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

Kaunas University of Medicine

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Procedure: prostate biopsy; Drug: dutasteride

Study type: Interventional

Funder types: Other

Identifiers

NCT00780754

BE-2-27

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

dutasteride

Experimental group

Description:

treatment group

Treatment:

Procedure: prostate biopsy

Drug: dutasteride

watchful waiting strategy

Active Comparator group

Treatment:

Procedure: prostate biopsy