Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05806515

Provider View

This study is testing if the chemotherapy drug carboplatin, given before surgery, can help shrink tumors in patients with high-risk prostate cancer who have inherited BRCA1 or BRCA2 gene mutations. Carboplatin is similar to another cancer drug, cisplatin, but may be easier to tolerate.

Patient Parameters

Program Overview

This phase II clinical trial is exploring how well the chemotherapy drug carboplatin works when given before surgery to treat patients with high-risk prostate cancer who have inherited BRCA1 or BRCA2 gene mutations. Carboplatin is a type of medication that can kill or slow the growth of cancer cells. The study aims to see if using carboplatin before surgery can help reduce the size of tumors in these patients.

Description

The main goal of this study is to see if carboplatin can completely eliminate cancer in the prostate when given before surgery in patients with high-risk prostate cancer and BRCA1 or BRCA2 mutations. Researchers will also look at how long patients stay free from cancer progression after surgery, how long they live without the cancer spreading, and any side effects from the treatment.

Patients in the study will receive carboplatin through an IV and then undergo surgery. If the cancer progresses after surgery, patients will have imaging tests like CT or MRI scans to check for cancer spread. Blood samples will be collected throughout the study for further analysis.

The study also aims to collect and store tissue samples for future research.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of prostate cancer.
  • Must have high-risk disease, defined by specific medical criteria such as certain tumor sizes or PSA levels.
  • Must have a genetic mutation in BRCA1 or BRCA2 confirmed by a certified lab.
  • May have started certain hormone treatments for prostate cancer before joining the study, but these must not last beyond one month after joining.
  • Must be 18 years or older.
  • Must be in good overall health, with a performance status score between 0 and 2.
  • Must have a complete medical history and physical exam within 28 days before joining the study.
  • Must have adequate blood cell counts and organ function as determined by specific blood tests.
  • Must have good heart function, especially if there is a history of heart disease.
  • Must have controlled HIV, hepatitis B, or hepatitis C infections if present.
  • Must agree to use effective contraception if of reproductive potential.
  • Must have had a consultation with a urologist and be considered a candidate for surgery.
  • Must agree to participate in specimen banking for future research.
  • Must provide informed consent to participate in the study.

Exclusion Criteria

  • Must not have cancer that has spread to distant parts of the body, as shown by imaging tests.
  • Must not have received radiation therapy to the pelvic area.
  • Must not have another cancer that could interfere with the study treatment or its assessment.

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