Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer
Summary
This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.
Timeline
- Start
- 2014-01-22
- Primary completion
- 2018-11-02
- Completion
- 2024-08-31
Outcome
Missed primary endpoint
registry analysis (superiority test); Arm A: (Enzalutamide) vs Arm B: (Enzalutamide, Abiraterone, Prednisone); p = 0.33; Hazard Ratio (HR) 0.93 (95% CI 0.80 to 1.08); Log Rank NCT01949337 ↗
paper CONCLUSION: The addition of AAP to enzalutamide for first-line treatment of mCRPC was not associated with a statistically significant benefit in OS. PMID 36996380 ↗
Publications
- Norton N, Larson NB, Jenkins GD, Beumer JH, Langevin B, Gobbaru J, Morris MJ, Nakamura Y, Kroetz DL, Zhu HJ, O'Donnell PH, Lewis LD, Hertz DL. Association of SULT2A1 Locus With Abiraterone Clearance in the Alliance A031201: Randomized Phase III Study of Enzalutamide Compared With Enzalutamide Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer. Clin Transl Sci. 2025 Dec;18(12):e70425. doi: 10.1111/cts.70425.
- Knutson TP, Luo B, Kobilka A, Lyman J, Guo S, Munro SA, Li Y, Heer R, Gaughan L, Morris MJ, Beltran H, Ryan CJ, Antonarakis ES, Armstrong AJ, Halabi S, Dehm SM. AR alterations inform circulating tumor DNA detection in metastatic castration resistant prostate cancer patients. Nat Commun. 2024 Dec 11;15(1):10648. doi: 10.1038/s41467-024-54847-1.
- Morris MJ, Heller G, Hillman DW, Bobek O, Ryan C, Antonarakis ES, Bryce AH, Hahn O, Beltran H, Armstrong AJ, Schwartz L, Lewis LD, Beumer JH, Langevin B, McGary EC, Mehan PT, Goldkorn A, Roth BJ, Xiao H, Watt C, Taplin ME, Halabi S, Small EJ. Randomized Phase III Study of Enzalutamide Compared With Enzalutamide Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer (Alliance A031201 Trial). J Clin Oncol. 2023 Jun 20;41(18):3352-3362. doi: 10.1200/JCO.22.02394. Epub 2023 Mar 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Subject | Prednisone | Other / unclassified | 5 mg | Oral |