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Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

Primary Purpose

BRCA1 Syndrome, BRCA2 Syndrome, Lynch Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

PSA

IPSS questionnaire

DRE (Digital Rectal Examination )

urine flow and residual

a multiparametric prostate MRI

trans-rectal ultra-sound guided prostate biopsy

About this trial

This is an interventional screening trial for BRCA1 Syndrome focused on measuring prostate cancer, BRCA1 Syndrome, BRCA germ-line mutation, Lynch syndrome, BRCA2 Syndrome

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Rabin Medical Center - Beilinson HospitalRecruiting
Rabin Medical Center, Beilinson HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

screening tests

Arm 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.

Outcomes

Primary Outcome Measures

Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers

Secondary Outcome Measures

Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting prostate cancer among men with genetic predispositions.

Full Information

NCT ID

NCT02053805

First Posted

January 30, 2014

Last Updated

October 15, 2017

Sponsor

Rabin Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02053805

Brief Title

Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rabin Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

BRCA1 Syndrome, BRCA2 Syndrome, Lynch Syndrome

Keywords

prostate cancer, BRCA1 Syndrome, BRCA germ-line mutation, Lynch syndrome, BRCA2 Syndrome

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

screening tests

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

PSA

Intervention Description

PSA. Serum & plasma will be stored for future investigations

Intervention Type

Other

Intervention Name(s)

IPSS questionnaire

Intervention Description

the validated International Prostate Symptom Score

Intervention Type

Other

Intervention Name(s)

DRE (Digital Rectal Examination )

Intervention Description

physical examination for the prostate gland

Intervention Type

Other

Intervention Name(s)

urine flow and residual

Intervention Description

The post void residual will be recorded by using ultrasound. Creatinine level will be checked.

Intervention Type

Procedure

Intervention Name(s)

a multiparametric prostate MRI

Intervention Description

The MRI will be reported on a 5 point Likert Scale

Intervention Type

Procedure

Intervention Name(s)

trans-rectal ultra-sound guided prostate biopsy

Intervention Description

12 core Trans-rectal prostatic biopsy for diagnostic purposes

Primary Outcome Measure Information:

Title

Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers

Time Frame

within 2 years

Secondary Outcome Measure Information:

Title

Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting prostate cancer among men with genetic predispositions.

Time Frame

within 2 years

Other Pre-specified Outcome Measures:

Title

Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting clinically significant prostate cancer among men with genetic predispositions.

Time Frame

within 2 years

Title

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.

Time Frame

within 2 years

Title

Impact of genetic mutations (BRCA, Lynch) on lower urinary tract symptoms (IPSS, flow and post void urine residual) and BPH ( benign prostatic hyperplasia).

Time Frame

within 2 years

Title

Genomic and biological profiles in samples from BRCA and Lynch mutation carriers and characterize changes related to prostate cancer.

Time Frame

within 2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rachel Ozalvo, B.sc, MBA

Phone

+972(0)3-9376553

racheloz@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Margel, MD PhD

Organizational Affiliation

Rabn Medical Center, Beilinson Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rabin Medical Center - Beilinson Hospital

City

Petah Tikva

ZIP/Postal Code

4941492

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel Ozalvo, B.sc MBA

Phone

972-3-9376553

racheloz@gmail.com

First Name & Middle Initial & Last Name & Degree

David Margel, MD, PhD

Phone

972-3-9376553

sdmargel@gmail.com

First Name & Middle Initial & Last Name & Degree

David Margel, MD, PhD

First Name & Middle Initial & Last Name & Degree

Eli Rosenbaum, MD

First Name & Middle Initial & Last Name & Degree

Victoria Neiman, MD

First Name & Middle Initial & Last Name & Degree

Rinat Yerushalmi, MD

First Name & Middle Initial & Last Name & Degree

Ofer Benjaminov, MD

First Name & Middle Initial & Last Name & Degree

Inbal Kedar

First Name & Middle Initial & Last Name & Degree

Ofer Yossepowitch, MD

First Name & Middle Initial & Last Name & Degree

Daniel Kedar, MD

First Name & Middle Initial & Last Name & Degree

Jack Baniel, MD

First Name & Middle Initial & Last Name & Degree

Zohar Levi, MD

First Name & Middle Initial & Last Name & Degree

Baruch Brenner, MD

First Name & Middle Initial & Last Name & Degree

Irit Ben Aharon, MD

Facility Name

Rabin Medical Center, Beilinson Hospital

City

Petah Tikva

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Margel, MD PhD

Phone

+972(0)39378089

First Name & Middle Initial & Last Name & Degree

David Margel, MD Phd

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32958357

Citation

Segal N, Ber Y, Benjaminov O, Tamir S, Yakimov M, Kedar I, Rosenbaum E, Sela S, Ozalvo R, Shavit-Grievink L, Keder D, Baniel J, Margel D. Imaging-based prostate cancer screening among BRCA mutation carriers-results from the first round of screening. Ann Oncol. 2020 Nov;31(11):1545-1552. doi: 10.1016/j.annonc.2020.06.025. Epub 2020 Sep 18.

Results Reference

derived

PubMed Identifier

25047061

Citation

Margel D, Benjaminov O, Ozalvo R, Shavit Grievink L, Kedar I, Yerushalmi R, Ben-Aharon I, Neiman V, Yossepowitch O, Kedar D, Levy Z, Shohat M, Brenner B, Baniel J, Rosenbaum E. Personalized prostate cancer screening among men with high risk genetic predisposition- study protocol for a prospective cohort study. BMC Cancer. 2014 Jul 21;14:528. doi: 10.1186/1471-2407-14-528.

Results Reference

derived

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Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

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