Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

Overview

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

Full Title of Study: “Personalized Prostate Cancer Screening Among Men With High Risk Genetic Predisposition- a Prospective Cohort Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2018

Detailed 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.

Interventions

  • Other: PSA
    • PSA. Serum & plasma will be stored for future investigations
  • Other: IPSS questionnaire
    • the validated International Prostate Symptom Score
  • Other: DRE (Digital Rectal Examination )
    • physical examination for the prostate gland
  • Other: urine flow and residual
    • The post void residual will be recorded by using ultrasound. Creatinine level will be checked.
  • Procedure: a multiparametric prostate MRI
    • The MRI will be reported on a 5 point Likert Scale
  • Procedure: trans-rectal ultra-sound guided prostate biopsy
    • 12 core Trans-rectal prostatic biopsy for diagnostic purposes

Arms, Groups and Cohorts

  • Other: screening tests
    • The screening will include: DRE, PSA , a multiparametric prostate MRI and a trans-rectal ultra-sound guided prostate biopsy/ MRI-US fusion , IPSS questionnaire, trans-rectal US assessment of prostate size, urine flow and residual.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Male carrier of mutation in BRCA 12 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

Gender Eligibility: Male

Minimum Age: 40 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rabin Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Margel, MD PhD, Principal Investigator, Rabn Medical Center, Beilinson Campus
  • Overall Contact(s)
    • Rachel Ozalvo, B.sc, MBA, +972(0)3-9376553, racheloz@clalit.org.il

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.