Actively Recruiting
A Randomized Trial of Bicalutamide in Non-Muscle Invasive Bladder Cancer
Led by University of Wisconsin, Madison · Updated on 2026-05-05
80
Participants Needed
6
Research Sites
135 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
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
Official 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 cystoscopy or imaging by a certified urologist
- Cross-sectional imaging of abdomen and pelvis (CT or MRI) within 6 months prior showing no upper tract urothelial cancer, invasive, or metastatic disease
- Newly suspected, diagnosed, or occasionally recurrent bladder cancer (defined as 2 or fewer prior NMIBC episodes in the past 18 months)
- Participants with 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 institutional upper limit of normal (special consideration for Gilbert's syndrome)
- Aspartate aminotransferase (AST) less than or equal to 2 times institutional upper limit of normal
- Alanine aminotransferase (ALT) less than or equal to 2 times institutional upper limit of normal
- Urine culture with less than 50,000 colonies/cc, or treated with confirmed negative culture before starting study drug
- Serum testosterone level of at least 250 ng/dL
- Thyroid stimulating hormone (TSH) within normal institutional range
- White blood cell count at least 0.5 times institutional lower limit of normal
- Men who agree to use condoms during sexual activity and not donate sperm during the study and for 130 days after last dose
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Prior exposure to sex hormone or anti-androgen therapies within 6 months before enrollment
- Current use of Coumarin derivative anticoagulants (e.g., warfarin)
- Receiving any other investigational agents
- History of allergic reactions to bicalutamide or similar compounds
- History of muscle invasive urothelial carcinoma, prostatic urethral, urethral, or upper tract urothelial carcinoma, or non-urothelial bladder cancer
- History of radiation therapy to pelvis, prostate, prostatic bed, or rectum
- Any uncontrolled illness, psychiatric illness, or social situation that would compromise participation or assessments
- Severe or unstable angina, recent myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, recent thromboembolic events requiring anticoagulation, or significant ventricular arrhythmias
- Uncontrolled hypertension, high cholesterol, or diabetes as judged by investigator
- Allergy or hypersensitivity to bicalutamide or excipients, or unwillingness 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
Complete this quick 3-step screening to check your eligibility
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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