at subject matter expert level.
Discussion
The PCCP was launched in February 2021; however, provider documentation of PCCP is variable across the VA healthcare system and within the PCCP, specific flow maps have differential use. For example, the Very Low Risk flow map has seven unique Veterans entered, whereas the Molecular Testing flow map has over 3,900 unique Veterans entered. One clear reason for this disparity in pathway documentation use is that local prostate cancer is managed by urology and their documentation of the PCCP is not as widespread as the medical oncologists. The National Oncology Program developed clinical note templates to document PCCP that medical oncologist use which has increased utilization. To increase urology specific flow map use, a collaboration between the National Surgery Office and National Oncology Program was established to develop a Urology Prostate Cancer Note (UPCN). The UPCN was designed by urologists with assistance from a medical oncologist and a clinical applications coordinator. The UPCN will function as a working clinical note for urologists and has the PCCPs embedded into reminder dialog templates, which when completed generate health factors. The health factors that are generated from the UPCN are data mined to record PCCP use and to perform data analytics. The UPCN is in the testing phase at three pilot test sites and is scheduled to be deployed summer 2024. The collaborative effort is aligned with the VHA directives outlined in the Cleland Dole Act.
Background
Prostate cancer is the most common non-cutaneous malignancy diagnosis within the Department of Veterans Affairs (VA). The Prostate Cancer Clinical Pathways (PCCP) were developed to enable providers to treat all Veterans with prostate cancer at subject matter expert level.
Discussion
The PCCP was launched in February 2021; however, provider documentation of PCCP is variable across the VA healthcare system and within the PCCP, specific flow maps have differential use. For example, the Very Low Risk flow map has seven unique Veterans entered, whereas the Molecular Testing flow map has over 3,900 unique Veterans entered. One clear reason for this disparity in pathway documentation use is that local prostate cancer is managed by urology and their documentation of the PCCP is not as widespread as the medical oncologists. The National Oncology Program developed clinical note templates to document PCCP that medical oncologist use which has increased utilization. To increase urology specific flow map use, a collaboration between the National Surgery Office and National Oncology Program was established to develop a Urology Prostate Cancer Note (UPCN). The UPCN was designed by urologists with assistance from a medical oncologist and a clinical applications coordinator. The UPCN will function as a working clinical note for urologists and has the PCCPs embedded into reminder dialog templates, which when completed generate health factors. The health factors that are generated from the UPCN are data mined to record PCCP use and to perform data analytics. The UPCN is in the testing phase at three pilot test sites and is scheduled to be deployed summer 2024. The collaborative effort is aligned with the VHA directives outlined in the Cleland Dole Act.
Background
Prostate cancer is the most common non-cutaneous malignancy diagnosis within the Department of Veterans Affairs (VA). The Prostate Cancer Clinical Pathways (PCCP) were developed to enable providers to treat all Veterans with prostate cancer at subject matter expert level.
Discussion
The PCCP was launched in February 2021; however, provider documentation of PCCP is variable across the VA healthcare system and within the PCCP, specific flow maps have differential use. For example, the Very Low Risk flow map has seven unique Veterans entered, whereas the Molecular Testing flow map has over 3,900 unique Veterans entered. One clear reason for this disparity in pathway documentation use is that local prostate cancer is managed by urology and their documentation of the PCCP is not as widespread as the medical oncologists. The National Oncology Program developed clinical note templates to document PCCP that medical oncologist use which has increased utilization. To increase urology specific flow map use, a collaboration between the National Surgery Office and National Oncology Program was established to develop a Urology Prostate Cancer Note (UPCN). The UPCN was designed by urologists with assistance from a medical oncologist and a clinical applications coordinator. The UPCN will function as a working clinical note for urologists and has the PCCPs embedded into reminder dialog templates, which when completed generate health factors. The health factors that are generated from the UPCN are data mined to record PCCP use and to perform data analytics. The UPCN is in the testing phase at three pilot test sites and is scheduled to be deployed summer 2024. The collaborative effort is aligned with the VHA directives outlined in the Cleland Dole Act.
Impact of Stewardship Assistance Pilot Program for Veterans on Adherence and Persistence to Oral mCRPC Therapies
Background
Given the poor prognosis of patients with metastatic castration-resistant prostate cancer (mCRPC), interventions aimed at increasing adherence to oral treatments have the potential to improve patient outcomes. This study evaluates the impact of a patient stewardship assistance pilot program (stewardship program) on the adherence and persistence to oral treatments among patients with mCRPC at VA medical centers (VAMCs).
Methods
A non-randomized controlled study design and data from the VA Corporate Data Warehouse were used. The study included patients treated with an oral mCRPC therapy (i.e., abiraterone acetate or enzalutamide) between 08/2018 and 12/2019. Patients participating in the stewardship program formed the intervention arm and patients not participating the controls. Control patients were selected and matched 1:3 based on age, race and index year. The index date was the date of initiation of abiraterone acetate or enzalutamide. Outcomes included persistence (no gap >60 days of supply) and adherence (proportion of days covered [PDC] ≥80%) to oral mCRPC treatment post-index. Persistence and adherence were compared between the two arms using a Cox proportional hazard model and logistic regression model, respectively, adjusted for baseline characteristics.
