Clinical Trial: Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) In the Management of Symptomatic Prostatic Enlargement/Hypertro
Brief Summary: The study is to determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H).
Detailed Summary:
STUDY SUMMARY
TITLE: A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) in the Management of Symptomatic Prostatic Enlargement/Hypertrophy OBJECTIVE: To determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H)
EXPERIMENTAL PLAN:
PATIENT SELECTION: Inclusion Criteria
- Patients who demonstrate clinical evidence of failure after treatment with Finasteride for 12 or more months. Failure includes one or more of the following: (i) AUA SS > 10; (ii) Q-max < 10 cc/sec; (iii) Post void residual volume (PVR) >200cc.
- Patients who remain subjectively symptomatic of LUTS secondary to BPH after treatment with Finasteride for at least six months.
Exclusion Criteria Patients with Neurogenic Bladder/LUTS secondary to neurologic disease Patients with the diagnosis of prostate cancer Patients with an allergy to Finasteride/Dutasteride
STUDY DESIGN AND DURATION:
This will be a single institution, open label pilot study involving 26 patients over 18-24 months. Each patient will be treated with the standard dose of Dutasteride for at least twelve months and followed for an additional 12 months.
EFFICACY AND SAFETY MEASUREMENTS:
Improvement in flowmetry, AUASS and PVR will be the primary outcome measures of efficacy. Quality of life measurement will be made also. The explorator
Sponsor: North Florida/South Georgia Veterans Health System
Current Primary Outcome: Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS [ Time Frame: 12 months ]
Original Primary Outcome:
- The primary outcome measures of efficacywill be:
- Improvement in flowmetry
- AUASS
- PVR
- Quality of life measurement
- PSA
- Prostate volume.
Current Secondary Outcome: To assess safety and tolerability of Dutasteride [ Time Frame: 12 months ]
Original Secondary Outcome:
- To assess safety and tolerability of Dutasteride
- To assess clinical and histopathological effects of Dutasteride in the treated patients who eventually undergo prostatectomy.
Information By: North Florida/South Georgia Veterans Health System
Dates:
Date Received: September 28, 2006
Date Started: November 2004
Date Completion:
Last Updated: October 18, 2012
Last Verified: October 2012