RecruitingProstate AdenocarcinomaStage IIIB Prostate Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8

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

Eligible age

18+ yrs

Accepts

Men

Locations

19 states

Healthy volunteers

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About this study

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.

Sponsor: SWOG Cancer Research Network

You may qualify if…

✓ 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)
✓ PSA \> 20 ng/mL prior to registration
✓ Participant must have documented evidence of germline mutation (pathogenic/likely pathogenic variant) in BRCA2 or BRCA1 through testing in a Clinical Laboratory Improvement Act (CLIA)-certified lab
✓ NOTE: Local lab report is sufficient for eligibility
✓ Participant may have initiated gonadotrophin releasing hormone (gnRH) agonist, gnRH antagonist, oral anti-androgen (e.g. bicalutamide, nilutamide, flutamide), or other agent intended to treat prostate cancer prior to registration. The effectiveness of the current depot of such treatment must not extend beyond 1 month after study registration. Agents listed above cannot be started after participant registration

You may not qualify if…

✕ Participant must not have evidence of distant metastatic disease by conventional imaging within 90 days prior to registration
✕ NOTE: cN1 detected only by PSMA-PET is permitted if urologist deems sites of disease to be potentially completely resectable
✕ Participant must not have received prior radiation therapy (RT) to the pelvic region
✕ Participant must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of protocol treatment