Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H) - Full Text View

Sponsor:	North Florida/South Georgia Veterans Health System
Information provided by:	North Florida/South Georgia Veterans Health System
ClinicalTrials.gov Identifier:	NCT00382356

Purpose

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).

Condition	Intervention
Benign Prostatic Hypertrophy	Drug: Dutasteride

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)

Resource links provided by NLM:

Drug Information available for: Finasteride Dutasteride

U.S. FDA Resources

Further study details as provided by North Florida/South Georgia Veterans Health System:

Primary Outcome Measures:

Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess safety and tolerability of Dutasteride [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	20
Study Start Date:	November 2004
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
study drug: Experimental Open label, single arm	Drug: Dutasteride once daily dosing of 0.5mg Dutasteride for 12 months

Detailed Description:

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 exploratory measures will include PSA and prostate volume. All adverse events including tolerability of the test agent will be recorded.

SUMMARY:

A positive result showing objective (AUASS, Q-max, PVR) and subjective (satisfaction index) improvement in these previously treated patients should engender interest in a multicenter study to confirm our data. The clinical import is that this population should be switched to Dutasteride without prolonged treatment with Finasteride for no additional benefit to the patient. A failure of treatment with one hormonal agent does not necessarily imply a lack of response to another agent of the same class.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male with history of treatment with Finasteride for more than six months, and who demonstrate clinical evidence of failure (subjective symptoms of bladder outlet obstruction secondary to BPH-related LUTS; objective evidence: AUASS> 10;Q-max > 5cc/sec and <10c/sec (total voided volume of at least 125cc); post void volumes > 200cc)
Prostate volume > 30cc and < 80cc by transrectal ultrasound measurement
Total Serum PSA of < 15 ng/ml (corrected for Finasteride therapy)
Willingness and ability to give written informed consent and comply with study instructions and procedures.

Exclusion Criteria:

Clinical evidence of non-response to therapy with Finasteride for symptomatic BPH.
Total serum corrected PSA of greater than 15 ng/ml
History or clinical evidence of prostate cancer
History of acute urinary retention in three months prior.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382356

Locations

United States, Florida
Malcom Randall NF/SG Veterans Administration Health System
Gainesville, Florida, United States, 32608

Sponsors and Collaborators

North Florida/South Georgia Veterans Health System

Investigators

Principal Investigator:

Unyime o Nseyo, M.D.

NF/SGVAHS

More Information

No publications provided

Responsible Party:	North Florida/South Georgia Veterans Health System ( Unyime O. Nseyo )
Study ID Numbers:	AVODART-550-04
Study First Received:	September 28, 2006
Last Updated:	August 21, 2009
ClinicalTrials.gov Identifier:	NCT00382356 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by North Florida/South Georgia Veterans Health System:

Benign Prostatic Enlargement
Benign Prostatic Hypertrophy
Dutasteride
5-alpha reductase inhibitors
Hormonal therapy

Additional relevant MeSH terms:

Dutasteride
Finasteride
Pathological Conditions, Anatomical
Hypertrophy
Molecular Mechanisms of Pharmacological Action

Prostatic Diseases
Prostatic Hyperplasia
Enzyme Inhibitors
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010