Results
The study included 108 intervention patients (mean age: 74.6, 19.4% Black or African American, 44.4% from South, mean Quan-CCI: 6.7) and 324 control patients (mean age: 74.6, 19.4% Black or African American, 31.5% from South, mean Quan-CCI: 6.2). There was no statistically significant difference in persistence between the intervention and control arms (hazard ratio [95% confidence interval]: 0.84 [0.66-1.10], p-value: 0.211), with respective median times to discontinuation of 18 and 19 months. Over the first 12 months post-index, the proportion of adherent patients was not significantly different between the intervention arm and the control arm (50.6% vs. 50.9%; odds ratio [95% confidence interval]: 1.05 [0.80-1.38], p-value: 0.729).
Conclusions
In this racially diverse study of patients treated at VAMCs, high levels of persistence and adherence to oral mCRPC therapy were observed. The absence of any significant difference in adherence and persistence from the study intervention suggests that a stewardship assistance program aimed at improving adherence and persistence of patients with mCRPC may not be required at VAMCs.
Background
Given the poor prognosis of patients with metastatic castration-resistant prostate cancer (mCRPC), interventions aimed at increasing adherence to oral treatments have the potential to improve patient outcomes. This study evaluates the impact of a patient stewardship assistance pilot program (stewardship program) on the adherence and persistence to oral treatments among patients with mCRPC at VA medical centers (VAMCs).
Methods
A non-randomized controlled study design and data from the VA Corporate Data Warehouse were used. The study included patients treated with an oral mCRPC therapy (i.e., abiraterone acetate or enzalutamide) between 08/2018 and 12/2019. Patients participating in the stewardship program formed the intervention arm and patients not participating the controls. Control patients were selected and matched 1:3 based on age, race and index year. The index date was the date of initiation of abiraterone acetate or enzalutamide. Outcomes included persistence (no gap >60 days of supply) and adherence (proportion of days covered [PDC] ≥80%) to oral mCRPC treatment post-index. Persistence and adherence were compared between the two arms using a Cox proportional hazard model and logistic regression model, respectively, adjusted for baseline characteristics.
Results
The study included 108 intervention patients (mean age: 74.6, 19.4% Black or African American, 44.4% from South, mean Quan-CCI: 6.7) and 324 control patients (mean age: 74.6, 19.4% Black or African American, 31.5% from South, mean Quan-CCI: 6.2). There was no statistically significant difference in persistence between the intervention and control arms (hazard ratio [95% confidence interval]: 0.84 [0.66-1.10], p-value: 0.211), with respective median times to discontinuation of 18 and 19 months. Over the first 12 months post-index, the proportion of adherent patients was not significantly different between the intervention arm and the control arm (50.6% vs. 50.9%; odds ratio [95% confidence interval]: 1.05 [0.80-1.38], p-value: 0.729).
Conclusions
In this racially diverse study of patients treated at VAMCs, high levels of persistence and adherence to oral mCRPC therapy were observed. The absence of any significant difference in adherence and persistence from the study intervention suggests that a stewardship assistance program aimed at improving adherence and persistence of patients with mCRPC may not be required at VAMCs.
Background
Given the poor prognosis of patients with metastatic castration-resistant prostate cancer (mCRPC), interventions aimed at increasing adherence to oral treatments have the potential to improve patient outcomes. This study evaluates the impact of a patient stewardship assistance pilot program (stewardship program) on the adherence and persistence to oral treatments among patients with mCRPC at VA medical centers (VAMCs).
Methods
A non-randomized controlled study design and data from the VA Corporate Data Warehouse were used. The study included patients treated with an oral mCRPC therapy (i.e., abiraterone acetate or enzalutamide) between 08/2018 and 12/2019. Patients participating in the stewardship program formed the intervention arm and patients not participating the controls. Control patients were selected and matched 1:3 based on age, race and index year. The index date was the date of initiation of abiraterone acetate or enzalutamide. Outcomes included persistence (no gap >60 days of supply) and adherence (proportion of days covered [PDC] ≥80%) to oral mCRPC treatment post-index. Persistence and adherence were compared between the two arms using a Cox proportional hazard model and logistic regression model, respectively, adjusted for baseline characteristics.
Results
The study included 108 intervention patients (mean age: 74.6, 19.4% Black or African American, 44.4% from South, mean Quan-CCI: 6.7) and 324 control patients (mean age: 74.6, 19.4% Black or African American, 31.5% from South, mean Quan-CCI: 6.2). There was no statistically significant difference in persistence between the intervention and control arms (hazard ratio [95% confidence interval]: 0.84 [0.66-1.10], p-value: 0.211), with respective median times to discontinuation of 18 and 19 months. Over the first 12 months post-index, the proportion of adherent patients was not significantly different between the intervention arm and the control arm (50.6% vs. 50.9%; odds ratio [95% confidence interval]: 1.05 [0.80-1.38], p-value: 0.729).
Conclusions
In this racially diverse study of patients treated at VAMCs, high levels of persistence and adherence to oral mCRPC therapy were observed. The absence of any significant difference in adherence and persistence from the study intervention suggests that a stewardship assistance program aimed at improving adherence and persistence of patients with mCRPC may not be required at VAMCs.
In Prostate Cancer, Most Roads Lead to VA Pathway
The newly updated US Department of Veterans Affairs (VA) prostate cancer clinical pathway looks like a set of guidelines, but it’s really something unique. As attendees learned at an Association of VA Hematology/Oncology (AVAHO) regional meeting in Detroit in June, the clinical pathways are designed to point the way toward a standard ideal treatment for the majority of cases, not just to suggest a number of possible options.
