Recruiting
Phase 1

Bicalutamide

Sponsor:

University of Wisconsin, Madison

Code:

NCT05521698

Conditions

Non-Muscle Invasive Bladder Urothelial Carcinoma

Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bicalutamide

Biopsy Procedure

Biospecimen Collection

Questionnaire Administration

Transurethral Resection of Bladder Tumor

Study Details

Brief 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

Study ID

NCT05521698

Start date

Jun 25, 2026

Status verified date

Apr, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Bicalutamide

Given PO

Biopsy Procedure

Undergo tumor biopsy

Biospecimen Collection

Undergo blood and urine sample collection

Questionnaire Administration

Ancillary studies

Transurethral Resection of Bladder Tumor

Undergo TURBT

Primary outcome measure

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

Central Contacts and Locations

Locations

University of Arizona Cancer Center - Prevention Research Clinic

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Juan Chipollini

520-694-4032jchipollini@surgery.arizona.edu

Principal Investigator:

Juan Chipollini

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Kyle A. Richards

608-262-0759richardsk@urology.wisc.edu

Principal Investigator:

Kyle A. Richards

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jul 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-07-07.