S2210 A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations
SWOG Cancer Research Network
Summary
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the pathologic complete response rate at prostatectomy in patients with localized high-risk prostate cancer with germline BRCA2 or BRCA1 mutations who are treated with neoadjuvant carboplatin by central review of source documents. SECONDARY OBJECTIVES: I. To evaluate prostate specific antigen (PSA) progression-free survival post-prostatectomy over the duration of follow-up and specifically, at the 3-year landmark. II. To evaluate metastases free survival and overall survival. III. To evaluate the frequency and severity of toxicities of neoadjuvant carbopla…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 rele…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- DrugCarboplatin
Given IV
- ProcedureChest Radiography
Undergo chest X-ray
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePSMA PET Scan
Undergo PSMA PET
- ProcedureSurgical Procedure
Undergo surgery
Locations (133)
- Anchorage Associates in Radiation MedicineAnchorage, Alaska
- Anchorage Radiation Therapy CenterAnchorage, Alaska
- Alaska Breast Care and Surgery LLCAnchorage, Alaska
- Alaska Oncology and Hematology LLCAnchorage, Alaska
- Alaska Women's Cancer CareAnchorage, Alaska
- Anchorage Oncology CentreAnchorage, Alaska