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Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

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ClinicalTrials.gov Identifier: NCT02053805
Recruitment Status : Unknown
Verified October 2017 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : February 4, 2014
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE January 30, 2014
First Posted Date  ICMJE February 4, 2014
Last Update Posted Date October 17, 2017
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2014)
Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers [ Time Frame: within 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2014)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 2, 2014)
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Prostate Cancer Screening Among Men With High Risk Genetic Predisposition
Official Title  ICMJE Personalized Prostate Cancer Screening Among Men With High Risk Genetic Predisposition- a Prospective Cohort Study
Brief Summary This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • BRCA1 Syndrome
  • BRCA2 Syndrome
  • Lynch Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 7, 2014)
200
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2014)
220
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02053805
Other Study ID Numbers  ICMJE 0582_13_RMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Margel, MD PhD Rabn Medical Center, Beilinson Campus
PRS Account Rabin Medical Center
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP