Phase 3
Completed N=405
A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Source: ClinicalTrials.gov NCT02975934 ↗Enrolled (actual)
405
Serious AEs
28.7%
Results posted
Aug 2023
Primary outcomePrimary: Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration — 11.2; 6.4 months — p=<0.001
◆ Published Evidence
Highly cited
423citations · ~141 / year
Rucaparib or Physician's Choice in Metastatic Prostate Cancer.
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.
Linked Publications (3)
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Rucaparib or Physician's Choice in Metastatic Prostate Cancer.
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Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers.
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Reprint of: morphologic spectrum of treatment-related changes in prostate tissue and prostate cancer: an updated review.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration |
11.2; 6.4 | <0.001 sig |
| PRIMARY Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined |
10.2; 6.4 | <0.001 sig |
| SECONDARY Overall Survival in Participants With a BRCA Alteration |
23.2; 21.2 | 0.5044 |
| SECONDARY Overall Survival in Participants With a BRCA or ATM Alteration Combined |
22.8; 21.7 | 0.9368 |
| SECONDARY Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration |
37; 7 | — |
| SECONDARY Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined |
37; 9 | — |
| SECONDARY Duration of Response (DOR) by IRR in Participants With a BRCA Alteration |
7.4; 7.4 | — |
| SECONDARY Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined |
7.4; 7.4 | — |
| SECONDARY PSA Response in Participants With a BRCA Alteration |
54.7; 26.7 | — |
| SECONDARY PSA Response in Participants With a BRCA or ATM Alteration Combined |
41.9; 26.7 | — |
| SECONDARY Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration |
63.0; 22.7 | — |
| SECONDARY Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined |
57.6; 25.4 | — |
| SECONDARY Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration |
6.6; 3.8 | — |
| SECONDARY Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined |
5.7; 3.6 | — |
| SECONDARY Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P |
-0.8; -3.9 | — |
| SECONDARY Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF |
-0.32; 0.14; -0.28; 0.65 | — |
| SECONDARY Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L |
2.4; 1.8 | — |
| SECONDARY Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling |
1310 | — |
Eligibility Criteria
Inclusion Criteria
- Be 18 years old at the time the informed consent is signed
- Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic
- Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
- Be eligible for treatment with physician's choice of comparator treatment (abiraterone acetate, enzalutamide or docetaxel)
- Experienced disease progression after having received 1 prior next generation androgen receptor-targeted therapy
- Have a deleterious mutation in a BRCA1/2 or ATM gene
Exclusion Criteria
- Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
- Prior treatment with any PARP inhibitor
- Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
- Symptomatic and/or untreated central nervous system metastases
- Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug
Data sourced from ClinicalTrials.gov (NCT02975934) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.