Transurethral Resection of Bladder Tumor for Urinary Bladder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Rochester, Rochester, NY
Urinary Bladder+4 More
Transurethral Resection of Bladder Tumor - Procedure
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This phase I trial tests the molecular effects of apalutamide in patients with non-muscle invasive bladder cancer. Apalutamide 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 epidermal growth factor receptor (EGFR) on tumor cells is related to bladder cancer disease progression. This trial may help doctors evaluate if apalutamide has any effect on EGFR expression in patients with non-muscle invasive bladder cancer.

Eligible Conditions

  • Urinary Bladder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Urinary Bladder

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 28 days

Up to 28 days
AR and EGFR (and possibly phosphorylated EGFR [pEGFR]) staining levels
AR expression in adjacent urothelium with EGFR expression in treated and untreated participants.
Analysis of fibroblast growth factor receptor 3 (FGFR3) in deoxyribonucleic acid (DNA)
Analysis of tumor (biopsy specimen) infiltrating CD8+ T-cells
Change in EGFR expression in tumor from treated vs. untreated participants
Changes in the tumor immune microenvironment pre- and post-apalutamide
Demographics of two groups
Differences in expression of AR, EGFR, pEGFR, and Ki-67
Effect of apalutamide on EGFR expression
Exploratory markers
Expression of direct androgen response gene (ADAR)-2
Ki-67 expression
Ki-67 expression in the AR+ subgroup
Morbidities of treatment
Pre vs. post intervention urinary biomarkers
The relative Epidermal Growth Factor Receptor (EGFR) expression level
Toxicity of treated to untreated control

Trial Safety

Safety Progress

1 of 3

Other trials for Urinary Bladder

Trial Design

2 Treatment Groups

ARM 2 (TURBT)
1 of 2
ARM 1 (apalutamide,TURBT)
1 of 2
Active Control
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Transurethral Resection of Bladder Tumor · No Placebo Group · Phase 1

ARM 1 (apalutamide,TURBT)Experimental Group · 4 Interventions: Transurethral Resection of Bladder Tumor, Apalutamide, Biospecimen Collection, Questionnaire Administration · Intervention Types: Procedure, Drug, Procedure, Other
ARM 2 (TURBT)ActiveComparator Group · 3 Interventions: Transurethral Resection of Bladder Tumor, Biospecimen Collection, Questionnaire Administration · Intervention Types: Procedure, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
2019
Completed Phase 2
~450
Biospecimen Collection
2004
Completed Phase 1
~430

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 28 days
Closest Location: University of Rochester · Rochester, NY
Photo of University of Rochester 1Photo of University of Rochester 2Photo of University of Rochester 3
2013First Recorded Clinical Trial
0 TrialsResearching Urinary Bladder
558 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,930 Previous Clinical Trials
41,294,380 Total Patients Enrolled
Edward M MessingPrincipal InvestigatorUniversity of Wisconsin, Madison

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
This study is evaluating whether apalutamide may help slow the progression of prostate cancer in men with early-stage disease.
You have a single or multiple tumor lesion.
You have a performance status of 0, 1, 2, or 3.
Total bilirubin =< 1.5 x institutional upper limit of normal (note: in participants with Gilbert's syndrome, if total bilirubin is > 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.