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NOT YET RECRUITING
NCT05521698
PHASE1

Study to Determine Possible Effects of Apalutamide, Compared to Placebo, on EGFR Expression in Patients With Non-muscle Invasive Bladder Cancer

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

Summary

This phase I trial evaluates the effects of apalutamide, compared to placebo, on epidermal growth factor receptor (EGFR) protein expression in patients with non-muscle invasive bladder cancer. Apalutamide 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 apalutamide has any effect on EGFR expression in patients with non-muscle invasive bladder cancer.

Official title: A Randomized Trial of Apalutamide in Non-Muscle Invasive Bladder Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-04

Completion Date

2028-12-01

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DRUG

Apalutamide

Given PO

PROCEDURE

Biopsy Procedure

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood and urine sample collection

DRUG

Placebo Administration

Given PO

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Transurethral 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