Perioperative Apalutamide in High-Risk Localized Prostate Cancer.

Area of Science:

• Oncology
• Urology
• Clinical Trials

Background:

• Radical prostatectomy offers curative potential for high-risk localized or locally advanced prostate cancer.
• Up to 50% of patients experience cancer relapse within five years post-surgery.

Purpose of the Study:

• To evaluate the efficacy of perioperative apalutamide combined with androgen-deprivation therapy (ADT) in high-risk prostate cancer patients.
• To assess the impact on pathological response and metastasis-free survival following radical prostatectomy.

Main Methods:

• Phase 3, double-blind, placebo-controlled trial involving 2109 patients.
• Random assignment to ADT plus apalutamide or ADT plus placebo for 6 cycles pre- and post-radical prostatectomy.
• Dual primary endpoints: pathological complete response/minimal residual disease and metastasis-free survival.

Main Results:

• Significantly higher pathological complete response/minimal residual disease rates in the apalutamide group (8.9% vs. 1.0%).
• Improved metastasis-free survival at 5 years (78.2% vs. 73.5%) with apalutamide.
• Event-free survival and time to subsequent treatment favored the apalutamide arm; higher incidence of Grade 3/4 adverse events, mainly rash.

Conclusions:

• Perioperative ADT plus apalutamide demonstrated superior oncologic outcomes compared to ADT plus placebo for high-risk prostate cancer.
• Increased adverse events were observed in the apalutamide group, necessitating careful monitoring.