Key clinical point: Apalutamide plus androgen deprivation therapy (ADT) leads to higher PSA responses by 6 months in patients with nonmetastatic castration-resistant prostate cancer (CRPC).
Major finding: At 6 months, a higher proportion of patients in the apalutamide vs placebo group reported a PSA reduction of ≥50% (90% vs 1.5%) and ≥90% (57% vs 0%). Deep PSA responses (PSA reduction of ≥50% or PSA levels of ≤0.2 ng/mL) at 6 months after apalutamide treatment were associated with a significant improvement in metastasis-free survival ( P < .001) and overall survival ( P < .001).
Study details: A post hoc analysis of phase 3 randomized SPARTAN trial of 1,207 patients with nonmetastatic CRPC randomly assigned to receive apalutamide (n=806) or placebo (n=401) plus ADT.
Disclosures: This study was sponsored by Janssen Research & Development. The authors reported employment, research funding, advisory/consulting roles, travel compensation, honoraria, stock ownership, royalties, or patents outside this work.
Source: Saad F et al. Eur Urol. 2021 Dec 13. doi: 10.1016/j.eururo.2021.11.020 .