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

A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)

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).

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hypertrophy
• Intervention / Treatment: Drug: Dutasteride

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

1. 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.
2. 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. 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)
2. Prostate volume > 30cc and < 80cc by transrectal ultrasound measurement
3. Total Serum PSA of < 15 ng/ml (corrected for Finasteride therapy)
4. Willingness and ability to give written informed consent and comply with study instructions and procedures.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study drug; Open label, single arm	Drug: Dutasteride; once daily dosing of 0.5mg Dutasteride for 12 months; Other Names: Avodart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess safety and tolerability of Dutasteride	12 months

Collaborators and Investigators

• Sponsor: North Florida/South Georgia Veterans Health System
• Investigators: Principal Investigator: Unyime O Nseyo, M.D., NF/SGVAHS

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: September 28, 2006
• First Submitted That Met QC Criteria: September 28, 2006
• First Posted (Estimate): September 29, 2006

Study Record Updates

• Last Update Posted (Estimate): October 19, 2012
• Last Update Submitted That Met QC Criteria: October 18, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Hormonal therapy; Dutasteride; Benign Prostatic Hypertrophy; Benign Prostatic Enlargement; 5-alpha reductase inhibitors
• Additional Relevant MeSH Terms: Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Hypertrophy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Dutasteride
• Other Study ID Numbers: AVODART-550-04