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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIPreventionActive40 to 80OtherBE-2-27
NCT00780754

Trial Description

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).

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Kaunas University of Medicine

    Daimantas Milonas, assist professor, Principal Investigator
    Stasys Auskalnis
    Ph: +37037326090
    Email: auskalnis74@gmail.com

    Trial Sites

    Lithuania

    Kaunas

    Kaunas University of Medicine

    Daimantas Milonas, MD, PhD
    Ph: +370 37 326090
    Email: daimantasmilonas@yahoo.com

    Stasys Auskalnis
    Ph: +370 37 326090
    Email: auskalnis74@gmail.com

    Daimantas Milonas, assist professor
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00780754
    ClinicalTrials.gov processed this data on September 16, 2014

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.