Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

NCT02053805 | Unknown DMC

• 1 other identifier: 0582_13_RMC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

BRCA1 Syndrome; BRCA2 Syndrome; Lynch Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  within 2 years

Secondary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

screening tests

OTHER

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.

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

Interventions

PSA OTHER

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

screening tests

IPSS questionnaire OTHER

the validated International Prostate Symptom Score

screening tests

DRE (Digital Rectal Examination ) OTHER

physical examination for the prostate gland

screening tests

urine flow and residual OTHER

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

screening tests

a multiparametric prostate MRI PROCEDURE

The MRI will be reported on a 5 point Likert Scale

screening tests

trans-rectal ultra-sound guided prostate biopsy PROCEDURE

12 core Trans-rectal prostatic biopsy for diagnostic purposes

screening tests

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous cancer with a terminal prognosis of less than five years.
• Previous prostate cancer

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (2)

Rabin Medical Center - Beilinson Hospital

Petah Tikva, 4941492, Israel

RECRUITING

Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

RECRUITING

Related Publications (2)

• 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.

  PMID: 32958357 DERIVED

• 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.

  PMID: 25047061 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• David Margel, MD PhD

  Rabn Medical Center, Beilinson Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Ozalvo, B.sc, MBA

CONTACT

+972(0)3-9376553; racheloz@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 4, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: October 17, 2017

Record last verified: 2017-10

Locations

IL (2)