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 and TRITON-3, treatment with PARP inhibitors was favored in both chemotherapy-naïve patients and those who had received prior taxane-based chemotherapy.
“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]
The TRITON3 results report longer imaging-based progression-free survival with rucaparib than with control treatment, and the trial enrolled patients without prior chemotherapy for metastatic castration-resistant disease. The Results (Patient Characteristics) note that some participants had received docetaxel earlier for hormone-sensitive disease, but the cited paper does not establish a separate treatment benefit for patients previously treated with taxanes. Its statement about activity after prior taxane chemotherapy concerns the phase 2 TRITON2 study, not TRITON3. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn 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).
“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]
The Exploratory Outcomes section reports longer imaging-based progression-free survival with rucaparib than with docetaxel in the BRCA subgroup, but the medians were 11.2 and 8.3 months, not 11.2 and 6.4 months. The Primary Outcome section gives 6.4 months and P<0.001 for the comparison with the overall control group, not the exploratory docetaxel comparison. (LLM, conf=0.90)
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Self-citation
- 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
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › 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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