Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

Lynch Syndrome Clinical Trial

Official title:

Personalized Prostate Cancer Screening Among Men With High Risk Genetic Predisposition- a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02053805
• Other study ID #: 0582_13_RMC
• 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
• 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

Related Conditions & MeSH terms

• BRCA1 Syndrome
• BRCA2 Syndrome
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Disease Susceptibility
• Genetic Predisposition to Disease
• Lynch Syndrome
• Prostatic Neoplasms
• Syndrome

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