“Pathways will always offer one scenario. They try to get oncologists to practice in a similar fashion so things can be managed more uniformly,” Michael M. Goodman, MD, told Federal Practitioner prior to the AVAHO meeting that was focused on prostate cancer care. Goodman is an associate professor of medicine with Atrium Health Wake Forest Baptist Medical Center and helped develop the VA genitourinary oncology pathways.
“The overall goal is not just to standardize care as much as possible but also to synthesize the best and most cost-effective practices,” Goodman said. For example, “If you have 5 different therapies, and they all have about the same efficacy and safety, and 1 is less costly than the other 4, then it would make sense to choose that.”
The VA has offered pathways for multiple types of cancer since 2021, and the pathway for prostate cancer is among the most comprehensive. The VA system updated the pathway in March 2024, is available online both via SharePoint and externally.
“It goes through the entire gamut from screening, diagnosis, and management to end of life,” Goodman explained. Multiple disciplines, from primary care and surgery to genetics and imaging, can rely on the pathway to assist decision-making.
In terms of screening, the pathway offers a flow map guiding the screening choices. In patients aged ≤ 54 years, only certain high-risk groups, such as African Americans and those with a family history of prostate cancer, should be screened. From ages 54 to 69 years, patients should be consulted as part of a shared decision making process, while screening is not recommended for patients aged ≥ 70 years.
Pathway flow maps also provide information about diagnostic standards, evaluation of the newly diagnosed, risk stratification, molecular testing, and end-of-life care.
Goodman says the pathway is now integrated into the VA electronic health record system via a template so clinicians can easily document pathway use. This allows the VA to track the use of the pathways locally, regionally, and nationally track the use of the pathways.
Clinicians are not mandated to follow every step in the pathway, but Goodman said the goal is > 80% adherence. If clinicians follow the standards, he said, “you’re considering efficacy, safety, and cost for that veteran.”
Prospective data suggests that adherence to the pathway eliminates certain disparities. African American veterans, for example, are as well-represented or even better represented than White veterans in prostate cancer care when pathways are followed.
Why might clinicians veer from the pathway? “If you’re seeing a patient who was treated in the community with drug X, but drug Y is chosen by the pathway, you can carry on with the previous care.” Alternatively, in some cases, patients may not tolerate the pathway standard, Goodman noted.
Goodman reports that he consults the pathway every day. “It’s helped standardize the care I provide to ensure there’s no gaps in how I’m treating patients.”
The newly updated US Department of Veterans Affairs (VA) prostate cancer clinical pathway looks like a set of guidelines, but it’s really something unique. As attendees learned at an Association of VA Hematology/Oncology (AVAHO) regional meeting in Detroit in June, the clinical pathways are designed to point the way toward a standard ideal treatment for the majority of cases, not just to suggest a number of possible options.
“Pathways will always offer one scenario. They try to get oncologists to practice in a similar fashion so things can be managed more uniformly,” Michael M. Goodman, MD, told Federal Practitioner prior to the AVAHO meeting that was focused on prostate cancer care. Goodman is an associate professor of medicine with Atrium Health Wake Forest Baptist Medical Center and helped develop the VA genitourinary oncology pathways.
“The overall goal is not just to standardize care as much as possible but also to synthesize the best and most cost-effective practices,” Goodman said. For example, “If you have 5 different therapies, and they all have about the same efficacy and safety, and 1 is less costly than the other 4, then it would make sense to choose that.”
The VA has offered pathways for multiple types of cancer since 2021, and the pathway for prostate cancer is among the most comprehensive. The VA system updated the pathway in March 2024, is available online both via SharePoint and externally.
“It goes through the entire gamut from screening, diagnosis, and management to end of life,” Goodman explained. Multiple disciplines, from primary care and surgery to genetics and imaging, can rely on the pathway to assist decision-making.
In terms of screening, the pathway offers a flow map guiding the screening choices. In patients aged ≤ 54 years, only certain high-risk groups, such as African Americans and those with a family history of prostate cancer, should be screened. From ages 54 to 69 years, patients should be consulted as part of a shared decision making process, while screening is not recommended for patients aged ≥ 70 years.
Pathway flow maps also provide information about diagnostic standards, evaluation of the newly diagnosed, risk stratification, molecular testing, and end-of-life care.
Goodman says the pathway is now integrated into the VA electronic health record system via a template so clinicians can easily document pathway use. This allows the VA to track the use of the pathways locally, regionally, and nationally track the use of the pathways.
Clinicians are not mandated to follow every step in the pathway, but Goodman said the goal is > 80% adherence. If clinicians follow the standards, he said, “you’re considering efficacy, safety, and cost for that veteran.”
Prospective data suggests that adherence to the pathway eliminates certain disparities. African American veterans, for example, are as well-represented or even better represented than White veterans in prostate cancer care when pathways are followed.
Why might clinicians veer from the pathway? “If you’re seeing a patient who was treated in the community with drug X, but drug Y is chosen by the pathway, you can carry on with the previous care.” Alternatively, in some cases, patients may not tolerate the pathway standard, Goodman noted.
Goodman reports that he consults the pathway every day. “It’s helped standardize the care I provide to ensure there’s no gaps in how I’m treating patients.”
The newly updated US Department of Veterans Affairs (VA) prostate cancer clinical pathway looks like a set of guidelines, but it’s really something unique. As attendees learned at an Association of VA Hematology/Oncology (AVAHO) regional meeting in Detroit in June, the clinical pathways are designed to point the way toward a standard ideal treatment for the majority of cases, not just to suggest a number of possible options.
