About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must have histologic diagnosis of prostate adenocarcinoma
cT3a - cT4x
Grade group 4 or 5 (Gleason sum 8-10)
PSA > 20 ng/mL prior to registration
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Carboplatin
DrugGiven IV
Chest Radiography
Procedure/SurgeryUndergo chest X-ray
Computed Tomography
Procedure/SurgeryUndergo CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
PSMA PET Scan
Procedure/SurgeryUndergo PSMA PET
Surgical Procedure
Procedure/SurgeryUndergo surgery
Treatment groups
Trial outcomes
Primary outcomes
Pathologic complete response after neoadjuvant carboplatin
A two-stage design will be used.
Sponsors and contacts
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SWOG Cancer Research Network
Lead sponsor
National Cancer Institute (NCI)
Collaborator