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

NCT05521698 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Bicalutamide

Given PO

PROCEDURE

Biopsy Procedure

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood and urine sample collection

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Transurethral Resection of Bladder Tumor

Undergo TURBT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Edward M Messing · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-06-01
Completion
2028-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05521698 on ClinicalTrials.gov