“Pathways will always offer one scenario. They try to get oncologists to practice in a similar fashion so things can be managed more uniformly,” Michael M. Goodman, MD, told Federal Practitioner prior to the AVAHO meeting that was focused on prostate cancer care. Goodman is an associate professor of medicine with Atrium Health Wake Forest Baptist Medical Center and helped develop the VA genitourinary oncology pathways.
“The overall goal is not just to standardize care as much as possible but also to synthesize the best and most cost-effective practices,” Goodman said. For example, “If you have 5 different therapies, and they all have about the same efficacy and safety, and 1 is less costly than the other 4, then it would make sense to choose that.”
The VA has offered pathways for multiple types of cancer since 2021, and the pathway for prostate cancer is among the most comprehensive. The VA system updated the pathway in March 2024, is available online both via SharePoint and externally.
“It goes through the entire gamut from screening, diagnosis, and management to end of life,” Goodman explained. Multiple disciplines, from primary care and surgery to genetics and imaging, can rely on the pathway to assist decision-making.
In terms of screening, the pathway offers a flow map guiding the screening choices. In patients aged ≤ 54 years, only certain high-risk groups, such as African Americans and those with a family history of prostate cancer, should be screened. From ages 54 to 69 years, patients should be consulted as part of a shared decision making process, while screening is not recommended for patients aged ≥ 70 years.
Pathway flow maps also provide information about diagnostic standards, evaluation of the newly diagnosed, risk stratification, molecular testing, and end-of-life care.
Goodman says the pathway is now integrated into the VA electronic health record system via a template so clinicians can easily document pathway use. This allows the VA to track the use of the pathways locally, regionally, and nationally track the use of the pathways.
Clinicians are not mandated to follow every step in the pathway, but Goodman said the goal is > 80% adherence. If clinicians follow the standards, he said, “you’re considering efficacy, safety, and cost for that veteran.”
Prospective data suggests that adherence to the pathway eliminates certain disparities. African American veterans, for example, are as well-represented or even better represented than White veterans in prostate cancer care when pathways are followed.
Why might clinicians veer from the pathway? “If you’re seeing a patient who was treated in the community with drug X, but drug Y is chosen by the pathway, you can carry on with the previous care.” Alternatively, in some cases, patients may not tolerate the pathway standard, Goodman noted.
Goodman reports that he consults the pathway every day. “It’s helped standardize the care I provide to ensure there’s no gaps in how I’m treating patients.”
Experts Focus on Quality-of-Life Data in Prostate Cancer
A central aim of prostate cancer treatment is to prolong survival, but trials often overlook another key goal: Improving — or at least maintaining — quality of life (QoL).
The trials explored the effects of treatment suspension or intensification on health-related QoL as well as interventions to manage side effects in different patient populations.
The first presentation focused on a post hoc analysis of the phase 3 EMBARK trial, which looked at the effect of suspending treatment on health-related QoL in men with nonmetastatic disease at a high risk for biochemical recurrence.
Earlier findings from the trial, presented at ESMO in 2023, showed enzalutamide alone or in combination with androgen deprivation therapy (ADT) was associated with a significant improvement in metastasis-free survival vs placebo plus leuprolide.
The initial trial randomized 1068 patients at a high risk for biochemical recurrence to these three treatment groups and suspended therapy at week 37 if prostate-specific antigen (PSA) levels fell below 0.2 ng/mL. Patients, however, were not randomized into the treatment suspension groups. Treatment resumed if PSA levels rose to ≥ 2.0 ng/mL in patients who had undergone radical prostatectomy or ≥ 5.0 ng/mL in those who had not had surgery.
The post hoc analysis, which assessed patient-reported QoL outcomes following treatment suspension at baseline and every 12 weeks until progression, found no meaningful changes in the worst pain in the past 24 hours, as measured by the Brief Pain Inventory–Short Form.
Patients also reported no meaningful changes in total and physical well-being scores on the Functional Assessment of Cancer Therapy–Prostate (FACT-P) and on the European Quality of Life Five-Dimensions (EuroQol-5D) visual analog scale score, as well as no meaningful changes in sexual activity and urinary and bowel symptoms, based on scores from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Prostate 25 (QLQ-PR25).
Hormone treatment-related symptoms on the QLQ-PR25, however, “quickly improved but eventually began to worsen after week 97,” explained lead author Stephen J. Freedland, MD, from Cedars-Sinai Medical Center, Los Angeles, California, who presented the new findings at ASCO.
Dr. Freedland concluded that the EMBARK results show that enzalutamide, with or without ADT, improves metastasis-free survival vs leuprolide alone, without affecting global health-related QoL during treatment or after treatment suspension.
However, Channing J. Paller, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine, Baltimore, Maryland, who was not involved in the research, pointed out that “patient selection is key” when choosing therapies, given that ADT has distinct adverse effects. Comorbidities and adverse effects “must be taken into consideration to help the doctor and patient make more personalized treatment choices.”
Treatment Intensification and QoL
Another presentation explored health-related QoL outcomes from the phase 3 PRESTO trial.
The study examined ADT intensification in 504 patients who had high-risk biochemically relapsed nonmetastatic hormone-sensitive prostate cancer and a PSA doubling time of 9 months or less. Patients were randomized to ADT monotherapy with degarelix or leuprolide, ADT plus apalutamide, or ADT plus apalutamide, abiraterone acetate, and prednisone.
