On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
Information source: University of Alberta
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: Finasteride (Drug); Placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: University of Alberta Official(s) and/or principal investigator(s):
Howard Evans, MD, Principal Investigator, Affiliation: AUIRC/University of Alberta
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.
Clinical Details
Official title: On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: 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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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).
Locations and Contacts
Alberta Urology Institute, Edmonton, Alberta T5H 4B9, Canada
Additional Information
Starting date: February 2008
Ending date: February 2011
Last updated: June 16, 2008
|
