Phase 3
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
Metastatic Castration Resistant Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02975934 ↗Enrolled (actual)
405
Serious AEs
28.7%
Results posted
Aug 2023
Primary outcome: Primary: Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration — 11.2; 6.4 months — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rucaparib (Drug); Abiraterone acetate or Enzalutamide or Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- pharmaand GmbH
- Primary completion
- Aug 2022
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 | — |
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.
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). 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.