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

Actively Recruiting

Phase 2

Age: 18Years +

MALE

NCT05806515

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

Led by SWOG Cancer Research Network · Updated on 2026-01-29

Participants Needed

133

Research Sites

378 weeks

Total Duration

AI-Summary

What this Trial Is About

This phase II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells. Giving carboplatin before surgery may shrink tumors in patients with high-risk prostate cancer with BRCA1 and BRCA2 gene mutations.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Participant must have histologic diagnosis of prostate adenocarcinoma
Participant must have high or very high-risk disease defined by at least one of the following: cT3a - cT4x, Grade group 4 or 5 (Gleason sum 8-10), or PSA > 20 ng/mL prior to registration
Participant must have documented germline mutation in BRCA2 or BRCA1 confirmed by a certified lab
Participant may have started certain prostate cancer treatments prior to registration but effectiveness must not extend beyond 1 month after registration
Participant must be 18 years or older
Participant must have Zubrod performance status of 0-2
Participant must have a complete medical history and physical exam within 28 days prior to registration
Absolute neutrophil count ≥ 1.5 x 10^3/uL within 28 days prior to registration
Platelets ≥ 100 x 10^3/uL within 28 days prior to registration
AST/ALT ≤ 3 times institutional upper limit of normal within 28 days prior to registration
Serum creatinine ≤ institutional upper limit of normal or creatinine clearance ≥ 50 mL/min within 28 days prior to registration
Adequate cardiac function with New York Heart Association class 2B or better within 28 days prior to registration
Participants with HIV must be on antiretroviral therapy with undetectable viral load within 6 months prior to registration
Participants with chronic hepatitis B must have undetectable viral load on suppressive therapy within 28 days prior to registration
Participants with hepatitis C must be treated and cured or have undetectable viral load within 28 days prior to registration
Participants of reproductive potential must agree to use effective contraception
Participant must have had a urologic consult and be deemed a surgical candidate with potentially resectable disease
Participants must be offered the opportunity to participate in specimen banking with consent
Participants must provide informed consent according to guidelines

You will not qualify if you...

Participant must not have evidence of distant metastatic disease by conventional imaging within 90 days prior to registration
cN1 detected only by PSMA-PET is allowed if disease is potentially completely resectable
Participant must not have received prior radiation therapy to the pelvic region
Participant must not have a prior or concurrent malignancy that may interfere with study treatment safety or efficacy

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Trial Site Locations

Total: 133 locations

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States, 98508

Actively Recruiting

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States, 99504

Actively Recruiting

Alaska Breast Care and Surgery LLC