Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer

Summary

This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer.

Timeline

Start

2005-06

Primary completion

2020-06-29

Completion

2020-06-29

Outcome

Missed primary endpoint

paper Although OS was not significantly increased in the docetaxel arm (the restricted mean survival time over 10 years was 9.11 v 8.82 years; P = .22), PMID 34197181 ↗

Publications

• Sayan M, Chen MH, Loffredo M, McMahon E, Moningi S, Orio PF, Nguyen PL, D'Amico AV. Elective Pelvic Lymph Node Radiation Therapy and the Risk of Death in Patients With Unfavorable-Risk Prostate Cancer: A Postrandomization Analysis. J Clin Oncol. 2024 Jul 20;42(21):2558-2564. doi: 10.1200/JCO.23.02394. Epub 2024 May 1.
• Sayan M, Huang J, Xie W, Chen MH, Loffredo M, McMahon E, Orio P, Nguyen P, D'Amico AV. Risk of Short-Term Prostate-Specific Antigen Recurrence and Failure in Patients With Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2336390. doi: 10.1001/jamanetworkopen.2023.36390.
• D'Amico AV, Xie W, McMahon E, Loffredo M, Medeiros S, Joseph D, Denham J, Kumar P, Bubley G, Sullivan M, Hellwig R, Carlos Vera J, Freter R, Jeffrey Baker W, Wong JY, Renshaw AA, Kantoff PW. Radiation and Androgen Deprivation Therapy With or Without Docetaxel in the Management of Nonmetastatic Unfavorable-Risk Prostate Cancer: A Prospective Randomized Trial. J Clin Oncol. 2021 Sep 10;39(26):2938-2947. doi: 10.1200/JCO.21.00596. Epub 2021 Jul 1.
• Guttilla A, Bortolus R, Giannarini G, Ghadjar P, Zattoni F, Gnech M, Palumbo V, Valent F, Garbeglio A, Zattoni F. Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial. Radiat Oncol. 2014 Jan 14;9:24. doi: 10.1186/1748-717X-9-24.

Drugs

Indications