Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 11, 2026
Date Accepted: Sep 14, 2026
Protocol: Randomized Phase II Trial of Neoadjuvant Apalutamide with or without Abiraterone Acetate plus Prednisone and GnRH Agonist Prior to Nerve-Sparing Radical Prostatectomy in High-Risk Prostate Cancer
ABSTRACT
Background:
Androgen receptor-targeted therapy has been proposed to improve survival in patients with advanced prostate cancer (PCa). However, the impact of androgen receptor blockade on localized disease remains largely unknown.
Objective:
This study aims to evaluate the effect of neoadjuvant apalutamide with or without abiraterone acetate plus prednisone, and gonadotropin-releasing hormone (GnRH) agonist on the feasibility of performing nerve-sparing radical prostatectomy (RP) in men with high-risk localized PCa.
Methods:
This is a prospective, multicenter randomized phase II clinical trial (ClinicalTrials.gov: NCT02949284). Eligible patients with high-risk PCa were randomized 1:1:1 to (1) apalutamide monotherapy for 3 months followed by RP, (2) apalutamide with abiraterone acetate plus prednisone, and GnRH agonist for 3 months followed by RP, or (3) immediate RP without neoadjuvant therapy. The primary endpoint is recovery of erectile function at 12 months postoperatively. Secondary endpoints include urinary continence recovery, pathological outcomes, biochemical recurrence, and quality-of-life measures.
Results:
As of March 2026, patient enrollment has been completed. A total of 96 patients were consented and screened, 88 randomized, and 73 received assigned treatment and were included within the final analysis cohort. Data collection for primary and secondary outcomes has been completed, with final analysis anticipated in 2026.
Conclusions:
This trial will provide prospective evidence regarding the role of neoadjuvant androgen receptor-targeted therapy in improving functional and oncologic outcomes in men undergoing RP for high-risk localized PCa. Clinical Trial: ClinicalTrials.gov NCT02949284; https://clinicaltrials.gov/study/NCT02949284
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