Could a prostate drug help fight bladder cancer?
NCT ID NCT05521698
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This early-stage trial is testing whether bicalutamide, a drug typically used for prostate cancer, can change a protein linked to bladder cancer growth. Researchers will compare men with non-muscle invasive bladder cancer who take the drug to those who don't. The goal is to see if the drug affects the EGFR protein, which may help guide future treatments. About 80 men will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars Sinai Medical Center
NOT_YET_RECRUITINGLos Angeles, California, 90048, United States
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National Cancer Institute Urologic Oncology Branch
NOT_YET_RECRUITINGBethesda, Maryland, 20892, United States
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Ohio State University Comprehensive Cancer Center
NOT_YET_RECRUITINGColumbus, Ohio, 43210, United States
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University of Arizona Cancer Center - Prevention Research Clinic
RECRUITINGTucson, Arizona, 85719, United States
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University of Rochester
NOT_YET_RECRUITINGRochester, New York, 14642, United States
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University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITINGMadison, Wisconsin, 53792, United States
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