MedDataX Logo

Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

NCT ID: NCT02053805

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

BRCA1 Syndrome BRCA2 Syndrome Lynch Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

screening tests

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.

Group Type OTHER

PSA

Intervention Type OTHER

PSA. Serum \& plasma will be stored for future investigations

IPSS questionnaire

Intervention Type OTHER

the validated International Prostate Symptom Score

DRE (Digital Rectal Examination )

Intervention Type OTHER

physical examination for the prostate gland

urine flow and residual

Intervention Type OTHER

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

a multiparametric prostate MRI

Intervention Type PROCEDURE

The MRI will be reported on a 5 point Likert Scale

trans-rectal ultra-sound guided prostate biopsy

Intervention Type PROCEDURE

12 core Trans-rectal prostatic biopsy for diagnostic purposes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PSA

PSA. Serum \& plasma will be stored for future investigations

Intervention Type OTHER

IPSS questionnaire

the validated International Prostate Symptom Score

Intervention Type OTHER

DRE (Digital Rectal Examination )

physical examination for the prostate gland

Intervention Type OTHER

urine flow and residual

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

Intervention Type OTHER

a multiparametric prostate MRI

The MRI will be reported on a 5 point Likert Scale

Intervention Type PROCEDURE

trans-rectal ultra-sound guided prostate biopsy

12 core Trans-rectal prostatic biopsy for diagnostic purposes

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Margel, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Rabn Medical Center, Beilinson Campus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rabin Medical Center - Beilinson Hospital

Petah Tikva, , Israel

Site Status RECRUITING

Rabin Medical Center, Beilinson Hospital

Petah Tikva, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rachel Ozalvo, B.sc, MBA

Role: CONTACT

Phone: +972(0)3-9376553

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rachel Ozalvo, B.sc MBA

Role: primary

David Margel, MD, PhD

Role: backup

David Margel, MD PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32958357 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25047061 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0582_13_RMC

Identifier Type: -

Identifier Source: org_study_id