Results of a randomized phase II trial of intense androgen deprivation therapy prior to radical prostatectomy in men with high-risk localized prostate cancer Journal Article
| Authors: | McKay, R. R.; Xie, W.; Ye, H.; Fennessy, F. M.; Zhang, Z.; Lis, R.; Calagua, C.; Rathkopf, D.; Laudone, V. P.; Bubley, G. J.; Einstein, D. J.; Chang, P. K.; Wagner, A. A.; Parsons, J. K.; Preston, M. A.; Kilbridge, K.; Chang, S. L.; Choudhury, A. D.; Pomerantz, M. M.; Trinh, Q. D.; Kibel, A. S.; Taplin, M. E. |
| Article Title: | Results of a randomized phase II trial of intense androgen deprivation therapy prior to radical prostatectomy in men with high-risk localized prostate cancer |
| Abstract: | PURPOSE: This multicenter randomized phase 2 trial investigates the impact of intense androgen deprivation on radical prostatectomy pathologic response and radiographic and tissue biomarkers in localized prostate cancer (NCT02903368). MATERIALS AND METHODS: Eligible patients had a Gleason score ≥4+3=7, prostate specific antigen >20 ng/mL or T3 disease and lymph nodes <20 mm. In Part 1, patients were randomized 1:1 to apalutamide, abiraterone acetate, prednisone and leuprolide (AAPL) or abiraterone, prednisone, leuprolide (APL) for 6 cycles (1 cycle=28 days) followed by radical prostatectomy. Surgical specimens underwent central review. The primary end point was the rate of pathologic complete response or minimum residual disease (minimum residual disease, tumor ≤5 mm). Secondary end points included prostate specific antigen response, positive margin rate and safety. Magnetic resonance imaging and tissue biomarkers of pathologic outcomes were explored. RESULTS: The study enrolled 118 patients at 4 sites. Median age was 61 years and 94% of patients had high-risk disease. The combined pathologic complete response or minimum residual disease rate was 22% in the AAPL arm and 20% in the APL arm (difference: 1.5%; 1-sided 95% CI -11%, 14%; 1-sided p=0.4). No new safety signals were observed. There was low concordance and correlation between posttherapy magnetic resonance imaging assessed and pathologically assessed tumor volume. PTEN-loss, ERG positivity and presence of intraductal carcinoma were associated with extensive residual tumor. CONCLUSIONS: Intense neoadjuvant hormone therapy in high-risk prostate cancer resulted in favorable pathologic responses (tumor <5 mm) in 21% of patients. Pathologic responses were similar between treatment arms. Part 2 of this study will investigate the impact of adjuvant hormone therapy on biochemical recurrence. |
| Keywords: | neoadjuvant therapy; prostatectomy; abiraterone acetate |
| Journal Title: | Journal of Urology |
| Volume: | 206 |
| Issue: | 1 |
| ISSN: | 0022-5347 |
| Publisher: | Elsevier Science, Inc. |
| Date Published: | 2021-07-01 |
| Start Page: | 80 |
| End Page: | 87 |
| Language: | English |
| DOI: | 10.1097/ju.0000000000001702 |
| PUBMED: | 33683939 |
| PROVIDER: | scopus |
| PMCID: | PMC9807004 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 July 2021 -- Source: Scopus |
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