On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
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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) |
- 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 ]
- 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 |
Inclusion Criteria:
- TRUS-confirmed prostate gland > 30 g,
- 18 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
Exclusion Criteria:
- 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).
Contacts and Locations| Canada, Alberta | |
| Alberta Urology Institute | |
| Edmonton, Alberta, Canada, T5H 4B9 | |
| 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 |
ClinicalTrials.gov processed this record on May 22, 2013