In previous data from PRESTO, the combination therapy groups both had significantly longer median PSA progression-free survival than the ADT monotherapy arm.
The latest data looked at the health-related QoL outcomes in the PRESTO population, measured using the Expanded Prostate Cancer Index Composite, the PROMIS Fatigue tool, the Hot Flash Related Daily Interference Scale, and the EuroQol-5D.
Ronald C. Chen, MD, MPH, of the University of Kansas Medical Center, Kansas City, who presented the new findings at ASCO, reported that ADT plus apalutamide improved PSA progression-free survival over ADT alone and did not meaningfully increase common treatment-related symptoms, such as hormonal symptoms, sexual dysfunction, hot flash interference, and fatigue.
However, treatment intensification with triple androgen regimen did not lead to further improvements in PSA progression-free survival but did increase the rate of serious adverse events, the time to testosterone recover, and increased hot flash interference.
PRESTO as well as EMBARK “provide a strong rationale for intensification of androgen blockade in men with high-risk biochemical recurrence after completing primary local therapy” and could even “reduce the need for subsequent treatment,” concluded Dr. Chen.
CBT for Managing ADT Side Effects
Up to 80% of men receiving ADT to treat prostate cancer experience night sweats and hot flashes, which are associated with sleep disturbance, anxiety, low mood, and cognitive impairments.
A third trial presented during the session looked at the impact of cognitive-behavioral therapy (CBT) on these side effects of ADT treatment.
Initial findings from the MANCAN study found that CBT delivered by a psychologist reduced the impact of hot flashes and night sweats at 6 weeks.
The MANCAN2 study assessed QoL at 6 months among 162 patients with localized or advanced prostate cancer who underwent at least 6 months of continuous ADT and who experienced more severe hot flashes and night sweats, defined as a score of ≥ 2 on the hot flashes and night sweats problem rating scale.
Study participants were randomized to CBT plus treatment as usual, or treatment as usual alone, with the intervention consisting of two CBT group sessions 4 weeks apart. Between CBT sessions, patients could refer to a booklet and CD, alongside exercises and CBT strategies.
MANCAN2 confirmed that CBT was associated with a significantly greater reduction in hot flash and night sweat scores over standard care alone at 6 weeks. Patients receiving CBT also reported better QoL, sleep, and functional status but those differences did not reach statistical significance.
By 6 months, those in the CBT group still reported better outcomes in each category, but no differences were statistically significant at this time point. Overall, however, 14% of treatment as usual alone patients discontinued ADT at 6 months vs none in the CBT arm.
“Further research is therefore needed to determine whether or not you can make this effect more durable” and to look at “the potential for CBT to support treatment compliance,” said study presenter Simon J. Crabb, PhD, MBBS, from the University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, England.
QoL With Radioligand Crossover
Finally, the phase 3 PSMAfore study compared 177Lu-PSMA-617 with abiraterone or enzalutamide in 468 taxane-naive patients with metastatic castration-resistant prostate cancer who had progressed on a previous androgen receptor pathway inhibitor.
In earlier analyses, Karim Fizazi, MD, PhD, Institut Gustave Roussy, Université Paris-Saclay, Paris, France, reported that 177Lu-PSMA-617 improved radiographic progression-free survival by 59% over androgen receptor pathway inhibitor therapy but did not lead to significant differences in overall survival.
In a new interim analysis, Dr. Fizazi and colleagues explored outcomes in patients eligible to cross over to 177Lu-PSMA-617 following androgen receptor pathway inhibitor therapy. Assessments of health-related QoL revealed that 177Lu-PSMA-617 led to about a 40% improvement in scores on two QoL tools — 41% with FACT-P and 39% with EuroQol-5D.
On subscales of FACT-P, Dr. Fizazi reported that 177Lu-PSMA-617 was also associated with a significantly longer time to worsening in physical, functional, and emotional well-being over standard therapy. A pain inventory score indicated that 177Lu-PSMA-617 led to a 31% improvement in the time to worsening pain intensity, as well as a 33% increase in the time to worsening pain interference.
With the treatment having a “favorable safety profile,” Dr. Fizazi said the results suggest 177Lu-PSMA-617 is a “treatment option” for patients with metastatic castration-resistant prostate cancer who have undergone androgen receptor pathway inhibitor treatment.
MANCAN2 was funded by the UK National Institute for Health and Care Research. EMBARK was funded by Astellas Pharma and Pfizer, the codevelopers of enzalutamide. PRESTO was funded by Alliance Foundation Trials and Johnson & Johnson. PSMAfore was funded by Novartis. Dr. Freedland declared relationships with Pfizer and Astellas Pharma, among others. Paller declared relationships with AstraZeneca, Dendreon, Exelixis, Janssen Oncology, Omnitura, Lilly, and Bayer. Dr. Chen declared relationships with Astellas Pharma, Pfizer, and others. Dr. Crabb declared relationships with AstraZeneca, Bristol-Myers Squibb, Ipsen, Merck, Amgen, Amphista Therapeutics, Bayer, Janssen, MSD, Pfizer, Astex Pharmaceuticals, Clovis Oncology, and Roche. Dr. Fizazi reported relationships with Novartis, AstraZeneca, and a dozen other companies.
A version of this article first appeared on Medscape.com.
