A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolideand Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss (SNARE)
The purpose of this study is to learn about how an investigational drug intervention completed before doing prostate surgery (specifically, radical prostatectomy with lymph node dissection) may help in the treatment of high-risk localized prostate cancers that are most resistant to standard treatments. This is a phase II research study. For this study, capivasertib, the study drug, will be taken with intensified androgen deprivation therapy drugs (iADT; abiraterone and leuprolide) prior to radical prostatectomy. This study drug treatment will be evaluated to see if it is effective in shrinking and destroying prostate cancer tumors prior to surgery and to further evaluate its safety prior to prostate cancer surgery.
ID: NCT05593497
Sponsor; Investigator: VA Office of Research and Development; Ryan P. Kopp, MD
Locations: VA Greater Los Angeles Healthcare System, James J. Peters VAMC, VA Portland Health Care System, South Texas Veterans Health Care System, VA Puget Sound Health Care System
Active, Not Recruiting
Intramuscular Mechanisms of Androgen Deprivation-related Sarcopenia
Prostate cancer is the most common cancer among men and is even more common in the military and veteran population. For patients with advanced prostate cancer, the most common treatment includes androgen deprivation therapy (ADT), or the lowering of the levels of the hormone testosterone as much as possible. Unfortunately, ADT also causes patients to be fatigued, weak, and to lose muscle. This is often referred to as “sarcopenia,” and it leads to falls, poor quality of life, and higher risk of death. Currently, there is no treatment for sarcopenia because the investigators do not understand the mechanisms that cause it. The mitochondria are part of the cells responsible for providing energy to muscles, but to this date, the investigators do not know if it is affected in prostate cancer patients with sarcopenia due to ADT.
ID: NCT03867357
Sponsor; Collaborators: Seattle Institute for Biomedical and Clinical Research; DoD, University of Washington
Location: VA Puget Sound Health Care System
Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer
RATIONALE: Radiation therapy uses high-energy X-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy (ADT) may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without ADT in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with ADT in treating patients with prostate cancer.
ID: NCT00936390
Sponsor; Collaborators: Radiation Therapy Oncology Group; National Cancer Institute, NRG Oncology
Locations: 518 locations, James A. Haley VA Hospital