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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00780754

Enrollment

200

Registered

2008-10-28

Start date

2007-04-30

Completion date

2010-12-31

Last updated

2018-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, chemoprevention, dutasteride

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).

Interventions

DRUGdutasteride

0.5mg

PROCEDUREprostate biopsy

prostate biopsy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026