c16-168 – Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects
Lay Title:A New Study to Treat Prostate Cancer in People who have Metastatic Castrate-Resistant Prostate Cancer (mCRPC) and DNA Repair Defects
Technical Title: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects
Disease Type:Metastatic, castration-resistant prostate cancer
Basic information: The purpose of this research is to study two US FDA approved drugs alone and in combination with each other in people who have mCRPC and DNA repair defects. Having DNA repair defects means that either your body or the cancer have a genetic defect (flaw) that causes problems with your body’s ability to repair damage to your DNA.
Patients in this study will be assigned to one of four groups, depending on the type of DNA repair defect they have. Patients with ATM, BRCA1 and/or BRCA2 mutation will be randomized to Treatment Arms I, II or III:
Patients with other types of DNA repair defects – such as FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, CDK12, CHEK2, HDAC2, ATR, GEN1, BRIP1, or FAM175A – will be assigned to Treatment Arm IV and receive Lynparza™ (olaparib) only.
Research Procedures (not a complete list):
To make sure you are eligible for the study, the study team will need to have genomic analyses performed on your tumor sample to test for DNA repair defects. If this testing has not been performed, your study doctor will either arrange for use of an archived tissue sample or schedule a biopsy procedure to obtain a new tissue sample to perform genomic analysis. If you do not have a DNA repair defect, you cannot participate in this research study.
Your participation in the study will depend on the type of DNA repair defect you have. If you have an ATM, BRCA1 and/or BRCA2 mutation you will be randomized to Treatment Arms I, II or III. If you have other types of DNA repair defects you will not be randomized; instead you will be assigned to Arm IV.
You will have clinic visits every 2 to 4 weeks. During your visits to the clinic, you may complete a physical exam, and blood and urine tests for safety and for research. You will also have CT or MRI scans every 8 to 12 weeks to see if your cancer is changing.
Eligibility Criteria (not a complete list):
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