Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects

Part of paid clinical trials in Los Angeles, California.

Sponsor
Northwestern University
Study ID
NCT03012321
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Abnormal DNA Repair
  • Metastatic Prostate Carcinoma
  • Prostate Cancer Metastatic Castration-Resistant
  • Stage IV Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
  • Abiraterone Acetate — DRUG
  • Prednisone — DRUG

Study 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.

Key Dates

Start date
Jan 12, 2017
Status verified
May 2026
Primary completion
Oct 21, 2023
Completion
Jan 16, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I: Abiraterone + Prednisone
    Abiraterone 1000 mg orally once daily and prednisone 5 mg orally twice daily, days 1-28 in 28 day cycles.
  • Active Comparator: Arm II: Olaparib
    Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.
  • Active Comparator: 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.
  • Active Comparator: Olaparib
    Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.

Primary Outcome Measure

Objective Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90073-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Northwestern MedicineChicagoIllinois60611-
Rush University Cancer CenterChicagoIllinois60612-
University of ChicagoChicagoIllinois60637-
Kellogg Cancer Center - NorthShore UniversityEvanstonIllinois60201-
Indiana University/ Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-
University of Michigan Health SystemAnn ArborMichigan48109-5946-
University of Michigan Rogel Cancer CenterDetroitMichigan48201-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Weill Cornell Medical CollegeNew YorkNew York10065-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Huntsman Cancer Institute - University of UtahSalt Lake CityUtah84112-
University of VirginiaCharlottesvilleVirginia22903-

Find similar trials in Los Angeles, CA

By research site
University of California Los Angeles· Los Angeles, CAH. Lee Moffitt Cancer Center and Research Institute· Tampa, FLNorthwestern Medicine· Chicago, ILRush University Cancer Center· Chicago, ILUniversity of Chicago· Chicago, ILKellogg Cancer Center - NorthShore University· Evanston, IL

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