← Back to Search

Androgen Receptor Inhibitor

Apalutamide for Bladder Cancer

Phase 1

Waitlist Available

Led By Edward M Messing

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Eastern Cooperative Oncology Group (ECOG) performance status =< 1

Must not have

History of radiation therapy to the pelvis, prostate or prostatic bed, or rectum

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days

Summary

This trial is testing a medication to see if it stops the growth and spread of bladder cancer cells.

Who is the study for?

This trial is for biologic male adults with non-muscle invasive bladder cancer, who are in good health and have not had certain treatments or conditions that could interfere with the study. They must be able to sign consent, have no signs of advanced disease on recent scans, and agree to use contraception.

What is being tested?

The trial is testing if Apalutamide affects a protein called EGFR in patients with non-muscle invasive bladder cancer. It includes biospecimen collection, questionnaires, surgery to remove the tumor from the bladder, and administration of Apalutamide.

What are the potential side effects?

Apalutamide may cause side effects such as fatigue, high blood pressure, rash, diarrhea, weight loss and fractures. It can also affect liver function tests and might lead to falls or injuries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My recent scans show no signs of cancer spread in my abdomen or pelvis.

Select...

I am fully active and can carry on all pre-disease activities without restriction.

Select...

I am a man and I am 18 years old or older.

Select...

My bladder cancer is suspected to be non-muscle invasive, as confirmed by a specialist.

Select...

I have been recently diagnosed with bladder cancer or it has come back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had radiation therapy to my pelvis, prostate, or rectum.

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Select...

I have had bladder cancer that spread into the muscle or other types of urinary cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Epidermal Growth Factor Receptor (EGFR) expression level

Secondary study objectives

AR expression in adjacent urothelium

Effect of apalutamide on EGFR expression

Toxicity of treatment

Other study objectives

AR and EGFR (and possibly phosphorylated EGFR [pEGFR]) staining levels

AR, EGFR, and pEGFR in biopsies of tumors

Analysis of fibroblast growth factor receptor 3 (FGFR3) in deoxyribonucleic acid (DNA)

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 1 (apalutamide,TURBT)Experimental Treatment5 Interventions

Patients receive apalutamide PO QD on days 1-21. Patients undergo TURBT on day 21. Up to 28 days of apalutamide 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.

Group II: Arm 2 (placebo, TURBT)Placebo Group5 Interventions

Patients receive placebo PO QD on days 1-21. Patients undergo TURBT on day 21. Up to 28 days of placebo 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 3

~2020