What is carboplatin studying for high-risk prostate cancer?

Carboplatin is being studied to see how well it works before surgery in patients with high-risk prostate cancer who have inherited BRCA1 or BRCA2 gene mutations. Researchers want to evaluate if carboplatin can shrink tumors and improve outcomes. The SWOG Cancer Research Network is leading this study to better understand treatment options.

Who may be eligible for this high-risk prostate cancer clinical trial?

Men aged 18 or older with a confirmed diagnosis of prostate adenocarcinoma and inherited BRCA1 or BRCA2 mutations may be eligible. Participants must have high-risk disease features and be suitable candidates for surgery. Certain prior treatments and health conditions can affect eligibility. Please review eligibility criteria for more details.

Is there any cost to participate in this high-risk prostate cancer clinical trial?

Study-related care, including the study drug carboplatin and all trial visits, is provided at no cost. However, personal expenses like travel to and from the study site are not guaranteed to be covered and may vary. Participants should plan accordingly for these potential costs.

Actively Recruiting

Phase 2

Age: 18Years +

MALE

ID05806515

A Phase II Study of Carboplatin Chemotherapy Before Surgery for Localized, High-Risk Prostate Cancer with Germline BRCA1 or BRCA2 Mutations

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

Participants Needed

133

Research Sites

204 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of carboplatin chemotherapy given before surgery in patients with high-risk prostate cancer who have inherited mutations in the BRCA1 or BRCA2 genes. This phase II trial aims to determine how well carboplatin works in shrinking tumors prior to surgery and to assess its impact on disease progression and survival. The study also monitors treatment side effects and collects tissue samples for future research. Participants receive carboplatin intravenously before undergoing prostate surgery. Those who show signs of disease progression after surgery will have imaging tests such as CT, MRI, chest X-ray, or PSMA PET scans. Blood samples are collected throughout the trial to monitor health and support additional studies. The study includes detailed follow-up to evaluate treatment outcomes and safety. During the trial, participants will have regular assessments including physical exams, PSA tests, and imaging scans if needed. Researchers will review the rate of complete tumor response after carboplatin treatment at surgery and track progression-free survival and overall survival over time. Safety and side effects of the treatment are closely monitored. Participation may last up to five years with ongoing collection of health data and specimens.

CONDITIONS

Brief 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...

Histologic diagnosis of prostate adenocarcinoma
High or very high-risk disease defined by at least one: clinical stage cT3a to cT4x, Grade group 4 or 5 (Gleason 8-10), or PSA > 20 ng/mL before registration
Documented germline BRCA1 or BRCA2 mutation confirmed by a CLIA-certified lab
May have started certain prostate cancer treatments prior to registration but treatment effect must not extend beyond 1 month after registration
18 years of age or older
Zubrod performance status 0 to 2
Complete medical history and physical exam within 28 days before registration
Adequate blood counts and liver function within 28 days before registration
Serum creatinine ≤ institutional upper limit or creatinine clearance ≥ 50 mL/min within 28 days before registration
Adequate cardiac function with NYHA class 2B or better within 28 days before registration
If HIV positive, on antiretroviral therapy with undetectable viral load within 6 months before registration
If hepatitis B history, undetectable viral load on suppressive therapy within 28 days before registration
If hepatitis C history, treated and cured or undetectable viral load if on treatment within 28 days before registration
Agreed to use effective contraception if of reproductive potential
Deemed surgical candidate by urologist with resectable disease
Consented to specimen banking via SWOG system
Signed informed consent according to regulations

You will not qualify if you...

Evidence of distant metastatic disease by conventional imaging within 90 days before registration (except cN1 detected only by PSMA-PET if resectable)
Prior radiation therapy to the pelvic region
Prior or concurrent malignancy that could interfere with safety or efficacy assessment per physician opinion

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