A Randomized Trial of Bicalutamide in Non-Muscle Invasive Bladder Cancer
University of Wisconsin, Madison
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.
Description
PRIMARY OBJECTIVE: I. To compare epidermal growth factor receptor (EGFR) messenger ribonucleic acid (mRNA) expression measured by reverse transcriptase polymerase chain reaction (rt-PCR) in normal appearing urothelium adjacent to tumor (measured as a ratio relative to urothelium and lamina-propria specific markers) in participants treated with anti-androgen therapy versus (vs.) participants given NSD. SECONDARY OBJECTIVES: I. To determine effect of bicalutamide on EGFR expression (by rtPCR) in the subgroup of patients whose normal appearing urothelium adjacent to tumor expresses the androge…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 non-muscle invasive bladder carcinoma (NMIBC) on clinic-based cystoscopy or imaging as viewed by an American Urological Association (AUA) board-certified urologist * Have had cross sectional imaging of the abdomen and pelvis (computed tomography \[CT\] or magnetic resonance…
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 ClinicTucson, Arizona
- Cedars Sinai Medical CenterLos Angeles, California
- National Cancer Institute Urologic Oncology BranchBethesda, Maryland
- University of RochesterRochester, New York
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio
- University of Wisconsin Carbone Cancer Center - University HospitalMadison, Wisconsin