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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02053805
Other study ID # 0582_13_RMC
Secondary ID
Status Recruiting
Phase N/A
First received January 30, 2014
Last updated October 15, 2017
Start date February 2014
Est. completion date June 2019

Study information

Verified date October 2017
Source Rabin Medical Center
Contact Rachel Ozalvo, B.sc, MBA
Phone +972(0)3-9376553
Email racheloz@clalit.org.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 2019
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
PSA
PSA. Serum & plasma will be stored for future investigations
IPSS questionnaire
the validated International Prostate Symptom Score
DRE (Digital Rectal Examination )
physical examination for the prostate gland
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
trans-rectal ultra-sound guided prostate biopsy
12 core Trans-rectal prostatic biopsy for diagnostic purposes

Locations

Country Name City State
Israel Rabin Medical Center - Beilinson Hospital Petah Tikva
Israel Rabin Medical Center, Beilinson Hospital Petah Tikva

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Other Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting clinically significant prostate cancer among men with genetic predispositions. within 2 years
Other 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. within 2 years
Other Impact of genetic mutations (BRCA, Lynch) on lower urinary tract symptoms (IPSS, flow and post void urine residual) and BPH ( benign prostatic hyperplasia). within 2 years
Other Genomic and biological profiles in samples from BRCA and Lynch mutation carriers and characterize changes related to prostate cancer. within 2 years
Primary Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers within 2 years
Secondary Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting prostate cancer among men with genetic predispositions. within 2 years
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