RecruitingPhase 1NCT05521698

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

Sponsor

University of Wisconsin, Madison

Enrollment

80 participants

Start Date

Jun 25, 2026

Study Type

INTERVENTIONAL

Conditions

Non-Muscle Invasive Bladder Urothelial Carcinoma Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bicalutamide, Biopsy Procedure, and others for people with non-muscle invasive bladder urothelial carcinoma and recurrent non-muscle invasive bladder urothelial carcinoma. The study is currently recruiting participants at 6 locations. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBicalutamide

Given PO

PROCEDUREBiopsy Procedure

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood and urine sample collection

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURETransurethral Resection of Bladder Tumor

Undergo TURBT

Locations(6)

University of Arizona Cancer Center - Prevention Research Clinic

Tucson, Arizona, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

National Cancer Institute Urologic Oncology Branch

Bethesda, Maryland, United States

University of Rochester

Rochester, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05521698

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