A Clinical Trial Comparing Laser TURP With and Without Dutasteride.
This study has been terminated.
Information provided by (Responsible Party):
Kevin McVary, Northwestern University
First received: February 2, 2007
Last updated: January 2, 2015
Last verified: January 2015
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.
Benign Prostatic Hyperplasia
Drug: Dutasteride (Avodart)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||A Randomized, Placebo-Controlled, Double-Masked Clinical Trial Comparing Laser TURP With and Without Neo-Adjuvant Dutasteride
Primary Outcome Measures:
- Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index [ Time Frame: one year ] [ Designated as safety issue: No ]
AUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2009 (Final data collection date for primary outcome measure)
Experimental: Laser TURP with dutasteride
Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient
Drug: Dutasteride (Avodart)
Placebo Comparator: Laser TURP with placebo
Prior to and after standard treatment with laser TURP, placebo is applied to each patient
|Ages Eligible for Study:
||50 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
||Kevin T. McVary, MD
No publications provided
||Kevin McVary, Professor, Northwestern University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 2, 2007
|Results First Received:
||December 19, 2014
||January 2, 2015
||United States: Institutional Review Board
Keywords provided by Northwestern University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 26, 2015
Genital Diseases, Male
5-alpha Reductase Inhibitors
Molecular Mechanisms of Pharmacological Action