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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Wisconsin, Madison
Study ID
NCT05521698
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bicalutamide — DRUG
    Given PO
  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Transurethral Resection of Bladder Tumor — PROCEDURE
    Undergo TURBT

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm 1 (bicalutamide,TURBT)
    Patients receive bicalutamide PO QD on days 1-21. Patients undergo TURBT on day 21. Up to 28 days of bicalutamide prior to TURBT is permitted in the absence of unacceptable toxicity. Patients undergo blood and urine sample collection throughout the study. Patients may optionally undergo tumor biopsy at baseline.
  • Experimental: Arm 2 (TURBT)
    Patients undergo TURBT on day 21. Patients undergo blood and urine sample collection throughout the study. Patients may optionally undergo tumor biopsy at baseline.

Primary Outcome Measure

Average Epidermal Growth Factor Receptor (EGFR) expression level [ Time Frame: Up to 28 days ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer Center - Prevention Research ClinicTucsonArizona85719
Juan Chipollini
[email protected]
520-694-4032
Juan Chipollini (PRINCIPAL_INVESTIGATOR)
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Michael A. Ahdoot
[email protected]
310-423-2659
Michael A. Ahdoot (PRINCIPAL_INVESTIGATOR)
National Cancer Institute Urologic Oncology BranchBethesdaMaryland20892
Sandeep Gurram
[email protected]
240-858-3700
Sandeep Gurram (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14642
Edward M. Messing
[email protected]
585-275-3345
Edward M. Messing (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Debasish Sundi
[email protected]
219-713-9783
Debasish Sundi (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792
Kyle A. Richards
[email protected]
608-262-0759
Kyle A. Richards (PRINCIPAL_INVESTIGATOR)

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By research site
University of Arizona Cancer Center - Prevention Research Clinic· Tucson, AZCedars Sinai Medical Center· Los Angeles, CANational Cancer Institute Urologic Oncology Branch· Bethesda, MDUniversity of Rochester· Rochester, NYOhio State University Comprehensive Cancer Center· Columbus, OHUniversity of Wisconsin Carbone Cancer Center - University Hospital· Madison, WI

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