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 Journal Article
| Authors: | McKay, R. R.; Xie, W.; Yang, X.; Acosta, A.; Rathkopf, D.; Laudone, V. P.; Bubley, G. J.; Einstein, D. J.; Chang, P.; Wagner, A. A.; Kane, C. J.; 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: | 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 |
| Abstract: | 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 <5 mm) in 20.3% of patients (n = 24 of 118). Herein, the authors report the results of part 2. Methods: For part 2, patients were randomized 1:1 to receive either AAPL for 12 months (arm 2A) or observation (arm 2B), stratified by neoadjuvant therapy and pathologic tumor classification. The primary end point was 3-year biochemical progression-free survival. Secondary end points included safety and testosterone recovery (>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 <12 months in both arms. Conclusions: In this study, because 30% of patients declined adjuvant treatment, part B was underpowered to detect differences between arms. Future perioperative studies should be biomarker-directed and include strategies for investigator and patient engagement to ensure compliance with protocol procedures. © 2024 American Cancer Society. |
| Keywords: | adult; controlled study; aged; major clinical study; prednisone; clinical trial; fatigue; drug safety; drug withdrawal; hypertension; systemic therapy; cancer radiotherapy; neoadjuvant therapy; nuclear magnetic resonance imaging; follow up; sensitivity analysis; prostate specific antigen; progression free survival; quality of life; computer assisted tomography; phase 2 clinical trial; randomized controlled trial; histology; prostate cancer; leuprorelin; depression; multicenter study; sepsis; radical prostatectomy; hot flush; high risk population; androgen deprivation therapy; testosterone; biochemical recurrence; tumor classification; skin infection; high-risk; androgen-deprivation therapy; abiraterone; clinical outcome; pyelonephritis; acute coronary syndrome; postradical prostatectomy; pathologic response; multiparametric magnetic resonance imaging; human; male; article; apalutamide; ecog performance status; biochemical progression free survival; neoadjuvant hormone therapy; expanded prostate cancer index composite |
| Journal Title: | Cancer |
| Volume: | 130 |
| Issue: | 9 |
| ISSN: | 0008-543X |
| Publisher: | Wiley Blackwell |
| Date Published: | 2024-05-01 |
| Start Page: | 1629 |
| End Page: | 1641 |
| Language: | English |
| DOI: | 10.1002/cncr.35170 |
| PROVIDER: | scopus |
| PUBMED: | 38161319 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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