Bicalutamide for Non-Muscle Invasive Bladder Cancer

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

Recruiting Phase 1 Interventional Study
Non-Muscle Invasive Bladder Urothelial Carcinoma Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Prevention
Participants needed
80 (estimated)
Sponsor
University of Wisconsin, Madison · Other
Who this trial is looking for

This trial is looking for adult men with non-muscle invasive bladder cancer. Participants will take bicalutamide, a medication that may help block tumor growth and spread, while the effects on a specific protein related to cancer will be studied.

Are You a Good Fit for This Trial?
Must not be taking Warfarin
Rules you out Muscle-invasive cancerNon-urothelial bladder cancer

You may be able to join if

  • I am a biologic male adult aged 18 or older.
  • I have non-muscle invasive bladder cancer as seen by a doctor.
  • I have had imaging of my abdomen and pelvis within the last 6 months.
  • I have either a new diagnosis or infrequent recurrences of bladder cancer.
  • I do not have upper tract cancer or invasive disease.
  • I am in good health based on my doctor's assessment.
  • My testosterone levels are 250 ng/dL or higher.
  • I understand the study and agree to participate.

You may not be able to join if

  • I have taken anti-androgen treatments in the last 6 months.
  • I have a history of allergic reactions to bicalutamide.
  • I have had muscle-invasive cancer or non-urothelial bladder cancer.
  • I have had radiation therapy to my pelvis or prostate.
  • I have severe heart problems or unstable medical conditions.
  • I am allergic to bicalutamide or cannot take it.
  • I plan to father a child during the study or shortly after.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 c…
Trial Locations
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Eligibility 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 app…
Contacts

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