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

• Sponsor: Kaunas University of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00780754
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 44
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: dutasteride; Procedure: prostate biopsy	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dutasteride treatment group	Drug: dutasteride; 0.5mg; Procedure: prostate biopsy; prostate biopsy
Active Comparator: watchful waiting strategy	Procedure: prostate biopsy; prostate biopsy

Outcome Measures

Primary Outcome Measures

1. rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN [6, 12, 24, and 36 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology dep. of Kaunas University of Medicine	Kaunas		Lithuania	50009

Sponsors and Collaborators

• Kaunas University of Medicine

Investigators

• Principal Investigator: Daimantas Milonas, assist professor, Kaunas Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stasys Auskalnis, doctor, Lithuanian University of Health Sciences
• ClinicalTrials.gov Identifier: NCT00780754
• Other Study ID Numbers: BE-2-27
• First Posted: Oct 28, 2008
• Last Update Posted: Mar 6, 2018
• Last Verified: Oct 1, 2008

• Keywords provided by Stasys Auskalnis, doctor, Lithuanian University of Health Sciences: prostate cancer; chemoprevention; dutasteride
• Additional relevant MeSH terms: Prostatic Neoplasms; Dutasteride

Study Results

No Results Posted as of Mar 6, 2018