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Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

This study is currently recruiting participants.
Verified October 2017 by Rabin Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02053805
First Posted: February 4, 2014
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rabin Medical Center
  Purpose
This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition.

Condition Intervention
BRCA1 Syndrome BRCA2 Syndrome Lynch Syndrome Other: PSA Other: IPSS questionnaire Other: DRE (Digital Rectal Examination ) Other: urine flow and residual Procedure: a multiparametric prostate MRI Procedure: trans-rectal ultra-sound guided prostate biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Personalized Prostate Cancer Screening Among Men With High Risk Genetic Predisposition- a Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome 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 Outcome 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 ]

Other Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • Genomic and biological profiles in samples from BRCA and Lynch mutation carriers and characterize changes related to prostate cancer. [ Time Frame: within 2 years ]

Estimated Enrollment: 200
Study Start Date: February 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053805


Contacts
Contact: Rachel Ozalvo, B.sc, MBA +972(0)3-9376553 racheloz@clalit.org.il

Locations
Israel
Rabin Medical Center - Beilinson Hospital Recruiting
Petah Tikva, Israel, 4941492
Contact: Rachel Ozalvo, B.sc MBA    972-3-9376553    racheloz@gmail.com   
Contact: David Margel, MD, PhD    972-3-9376553    sdmargel@gmail.com   
Principal Investigator: David Margel, MD, PhD         
Sub-Investigator: Eli Rosenbaum, MD         
Sub-Investigator: Victoria Neiman, MD         
Sub-Investigator: Rinat Yerushalmi, MD         
Sub-Investigator: Ofer Benjaminov, MD         
Sub-Investigator: Inbal Kedar         
Sub-Investigator: Ofer Yossepowitch, MD         
Sub-Investigator: Daniel Kedar, MD         
Sub-Investigator: Jack Baniel, MD         
Sub-Investigator: Zohar Levi, MD         
Sub-Investigator: Baruch Brenner, MD         
Sub-Investigator: Irit Ben Aharon, MD         
Rabin Medical Center, Beilinson Hospital Recruiting
Petah Tikva, Israel
Contact: David Margel, MD PhD    +972(0)39378089      
Principal Investigator: David Margel, MD Phd         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: David Margel, MD PhD Rabn Medical Center, Beilinson Campus
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02053805     History of Changes
Other Study ID Numbers: 0582_13_RMC
First Submitted: January 30, 2014
First Posted: February 4, 2014
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rabin Medical Center:
prostate cancer
BRCA1 Syndrome
BRCA germ-line mutation
Lynch syndrome
BRCA2 Syndrome

Additional relevant MeSH terms:
Syndrome
Prostatic Neoplasms
Disease Susceptibility
Colorectal Neoplasms, Hereditary Nonpolyposis
Genetic Predisposition to Disease
Disease
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases