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Treatment Study for Patients with Prostate Cancer with DNA Repair Defects

Clinical Trial Title: 
A randomized phase II trial of abiraterone, olaparib, or abiraterone + olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair defects.
Clinical Trial Protocol ID: 
17011802
Clinical Trial Investigator Name: 
Nicklas Pfanzelter, MD
Clinical Trial Protocol Description: 

The purpose of this study is to test the safety and tolerability of abiraterone, olaparib, or abiraterone + olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair defects and to collect data.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are male and 18 years of age or older.
  • Have histological or cytological proof of prostate adenocarcinoma. (Note: Small-cell carcinoma of the prostate is not permitted.)
  • Have documented progressive mCRPC based on at least one of the following criteria:
    • PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2.0 ng/mL. 
    • Progression of bidimensionally measurable soft tissue or nodal metastasis assessed within one month prior to registration by a CT scan or MRI. 
    • Progression of bone disease (evaluable disease) (new bone lesion(s)) by bone scan.
  • Agree to undergo a biopsy of at least one metastatic site to determine DNA repair defects.

You will be excluded from the study if any of the following criteria apply to you:

  • Have prior exposure to CYP-17 (other than ketoconazole) or PARP inhibitors for prostate cancer. Patients with prior exposure to ketoconazole are eligible.
  • Have prior chemotherapy for castration resistant disease. Chemotherapy given in the hormonesensitive setting is permissible if stopped at least 4 weeks prior to registration.
  • Have prior exposure to enzalutamide, ARN-509 or other investigational AR-directed therapy in the setting of mCRPC.
  • Have a currently active second malignancy excluding non-melanomatous skin cancer or superficial transitional cell carcinoma.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Genitourinary Cancers
Contact Phone: 
(312) 942-5526
Contact Name: 
Pam Sroka, BS, MT(ASCP), BSN, RN, CCRC