Enzalutamide for Bladder Cancer Chemoprevention

NCT02605863 | Terminated Phase 2 Results DMC

• 1 other identifier: 52539
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Bladder Cancer

Keywords

Enzalutamide; Non-Muscle Invasive Bladder Cancer; Androgen Deprivation Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Recurrent Disease

  Bladder cystoscopy, urine cytology, and pathology report

  1 year

Study Arms (2)

Intermediate Risk NMIBC

EXPERIMENTAL

Enzalutamide 160mg by mouth daily for 12 months

Drug: Enzalutamide

High Risk NMIBC

EXPERIMENTAL

Enzalutamide 160mg by mouth daily for 12 months

Drug: Enzalutamide

Interventions

Enzalutamide DRUG

160 mg by mouth daily for 12 months

Also known as: Xtandi

High Risk NMIBC; Intermediate Risk NMIBC

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histologically confirmed NMIBC who have undergone their TURBT.
• Per the European Association of Urology (EAU) guidelines, only subjects with "Intermediate" or "High risk" bladder cancer will be enrolled21:
• For patients with "high risk" bladder cancer, only those who undergo BCG therapy following their TURBT will be eligible for enrollment.
• Subjects who receive BCG instillations post-operatively will be eligible for enrollment.
• Subjects of child-bearing potential must agree to 2 acceptable forms of birth control.

You may not qualify if:

• Subjects with "low risk" bladder cancer, as defined by the EAU guidelines21, will be ineligible for enrollment.
• Subjects with "high risk" bladder cancer who do not undergo BCG therapy following their TURBT will be ineligible for enrollment.
• Subjects who have "failed" BCG therapy in the past (had a recurrence of bladder cancer despite prior use of BCG) will be ineligible for enrollment.
• Subjects who receive an immediate post-TURBT single instillation of intravesical chemotherapy will be ineligible for enrollment.
• Subjects who receive a post-operative induction course of intravesical chemotherapy (ie. more than just a single immediate post-operative dose of intravesical chemotherapy) will be ineligible for enrollment.
• Subjects who undergo blue-light/fluorescence cystoscopy will be ineligible for enrollment.
• Subjects with a history of heart attack within the previous 12 months or who have unstable cardiovascular status will be ineligible for enrollment.
• Subjects who have uncontrolled hypertension (for our purposes, defined as those having a systolic blood pressure \> 160 documented on 2 occasions despite appropriate medical therapy) will similarly be ineligible.
• Subjects with a history of venous thrombo-embolism (DVT/PE) within the past 3 years.
• Subjects with a history of seizure disorders, or those with a history of stroke or transient ischemic attacks (TIA) within the previous 12 months will be ineligible.
• Subjects with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal will be ineligible.
• Subjects with kidney disease with an estimated glomerular filtration rate (eGFR) \< 30 will be ineligible.
• Subjects with neutropenia will be ineligible.
• Subjects with clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with various forms of hormonal therapy (not including 5-alpha reductase inhibitors) will also be ineligible for study enrollment.
• Subjects who have undergone therapy for any malignancy within the past 5 years except for basal and squamous cell carcinomas of the skin will also be ineligible.

Sponsors & Collaborators

• University of Rochester: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Edward Messing, ND
• Organization: University of Rochester

edward_messing@urmc.rochester.edu

585-275-0998

Study Officials

• Edward E. Messing, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 16, 2015
• Study Start: January 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: October 3, 2018
• Results First Posted: May 7, 2018

Record last verified: 2018-09

Locations

US (1)