Benign Prostatic Hypertrophy Clinical Trial
Official title:
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 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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