Clinical trial Recruiting at 3 sites Phase 1 Interventional Ages 18 and up Men only

Bicalutamide for non-muscle invasive bladder cancer

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

Run by University of Wisconsin, Madison · NCT05521698 · Data updated 2026-11-12

This trial tests whether the anti-androgen drug bicalutamide changes EGFR protein expression in adult men with non-muscle invasive bladder cancer.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment80 (estimated)
SponsorUniversity of Wisconsin, Madison
Academic / other
Drugs / interventionschemotherapy, radiation
Locations6 sites (Tucson, Arizona and 5 other locations)
StatusRecruiting
StartedJune 25, 2026
Main results expectedJune 1, 2028
Study endsDecember 1, 2028
Registry record updatedSeptember 30, 2026
Trial IDNCT05521698 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Biologic male adults (>=18 years) with suspected or newly diagnosed non-muscle invasive bladder urothelial carcinoma, no evidence of invasive or metastatic disease on recent imaging, and who can undergo TURBT/biopsy at a participating center are ideal candidates.

Probably not a fit

Biologic females, patients with invasive or metastatic bladder cancer, minors under 18, or those unable to undergo required biopsies/procedures are unlikely to benefit from this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized Phase I trial comparing bicalutamide to no study drug in biologic male adults with non-muscle invasive bladder cancer. Participants undergo standard procedures such as transurethral resection/biopsy and bladder wash cytology, with tissue and wash samples collected before and after treatment. The primary endpoint is EGFR mRNA expression in normal-appearing urothelium adjacent to tumor measured by RT-PCR, with secondary and exploratory analyses including AR and EGFR protein/IHC correlations, Ki-67, and toxicity comparisons. The goal is to determine whether short-term anti-androgen therapy alters molecular markers associated with disease progression to inform future trials.

Why it matters

Potential benefit: If successful, the drug could alter biomarker patterns linked to progression and guide future treatments that may reduce recurrence or progression risk.

How similar studies have gone: Preclinical work and limited clinical data suggest androgen receptor blockade can influence EGFR and tumor behavior, but use of bicalutamide specifically in NMIBC is novel with limited prior clinical evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 new or occasionally recurrent NMIBC (i.e., \</= 2 prior NMIBC episodes in the 18 months preceding the cystoscopy where the index tumor was identified) 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
* Participants with single and multiple tumor lesions
* In the opinion of the treating urologist, the participant is suitable to undergo surgery.
* Participants may have received intravesical chemotherapy at any time.
* 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
* Serum Testosterone \>= 250 ng/dL
* Thyroid stimulating hormone (TSH) within institutional 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 4 months 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 4 months 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.
* 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 4 months after the last dose of study intervention.
* Participants with suspected Carcinoma in Situ (CIS) without suspected Ta or T1 disease are not eligible.
* Participants with a history of documented CIS within 2 years are not eligible.
* Participants who have received Gacillus Calmette-Guerin (BCG) within 2 years are not eligible.

Where it's running

  • University of Arizona Cancer Center - Prevention Research Clinic
    Tucson, Arizona, United States
    Recruiting
  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio, United States
    Recruiting
  • University of Wisconsin Carbone Cancer Center - University Hospital
    Madison, Wisconsin, United States
    Recruiting
  • Cedars Sinai Medical Center
    Los Angeles, California, United States
    Not yet recruiting
  • National Cancer Institute Urologic Oncology Branch
    Bethesda, Maryland, United States
    Not yet recruiting
  • University of Rochester
    Rochester, New York, United States
    Not yet recruiting

Study contacts

  • Principal investigator: Edward M Messing — University of Wisconsin, Madison

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.