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

This study has been withdrawn prior to enrollment.
(Change of practice pattern. Green light laser)
Sponsor:
Collaborator:
Merck Frosst Canada Ltd.
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00564460
First received: November 26, 2007
Last updated: November 4, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: Finasteride
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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. [ Time Frame: During/post surgery ]

Secondary Outcome Measures:
  • 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 [ Time Frame: during/post surgery ]

Estimated Enrollment: 310
Study Start Date: February 2008
Estimated Study Completion Date: February 2011
Arms Assigned Interventions
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 Name: Proscar
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo once daily for 8 weeks

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564460

Locations
Canada, Alberta
Alberta Urology Institute
Edmonton, Alberta, Canada, T5H 4B9
Sponsors and Collaborators
University of Alberta
Merck Frosst Canada Ltd.
Investigators
Principal Investigator: Howard Evans, MD AUIRC/University of Alberta
  More Information

No publications provided

Responsible Party: Howard Evans, University of Alberta
ClinicalTrials.gov Identifier: NCT00564460     History of Changes
Obsolete Identifiers: NCT00547430
Other Study ID Numbers: E-2007
Study First Received: November 26, 2007
Last Updated: November 4, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Finasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014