Study on Using PARP Inhibitors Before Surgery for High-Risk Prostate Cancer with BRCA1/2 Gene Changes

Sponsor: Rana McKay, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05498272

Provider View

This clinical trial is testing a treatment plan that uses a drug called olaparib, along with hormone therapy, before surgery in men with high-risk prostate cancer who have specific changes in the BRCA1 or BRCA2 genes. The study aims to see if this approach is safe and effective.

Patient Parameters

Program Overview

This Phase 2 study is exploring the use of olaparib, a PARP inhibitor, combined with hormone therapy for six months before surgery in men with high-risk prostate cancer that has specific BRCA1 or BRCA2 gene changes. The goal is to evaluate the safety and effectiveness of this treatment. All participants will undergo genetic testing to confirm the presence of these gene changes. After six months of treatment, patients will have surgery to remove the prostate and nearby lymph nodes. The study will also monitor recovery and cancer progression after surgery.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and authorization to share health information.
  • Must be 18 years or older.
  • Have prostate cancer classified as T stage 1-3.
  • Confirmed prostate cancer diagnosis without more than 50% of the sample showing different types of cancer.
  • Must have at least 3 cancerous core biopsies, or fewer if MRI shows significant disease.
  • Have high-risk prostate cancer with specific features like a high Gleason score, high PSA levels, or T3 disease.
  • Must have BRCA1/2 gene changes confirmed by standard tests.
  • No signs of cancer spread to other parts of the body.
  • Must be eligible for prostate surgery.
  • Good overall health with an ECOG score of 0 or 1.
  • Adequate blood cell counts and organ function.
  • Life expectancy of at least 16 weeks.
  • Must agree to use effective birth control during and after treatment.
  • Must be able to understand and follow study procedures.

Exclusion Criteria

  • Active infection needing treatment.
  • Previous hormone or radiation therapy for prostate cancer, except for specific short-term treatments.
  • Previous treatment with a PARP inhibitor.
  • Low testosterone levels.
  • Active infections like tuberculosis or hepatitis.
  • HIV positive unless on effective treatment.
  • Severe liver problems.
  • Difficulty swallowing pills or digestive issues affecting medication absorption.
  • Need for long-term high-dose steroids.
  • Recent heart problems or severe heart disease.
  • Other active cancers or recent major surgery.
  • Recent treatment with investigational drugs.
  • Severe side effects from previous cancer treatments.
  • Blood disorders like myelodysplastic syndrome or leukemia.
  • Serious uncontrolled medical conditions.
  • Recent chemotherapy or radiotherapy.
  • Use of certain medications that interact with olaparib.
  • Previous bone marrow or cord blood transplants.
  • Recent whole blood transfusions.
  • Allergy to olaparib or its ingredients.

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