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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780754
• Other study ID #: BE-2-27
• Status: Completed
• Phase: Phase 3
• First received: October 26, 2008
• Last updated: March 4, 2018
• Start date: April 2007
• Est. completion date: December 2010

Study information

• Verified date: October 2008
• Source: Kaunas University of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• dutasteride
0.5mg

Procedure:
• prostate biopsy
prostate biopsy

Locations

Country	Name	City	State
Lithuania	Urology dep. of Kaunas University of Medicine	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Kaunas University of Medicine

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN		6, 12, 24, and 36 months
Secondary	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