Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

Clalit Health Services

Status: Unknown

Conditions: Lynch Syndrome; BRCA1 Syndrome; BRCA2 Syndrome

Treatments: Other: urine flow and residual; Procedure: a multiparametric prostate MRI; Other: PSA; Procedure: trans-rectal ultra-sound guided prostate biopsy; Other: DRE (Digital Rectal Examination ); Other: IPSS questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT02053805

0582_13_RMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

screening tests

Other group

Description:

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.

Treatment:

Procedure: a multiparametric prostate MRI

Other: PSA

Other: urine flow and residual

Other: IPSS questionnaire

Procedure: trans-rectal ultra-sound guided prostate biopsy

Other: DRE (Digital Rectal Examination )