A central aim of prostate cancer treatment is to prolong survival, but trials often overlook another key goal: Improving — or at least maintaining — quality of life (QoL).
The trials explored the effects of treatment suspension or intensification on health-related QoL as well as interventions to manage side effects in different patient populations.
The first presentation focused on a post hoc analysis of the phase 3 EMBARK trial, which looked at the effect of suspending treatment on health-related QoL in men with nonmetastatic disease at a high risk for biochemical recurrence.
Earlier findings from the trial, presented at ESMO in 2023, showed enzalutamide alone or in combination with androgen deprivation therapy (ADT) was associated with a significant improvement in metastasis-free survival vs placebo plus leuprolide.
The initial trial randomized 1068 patients at a high risk for biochemical recurrence to these three treatment groups and suspended therapy at week 37 if prostate-specific antigen (PSA) levels fell below 0.2 ng/mL. Patients, however, were not randomized into the treatment suspension groups. Treatment resumed if PSA levels rose to ≥ 2.0 ng/mL in patients who had undergone radical prostatectomy or ≥ 5.0 ng/mL in those who had not had surgery.
The post hoc analysis, which assessed patient-reported QoL outcomes following treatment suspension at baseline and every 12 weeks until progression, found no meaningful changes in the worst pain in the past 24 hours, as measured by the Brief Pain Inventory–Short Form.
Patients also reported no meaningful changes in total and physical well-being scores on the Functional Assessment of Cancer Therapy–Prostate (FACT-P) and on the European Quality of Life Five-Dimensions (EuroQol-5D) visual analog scale score, as well as no meaningful changes in sexual activity and urinary and bowel symptoms, based on scores from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Prostate 25 (QLQ-PR25).
Hormone treatment-related symptoms on the QLQ-PR25, however, “quickly improved but eventually began to worsen after week 97,” explained lead author Stephen J. Freedland, MD, from Cedars-Sinai Medical Center, Los Angeles, California, who presented the new findings at ASCO.
Dr. Freedland concluded that the EMBARK results show that enzalutamide, with or without ADT, improves metastasis-free survival vs leuprolide alone, without affecting global health-related QoL during treatment or after treatment suspension.
However, Channing J. Paller, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine, Baltimore, Maryland, who was not involved in the research, pointed out that “patient selection is key” when choosing therapies, given that ADT has distinct adverse effects. Comorbidities and adverse effects “must be taken into consideration to help the doctor and patient make more personalized treatment choices.”
Treatment Intensification and QoL
Another presentation explored health-related QoL outcomes from the phase 3 PRESTO trial.
The study examined ADT intensification in 504 patients who had high-risk biochemically relapsed nonmetastatic hormone-sensitive prostate cancer and a PSA doubling time of 9 months or less. Patients were randomized to ADT monotherapy with degarelix or leuprolide, ADT plus apalutamide, or ADT plus apalutamide, abiraterone acetate, and prednisone.
In previous data from PRESTO, the combination therapy groups both had significantly longer median PSA progression-free survival than the ADT monotherapy arm.
The latest data looked at the health-related QoL outcomes in the PRESTO population, measured using the Expanded Prostate Cancer Index Composite, the PROMIS Fatigue tool, the Hot Flash Related Daily Interference Scale, and the EuroQol-5D.
Ronald C. Chen, MD, MPH, of the University of Kansas Medical Center, Kansas City, who presented the new findings at ASCO, reported that ADT plus apalutamide improved PSA progression-free survival over ADT alone and did not meaningfully increase common treatment-related symptoms, such as hormonal symptoms, sexual dysfunction, hot flash interference, and fatigue.
However, treatment intensification with triple androgen regimen did not lead to further improvements in PSA progression-free survival but did increase the rate of serious adverse events, the time to testosterone recover, and increased hot flash interference.
PRESTO as well as EMBARK “provide a strong rationale for intensification of androgen blockade in men with high-risk biochemical recurrence after completing primary local therapy” and could even “reduce the need for subsequent treatment,” concluded Dr. Chen.
CBT for Managing ADT Side Effects
Up to 80% of men receiving ADT to treat prostate cancer experience night sweats and hot flashes, which are associated with sleep disturbance, anxiety, low mood, and cognitive impairments.
A third trial presented during the session looked at the impact of cognitive-behavioral therapy (CBT) on these side effects of ADT treatment.
Initial findings from the MANCAN study found that CBT delivered by a psychologist reduced the impact of hot flashes and night sweats at 6 weeks.
The MANCAN2 study assessed QoL at 6 months among 162 patients with localized or advanced prostate cancer who underwent at least 6 months of continuous ADT and who experienced more severe hot flashes and night sweats, defined as a score of ≥ 2 on the hot flashes and night sweats problem rating scale.
Study participants were randomized to CBT plus treatment as usual, or treatment as usual alone, with the intervention consisting of two CBT group sessions 4 weeks apart. Between CBT sessions, patients could refer to a booklet and CD, alongside exercises and CBT strategies.
MANCAN2 confirmed that CBT was associated with a significantly greater reduction in hot flash and night sweat scores over standard care alone at 6 weeks. Patients receiving CBT also reported better QoL, sleep, and functional status but those differences did not reach statistical significance.
By 6 months, those in the CBT group still reported better outcomes in each category, but no differences were statistically significant at this time point. Overall, however, 14% of treatment as usual alone patients discontinued ADT at 6 months vs none in the CBT arm.
