drugset / Trial / NCT02975934
A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine how participants with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
Timeline
- Start
- 2017-06-13
- Primary completion
- 2022-08-25
- Completion
- 2024-08-08
Outcome
Met primary endpoint
registry analysis (superiority test); Rucaparib vs Abiraterone Acetate or Enzalutamide or Docetaxel; p <0.001; Hazard Ratio (HR) 0.50 (95% CI 0.36 to 0.69); Log Rank NCT02975934 ↗
registry analysis (superiority test); Rucaparib vs Abiraterone Acetate or Enzalutamide or Docetaxel; p <0.001; Hazard Ratio (HR) 0.61 (95% CI 0.47 to 0.80); Log Rank NCT02975934 ↗
Publications
- Results Fizazi K, Piulats JM, Reaume MN, Ostler P, McDermott R, Gingerich JR, Pintus E, Sridhar SS, Bambury RM, Emmenegger U, Lindberg H, Morris D, Nole F, Staffurth J, Redfern C, Saez MI, Abida W, Daugaard G, Heidenreich A, Krieger L, Sautois B, Loehr A, Despain D, Heyes CA, Watkins SP, Chowdhury S, Ryan CJ, Bryce AH; TRITON3 Investigators. Rucaparib or Physician's Choice in Metastatic Prostate Cancer. N Engl J Med. 2023 Feb 23;388(8):719-732. doi: 10.1056/NEJMoa2214676. Epub 2023 Feb 16.
- Collins K, Cheng L. Reprint of: morphologic spectrum of treatment-related changes in prostate tissue and prostate cancer: an updated review. Hum Pathol. 2023 Mar;133:92-101. doi: 10.1016/j.humpath.2023.02.007. Epub 2023 Mar 8.
- Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abiraterone acetate | Small molecule | — | Oral |
| Comparator | Docetaxel | Small molecule | — | Intravenous |
| Comparator | Enzalutamide | Other / unclassified | — | Oral |
| Subject | Rucaparib | Small molecule | 600 mg | Oral |