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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 June 2014 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT02053805
First received: January 30, 2014
Last updated: September 7, 2014
Last verified: June 2014
  Purpose

Prostate cancer screening among the general population is highly debatable. Prior data suggests that men carrying mutations in the BRCA1& 2 (BReast CAncer) genes and LYNCH Syndrome (MMR genes - MisMatching Repair gene) maybe at increased risk of developing prostate cancer.

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

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. Finally, this study will identify an inception cohort for future interventional studies of primary and secondary prevention.


Condition Intervention
BRCA1 Syndrome
BRCA2 Syndrome
Lynch Syndrome
Procedure: PSA
Other: IPSS questionnaire
Procedure: DRE (Digital Rectal Examination )
Procedure: 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 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.
Procedure: PSA
PSA. Serum & plasma will be stored for future investigations
Other: IPSS questionnaire
the validated International Prostate Symptom Score
Procedure: DRE (Digital Rectal Examination ) Procedure: urine flow and residual
The post void residual will be recorded by using ultrasound. Creatinine level will be checked.
Procedure: a multiparametric prostate MRI Procedure: trans-rectal ultra-sound guided prostate biopsy
12 core Trans-rectal prostatic biopsy for diagnostic purposes

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
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)
  • No previous history of prostate cancer
  • No previous prostate biopsy
  • 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

Locations
Israel
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

No publications provided by Rabin Medical Center

Additional 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: September 7, 2014
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Disease Susceptibility
Genetic Predisposition to Disease
Prostatic Neoplasms
Syndrome
Disease
Disease Attributes
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014