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Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT02053805
First received: January 30, 2014
Last updated: April 21, 2016
Last verified: March 2016
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Genomic and biological profiles in samples from BRCA and Lynch mutation carriers and characterize changes related to prostate cancer. [ Time Frame: within 2 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: January 30, 2014
Last Updated: April 21, 2016
Health Authority: Israel: Ministry of Health
Individual Participant Data  
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

ClinicalTrials.gov processed this record on September 26, 2016