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

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ClinicalTrials.gov Identifier: NCT00780754
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Stasys Auskalnis, Lithuanian University of Health Sciences

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Drug: dutasteride Procedure: prostate biopsy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : April 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride

Arm Intervention/treatment
Experimental: dutasteride
treatment group
Drug: dutasteride
0.5mg

Procedure: prostate biopsy
prostate biopsy

Active Comparator: watchful waiting strategy Procedure: prostate biopsy
prostate biopsy




Primary Outcome Measures :
  1. rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN [ Time Frame: 6, 12, 24, and 36 months ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780754


Locations
Lithuania
Urology dep. of Kaunas University of Medicine
Kaunas, Lithuania, 50009
Sponsors and Collaborators
Kaunas University of Medicine
Investigators
Principal Investigator: Daimantas Milonas, assist professor Kaunas Medical University

Responsible Party: Stasys Auskalnis, doctor, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT00780754     History of Changes
Other Study ID Numbers: BE-2-27
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: October 2008

Keywords provided by Stasys Auskalnis, Lithuanian University of Health Sciences:
prostate cancer
chemoprevention
dutasteride

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs