Results Of A Phase Ii Trial Of Neoadjuvant Abiraterone Plus Prednisone Plus Enzalutamide Plus Leuprolide (Apel) Versus Enzalutamide Plus Leuprolide (El) For Patients With High-Risk Localized Prostate Cancer (Pc) Undergoing Radical Prostatectomy (Rp).

79Background: Patients with high-risk PC have an increased risk of recurrence and mortality despite therapy. Abiraterone, a CYP17 inhibitor, and enzalutamide, a next generation anti-androgen, have demonstrated improved overall survival in metastatic PC. In this multicenter randomized phase II trial, we evaluate the impact of second generation hormone therapy on RP pathologic outcomes. Methods: Eligible patients had biopsy Gleason score ≥4+3=7, PSA u003e20 ng/mL or cT3 disease (by prostate MRI). Lymph node were require to be u003c20 mm. Patients were randomized 2:1 to APE:EL for 6 cycles (24 weeks) followed by RP. All RPs underwent central pathology review. The primary endpoint was the rate of pathologic complete response (pCR) or minimum residual disease (MRD, tumor ≤5 mm). Secondary endpoints include PSA response, surgical staging at RP, positive margin rate, and safety. Results: 75 patients were enrolled at four sites: DFCI/BWH (n=55), BIDMC (n=11), UW (n=5), JHU (n=4). Median age was 62 years. Most patients ha...