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A Randomized Phase 2 Trial of Abiraterone, Olaparib or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects

Clinical Trial Details

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. 

Arm I: Abiraterone + Prednisone 
Abiraterone 1000 mg orally once daily and prednisone 5 mg orally twice daily, days 1-28 in 28 day cycles.    

Arm II: Olaparib 
Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles. 

Arm III: Abiraterone + Prednisone + Olaparib 
Abiraterone 1000 mg orally once daily, prednisone 5 mg orally twice daily, olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles. 

Key Eligibility: 
  • Men age 18 an older 
  • Documented progressive metastatic castration-resistant prostate cancer 
  • Adequate organ function 
  • Detailed eligibility reviewed when you contact the study team 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amie Patel, RN
212-746-1480
amp3002@med.cornell.edu

Angela Tan, RN
212-746-4154
ant4009@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1702017992

ClinicalTrials.gov:

NCT03012321

Status

Open to Enrollment

Age Group

Adult

Sponsor