Enzalutamide for Bladder Cancer Chemoprevention

Bladder Cancer Clinical Trial

Official title: The Effect of Androgen Deprivation Therapy With Enzalutamide on Bladder Cancer Chemoprevention

Status Terminated

Clinical Trial Summary

The purpose of this study is to examine the effect of androgen deprivation therapy through administration of enzalutamide on preventing bladder cancer recurrences in patients with non-muscle invasive bladder cancer (NMIBC).

Clinical Trial Description

• A blood draw and an electrocardiogram (EKG). The blood draw will check levels of testosterone, dihydro-testosterone, estradiol, and Vitamin D. Pre-study blood-work will also include a complete blood count (CBC), basic metabolic panel (BMP/CHEM8) and liver function test (LFT) if any of these labs were not drawn within 1 month prior to the transurethral resection of bladder tumor (TURBT).

• Bladder tumor sample that is stored in the Department of Pathology will have additional tests run on it to confirm study eligibility and to test for certain cell markers.

• After 1 month following the original TURBT, subjects will begin therapy with enzalutamide. The study drug will be administered orally at a dose of 160mg daily for 12 months.

• Subjects will be monitored for adverse reactions or side effects from enzalutamide at scheduled office visits.

• If the bladder tumor is classified as being "intermediate risk", regularly scheduled office visits will occur at 2 months post-operatively (i.e., 1 month after starting enzalutamide), and then again at post-operative months 3, 6, 9 and 12, as is part of the usual standard of care.

• If the bladder tumor is classified as being "high risk" and the subject receives BCG therapy, then the office visits will occur on a slightly different schedule to conform to the standard of care for this type of disease. Subjects in this group typically start their intravesical BCG instillations 4-6 weeks post-operatively. Therefore, the subjects will be seen approximately 1 month following the initial TURBT, and will begin therapy with enzalutamide at that time, as described above. Subjects will be on study drug at least 7 days prior to the initiation of BCG therapy, which will occur once a week for 6 weeks. Similar to the subjects in the intermediate risk group, the subjects receiving BCG will also be seen 1 month after initiation of enzalutamide therapy to ensure there are no adverse reactions to the study drug. Following this visit, they will be seen again at the time of the post-BCG cystoscopy, which occurs 1 month after your 6th instillation. Subjects will be seen again at the 3, 6, 9 and 12-month post-BCG cystoscopy office visits, as part of routine care.

• Repeat blood work (CBC, BMP and LFTs) will be checked 1 month after starting enzalutamide (approximately 2 months post-operatively). For subjects with intermediate risk bladder cancer, these labs will be checked again at 3, 6, 9 and 12 months post-operatively (as per the regularly scheduled office visits). For the high risk patients receiving BCG therapy, these labs will be checked again at the 1, 3, 6 and 9-month post-BCG office visits (per the regularly scheduled office visits for these patients).

• An EKG will be obtained at baseline (before starting the study drug), but will also be re-checked at approximately 6 months (half-way through therapy with enzalutamide) to ensure there are no signs of worsening cardiac disease while on the study drug.

• A cystoscopy will be done every 3 months as part of the standard of care for bladder cancer follow-up. Lesions suspicious for tumor recurrence will be biopsied as per usual standard of care. If a recurrence is documented, subjects will discontinue use of enzalutamide.

• For subjects scheduled to undergo therapy with BCG, additional tests will be run on the urine samples that subjects will already be providing in the Urology office as part of the standard of care. ;

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

• NCT number: NCT02605863
• Study type: Interventional
• Source: University of Rochester
• Status: Terminated
• Phase: Phase 2
• Start date: January 2016
• Completion date: February 2018