Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia
Information source: Kaunas University of Medicine
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: dutasteride (Drug); prostate biopsy (Procedure)
Phase: Phase 3
Status: Recruiting
Sponsored by: Kaunas University of Medicine Official(s) and/or principal investigator(s):
Daimantas Milonas, assist professor, Principal Investigator, Affiliation: Kaunas Medical University
Overall contact:
Stasys Auskalnis, Phone: +37037326090, Email: auskalnis74@gmail.com
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).
Clinical Details
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
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN
Secondary outcome: effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Male.
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.
Locations and Contacts
Stasys Auskalnis, Phone: +37037326090, Email: auskalnis74@gmail.com
Urology dep. of Kaunas University of Medicine, Kaunas 50009, Lithuania; Recruiting
Daimantas Milonas, MD, PhD, Phone: +370 37 326090, Email: daimantasmilonas@yahoo.com
Stasys Auskalnis, Phone: +370 37 326090, Email: auskalnis74@gmail.com
Daimantas Milonas, assist professor, Principal Investigator
Additional Information
Starting date: April 2007
Ending date: December 2010
Last updated: October 27, 2008
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