On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
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.
The proposed trial is warranted for two main reasons. First, no study has examined the effect
 of preoperative Finasteride on important clinical outcomes such as the incidence of red blood
 cell transfusion, standard units of red blood cells transfused, readmission, return to
 hospital, and length of hospital stay. Second, a definitive randomized, double-blind,
 placebo-controlled trial documenting the efficacy of preoperative Finasteride on blood loss
 variables (e.g., intra-operative blood loss, change in serum hemoglobin) has yet to be
 conducted.

 Participants will be recruited from the practices of Credentialed Urologists at the Alberta
 Urology Institute (AUI) and UAH in Edmonton, Alberta, Canada. The eligibility criteria
 include medical, demographic, and logistic criterion, and focus on internal validity as well
 as external validity. Eligibility criteria for the study are: (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, (6) no active psychiatric condition, (7) no previous Finasteride use, (8)
 normal DRE, (9) PSA greater than or equal to 4.0 ng/ml, (10) no current anticoagulation use
 (Heparin, Warfarin), (11) no ESRD, (12) no previous prostate or urethral surgery, and (13)
 not deemed to be a candidate for immediate surgery (within 1 week of initial evaluation).
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).