Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT02053805
Status:
UNKNOWN
Last Update Posted:
2017-10-17
First Post:
2014-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prostate Cancer Screening Among Men With High Risk Genetic Predisposition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-15', 'studyFirstSubmitDate': '2014-01-30', 'studyFirstSubmitQcDate': '2014-02-02', 'lastUpdatePostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting clinically significant prostate cancer among men with genetic predispositions.', 'timeFrame': 'within 2 years'}, {'measure': '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.', 'timeFrame': 'within 2 years'}, {'measure': 'Impact of genetic mutations (BRCA, Lynch) on lower urinary tract symptoms (IPSS, flow and post void urine residual) and BPH ( benign prostatic hyperplasia).', 'timeFrame': 'within 2 years'}, {'measure': 'Genomic and biological profiles in samples from BRCA and Lynch mutation carriers and characterize changes related to prostate cancer.', 'timeFrame': 'within 2 years'}], 'primaryOutcomes': [{'measure': 'Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers', 'timeFrame': 'within 2 years'}], 'secondaryOutcomes': [{'measure': 'Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting prostate cancer among men with genetic predispositions.', 'timeFrame': 'within 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prostate cancer', 'BRCA1 Syndrome', 'BRCA germ-line mutation', 'Lynch syndrome', 'BRCA2 Syndrome'], 'conditions': ['BRCA1 Syndrome', 'BRCA2 Syndrome', 'Lynch Syndrome']}, 'referencesModule': {'references': [{'pmid': '32958357', 'type': 'DERIVED', '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.'}, {'pmid': '25047061', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male carrier of mutation in BRCA 1\\\\2 or germ-line mutations in the MMR genes (MLH1, MSH2 , MSH6 or PMS2).\n* WHO performance status 0-2 (Appendix 2)\n* Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.\n* Individuals that cannot undergo the MRI exam due to high creatinine level or claustrophobic will be disc loud from the MRI part.\n* Informed written consent must be sought according to ICH/EU GCP, before subject registration.\n\nExclusion Criteria:\n\n* Previous cancer with a terminal prognosis of less than five years.\n* Previous prostate cancer'}, 'identificationModule': {'nctId': 'NCT02053805', 'briefTitle': 'Prostate Cancer Screening Among Men With High Risk Genetic Predisposition', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Personalized Prostate Cancer Screening Among Men With High Risk Genetic Predisposition- a Prospective Cohort Study', 'orgStudyIdInfo': {'id': '0582_13_RMC'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'PSA', 'type': 'OTHER', 'description': 'PSA. Serum \\& plasma will be stored for future investigations', 'armGroupLabels': ['screening tests']}, {'name': 'IPSS questionnaire', 'type': 'OTHER', 'description': 'the validated International Prostate Symptom Score', 'armGroupLabels': ['screening tests']}, {'name': 'DRE (Digital Rectal Examination )', 'type': 'OTHER', 'description': 'physical examination for the prostate gland', 'armGroupLabels': ['screening tests']}, {'name': 'urine flow and residual', 'type': 'OTHER', 'description': 'The post void residual will be recorded by using ultrasound. Creatinine level will be checked.', 'armGroupLabels': ['screening tests']}, {'name': 'a multiparametric prostate MRI', 'type': 'PROCEDURE', 'description': 'The MRI will be reported on a 5 point Likert Scale', 'armGroupLabels': ['screening tests']}, {'name': 'trans-rectal ultra-sound guided prostate biopsy', 'type': 'PROCEDURE', 'description': '12 core Trans-rectal prostatic biopsy for diagnostic purposes', 'armGroupLabels': ['screening tests']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4941492', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Rachel Ozalvo, B.sc MBA', 'role': 'CONTACT', 'email': 'racheloz@gmail.com', 'phone': '972-3-9376553'}, {'name': 'David Margel, MD, PhD', 'role': 'CONTACT', 'email': 'sdmargel@gmail.com', 'phone': '972-3-9376553'}, {'name': 'David Margel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eli Rosenbaum, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Victoria Neiman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rinat Yerushalmi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ofer Benjaminov, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Inbal Kedar', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ofer Yossepowitch, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniel Kedar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jack Baniel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Zohar Levi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Baruch Brenner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Irit Ben Aharon, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rabin Medical Center - Beilinson Hospital', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'David Margel, MD PhD', 'role': 'CONTACT', 'phone': '+972(0)39378089'}, {'name': 'David Margel, MD Phd', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rabin Medical Center, Beilinson Hospital', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Rachel Ozalvo, B.sc, MBA', 'role': 'CONTACT', 'email': 'racheloz@clalit.org.il', 'phone': '+972(0)3-9376553'}], 'overallOfficials': [{'name': 'David Margel, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabn Medical Center, Beilinson Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}