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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSWOG Cancer Research Network

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Carboplatin

    Drug

    Given IV

  • Chest Radiography

    Procedure/Surgery

    Undergo chest X-ray

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • PSMA PET Scan

    Procedure/Surgery

    Undergo PSMA PET

  • Surgical Procedure

    Procedure/Surgery

    Undergo surgery

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: Treatment (carboplatin)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Pathologic complete response after neoadjuvant carboplatin

A two-stage design will be used.

Time frame
Up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator