Clinical trial NCT00564460: On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
Official title: On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Merck Frosst Canada Ltd.
First posted: 2007-11-28
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

Eligibility 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).

Primary outcomes:
measure: To compare the incidence of red blood cell transfusion after TURP in BPH patients randomized to receive preoperative Finasteride with those randomized to receive placebo.
timeFrame: During/post surgery
Secondary outcomes:
measure: To compare standard units of red blood cells transfused, variables related to perioperative bleeding, blood loss, serum hemoglobin, serum hematocrit, blood loss per gram of resected prostate tissue, operating time, AUA-SS, HRQOL after TURP
timeFrame: during/post surgery
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta Urology Institute
state: Alberta
Study officials:
affiliation: AUIRC/University of Alberta
name: Howard Evans, MD
role: PRINCIPAL_INVESTIGATOR
References: