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Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Kaunas University of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kaunas University of Medicine
ClinicalTrials.gov Identifier:
NCT00780754
First received: October 26, 2008
Last updated: October 27, 2008
Last verified: October 2008
History of Changes
  Purpose

Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups: dutasteride treatment group and watchful waiting strategy group. According to the study protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after randomization.

There are assessed the rate of prostate cancer at repeated transrectal ultrasound guided biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).


Condition Intervention Phase
Prostate Cancer
 Drug: dutasteride
Procedure: prostate biopsy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate

Resource links provided by NLM:

Drug Information available for: Dutasteride
U.S. FDA Resources

Further study details as provided by Kaunas University of Medicine:

Primary Outcome Measures:
  • rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN [ Time Frame: 6, 12, 24, and 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN). [ Time Frame: 6, 12, 24, and 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: April 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dutasteride
treatment group
 Drug: dutasteride
0.5mg
Procedure: prostate biopsy
prostate biopsy
Active Comparator: watchful waiting strategy Procedure: prostate biopsy
prostate biopsy

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age - 40-80 years
  2. HPIN on prostate biopsy specimens
  3. PSA below 20ng/ml
  4. No hormone therapy or radiation in pelvic region
  5. No previous treatment with 5alfa reductase inhibitors
  6. Signed Subject Information and Informed Subject Consent Form.

Exclusion Criteria:

1. Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780754

Contacts
Contact: Stasys Auskalnis +37037326090 auskalnis74@gmail.com

Locations
Lithuania
Urology dep. of Kaunas University of Medicine Recruiting
Kaunas, Lithuania, 50009
Contact: Daimantas Milonas, MD, PhD     +370 37 326090     daimantasmilonas@yahoo.com    
Contact: Stasys Auskalnis     +370 37 326090     auskalnis74@gmail.com    
Principal Investigator: Daimantas Milonas, assist professor            
Sponsors and Collaborators
Kaunas University of Medicine
Investigators
Principal Investigator: Daimantas Milonas, assist professor Kaunas Medical University
  More Information

No publications provided

Responsible Party: Stasys Auskalnis, Kaunas University of Medicine
ClinicalTrials.gov Identifier: NCT00780754     History of Changes
Other Study ID Numbers: BE-2-27
Study First Received: October 26, 2008
Last Updated: October 27, 2008
Health Authority: Lithuania: Kaunas University of Medicine

Keywords provided by Kaunas University of Medicine:
prostate cancer
chemoprevention
dutasteride

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
 Prostatic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013