Adding a hormone-blocking pill to standard bladder cancer treatment

Plain-English translation of NCT05327647 on ClinicalTrials.gov ↗ · Source last updated December 2025 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing whether a medication called , taken as a daily pill, can help improve the standard treatment for early-stage bladder cancer. The standard treatment involves putting a special liquid (BCG) directly into the bladder through a tube over several months. Researchers believe that adding this medication might reduce the chance that the cancer will return or get worse.

About 30 to 40 percent of patients with this type of bladder cancer experience their cancer returning or progressing after standard treatment. Laboratory research suggests that the medication blocks a hormone that may help cancer cells grow, so combining it with the standard treatment might improve outcomes.

Do you qualify?

You likely qualify if…

you are a man age 18 or older
you have been diagnosed with early-stage bladder cancer (non-muscle invasive urothelial carcinoma)
your urologist has recommended BCG treatment as your next step
you have not received BCG treatment in the past 5 years
you agree to use two forms of birth control if you have a partner who could become pregnant, and continue for at least 3 months after stopping the study drug

You likely don't qualify if…

you have had a heart attack or been hospitalized for heart failure in the past year, or your heart condition is unstable
you have very high blood pressure (over 160) that hasn't been controlled with medication
you have liver disease or liver blood test results that are more than twice the normal range
you are currently taking hormone replacement therapy, have low testosterone being treated, or have been diagnosed with prostate cancer
you are taking or planning to take a blood thinner called coumadin

What participation looks like

You would be randomly assigned to either take the medication along with standard BCG treatment, or to take a placebo (dummy pill) along with standard BCG treatment. The standard treatment involves receiving six rounds of BCG liquid instilled directly into your bladder, and you would take your daily pill (medication or placebo) for three months while this happens. You would then be followed by your doctor for about 3 years total, with regular check-ups to see if the cancer returns and to monitor for any side effects.

AI-generated summary from trial data · Jun 7, 2026 · Not medical advice

Trial locations(7 sites)

Canada

London Health Sciences Centre, London, Ontario

University Health Network, Princess Margaret Cancer Centre, Toronto, Ontario

Centre intégré de santé et services sociaux de Chaudière Appalaches, Lévis, Quebec

Centre Hospitalier de l'Université De Montréal_CHUM, Montreal, Quebec

McGill University Health Centre_CUSM, Montreal, Quebec