BRCA1 Syndrome, BRCA2 Syndrome, Lynch Syndrome
Conditions
Keywords
prostate cancer, BRCA1 Syndrome, BRCA germ-line mutation, Lynch syndrome, BRCA2 Syndrome
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.
Interventions
OTHERPSA
PSA. Serum & plasma will be stored for future investigations
OTHERIPSS questionnaire
the validated International Prostate Symptom Score
OTHERDRE (Digital Rectal Examination )
physical examination for the prostate gland
OTHERurine flow and residual
The post void residual will be recorded by using ultrasound. Creatinine level will be checked.
PROCEDUREa multiparametric prostate MRI
The MRI will be reported on a 5 point Likert Scale
PROCEDUREtrans-rectal ultra-sound guided prostate biopsy
12 core Trans-rectal prostatic biopsy for diagnostic purposes
Sponsors
Rabin Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers | within 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting prostate cancer among men with genetic predispositions. | within 2 years |
Other
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Genomic and biological profiles in samples from BRCA and Lynch mutation carriers and characterize changes related to prostate cancer. | within 2 years |
Countries
Israel
Contacts
Primary ContactRachel Ozalvo, B.sc, MBA
Outcome results
None listed