Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT00382356
Status:
COMPLETED
Last Update Posted:
2012-10-19
First Post:
2006-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)
Sponsor:
North Florida/South Georgia Veterans Health System
Organization:
Study Overview
Official Title:
A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: