Enzalutamide + Relacorilant for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Russell Zelig Szmulewitz, MD - UChicago ...

Overseen byRussell Szmulewitz, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Trial Summary

What is the purpose of this trial?The study is an open-label Phase 1 study of the combination of relacorilant with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC).

Eligibility Criteria

Men with advanced prostate cancer that has resisted castration and shown progression despite previous treatments, but not including prior GR antagonist therapy. Participants must have stable vital functions, no history of seizures or certain other medical conditions, and agree to use two forms of birth control if applicable.

Inclusion Criteria

My prostate cancer has spread and this was confirmed through testing.

My testosterone levels are very low or I've had surgery to lower them.

I have been treated with medications like abiraterone for prostate cancer.

+11 more

Exclusion Criteria

I have been able to stop taking steroids after using them for more than 3 months.

My scans show internal organ cancer, and I can undergo strong chemotherapy.

Active psychiatric illness/social situations that would limit compliance with protocol requirements

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Participant Groups

The trial is testing a combination of Enzalutamide and Relacorilant in men with metastatic castration-resistant prostate cancer (mCRPC). It's an early-phase study where both drugs are given openly to see how well they work together.

1Treatment groups

Experimental Treatment

Group I: Dose LevelExperimental Treatment2 Interventions

Relacorilant will be given at a dose once daily. Enzalutamide will be given at a dose once daily.

Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Xtandi for: