Intense neoadjuvant androgen deprivation therapy (ADT) prior to radical prostatectomy (RP) does not appear to improve pathologic response in patients with high-risk prostate cancer.

In a phase 2 trial (NCT02903368), investigators randomly assigned 118 patients to receive neoadjuvant abiraterone, prednisone, and leuprolide with or without the addition of apalutamide (240 mg/d) for 6 cycles followed by RP. Eligible patients had tumors with a Gleason score of 4+3 or higher, PSA exceeding 20 ng/mL, or T3 disease and lymph nodes of less than 20 mm in size. The vast majority (94%) of men had high-risk disease.

The primary endpoint of pathologic complete response or minimum residual disease of 5 mm or less occurred in 22% of patients also taking apalutamide and 20% of patients not taking apalutamide – a statistically nonsignificant and clinically irrelevant difference, Mary-Ellen Taplin, MD, of the Dana-Farber Cancer Center in Boston, Massachusetts, and colleagues reported in The Journal of Urology. The presence of intraductal carcinoma, PTEN loss, and ERG positivity correlated with extensive residual tumor. No new safety signals were observed.

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“As demonstrated in castration-resistant prostate cancer, it does not appear that more intense hormone therapy combining CYP17 inhibition and [androgen receptor] antagonism was superior to single agent therapy,” Dr Taplin’s team stated. “We did demonstrate that 21% of patients achieved an exceptional pathologic response. Furthermore, we demonstrate that neoadjuvant therapy prior to RP is feasible with limited toxicity and operative and perioperative complications.”

Disclosure: This research was supported by Janssen Pharmaceuticals. Please see the original reference for a full list of disclosures.


McKay RR, Xie W, Ye H, et al. Results of a randomized phase II trial of intense androgen deprivation therapy prior to radical prostatectomy in men with high-risk localized prostate cancer. J Urol. 2021;206:80-87.doi:10.1097/JU.0000000000001702