Vizient has ranked Rush University Medical Center #1 for quality among the nation’s most prestigious academic medical centers. Learn more.

Excellence is just the beginning.

Translate

French German Italian Portuguese Russian

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