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Rucaparib or Physician’s Choice in Metastatic Prostate Cancer
Open accessAbstract
BACKGROUND: alteration. Data are needed to confirm and expand on the findings of the phase 2 study. METHODS: alteration and who had disease progression after treatment with a second-generation androgen-receptor pathway inhibitor (ARPI). We randomly assigned the patients in a 2:1 ratio to receive oral rucaparib (600 mg twice daily) or a physician's choice control (docetaxel or a second-generation ARPI [abiraterone acetate or enzalutamide]). The primary outcome was the median duration of imaging-based progression-free survival according to independent review. RESULTS: alteration. At 62 months, the duration of imaging-based progression-free survival was significantly longer in the rucaparib group than in the control group, both in the BRCA subgroup (median, 11.2 months and 6.4 months, respectively; hazard ratio, 0.50; 95% confidence interval [CI], 0.36 to 0.69) and in the intention-to-treat group (median, 10.2 months and 6.4 months, respectively; hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001 for both comparisons). In an exploratory analysis in the ATM subgroup, the median duration of imaging-based progression-free survival was 8.1 months in the rucaparib group and 6.8 months in the control group (hazard ratio, 0.95; 95% CI, 0.59 to 1.52). The most frequent adverse events with rucaparib were fatigue and nausea. CONCLUSIONS: alteration. (Funded by Clovis Oncology; TRITON3 ClinicalTrials.gov number, NCT02975934.).
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“In the phase 3 randomized trials PROfound (NCT02987543), and TRITON-3 (NCT02975934), treatment with PARP inhibitors was favored in both chemotherapy-naïve patients and those who had received prior taxane-based chemotherapy [57, 58].”
From Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey (2025) · cites this paper as [57]
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“In an exploratory analysis of a subgroup of TRITON-3 evaluating patients with BRCA alterations, the median PFS with rucaparib (11.2 months) was longer than with docetaxel (6.4 months; p < 0.001) [57].”
From Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey (2025) · cites this paper as [57]
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- Rubraca (rucaparib) tablets. Boulder, CO: Clovis Oncology, 2022 (package insert).
- Lynparza (olaparib) tablets. Wilmington, DE: AstraZeneca Pharmaceuticals, 2022 (package insert).
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Metadata
- Authors
- Fizazi, K., Piulats, J. M., Reaume, M. N., Ostler, P., McDermott, R., Gingerich, J. R., Pintus, E., Sridhar, S. S., Bambury, R. M., Emmenegger, U., Lindberg, H., Morris, D., Nolè, F., Staffurth, J., Redfern, C., Sáez, M. I., Abida, W., Daugaard, G., Heidenreich, A., Krieger, L., Sautois, B., Loehr, A., Despain, D., Heyes, C. A., Watkins, S. P., Chowdhury, S., Ryan, C. J., & Bryce, A. H.
- Affiliations
- Sunnybrook Health Science Centre (CA)
- Guy's Hospital (GB)
- University of Minnesota (US)
- ORCID
- Fizazi, Karim
- Piulats, Josep M.
- Reaume, M. Neil
- Ostler, Peter
- McDermott, Ray
- Gingerich, Joel R.
- Pintus, Elias
- Sridhar, Srikala S.
- Bambury, Richard M.
- Emmenegger, Urban
- Lindberg, Henriette
- Morris, David
- Nolè, Franco
- Staffurth, John
- Abida, Wassim
- Daugaard, Gedske
- Heidenreich, Axel
- Krieger, Laurence
- Sautois, Brieuc
- Loehr, Andrea
- Despain, Darrin
- Watkins, Simon P.
- Ryan, Charles J.
- Bryce, Alan H.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2023-02-23
- Volume
- 388
- Issue
- 8
- Pages
- 719-732
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC10064172
- OpenAlex
- W4321079951
- Cited by
- 449
- References
- 27
- Citations by year
- 2026: 91 · 2025: 134 · 2024: 139 · 2023: 85
- FWCI
- 82.36
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, cc-by-nc-nd)
- ORCA Online Research @Cardiff (Cardiff University) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Open Repository and Bibliography (University of Liège) (submittedVersion, other-oa)
- Funders
- Clovis Oncology
- National Cancer Institute (P30-CA008748)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Prostate Cancer Treatment and Research
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Health Sciences › Medicine › Oncology › Advanced Breast Cancer Therapies
- Keywords
- rucaparib, metastatic prostate cancer, PARP inhibitors, BRCA mutations, ATM mutations, progression-free survival, androgen receptor pathway inhibitors, docetaxel, abiraterone, enzalutamide, PARP inhibitor resistance
- MeSH terms
- Poly(ADP-ribose) Polymerase Inhibitors, Docetaxel, Progression-Free Survival, Androgen Antagonists, Androstenes, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Benzamides, Humans, Indoles, Male, Nitriles, Phenylthiohydantoin, Disease Progression, Genes, BRCA1, Genes, BRCA2, Ataxia Telangiectasia Mutated Proteins, Prostatic Neoplasms, Castration-Resistant
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