A Randomized Trial of Bicalutamide in Non-Muscle Invasive Bladder Cancer

Conditions: Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma

Sex: Male

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE1

Enrollment: 80

Sponsor: University of Wisconsin, Madison

Location: University of Arizona Cancer Center - Prevention Research Clinic Tucson Arizona

Summary

This phase I trial evaluates the effects of bicalutamide, compared to no study drug (NSD), on epidermal growth factor receptor (EGFR) protein expression in patients with non-muscle invasive bladder cancer. Bicalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Previous studies have suggested that expression of a protein called EGFR on tumor cells is related to bladder cancer disease progression. This trial may help doctors evaluate if bicalutamide has any effect on EGFR expression in patients with non-muscle invasive bladder cancer.

Eligibility Criteria

Inclusion Criteria: * Biologic male adults (\>= 18 years old) * Note: Because no dosing or adverse event (AE) data are currently available on the use of bicalutamide in participants \< 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable * Have suspected new or occasionally recurrent NMIBC (i.e., \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05521698). StuddyBuddy aggregates publicly available trial information.