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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Unyime O. Nseyo, MD, North Florida/South Georgia Veterans Health System
ClinicalTrials.gov Identifier:
NCT00382356
First received: September 28, 2006
Last updated: October 18, 2012
Last verified: October 2012

September 28, 2006
October 18, 2012
November 2004
July 2009   (final data collection date for primary outcome measure)
Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • AUASS
  • The primary outcome measures of efficacywill be:
  • Improvement in flowmetry
  • PVR
  • Quality of life measurement
  • PSA
  • Prostate volume.
Complete list of historical versions of study NCT00382356 on ClinicalTrials.gov Archive Site
To assess safety and tolerability of Dutasteride [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To assess safety and tolerability of Dutasteride
  • To assess clinical and histopathological effects of Dutasteride in the treated patients who eventually undergo prostatectomy.
Not Provided
Not Provided
 
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 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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Benign Prostatic Hypertrophy
Drug: Dutasteride
once daily dosing of 0.5mg Dutasteride for 12 months
Other Name: Avodart
Experimental: study drug
Open label, single arm
Intervention: Drug: Dutasteride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Male
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00382356
AVODART-550-04
Yes
Unyime O. Nseyo, MD, North Florida/South Georgia Veterans Health System
North Florida/South Georgia Veterans Health System
Not Provided
Principal Investigator: Unyime O Nseyo, M.D. NF/SGVAHS
North Florida/South Georgia Veterans Health System
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP