On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)

• Status: Withdrawn
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic hyperplasia (BPH). A common complication of TURP is blood loss. Preliminary data suggest that preoperative Finasteride, a 5 alpha-reductase inhibitor, may reduce blood loss during TURP. However, no study has examined the effect of preoperative Finasteride on clinical outcomes.

The study is a randomized, double-blind, placebo-controlled trial of preoperative Finasteride versus placebo in BPH patients undergoing TURP. Participants will be stratified by prostate volume (30 to 65 grams versus 66 to 100 grams) and randomly assigned to preoperative Finasteride or placebo. The primary end point is incidence of RBCT. Secondary end points are standard units of red blood cells transfused, variables related to perioperative bleeding (incidence of readmission, incidence of return to hospital, length of hospital stay), blood loss, change in serum hemoglobin, change in serum hematocrit, blood loss per gram of resected prostate tissue, operating time, change in AUA-SS, and change in HRQOL.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Collaborator: Merck Frosst Canada Ltd.
• Treatments: Finasteride

Criteria

Inclusion Criteria:

1. TRUS-confirmed prostate gland > 30 g,

2. 18 years of age or older,

3. fit and scheduled to receive TURP,

4. approval of the treating urologist,

5. able to understand and provide written informed consent in English

Exclusion Criteria:

6. active psychiatric condition,

7. previous Finasteride use,

8. abnormal DRE,

9. PSA greater than 4.0 ng/ml,

10. current anticoagulation use (Heparin, Warfarin),

11. ESRD,

12. previous prostate or urethral surgery,

13. deemed to be a candidate for immediate surgery (within 1 week of initial evaluation).