Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

N/AUnknownNCT02053805

Rabin Medical Center200 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

200

Conditions

BRCA1 Syndrome BRCA2 Syndrome Lynch Syndrome

Interventions

PSAOTHER

PSA. Serum \& plasma will be stored for future investigations

IPSS questionnaireOTHER

the validated International Prostate Symptom Score

DRE (Digital Rectal Examination )OTHER

physical examination for the prostate gland

Eligibility

Sex: MALEMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male carrier of mutation in BRCA 1\\2 or germ-line mutations in the MMR genes (MLH1, MSH2 , MSH6 or PMS2). * WHO performance status 0-2 (Appendix 2) * Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule. * Individuals that cannot undergo the MRI exam due to high creatinine level or claustrophobic will be disc loud from the MRI part. * Informed written consent must be sought according to ICH/EU GCP, before subject registration. Exclusion Criteria: * Previous cancer with a terminal prognosis of less than five years. * Previous prostate cancer

Locations (2)

Rabin Medical Center - Beilinson Hospital

Petah Tikva, Israel

RECRUITING

Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

RECRUITING

Outcomes

Primary Outcomes

Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers

Time frame: within 2 years

Secondary Outcomes

Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting prostate cancer among men with genetic predispositions.

Time frame: within 2 years

Central Contacts

Rachel Ozalvo, B.sc, MBA

CONTACT

+972(0)3-9376553 racheloz@clalit.org.il

Data from ClinicalTrials.gov

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