Postradical prostatectomy prostate‐specific antigen outcomes after 6 versus 18 months of perioperative androgen‐deprivation therapy in men with localized, unfavorable intermediate‐risk or high‐risk prostate cancer: Results of part 2 of a randomized phase 2 trial

Background Patients with localized, unfavorable intermediate–risk and high‐risk prostate cancer have an increased risk of relapse after radical prostatectomy (RP). The authors previously reported on part 1 of this phase 2 trial testing neoadjuvant apalutamide, abiraterone, prednisone, plus leuprolid...

Full description

Saved in:
Bibliographic Details
Published in:Cancer 2024-05, Vol.130 (9), p.1629-1641
Main Authors: McKay, Rana R., Xie, Wanling, Yang, Xiaoyu, Acosta, Andres, Rathkopf, Dana, Laudone, Vincent P., Bubley, Glenn J., Einstein, David J., Chang, Peter, Wagner, Andrew A., Kane, Christopher J., Preston, Mark A., Kilbridge, Kerry, Chang, Steven L., Choudhury, Atish D., Pomerantz, Mark M., Trinh, Quoc‐Dien, Kibel, Adam S., Taplin, Mary‐Ellen
Format: Article
Language:English
Subjects:
Adjuvant therapy
Androgen Antagonists - adverse effects
Androgens
androgen‐deprivation therapy
Antigens
biochemical recurrence
Biomarkers
Cancer
high‐risk
Humans
Leuprolide - therapeutic use
Male
neoadjuvant hormone therapy
Neoplasm Recurrence, Local - surgery
Neoplasms
pathologic response
Prednisone
Prostate cancer
Prostate-Specific Antigen
Prostatectomy
Prostatectomy - methods
Prostatic Neoplasms - diagnosis
Prostatic Neoplasms - drug therapy
Prostatic Neoplasms - surgery
radical prostatectomy
Recovery
Risk
Survival
Testosterone
Therapy
Treatment Outcome
Tumors
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Background Patients with localized, unfavorable intermediate–risk and high‐risk prostate cancer have an increased risk of relapse after radical prostatectomy (RP). The authors previously reported on part 1 of this phase 2 trial testing neoadjuvant apalutamide, abiraterone, prednisone, plus leuprolide (AAPL) or abiraterone, prednisone, and leuprolide (APL) for 6 months followed by RP. The results demonstrated favorable pathologic responses (tumor 200 ng/dL). Results Overall, 82 of 118 patients (69%) enrolled in part 1 were randomized to part 2. A higher proportion of patients who were not randomized to adjuvant therapy had a favorable prostatectomy pathologic response (32.3% in nonrandomized patients compared with 17.1% in randomized patients). In the intent‐to‐treat analysis, the 3‐year biochemical progression‐free survival rate was 81% for arm 2A and 72% for arm 2B (hazard ratio, 0.81; 90% confidence interval, 0.43–1.49). Of the randomized patients, 81% had testosterone recovery in the AAPL group compared with 95% in the observation group, with a median time to recovery of
ISSN:0008-543X
1097-0142
DOI:10.1002/cncr.35170