Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

October 15, 2017 updated by: Rabin Medical Center

Personalized Prostate Cancer Screening Among Men With High Risk Genetic Predisposition- a Prospective Cohort Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center - Beilinson Hospital
        • Contact:
        • Sub-Investigator:
          • Rinat Yerushalmi, MD
        • Sub-Investigator:
          • Ofer Benjaminov, MD
        • Sub-Investigator:
          • Inbal Kedar
        • Sub-Investigator:
          • Ofer Yossepowitch, MD
        • Sub-Investigator:
          • Zohar Levi, MD
        • Sub-Investigator:
          • Baruch Brenner, MD
        • Sub-Investigator:
          • Irit Ben Aharon, MD
      • Petah Tikva, Israel
        • Recruiting
        • Rabin Medical Center, Beilinson Hospital
        • Contact:
          • David Margel, MD PhD
          • Phone Number: +972(0)39378089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers
Time Frame: within 2 years
within 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
within 2 years

Other Outcome Measures

Outcome Measure
Time Frame
Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting clinically significant prostate cancer among men with genetic predispositions.
Time Frame: within 2 years
within 2 years
Cost effectiveness of different screening tests (PSA, free to total PSA, prostate MRI) in detecting prostate cancer and clinically significant prostate cancer among men with genetic predispositions.
Time Frame: within 2 years
within 2 years
Impact of genetic mutations (BRCA, Lynch) on lower urinary tract symptoms (IPSS, flow and post void urine residual) and BPH ( benign prostatic hyperplasia).
Time Frame: within 2 years
within 2 years
Genomic and biological profiles in samples from BRCA and Lynch mutation carriers and characterize changes related to prostate cancer.
Time Frame: within 2 years
within 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: David Margel, MD PhD, Rabn Medical Center, Beilinson Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

February 2, 2014

First Posted (Estimate)

February 4, 2014

Study Record Updates

Last Update Posted (Actual)

October 17, 2017

Last Update Submitted That Met QC Criteria

October 15, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0582_13_RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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