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Abiraterone/Prednisone and Olaparib Alone or In Combination for Treatment of Metastatic Castration-Resistant Prostate Cancer With Mutations Related to DNA Repair

https://www.facingourrisk.org/research-clinical-trials/study/203/abirateroneprednisone-and-olaparib-alone-or-in-combination-for-treatment-of-metastatic-castration-resistant-prostate-cancer-with-mutations-related-to-dna-repair

Clinicaltrials.gov identifier:
NCT03012321 (https://clinicaltrials.gov/show/NCT03012321)


Men with mCRPC with an inherited mutation or a tumor mutation in a DNA damage repair gene

Study Contact Information:

Study coordinator  (312)695-1301 or by email at: [email protected]           
Principal Investigator: Maha Hussain, MD, Northwestern University


About the Study

This study will comparing three different treatments for men with metastatic castration-resistant prostate cancer, (mCRPC) who also have an inherited mutation or a tumor mutation in a gene that affects DNA damage repair. The study is open to men with inherited mutations found on genetic testing or acquired mutations found on tumor testing in one of the following genes: ATM, BRCA1, BRCA2, FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A. NOTE: This study is now closed. 

Type of Study

This is a phase 2, randomized, open-label study.

What the Study Involves:

Participants will be divided into one of four groups.

Groups 1, 2, and 3 will consist only of men with inherited or tumor mutations in ATM, BRCA1, or BRCA2 genes. Participants with a tumor mutation in one of these genes will be randomly assigned to one of these 3 groups

Participants with inherited or tumor mutations in FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A genes will be placed into group 4.

Participants will be followed for 2 years.
 

Study Sites

California

Florida

Illinois

Indiana

Maryland

Michigan

Minnesota

Missouri

New York

North Carolina

Utah

Virginia


This Study is Open To:

NOTE: This study is now closed. 

 

This Study is Not Open To:

NOTE: This study is now closed. 


About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.