A Clinical Trial Comparing Laser TURP With and Without Dutasteride.

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00431626
First received: February 2, 2007
Last updated: July 5, 2011
Last verified: July 2011
  Purpose

The purpose of this research study is to determine if the study drug Dutasteride taken before and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and safe, long term improvement of lower urinary tract symptoms.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: Dutasteride (Avodart)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Masked Clinical Trial Comparing Laser TURP With and Without Neo-Adjuvant Dutasteride

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Primary Outcome Measure will be the mean change in AUA Symptom Index at one year.

Secondary Outcome Measures:
  • Secondary Outcome Measures will be changes in AUA Symptom Index; Urinary Symptoms, Problems Due to Urinary Symptoms, Quality of Life Due to Urinary Problems, Qmax, prostate size (transitional zone) and total prostate volume.

Estimated Enrollment: 60
Study Start Date: October 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is a male at least 50 years of age.
  • The patient's peak urinary flow rate is at least 4 ml/sec, but not greater than 15 ml/sec, and the voided volume is at least 125 ml.
  • Prostate volume must be greater than 30 grams
  • The AUA-SI is greater than or equal to 9.
  • Patient must be scheduled for a Laser TURP or eligible to be scheduled for Laser TURP
  • Patient must be able to complete the study requirements prior to the scheduled laser TURP.
  • The patient has signed the informed consent prior to the performance of any study procedures.

Exclusion Criteria:

  • The patient has had any prior surgical intervention for BPH.
  • The patient is receiving any intervention for prostate disease (either medical or surgical) or is presently enrolled in any study protocol.
  • The patient has had a previous hypersensitivity, idiosyncrasy, or clinically suspected drug reaction to dutasteride.
  • The patient has taken an alpha-1 blocker within 1 month of randomization.
  • The patient has taken finasteride or dutasteride within 3 months of randomization.
  • The patient has taken phenylephrine, pseudoephedrine, imipramine, and an anticholinergic or cholinergic medication within 4 weeks of the screening visit.
  • The patient has taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids.
  • The patient has an inability to urinate.
  • The patient has clinically significant renal or hepatic impairment (i.e., creatinine greater than 2.0 mg/dl or AST greater than 1.5 times the upper limit of normal).
  • The patient has a PSA level greater than 10 ug/ml (Hybritech).
  • The patient requires the daily use of a pad or device for incontinence.
  • The patient has had an episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.
  • The patient has a penile prosthesis or artificial urinary sphincter.
  • The patient has a history or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, prior surgery for BPH, or bladder neck obstruction.
  • The patient has an active urinary tract disease or has undergone cystoscopy or biopsy of the prostate within two weeks prior to the first screening visit.
  • The patient has known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
  • The patient has had documented bacterial prostatitis within the past year.
  • The patient has had two documented urinary tract infections of any type in the past year. A urinary tract infection is defined as >100,000 colonies per ml urine from midstream clean catch or catheterized specimen.
  • The patient has a severe bleeding disorder that makes laser TURP impossible.
  • The patient must be able to stop any anticoagulant, NSAID or anti-platelet for 7 days prior to the laser TURP.
  • The patient has had cancer that is not considered cured (except basal cell or squamous cell carcinoma of the skin). A patient is considered cured if there has been no evidence of cancer within five years of randomization.
  • The patient has a diagnosis of a thought disorder (i.e., schizophrenia, bipolar disorder)
  • The patient has any serious medical condition likely to impede successful completion of the study.
  • The patient has a defibrillator that cannot be deactivated during laser TURP treatment.
  • A bladder neck to verumontanum distance which is less than 30mm in length as measured by flexible cystoscopy and a total prostate volume <25 ml or >110 ml as measured by prostate volume ellipsoid formula during TRUS.
  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: NCT00431626

Sponsors and Collaborators
Northwestern University
GlaxoSmithKline
Investigators
Principal Investigator: Kevin T. McVary, MD Northwestern University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00431626     History of Changes
Other Study ID Numbers: 0348-040
Study First Received: February 2, 2007
Last Updated: July 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Benign
Prostatic
Hyperplasia
Lower
Urinary
Track
Symptoms
Laser
Transurethral
Prostate

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

ClinicalTrials.gov processed this record on October 01, 2014