Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

Status Recruiting

Clinical Trial Summary

This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition.

Clinical Trial Description

This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition. The target population is males (40-70 year old) carrying a BRCA1 and/or BRCA2 germ line mutation. They will be identified via our Genetic counseling unit. All men after signing an informed consent will undergo the following tests: PSA, free to total PSA, MRI of prostate and prostate biopsy. The primary endpoint will be to estimate the prevalence, stage and grade of prostate cancer in this population. Additionally, the study aims to estimate the impact of these germ line mutations on benign prostatic hyperplasia. Furthermore, this study aims to create a bio-bank of tissue, urine and serum of this unique cohort for future investigations. Finally, this study will identify an inception cohort for future interventional studies of primary and secondary prevention. ;

Study Design

Related Conditions & MeSH terms

BRCA1 Syndrome
BRCA2 Syndrome
Colorectal Neoplasms, Hereditary Nonpolyposis
Disease Susceptibility
Genetic Predisposition to Disease
Lynch Syndrome
Prostatic Neoplasms
Syndrome

Clinical Trial Details

NCT number	NCT02053805
Study type	Interventional
Source	Rabin Medical Center
Contact	Rachel Ozalvo, B.sc, MBA
Phone	+972(0)3-9376553
Email	racheloz@clalit.org.il
Status	Recruiting
Phase	N/A
Start date	February 2014
Completion date	June 2019

View Details

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