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Bicalutamide for Non-Muscle Invasive Bladder Cancer

This study is looking at how a drug called bicalutamide affects non-muscle invasive bladder cancer. Bicalutamide is a medication that blocks male hormones, which can help stop cancer cells from growing. Researchers want to see if bicalutamide changes the levels of a protein called EGFR in your tumor cells. High levels of EGFR have been linked to bladder cancer getting worse. You would be a man at least 18 years old with suspected non-muscle invasive bladder cancer. The study aims to see if bicalutamide can lower EGFR levels, which could help doctors understand if this drug might be useful for treating this type of cancer. This study plans to enroll 80 participants, but its current status is unclear.

Study design
This is a randomized study, meaning participants will be assigned by chance to receive bicalutamide or no study drug. It plans to include 80 adult men.
What's involved
You would undergo a tumor biopsy, blood and urine sample collection, and a procedure called Transurethral Resection of Bladder Tumor (TURBT). You would also complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
The main measurement of EGFR levels will be taken up to 28 days after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05521698

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

Recruiting
PHASE1Ages 18+InterventionalPrevention
University of Wisconsin, Madison
~80 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:BicalutamideBiopsy ProcedureBiospecimen CollectionQuestionnaire AdministrationTransurethral Resection of Bladder Tumor

At a glance

Recruiting sites
2 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average Epidermal Growth Factor Receptor (EGFR) expression level
Measured over Up to 28 days

Conditions

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

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Where it's being run

6 sites across 6 states
Arizona1
California1
Maryland1
New York1
Ohio1
Wisconsin1

Study leadership

  • Edward M Messing · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Juan Chipollini
[email protected]
520-694-4032
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 imaging \[MRI\] with or without contrast) within 6 months prior to enrollment with no signs of upper tract urothelial cancer (UC), invasive, nor metastatic disease
Note: If adenopathy or upper tract abnormalities are identified, a negative biopsy and or ureteroscopy is required prior to enrollment
Newly suspected, diagnosed, or occasionally recurrent bladder cancer (BC)
Note: Occasional recurrence is defined as =\< 2 prior NMIBC episodes in the 18 months preceding cystoscopy where the index tumor was identified
Participants with single and multiple tumor lesions
Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
Total bilirubin =\< 1.5 x institutional upper limit of normal (note: in participants with Gilbert's syndrome, if total bilirubin is \> 1.5 x upper limit of normal, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 x upper limit of normal, participants may be eligible)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2 × institutional upper limit of normal
Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2 × institutional upper limit of normal
Urine Culture \< 50,000 colonies/cc of 1 or more organisms (if found and treated and a confirmed negative culture obtained off antibiotics before study drug is started, they will be eligible)
Serum Testosterone \>= 250 ng/dL
Thyroid stimulating hormone (TSH) within institutional normal
White blood cell count (WBC) \>= 0.5 × institutional lower limit of normal
The effects of bicalutamide on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men who are having sex must wear a condom when engaging in any activity that allows for passage of ejaculate to another person throughout the course of the study and 130 days after receiving last dose of study intervention. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak. Additionally, men must agree to not donate sperm for the purpose of reproduction during the study and for a minimum of 130 days after receiving the last dose of study intervention
Ability to understand and the willingness to sign a written informed consent document

Exclusion

Participants who have had a previous exposure to sex hormone (e.g., exogenous androgens) or anti-androgenic therapies (e.g., luteinizing hormone-releasing hormone \[LHRH\] agonists, LHRH antagonists, 5 alpha reductase-inhibitors, abiraterone or other anti-androgens) within 6 months of accrual
Participants taking Coumarin derivative anticoagulation (e.g., warfarin). Other anticoagulation medications are allowed.
Participants receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to bicalutamide.
History of prior or concurrent muscle invading UC, or concurrent prostatic urethral, urethral, or upper tract UC or non-urothelial bladder cancer
History of radiation therapy to the pelvis, prostate or prostatic bed, or rectum
Any condition (uncontrolled intercurrent illness, psychiatric illness, or social situation) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Participants with severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, recent arterial or venous thromboembolic events (e.g. pulmonary embolism, cerebrovascular accident including transient ischemic attacks) for which anticoagulation therapy is ongoing, or clinically significant ventricular arrhythmias.
In the opinion of the investigator, participant has underlying uncontrolled hypertension, high cholesterol, or diabetes.
Allergy or hypersensitivity to bicalutamide, or excipients, unable or unwilling to take ADT.
Plans to father a child while enrolled in this study or within 130 days after the last dose of study intervention.

What this trial measures

  • Average Epidermal Growth Factor Receptor (EGFR) expression levelUp to 28 days

    Will be analyzed as a continuous variable. A two-sample t-test will be conducted to test whether there are significant differences of the log-transformed EGFR expression level (measured by reverse transcriptase polymerase chain reaction \[rtPCR\]) in normal appearing urothelium adjacent to tumor in participants treated with anti-androgen therapy versus (vs.) NSD participants. In case the normality assumption of the two-sample t-test does not hold, Wilcoxon rank-sum test will be performed as a sensitivity analysis. Considering androgen receptor (AR) status can be a treatment effect modifier, a regression analysis will also be performed with the log-transformed EGFR expression level as the outcome and treatment status (bicalutamide or NSD), AR status, and treatment-AR interaction as the predictors.