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

Back to Clinical Trials

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

INTRODUCTION

  • Org Study ID: 2026-0131
  • Secondary ID: N/A
  • NCT ID: NCT05521698
  • Sponsor: University of Wisconsin, Madison

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.

DETAILED DESCRIPTION

PRIMARY OBJECTIVE:

1. To compare epidermal growth factor receptor (EGFR) messenger ribonucleic acid (mRNA) expression measured by reverse transcriptase polymerase chain reaction (rt-PCR) in normal appearing urothelium adjacent to tumor (measured as a ratio relative to urothelium and lamina-propria specific markers) in participants treated with anti-androgen therapy versus (vs.) participants given NSD.

SECONDARY OBJECTIVES:

1. To determine effect of bicalutamide on EGFR expression (by rtPCR) in the subgroup of patients whose normal appearing urothelium adjacent to tumor expresses the androgen receptor (AR) (at least "1" by immunohistochemistry [IHC] score).
2. To correlate AR expression in adjacent urothelium (by IHC score) with EGFR expression by rtPCR in participants randomized to bicalutamide versus NSD.
3. Comparison of pre vs. post intervention urinary biomarkers (CxBladderTM) in both groups, examining the 5 RNAs (by RT-PCR) that make up the test, both as a group and each RNA separately.

EXPLORATORY OBJECTIVES:

1. Comparison of AR and EGFR (and possibly phosphorylated EGFR [pEGFR]) staining levels (low, moderate, high; by immunocytology) in pre-treatment vs. post-treatment bladder wash immunocytology.
2. To compare expression of direct androgen response gene (ADAR)-2 measured by rtPCR in normal appearing adjacent (to tumor) urothelium that does and does not express AR (by IHC), in participants randomized to bicalutamide versus NSD.
3. Ki-67 expression (by IHC) in normal appearing urothelium adjacent to tumor in participants randomized to bicalutamide versus NSD.
4. Subgroup analysis of Ki-67 expression in the AR+ subgroup.
5. Differences in expression of AR, EGFR, pEGFR, and Ki-67 (by semi-quantitative IHC) in tumor in participants randomized to bicalutamide versus NSD.
6. Change in EGFR expression by rt-PCR in tumor in participants randomized to bicalutamide versus NSD.
7. Fibroblast growth factor receptor 3 (FGFR3) mutation analysis in deoxyribonucleic acid (DNA) extracted from formalin fixed paraffin embedded (FFPE) blocks from neighboring normal urothelium and tumor tissue in participants randomized to bicalutamide versus NSD.
8. Define changes in the tumor immune microenvironment pre- and post-bicalutamide through liquid biopsies of blood and urine using high-dimensional flow cytometry.
9. Analyze tumor (biopsy specimen) immune microenvironment via multiplex immunofluorescence and spatial transcriptomics.
10. Other exploratory markers such as changes in the urinary microbiome in bladder cancer participants randomized to bicalutamide versus NSD.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive bicalutamide orally (PO) once daily (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.

ARM 2: Patients receive NSD PO QD on days 1-21. Patients undergo TURBT on day 21. Up to 28 days of NSD 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.

After completion of study treatment, patients are followed up 20-30 days after TURBT.



  • Overall Status
    Recruiting
  • Start Date
    June 25, 2026
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Average Epidermal Growth Factor Receptor (EGFR) expression level

Primary Outcome 1 - Timeframe: Up to 28 days

CONDITION

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

ELIGIBILITY

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., * 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.

Gender: Male

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Edward M Messing

Role: Principal Investigator

Affiliation: University of Wisconsin, Madison

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: University of Arizona Cancer Center - Prevention Research Clinic
Tucson, Arizona 85719
United States 		Status: Recruiting Contact: Contact
Juan Chipollini
520-694-4032
[email protected]

Principal Investigator
Juan Chipollini
Facility: Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States 		Status: Recruiting Contact: Contact
Debasish Sundi
219-713-9783
[email protected]

Principal Investigator
Debasish Sundi
Facility: University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
United States 		Status: Recruiting Contact: Contact
Kyle A. Richards
608-262-0759
[email protected]

Principal Investigator
Kyle A. Richards

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