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Effect Of Neoadjuvant Abiraterone Acetate (AA) Plus Leuprolide Acetate (LHRHa) On PSA, Pathological Complete Response (pCR), And Near PCR In Localized High-risk Prostate Cancer (LHRPC): Results Of A Randomized Phase II Study.

Mary-Ellen Taplin, Robert B. Montgomery, Christopher Logothetis, Glenn J. Bubley, Jerome P. Richie, Bruce L. Dalkin, Martin G. Sanda, Massimo F. Loda, Lawrence D. True, Patricia Troncoso, Elizabeth M. Genega, Steven P. Balk, Peter Nelson, Wanling Xie, Christopher M. Haqq, Namphuong Tran, Cameron S. Liu, Thian San Kheoh, Arturo Molina, Philip Kantoff

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4521 Background: LHRPC is infrequently cured with prostatectomy (RP). To date neoadjuvant androgen deprivation therapy (ADT) has not improved outcomes and residual intra-prostatic androgens remain. AA lowers serum testosterone (T) and DHT to < 1 ng/dL and has improved survival in advanced PC. Methods: We conducted a neoadjuvant, phase II trial of AA/LHRHa in LHRPC. The primary aim was to evaluate intra-prostatic T/DHT with LHRHa vs LHRHa/AA. We report secondary endpoints of PSA, pCR and near pCR ([≤ 5mm residual tumor]) and safety. Eligibility: ≥ 3 positive biopsies and either Gleason ≥ 7 (4+3), T3, PSA ≥ 20 ng/mL or PSA velocity > 2 ng/mL/year. For the first 12 wks men were randomized to LHRHa or LHRHa/AA/prednisone (P) 5mg qd. After 12 wks, a prostate biopsy was done to measure T/DHT. Men received 12 more wks of LHRHa/AA/P followed by RP. Results: 58 men enrolled: 28 to initial LHRHa and 30 to initial AA/LHRHa. 2 withdrew prior to RP (1/group). Median age was 58 (50-75). pCR/near pCR was 14/56 (25%). Grade 3 AEs included elevated AST/ALT 5/58 (9%) and hypokalemia 3/58 (5%). No grade 4 mineralocorticoid-related AEs were observed. Conclusions: Neoadjuvant ADT with AA was well tolerated in LHRPC. PSA (<0.2) declines were high and achieved earlier on AA/LHRHa compared to LHRHa. The pCR/near pCR rates were higher for 24 wks AA (34%) than 12 wks AA (15%). No new safety signals were seen with AA used with P 5 mg. These results support further evaluation of aggressive ADT as neoadjuvant/adjuvant therapy for LHRPC. [Table: see text]