18 and older, male only, with Prostate Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Prostate Specific Antigen (PSA) >=50 ResponsePrimary· 4 weeks
Response Rate(PSA) Prostate Specific Antigen to rucaparib for patients with metastatic hormone sensitive prostate cancer harboring germline mutation in homologous recombination DNA (Deoxyribonucleic acid) repair gene. Measured by decline in PSA to 50% of baseline, confirmed with second measurement at least 4 weeks apart.
Group
Value
95% CI
Rucaparib 600 mg BID
5
Number of Participants With Treatment-related Adverse EventsSecondary· 4 years 8 months
As assessed by CTCAE v4.0
Group
Value
95% CI
Rucaparib 600 mg BID
12
PSA Progression-free SurvivalSecondary· 2 years
Defined as a time (months) from initiation of rucaparib therapy until PSA increase of 25 %, confirmed with another measurement at least 3 weeks later
Group
Value
95% CI
Rucaparib 600 mg BID
11.2
3.7 – NA
Progression-free SurvivalSecondary· 2 years
Defined as time (months) from initiation of rucaparib therapy to radiographic or clinical progression or death, whichever comes first.
Group
Value
95% CI
Rucaparib 600 mg BID
12
8.0 – NA
Objective ResponseSecondary· 2 years
Defined as patients achieving a complete or partial response in target lesions found on radiographic scans among patients who have measurable disease at baseline.
Group
Value
95% CI
Rucaparib 600 mg BID
3
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline to End of Treatment approximately 4 years 8 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The aim of this research is to find out if the study drug rucaparib leads to lowering of PSA levels in men with metastatic prostate cancer that has not yet been treated with androgen deprivation therapy (also referred to as metastatic hormone sensitive prostate cancer) and who have an inherited mutation in a gene involved in repairing DNA damage. The research will also examine if rucaparib is safe in individuals with metastatic prostate cancer.
Prior research studies have shown that drugs like rucaparib can be of benefit to patients with advanced metastatic prostate cancer who are resistant to androgen deprivation therapy AND who carry a mutation in a DNA repair gene. We are studying if rucaparib will be an effective treatment for these patients earlier in their treatment course (for example, prior to the start of medicines that lower testosterone level). It is unknown whether rucaparib will have the same benefit in men with metastatic prostate cancer carrying a mutation in a DNA repair gene, prior to the use of medicines that lower your testosterone level.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04676334 — CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib
· Phase 3
· completed
NCT03462212 — Carboplatin-Paclitaxel-Bevacizumab vs Carbo-Pacli-Beva-Rucaparib vs Carbo-Pacli-Ruca, Selected According to HRD Status,
· Phase 1, PHASE2
· unknown
NCT04624178 — A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma
· Phase 2
· active not recruiting
NCT04826198 — Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to PARP Inhibitors in Pa
· Phase 1, PHASE2
· terminated
NCT04539327 — Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last refreshed: 16 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03413995.