Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)
Information source: North Florida/South Georgia Veterans Health System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hypertrophy
Intervention: Dutasteride (Drug)
Phase: N/A
Status: Completed
Sponsored by: North Florida/South Georgia Veterans Health System Official(s) and/or principal investigator(s): Unyime O Nseyo, M.D., Principal Investigator, Affiliation: NF/SGVAHS
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).
Clinical Details
Official title: A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS
Secondary outcome: To assess safety and tolerability of 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.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: November 2004
Last updated: October 18, 2012
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