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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Lithuania
Study Type
Interventional
Intervention
dutasteride
prostate biopsy
Sponsored by
Kaunas University of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer, chemoprevention, dutasteride

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Urology dep. of Kaunas University of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dutasteride

watchful waiting strategy

Arm Description

treatment group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).

Full Information

First Posted
October 26, 2008
Last Updated
March 4, 2018
Sponsor
Kaunas University of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00780754
Brief Title
Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia
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 Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (Actual)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaunas University of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, chemoprevention, dutasteride

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dutasteride
Arm Type
Experimental
Arm Description
treatment group
Arm Title
watchful waiting strategy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
dutasteride
Intervention Description
0.5mg
Intervention Type
Procedure
Intervention Name(s)
prostate biopsy
Intervention Description
prostate biopsy
Primary Outcome Measure Information:
Title
rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN
Time Frame
6, 12, 24, and 36 months
Secondary Outcome Measure Information:
Title
effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).
Time Frame
6, 12, 24, and 36 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age - 40-80 years HPIN on prostate biopsy specimens PSA below 20ng/ml No hormone therapy or radiation in pelvic region No previous treatment with 5alfa reductase inhibitors Signed Subject Information and Informed Subject Consent Form. Exclusion Criteria: 1. Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daimantas Milonas, assist professor
Organizational Affiliation
Kaunas Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology dep. of Kaunas University of Medicine
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania

12. IPD Sharing Statement

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

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