NCT00780754

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 6, 2018

Status Verified

October 1, 2008

Enrollment Period

3.7 years

First QC Date

October 26, 2008

Last Update Submit

March 4, 2018

Conditions

Prostate Cancer

Keywords

prostate cancerchemopreventiondutasteride

Outcome Measures

Primary Outcomes (1)

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

    6, 12, 24, and 36 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

dutasteride

EXPERIMENTAL

treatment group

Drug: dutasterideProcedure: prostate biopsy

watchful waiting strategy

ACTIVE COMPARATOR
Procedure: prostate biopsy

Interventions

dutasterideDRUG

0.5mg

dutasteride
prostate biopsyPROCEDURE

prostate biopsy

dutasteridewatchful waiting strategy

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology dep. of Kaunas University of Medicine

Kaunas, 50009, Lithuania

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AzasteroidsSteroids, HeterocyclicSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Daimantas Milonas, assist professor

    Kaunas Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

October 26, 2008

First Posted

October 28, 2008

Study Start

April 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 6, 2018

Record last verified: 2008-10

Locations

LI(1)