“Further research is therefore needed to determine whether or not you can make this effect more durable” and to look at “the potential for CBT to support treatment compliance,” said study presenter Simon J. Crabb, PhD, MBBS, from the University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, England.
QoL With Radioligand Crossover
Finally, the phase 3 PSMAfore study compared 177Lu-PSMA-617 with abiraterone or enzalutamide in 468 taxane-naive patients with metastatic castration-resistant prostate cancer who had progressed on a previous androgen receptor pathway inhibitor.
In earlier analyses, Karim Fizazi, MD, PhD, Institut Gustave Roussy, Université Paris-Saclay, Paris, France, reported that 177Lu-PSMA-617 improved radiographic progression-free survival by 59% over androgen receptor pathway inhibitor therapy but did not lead to significant differences in overall survival.
In a new interim analysis, Dr. Fizazi and colleagues explored outcomes in patients eligible to cross over to 177Lu-PSMA-617 following androgen receptor pathway inhibitor therapy. Assessments of health-related QoL revealed that 177Lu-PSMA-617 led to about a 40% improvement in scores on two QoL tools — 41% with FACT-P and 39% with EuroQol-5D.
On subscales of FACT-P, Dr. Fizazi reported that 177Lu-PSMA-617 was also associated with a significantly longer time to worsening in physical, functional, and emotional well-being over standard therapy. A pain inventory score indicated that 177Lu-PSMA-617 led to a 31% improvement in the time to worsening pain intensity, as well as a 33% increase in the time to worsening pain interference.
With the treatment having a “favorable safety profile,” Dr. Fizazi said the results suggest 177Lu-PSMA-617 is a “treatment option” for patients with metastatic castration-resistant prostate cancer who have undergone androgen receptor pathway inhibitor treatment.
MANCAN2 was funded by the UK National Institute for Health and Care Research. EMBARK was funded by Astellas Pharma and Pfizer, the codevelopers of enzalutamide. PRESTO was funded by Alliance Foundation Trials and Johnson & Johnson. PSMAfore was funded by Novartis. Dr. Freedland declared relationships with Pfizer and Astellas Pharma, among others. Paller declared relationships with AstraZeneca, Dendreon, Exelixis, Janssen Oncology, Omnitura, Lilly, and Bayer. Dr. Chen declared relationships with Astellas Pharma, Pfizer, and others. Dr. Crabb declared relationships with AstraZeneca, Bristol-Myers Squibb, Ipsen, Merck, Amgen, Amphista Therapeutics, Bayer, Janssen, MSD, Pfizer, Astex Pharmaceuticals, Clovis Oncology, and Roche. Dr. Fizazi reported relationships with Novartis, AstraZeneca, and a dozen other companies.
A version of this article first appeared on Medscape.com.
A central aim of prostate cancer treatment is to prolong survival, but trials often overlook another key goal: Improving — or at least maintaining — quality of life (QoL).
The trials explored the effects of treatment suspension or intensification on health-related QoL as well as interventions to manage side effects in different patient populations.
The first presentation focused on a post hoc analysis of the phase 3 EMBARK trial, which looked at the effect of suspending treatment on health-related QoL in men with nonmetastatic disease at a high risk for biochemical recurrence.
Earlier findings from the trial, presented at ESMO in 2023, showed enzalutamide alone or in combination with androgen deprivation therapy (ADT) was associated with a significant improvement in metastasis-free survival vs placebo plus leuprolide.
The initial trial randomized 1068 patients at a high risk for biochemical recurrence to these three treatment groups and suspended therapy at week 37 if prostate-specific antigen (PSA) levels fell below 0.2 ng/mL. Patients, however, were not randomized into the treatment suspension groups. Treatment resumed if PSA levels rose to ≥ 2.0 ng/mL in patients who had undergone radical prostatectomy or ≥ 5.0 ng/mL in those who had not had surgery.
The post hoc analysis, which assessed patient-reported QoL outcomes following treatment suspension at baseline and every 12 weeks until progression, found no meaningful changes in the worst pain in the past 24 hours, as measured by the Brief Pain Inventory–Short Form.
Patients also reported no meaningful changes in total and physical well-being scores on the Functional Assessment of Cancer Therapy–Prostate (FACT-P) and on the European Quality of Life Five-Dimensions (EuroQol-5D) visual analog scale score, as well as no meaningful changes in sexual activity and urinary and bowel symptoms, based on scores from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Prostate 25 (QLQ-PR25).
Hormone treatment-related symptoms on the QLQ-PR25, however, “quickly improved but eventually began to worsen after week 97,” explained lead author Stephen J. Freedland, MD, from Cedars-Sinai Medical Center, Los Angeles, California, who presented the new findings at ASCO.
Dr. Freedland concluded that the EMBARK results show that enzalutamide, with or without ADT, improves metastasis-free survival vs leuprolide alone, without affecting global health-related QoL during treatment or after treatment suspension.
However, Channing J. Paller, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine, Baltimore, Maryland, who was not involved in the research, pointed out that “patient selection is key” when choosing therapies, given that ADT has distinct adverse effects. Comorbidities and adverse effects “must be taken into consideration to help the doctor and patient make more personalized treatment choices.”
Treatment Intensification and QoL
Another presentation explored health-related QoL outcomes from the phase 3 PRESTO trial.
The study examined ADT intensification in 504 patients who had high-risk biochemically relapsed nonmetastatic hormone-sensitive prostate cancer and a PSA doubling time of 9 months or less. Patients were randomized to ADT monotherapy with degarelix or leuprolide, ADT plus apalutamide, or ADT plus apalutamide, abiraterone acetate, and prednisone.
