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

Conditions

• Prostate Adenocarcinoma
• Stage IIIB Prostate Cancer AJCC v8
• Stage IIIC Prostate Cancer AJCC v8

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Carboplatin — DRUG
  Given IV
• Chest Radiography — PROCEDURE
  Undergo chest X-ray
• Computed Tomography — PROCEDURE
  Undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• PSMA PET Scan — PROCEDURE
  Undergo PSMA PET
• Surgical Procedure — PROCEDURE
  Undergo surgery

Study Details

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.

Key Dates

Start date

Mar 1, 2024

Status verified

Jan 2026

Primary completion

Jul 31, 2027

Completion

Jun 30, 2031

Study Design

Enrollment

44 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (carboplatin)
  Patients receive carboplatin IV on study. Patients then undergo surgery on study. Patients who experience PSA progression after surgery undergo CT or MRI of the abdomen and pelvis, CT of the chest or chest X-ray, or PSMA-PET throughout the trial. Patients also undergo collection of blood samples throughout the trial.

Primary Outcome Measure

Pathologic complete response after neoadjuvant carboplatin [ Time Frame: Up to 5 years ]

Locations (133)

Find similar trials in Anchorage, AK

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