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NCT05521698 · ClinicalTrials.gov registry record · Phase 1
A Randomized Trial of Bicalutamide in Non-Muscle Invasive Bladder Cancer
A Phase 1 study, sponsored by University of Wisconsin, Madison.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT05521698: Recruiting Phase 1 study, sponsored by University of Wisconsin, Madison.
NCT05521698 is a Phase 1 study that is actively recruiting participants, run by University of Wisconsin, Madison. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05521698, a Phase 1 study, is actively recruiting participants, sponsored by University of Wisconsin, Madison.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study 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.
Primary Outcome
Will be analyzed as a continuous variable. A two-sample t-test will be conducted to test whether there are significant differences of the log-transformed EGFR expression level (measured by reverse transcriptase polymerase chain reaction \[rtPCR\]) in normal appearing urothelium adjacent to tumor in participants treated with anti-androgen therapy versus (vs.) NSD participants. In case the normality assumption of the two-sample t-test does not hold, Wilcoxon rank-sum test will be performed as a se
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- OTHER Questionnaire Administration
- DRUG Bicalutamide
- PROCEDURE Transurethral Resection of Bladder Tumor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-06-25 |
| Est. Completion | 2028-12-01 |
| Phase | Phase 1 |
What NCT05521698 shows while recruiting
NCT05521698 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05521698 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05521698 about?
NCT05521698 is a clinical study titled "A Randomized Trial of Bicalutamide in Non-Muscle Invasive Bladder Cancer". 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 blo...
What is the current status of trial NCT05521698?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2026-06-25. Estimated completion is 2028-12-01.
What interventions are being tested in trial NCT05521698?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Questionnaire Administration (OTHER), Bicalutamide (DRUG), Transurethral Resection of Bladder Tumor (PROCEDURE).
Who is sponsoring clinical trial NCT05521698?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05521698's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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