NCT02053805

Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• BRCA1 Syndrome
• BRCA2 Syndrome
• Lynch Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-02-01
• Primary completion: 2018-06-01
• Completion: 2019-06-01
• First posted: 2014-02-04
• Last updated: 2017-10-17

Locations

2 sites across 1 country: Israel