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Completed

NCT Number: NCT00780754

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

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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Urology dep. of Kaunas University of Medicine

Kaunas, 50009, Lithuania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

dutasteride

Drug

0.5mg

Prostate biopsy

Procedure

prostate biopsy

Primary outcomes

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

    Time frame: 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).

    Time frame: 6, 12, 24, and 36 months

Sponsors and collaborators

Lead sponsor

Kaunas University of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 28, 2008
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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