Testing a new medication combined with existing prostate cancer drugs

Plain-English translation of NCT07190300 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This trial is testing a new medication called to see if it works better when combined with existing prostate cancer treatments ( or ). The study has two parts: first, doctors will find the right dose of to use with these other medications, and then they'll compare how well the combination works compared to the standard treatment alone in men with metastatic hormone-sensitive prostate cancer.

Metastatic hormone-sensitive prostate cancer is a serious disease that spreads to other parts of the body. Researchers believe that adding this new treatment to existing therapies may help control the cancer better and give men more treatment options.

Do you qualify?

You likely qualify if…

you are an adult man 18 years or older diagnosed with metastatic hormone-sensitive prostate cancer (either new or returning after previous treatment)
you have already started hormone therapy (androgen deprivation therapy) within the last month to a year and are willing to continue it
you have castrate levels of testosterone (very low testosterone levels, measured as 50 ng/dL or lower), which is checked by blood tests
you are in generally good health with adequate organ and bone marrow function
you may have received prior chemotherapy (taxane-based) or other hormone-blocking medications, as long as you stopped darolutamide before joining the study

You likely don't qualify if…

you have castration-resistant prostate cancer (cancer that has stopped responding to hormone therapy) or PSA-only disease without visible metastases
you have brain metastases unless you've already been treated and are stable and not taking steroids for this
you are currently taking certain older hormone-blocking medications like bicalutamide
your PSA levels are very low (0.5 ng/mL or lower without prior hormone-blocking therapy, or 0.2 ng/mL or lower with prior hormone therapy)
you have not received any hormone-blocking medication and your prostate cancer has not spread or caused symptoms

What participation looks like

You will take the new medication by mouth once daily, along with your regular prostate cancer treatment (either twice daily or once daily with a steroid). The study begins with a screening period to make sure you qualify, followed by treatment visits and regular check-ups to monitor how you're doing through blood tests and imaging scans. After treatment ends, you'll continue to have long-term follow-up appointments to track your health.

AI-generated summary from trial data · Jun 27, 2026 · Not medical advice

Trial locations(31 sites)

United States

Univ of Alabama at Birmingham, Birmingham, Alabama

Uni Of Iowa Hospitals And Clinics, Iowa City, Iowa

University of Kansas Cancer Center, Westwood, Kansas

Wichita Urology Group PA, Wichita, Kansas

Duke University Medical Center, Durham, North Carolina