In previous data from PRESTO, the combination therapy groups both had significantly longer median PSA progression-free survival than the ADT monotherapy arm.
The latest data looked at the health-related QoL outcomes in the PRESTO population, measured using the Expanded Prostate Cancer Index Composite, the PROMIS Fatigue tool, the Hot Flash Related Daily Interference Scale, and the EuroQol-5D.
Ronald C. Chen, MD, MPH, of the University of Kansas Medical Center, Kansas City, who presented the new findings at ASCO, reported that ADT plus apalutamide improved PSA progression-free survival over ADT alone and did not meaningfully increase common treatment-related symptoms, such as hormonal symptoms, sexual dysfunction, hot flash interference, and fatigue.
However, treatment intensification with triple androgen regimen did not lead to further improvements in PSA progression-free survival but did increase the rate of serious adverse events, the time to testosterone recover, and increased hot flash interference.
PRESTO as well as EMBARK “provide a strong rationale for intensification of androgen blockade in men with high-risk biochemical recurrence after completing primary local therapy” and could even “reduce the need for subsequent treatment,” concluded Dr. Chen.
CBT for Managing ADT Side Effects
Up to 80% of men receiving ADT to treat prostate cancer experience night sweats and hot flashes, which are associated with sleep disturbance, anxiety, low mood, and cognitive impairments.
A third trial presented during the session looked at the impact of cognitive-behavioral therapy (CBT) on these side effects of ADT treatment.
Initial findings from the MANCAN study found that CBT delivered by a psychologist reduced the impact of hot flashes and night sweats at 6 weeks.
The MANCAN2 study assessed QoL at 6 months among 162 patients with localized or advanced prostate cancer who underwent at least 6 months of continuous ADT and who experienced more severe hot flashes and night sweats, defined as a score of ≥ 2 on the hot flashes and night sweats problem rating scale.
Study participants were randomized to CBT plus treatment as usual, or treatment as usual alone, with the intervention consisting of two CBT group sessions 4 weeks apart. Between CBT sessions, patients could refer to a booklet and CD, alongside exercises and CBT strategies.
MANCAN2 confirmed that CBT was associated with a significantly greater reduction in hot flash and night sweat scores over standard care alone at 6 weeks. Patients receiving CBT also reported better QoL, sleep, and functional status but those differences did not reach statistical significance.
By 6 months, those in the CBT group still reported better outcomes in each category, but no differences were statistically significant at this time point. Overall, however, 14% of treatment as usual alone patients discontinued ADT at 6 months vs none in the CBT arm.
“Further research is therefore needed to determine whether or not you can make this effect more durable” and to look at “the potential for CBT to support treatment compliance,” said study presenter Simon J. Crabb, PhD, MBBS, from the University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, England.
QoL With Radioligand Crossover
Finally, the phase 3 PSMAfore study compared 177Lu-PSMA-617 with abiraterone or enzalutamide in 468 taxane-naive patients with metastatic castration-resistant prostate cancer who had progressed on a previous androgen receptor pathway inhibitor.
In earlier analyses, Karim Fizazi, MD, PhD, Institut Gustave Roussy, Université Paris-Saclay, Paris, France, reported that 177Lu-PSMA-617 improved radiographic progression-free survival by 59% over androgen receptor pathway inhibitor therapy but did not lead to significant differences in overall survival.
In a new interim analysis, Dr. Fizazi and colleagues explored outcomes in patients eligible to cross over to 177Lu-PSMA-617 following androgen receptor pathway inhibitor therapy. Assessments of health-related QoL revealed that 177Lu-PSMA-617 led to about a 40% improvement in scores on two QoL tools — 41% with FACT-P and 39% with EuroQol-5D.
On subscales of FACT-P, Dr. Fizazi reported that 177Lu-PSMA-617 was also associated with a significantly longer time to worsening in physical, functional, and emotional well-being over standard therapy. A pain inventory score indicated that 177Lu-PSMA-617 led to a 31% improvement in the time to worsening pain intensity, as well as a 33% increase in the time to worsening pain interference.
With the treatment having a “favorable safety profile,” Dr. Fizazi said the results suggest 177Lu-PSMA-617 is a “treatment option” for patients with metastatic castration-resistant prostate cancer who have undergone androgen receptor pathway inhibitor treatment.
MANCAN2 was funded by the UK National Institute for Health and Care Research. EMBARK was funded by Astellas Pharma and Pfizer, the codevelopers of enzalutamide. PRESTO was funded by Alliance Foundation Trials and Johnson & Johnson. PSMAfore was funded by Novartis. Dr. Freedland declared relationships with Pfizer and Astellas Pharma, among others. Paller declared relationships with AstraZeneca, Dendreon, Exelixis, Janssen Oncology, Omnitura, Lilly, and Bayer. Dr. Chen declared relationships with Astellas Pharma, Pfizer, and others. Dr. Crabb declared relationships with AstraZeneca, Bristol-Myers Squibb, Ipsen, Merck, Amgen, Amphista Therapeutics, Bayer, Janssen, MSD, Pfizer, Astex Pharmaceuticals, Clovis Oncology, and Roche. Dr. Fizazi reported relationships with Novartis, AstraZeneca, and a dozen other companies.
A version of this article first appeared on Medscape.com.
FROM ASCO 2024