Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Prevention | Active | 40 to 80 | Other | BE-2-27 NCT00780754 |
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 Lead Organizations/Sponsors
Kaunas University of Medicine
| Daimantas Milonas, assist professor |  | Principal Investigator |
| Stasys Auskalnis | | Ph: +37037326090 |
| Email: auskalnis74@gmail.com | ||
Trial Sites
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| Lithuania | |||
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| Kaunas | |||
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| 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 Identifer NCT00780754
Information obtained from ClinicalTrials.gov on December 18, 2012
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