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

NCT00564460 | Withdrawn Phase 3

• 1 other identifier: E-2007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Finasteride 5 mg PO once daily for 8 weeks prior to TURP

Drug: Finasteride

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Finasteride DRUG

Finasteride 5 mg PO once daily for 8 weeks prior to TURP

Also known as: Proscar

1

Placebo DRUG

Placebo once daily for 8 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TRUS-confirmed prostate gland \> 30 g,
• years of age or older,
• fit and scheduled to receive TURP,
• approval of the treating urologist,
• able to understand and provide written informed consent in English

You may not qualify if:

• active psychiatric condition,
• previous Finasteride use,
• abnormal DRE,
• PSA greater than 4.0 ng/ml,
• current anticoagulation use (Heparin, Warfarin),
• ESRD,
• previous prostate or urethral surgery,
• deemed to be a candidate for immediate surgery (within 1 week of initial evaluation).

Sponsors & Collaborators

• University of Alberta: lead
• Merck Frosst Canada Ltd.: collaborator

Study Sites (1)

Alberta Urology Institute

Edmonton, Alberta, T5H 4B9, Canada

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Finasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Howard Evans, MD

  AUIRC/University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 28, 2007
• Study Start: February 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 30, 2017

Record last verified: 2009-11

Locations

CA (1)