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Trial Summary

Protocol No.C16-168
StatusOPEN TO ACCRUAL
Principal InvestigatorPili, Roberto
ScopeNational
PhasePhase II
Age GroupAdult
TitleA Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects
DescriptionThis 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.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Males 18 years or older
  • Diagnosis of Prostate Adenocarcinoma
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesProstate
Participating InstitutionsIndiana University (IU)
  • Eskenazi Hospital
  • Indiana University Hospital / IU Simon Cancer Center
Treatment TypeTreatment
ContactPhone: (317) 278-5632
Email: iutrials@iu.edu