Actively Recruiting
A Randomized Trial of Bicalutamide in Non-Muscle Invasive Bladder Cancer
Led by University of Wisconsin, Madison · Updated on 2026-06-04
80
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of bicalutamide, an androgen receptor inhibitor, on epidermal growth factor receptor (EGFR) protein expression in male patients with non-muscle invasive bladder cancer. This phase I trial compares bicalutamide to no study drug (NSD) to understand if blocking androgen effects can influence EGFR expression, which is linked to bladder cancer progression. The study aims to provide insights into how bicalutamide might affect tumor biology and related markers in this condition. Participants are randomly assigned to one of two groups. One group receives oral bicalutamide daily for 21 days before undergoing transurethral resection of bladder tumor (TURBT) on day 21. The other group receives no study drug before TURBT on the same schedule. Both groups may have tumor biopsies at baseline and undergo blood and urine sample collection throughout the study. Treatment lasts up to 28 days, with follow-up 20-30 days after TURBT. During the study, researchers collect various samples and perform tests including measurements of EGFR, androgen receptor, and other molecular markers using techniques like rt-PCR and immunohistochemistry. They also monitor treatment side effects, urinary biomarkers, and immune environment changes through blood and urine analyses. The main outcome is the average EGFR expression level up to 28 days. Safety, toxicity, and other exploratory markers are also assessed to understand the treatment's biological impact over the study period.
CONDITIONS
Brief Title
A Randomized Trial of Bicalutamide in Non-Muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biologic male adults (18 years or older)
- Suspected non-muscle invasive bladder carcinoma confirmed by a urologist
- Cross-sectional imaging (CT or MRI) of abdomen and pelvis within 6 months showing no invasive or metastatic disease
- Newly suspected, diagnosed, or occasional recurrent bladder cancer (2 or fewer prior episodes in 18 months)
- Single or multiple tumor lesions
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Total bilirubin less than or equal to 1.5 times the institutional upper limit of normal
- AST (SGOT) less than or equal to 2 times the institutional upper limit of normal
- ALT (SGPT) less than or equal to 2 times the institutional upper limit of normal
- Negative urine culture or treated and confirmed negative before study drug
- Serum testosterone level 250 ng/dL or higher
- Normal thyroid stimulating hormone (TSH) level
- White blood cell count 0.5 times or higher than institutional lower limit of normal
- Agreement to use condoms during sexual activity and not donate sperm during the study and for 130 days after last dose
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Previous use of sex hormone or anti-androgen therapies within 6 months
- Use of Coumarin derivative anticoagulants (e.g., warfarin)
- Use of other investigational agents
- Allergic reactions to bicalutamide or similar compounds
- History of muscle invasive urothelial carcinoma or other concurrent urinary tract cancers
- Prior radiation therapy to pelvis, prostate, or rectum
- Uncontrolled illnesses, psychiatric conditions, or social situations that interfere with study participation
- Severe or unstable heart conditions or recent thromboembolic events
- Underlying uncontrolled hypertension, high cholesterol, or diabetes
- Allergy or hypersensitivity to bicalutamide or inability to take androgen deprivation therapy
- Plans to father a child during the study or within 130 days after last dose of study drug
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive either bicalutamide or no study drug daily for up to 28 days before undergoing transurethral resection of bladder tumor (TURBT). Blood and urine samples are collected throughout this period. Optional tumor biopsy may be performed at baseline.
Daily oral medication for up to 28 days and 1 procedure visit for TURBT
Duration - 20 to 30 days
Participants are followed up 20 to 30 days after TURBT to monitor recovery and any side effects.
1 follow-up visit
Trial Site Locations
Total: 6 locations
1
University of Arizona Cancer Center - Prevention Research Clinic
Tucson, Arizona, United States, 85719
Not Yet Recruiting
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
3
National Cancer Institute Urologic Oncology Branch
Bethesda, Maryland, United States, 20892
Not Yet Recruiting
4
University of Rochester
Rochester, New York, United States, 14642
Not Yet Recruiting
5
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Not Yet Recruiting
6
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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