Enzalutamide for Bladder Cancer Chemoprevention

• Status: Terminated
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Astellas Pharma Inc
• Treatments: Androgens

Criteria

Inclusion Criteria:

1. Subjects with histologically confirmed NMIBC who have undergone their TURBT.

2. 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.

3. Subjects who receive BCG instillations post-operatively will be eligible for enrollment.

4. Subjects whose tumors are AR(+) as well as AR(-) will be included, but we will restrict inclusion of AR(-) subjects so that they represent no more than 1/3 of the total study population, or any single cohort (ie. the intermediate or high-risk groups).

5. Subjects of child-bearing potential must agree to 2 acceptable forms of birth control.

Exclusion Criteria:

1. Subjects with "low risk" bladder cancer, as defined by the EAU guidelines21, will be ineligible for enrollment.

2. Subjects with "high risk" bladder cancer who do not undergo BCG therapy following their TURBT will be ineligible for enrollment.

3. 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.

4. Subjects who receive an immediate post-TURBT single instillation of intravesical chemotherapy will be ineligible for enrollment.

5. 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.

6. Subjects who undergo blue-light/fluorescence cystoscopy will be ineligible for enrollment.

7. Subjects with a history of heart attack within the previous 12 months or who have unstable cardiovascular status will be ineligible for enrollment.

8. 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.

9. Subjects with a history of venous thrombo-embolism (DVT/PE) within the past 3 years.

10. 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.

11. 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.

12. Subjects with kidney disease with an estimated glomerular filtration rate (eGFR) < 30 will be ineligible.

13. Subjects with neutropenia will be ineligible.

14. 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.

15. 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.

16. Subjects with prior histories of prostate cancer treated by definitive local therapy > 5 years ago will only be eligible if they have had no clinical or biochemical evidence of recurrent prostate cancer.