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.

Study Overview

• Status: Withdrawn
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Placebo; Drug: Finasteride

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).

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 4B9
      • Alberta Urology Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo; Placebo once daily for 8 weeks
Active Comparator: 1; Finasteride 5 mg PO once daily for 8 weeks prior to TURP	Drug: Finasteride; Finasteride 5 mg PO once daily for 8 weeks prior to TURP; Other Names: Proscar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	During/post surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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	during/post surgery

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Merck Frosst Canada Ltd.
• Investigators: Principal Investigator: Howard Evans, MD, AUIRC/University of Alberta

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: November 26, 2007
• First Submitted That Met QC Criteria: November 26, 2007
• First Posted (Estimate): November 28, 2007

Study Record Updates

• Last Update Posted (Actual): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Finasteride
• Other Study ID Numbers: E-2007