Text Size

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

October 26, 2008
October 27, 2008
April 2007
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00780754 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia
Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate

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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Prostate Cancer
  • Drug: dutasteride
    0.5mg
  • Procedure: prostate biopsy
    prostate biopsy
  • Experimental: dutasteride
    treatment group
    Interventions:
    • Drug: dutasteride
    • Procedure: prostate biopsy
  • Active Comparator: watchful waiting strategy
    Intervention: Procedure: prostate biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Male
40 Years to 80 Years
No
Contact: Stasys Auskalnis +37037326090 auskalnis74@gmail.com
Lithuania
 
NCT00780754
BE-2-27
No
Stasys Auskalnis, Kaunas University of Medicine
Kaunas University of Medicine
Not Provided
Principal Investigator: Daimantas Milonas, assist professor Kaunas Medical University
Kaunas University of Medicine
October 2008

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