Apalutamide for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byEdward M Messing

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase I trial evaluates the effects of apalutamide, compared to placebo, on epidermal growth factor receptor (EGFR) protein expression 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 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.

Eligibility Criteria

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.

Inclusion Criteria

Your testosterone levels are at least 300 ng/dL.

Ability to understand and the willingness to sign a written informed consent document

I have one or more tumors.

+12 more

Exclusion Criteria

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

I haven't taken hormone therapies or anti-hormone treatments in the last 6 months.

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

+3 more

Participant Groups

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.

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.

Apalutamide is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Erleada for: