Trials / Active Not Recruiting
Active Not RecruitingNCT03012321
Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
BRCAAway: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Northwestern University · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a 1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.
Conditions
- Prostate Cancer Metastatic Castration-Resistant
- Abnormal DNA Repair
- Metastatic Prostate Carcinoma
- Stage IV Prostate Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olaparib | |
| DRUG | Abiraterone Acetate | |
| DRUG | Prednisone |
Timeline
- Start date
- 2017-01-12
- Primary completion
- 2023-10-21
- Completion
- 2027-01-16
- First posted
- 2017-01-06
- Last updated
- 2025-10-21
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03012321. Inclusion in this directory is not an endorsement.