Berzosertib + Carboplatin +/- Docetaxel for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+24 other locations

Overseen byAtish D Choudhury

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well berzosertib (M6620) and carboplatin with or without docetaxel works in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving M6620, carboplatin and docetaxel may work better in treating patients with metastatic castration-resistant prostate cancer compared to carboplatin and docetaxel alone.

Eligibility Criteria

This trial is for men with metastatic castration-resistant prostate cancer that has progressed despite previous treatments. Participants must have a low testosterone level, adequate organ function, and no severe side effects from past cancer therapies. They should not have brain metastases or active infections and must not be on certain drugs that could interact with the study medication.

Inclusion Criteria

My prostate cancer is confirmed and getting worse.

My cancer has spread, shown by scans, and I have low testosterone levels.

I have previously been treated with mTOR inhibitors, TKIs, or biologic therapies.

+11 more

Exclusion Criteria

I have been treated with platinum-based drugs or ATR inhibitors for prostate cancer.

I am on medication that could harm my hearing or kidneys and cannot stop taking it.

I do not have any uncontrolled illnesses.

+7 more

Participant Groups

The trial is testing the effectiveness of berzosertib (M6620) combined with carboplatin, with or without docetaxel, in treating advanced prostate cancer. Berzosertib blocks enzymes needed for cell growth while carboplatin and docetaxel are chemotherapy drugs aiming to kill or stop the spread of tumor cells.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (carboplatin, berzosertib)Experimental Treatment3 Interventions

Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (docetaxel, carboplatin)Active Control3 Interventions

Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.