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

Tracking Information

First Received Date ^ICMJE

October 26, 2008

Last Updated Date

October 27, 2008

Start Date ^ICMJE

April 2007

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN [ Time Frame: 6, 12, 24, and 36 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00780754 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: dutasteride
Procedure: prostate biopsy

Study Arms / Comparison Groups

Experimental: treatment group

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Stasys Auskalnis

+37037326090

auskalnis74@gmail.com

Location Countries ^ICMJE

Lithuania

Administrative Information

NCT ID ^ICMJE

NCT00780754

Responsible Party

Stasys Auskalnis, Kaunas University of Medicine

Study ID Numbers ^ICMJE

BE-2-27

Study Sponsor ^ICMJE

Kaunas University of Medicine

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Daimantas Milonas, assist professor

Kaunas Medical University

Information Provided By

Kaunas University of Medicine

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP