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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: dutasteride; Procedure: prostate biopsy

• Registration Number: NCT00780754
• Lead Sponsor: Kaunas University of Medicine

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Status Verified: 2008-10
• Study First Submitted: 2008-10-26
• Study First Submitted QC: 2008-10-27
• Study First Posted: 2008-10-28
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2018-03-04
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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.

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Exclusion Criteria

1. Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dutasteride	dutasteride	treatment group
watchful waiting strategy	prostate biopsy	-
dutasteride	prostate biopsy	treatment group

Primary Outcome Measures

Name	Time	Method
rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN	6, 12, 24, and 36 months

Secondary Outcome Measures

Name	Time	Method
effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).	6, 12, 24, and 36 months

Trial Locations

Locations (1)

Urology dep. of Kaunas University of Medicine; 🇱🇹 Kaunas, Lithuania