BRCAAway: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects

Investigation of Treatments for Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects

Recruiting
18 years - 100 years
Male
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to study two US FDA approved drugs alone and in combination with each other in people who have mCRPC and DNA repair defects.

Detailed description of study

This is a prospective, 4 arm, multicenter, randomized, Phase II study in subjects with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects. This study will evaluate the use of two US FDA approved drugs alone and in combination with each other in people who have mCRPC and DNA repair defects. The primary objective is to evaluate the objective PFS of abiraterone/prednisone, olaparib or the combination abiraterone/prednisone + olaparib in mCRPC patients with canonical DNA repair defects in BRCA1,BRCA2, or ATM.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: metastatic,metastasize ,prostate cancer,prostate,cancer,oncology
  • Age: 18 years - 100 years
  • Gender: Male

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Males 18 years or older
  • Diagnosis of Prostate Adenocarcinoma

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1708862929 (C16-168)

This study investigates treatments for men with metastatic castration-resistant prostate cancer (mCRPC) who have DNA repair defects. The purpose is to assess the effectiveness of two drugs that are approved by the US FDA, both individually and in combination. Metastatic castration-resistant prostate cancer is a type of prostate cancer that continues to grow even when the amount of testosterone in the body is reduced to very low levels. DNA repair defects refer to problems in the body's ability to fix damaged DNA, which can affect cancer growth.

Participants in this study may receive one of the following: abiraterone with prednisone, olaparib, or a combination of abiraterone/prednisone with olaparib. A placebo is not mentioned in this study. The study aims to measure progression-free survival (PFS), which is the length of time during and after treatment that a patient lives with the disease without it getting worse.

  • Who can participate: Men aged 18 years or older with a diagnosis of prostate adenocarcinoma are eligible to participate. For a full list of criteria, please refer to the study's official page.
  • Study details: Participants will receive either investigational medications or a combination of these treatments. The study focuses on assessing the effectiveness of these treatments in individuals with specific DNA repair defects.

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