Study on Carboplatin or Olaparib for Prostate Cancer with BRCA Mutations

Sponsor: VA Office of Research and Development

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04038502

Provider View

This clinical trial is comparing two treatments, carboplatin and olaparib, for men with advanced prostate cancer that has specific genetic mutations. The study aims to find out which treatment is more effective in controlling the cancer.

Patient Parameters

Program Overview

This study is testing two different treatments for men with advanced prostate cancer that has specific genetic mutations affecting DNA repair. The treatments being compared are carboplatin, a chemotherapy drug, and olaparib, a medication that targets cancer cells with DNA repair issues. Participants will start with one treatment and may switch to the other if the cancer progresses. The goal is to see which treatment works better in controlling the cancer.

Description

This clinical trial is designed to explore treatment options for men with advanced prostate cancer that has specific DNA repair mutations. The study compares two treatments: carboplatin, a chemotherapy drug, and olaparib, a medication that targets cancer cells with DNA repair issues.

Participants will be randomly assigned to start with either carboplatin or olaparib. If the cancer progresses, they may switch to the other treatment. The study will monitor participants' health, cancer progression, and any side effects throughout the trial.

The trial aims to enroll 100 men with advanced prostate cancer that has worsened after previous treatments and has specific DNA repair mutations. Participants will be closely monitored for their response to the treatments, and the study will help determine which treatment is more effective.

Both carboplatin and olaparib are approved by the FDA and will be administered according to standard guidelines. Participants will receive regular health checks and assessments to ensure their safety and well-being during the trial.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years or older.
  • Diagnosed with prostate cancer, excluding certain rare types.
  • Undergoing hormone therapy to lower testosterone levels.
  • Advanced prostate cancer that has worsened despite previous treatments.
  • Specific genetic mutations in DNA repair genes.
  • Good overall health with normal organ and bone marrow function.
  • Able to provide informed consent and comply with study requirements.

Exclusion Criteria

  • Currently receiving treatment for another type of cancer.
  • Participating in another clinical trial.
  • Previous treatment with certain chemotherapy or PARP inhibitors for prostate cancer.
  • Known brain metastasis.
  • Active liver disease or hepatitis.
  • Blood disorders like myelodysplastic syndrome.
  • Taking certain medications that interact with the study drugs.
  • Unable to swallow pills or have digestive issues affecting medication absorption.
  • Significant heart disease or recent heart attack.
  • Recent participation in another investigational study.
  • Conditions that may affect understanding or compliance with the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.