A Clinical Trial Comparing Laser TURP With and Without Dutasteride.

NCT00431626 | Terminated Phase 3 Results DMC

• 1 other identifier: 0348-040
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign; Prostatic; Hyperplasia; Lower; Urinary; Track; Symptoms; Laser; Transurethral; Prostate

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index

  AUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)

  one year

Study Arms (2)

Laser TURP with dutasteride

EXPERIMENTAL

Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient

Drug: Dutasteride (Avodart)

Laser TURP with placebo

PLACEBO COMPARATOR

Prior to and after standard treatment with laser TURP, placebo is applied to each patient

Drug: Placebo

Interventions

Dutasteride (Avodart) DRUG

Laser TURP with dutasteride

Placebo DRUG

Placebo before and after treatment of TURP

Laser TURP with placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Conditions

Prostatic Hyperplasia; Hyperplasia

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Difficulty in recruitment forced the closing of this trial.

Results Point of Contact

• Title: Borko D. Jovanovic, MS, PhD
• Organization: Northwestern U

borko@northwestern.edu

312 503 2008

Study Officials

• Kevin T. McVary, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2007
• First Posted: February 6, 2007
• Study Start: October 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 28, 2015
• Results First Posted: January 1, 2015

Record last verified: 2015-10