Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

Not Applicable

• Conditions: BRCA2 Syndrome; BRCA1 Syndrome; Lynch Syndrome
• 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

• Registration Number: NCT02053805
• Lead Sponsor: Rabin Medical Center

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 Timeline

• Study First Submitted: 2014-01-30
• Study Start: 2014-02
• Study First Submitted QC: 2014-02-02
• Study First Posted: 2014-02-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-15
• Last Update Posted: 2017-10-17
• Primary Completion: 2018-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
screening tests	PSA	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.
screening tests	a multiparametric prostate MRI	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.
screening tests	DRE (Digital Rectal Examination )	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.
screening tests	trans-rectal ultra-sound guided prostate biopsy	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.
screening tests	IPSS questionnaire	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.
screening tests	urine flow and residual	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.

Primary Outcome Measures

Name	Time	Method
Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers	within 2 years

Secondary Outcome Measures

Name	Time	Method
Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting prostate cancer among men with genetic predispositions.	within 2 years

Trial Locations

Locations (2)

Rabin Medical Center, Beilinson Hospital; 🇮🇱 Petah Tikva, Israel

Rabin Medical Center - Beilinson Hospital; 🇮🇱 Petah Tikva, Israel