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

NCT ID: NCT00564460

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Finasteride

Intervention Type DRUG

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

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once daily for 8 weeks

Interventions

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Finasteride

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

Intervention Type DRUG

Placebo

Placebo once daily for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Proscar

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Frosst Canada Ltd.

INDUSTRY

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard Evans, MD

Role: PRINCIPAL_INVESTIGATOR

AUIRC/University of Alberta

Locations

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Alberta Urology Institute

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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E-2007

Identifier Type: -

Identifier Source: org_study_id

NCT00547430

Identifier Type: -

Identifier Source: nct_alias