Clinical trial · Interventional
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
NCT02053805CI-TRIAL-00029934unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Syndrome | — | UNRESOLVED | — |
| BRCA2 Syndrome | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| a multiparametric prostate MRI | Procedure | — | UNRESOLVED |
| DRE (Digital Rectal Examination ) | Other | — | UNRESOLVED |
| IPSS questionnaire | Other | — | UNRESOLVED |
| PSA | Other | — | UNRESOLVED |
| trans-rectal ultra-sound guided prostate biopsy | Procedure | — | UNRESOLVED |
| urine flow and residual | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- screening tests
- 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.
- interventionNames
- 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
Primary outcomes (1)
- measure
- Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers
- timeFrame
- within 2 years
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDSegal 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
- DERIVEDMargel 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