Carboplatin Chemotherapy before Surgery for Patients with High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation

About the Study

This study tests the effectiveness of taking the medication carboplatin between prostate cancer diagnosis and surgery to remove the prostate. Carboplatin works by killing, stopping, or slowing the growth of tumor cells. After surgery participants will follow up with the study team over three years to answer questions about their medical history since surgery.

What the Study Involves

The carboplatin is given intravenously (injected into the vein), once every 3 weeks for up to 4 doses.  Then, surgery to remove the prostate will be performed and the study team will follow how the participant does with a few more visits until 3 years after surgery.

Participants will be asked to bank a tissue sample from the prostate removal for use in future studies, but this is not a requirement to participate. Participants also undergo collection of blood samples throughout the trial.

PRIMARY OBJECTIVE:

1. To check how effective carboplatin treatment is for patients with aggressive prostate cancer who have BRCA1 or BRCA2 gene mutations. We'll do this by looking at the records of patients who had surgery after receiving this treatment to see if they had a complete response.

SECONDARY OBJECTIVES:

1. To evaluate how long patients stay free from prostate specific antigen (PSA) progression after prostate surgery, both overall and specifically, at the 3-year landmark.
2. To evaluate how long patients live without their cancer spreading to other parts of their body (metastases) as well as their overall survival.
3. To evaluate how often and how severe the side effects are for patients who get carboplatin treatment before having their prostate removed surgically. 

BANKING OBJECTIVE:

1. To bank (save) samples for later studies that will help us understand more about prostate cancer. 

Lead Researchers/Study PIs and Affiliation

Lead Organization SWOG
Principal Investigator Heather H. Cheng, MD PhD

This study is open to people assigned male at birth who:

• have a diagnosis of prostate cancer.
• have a high or very high-risk prostate cancer defined by AT LEAST ONE of the following prior to registration:  
  1. a minimum stage 3b prostate cancer, meaning the cancer extends beyond the prostate;
  2. Gleason Grade Group 4 or 5 (also known as Gleason sum 8-10); OR 
  3. Prostate Specific Antigen, PSA, is a blood test ordered by your doctor
• have an inherited BRCA1 or BRCA2 mutation.
• had surgery or radiation for prostate cancer before registration.

This study is not open to people who:

• will be treated for prostate cancer more thanone month into participating in this study.
• have been treated with radiation to the pelvic area.
• has metastatic cancer that is found through imaging less than 90 days before registration.
  • people who have a tumor that can be removed by surgery can reach out to the study team to confirm if you are still eligible.
• do not have evidence of distant metastatic disease by conventional imaging within 90 days prior to registration. 
• have initiated gonadotrophin releasing hormone (gnRH) agonist, gnRH antagonist, oral anti-androgen (e.g. bicalutamide, nilutamide, flutamide), or other drug 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.
• are can undergo surgery and receive carboplatin.