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Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate


Phase 3
40 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN

Outcome Time Frame:

6, 12, 24, and 36 months

Safety Issue:

Yes

Principal Investigator

Daimantas Milonas, assist professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kaunas Medical University

Authority:

Lithuania: Kaunas University of Medicine

Study ID:

BE-2-27

NCT ID:

NCT00780754

Start Date:

April 2007

Completion Date:

December 2010

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • chemoprevention
  • dutasteride
  • Neoplasms
  • Prostatic Neoplasms

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