Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT03749993
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2018-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a MRI-based Prostate Cancer Screening Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2018-09-24', 'studyFirstSubmitQcDate': '2018-11-19', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total costs of the MRI based prostate cancer screening', 'timeFrame': '24 months', 'description': 'Total costs of the program'}], 'secondaryOutcomes': [{'measure': 'Comparison of costs of classical screening based on PSA and DRE', 'timeFrame': '24 months', 'description': 'Total costs per patient'}, {'measure': 'number of patients undergoing active surveillance', 'timeFrame': '24 months', 'description': 'Number of follow-up interventions'}, {'measure': 'number of patients undergoing radical cystoprostatectomy', 'timeFrame': '24 months', 'description': 'Number of follow-up interventions'}, {'measure': 'number of patients undergoing radiotherapy', 'timeFrame': '24 months', 'description': 'Number of follow-up interventions'}, {'measure': 'number of patients undergoing androgen deprivation therapy', 'timeFrame': '24 months', 'description': 'Number of follow-up interventions'}, {'measure': 'number of patients undergoing chemotherapy', 'timeFrame': '24 months', 'description': 'Number of follow-up interventions'}, {'measure': 'Quality of Life (Qol)', 'timeFrame': '24 months', 'description': 'Qol Questionnaire (SF- 36) score (0-100), 0 means best, 100 worst case'}, {'measure': 'Distress Thermometer Assessment', 'timeFrame': '24 months', 'description': '"Distress Thermometer" score (0-10)'}, {'measure': 'AI Evaluation', 'timeFrame': '24 months', 'description': 'Evaluation of algorithms (AI) for CAD MRI based PCA diagnostic'}, {'measure': 'Number of patients', 'timeFrame': '24 months', 'description': 'Number of patients needed to screen'}, {'measure': 'Number of consultations', 'timeFrame': '24 months', 'description': 'Number of total consultations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effort and resources (incl. costs) required to detect 20 clinically relevant prostate cancer (PCA) in a screening program based on bpMRI of the prostate.', 'detailedDescription': 'Informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening. According to European guidelines we will include men \\> 50 years of age and men \\>45 years of age and a family history of PCA as well as African-Americans \\>45 years of age. In this study, bpMRI will be used for opportunistic prostate cancer screening.\n\nThe indication for prostate biopsy is based solely on the results of bpMRI. In case of detection of lesions suspicious for prostate cancer ( PIRADS 3), targeted MRI-TRUS fusion biopsy with 3 biopsies per lesion will be performed. In case no lesions suspicious for PCA ( PIRADS 3) are detected, SB will performed if PSA exceeds 10ng/ml and/or DRE is suspicious for PCA.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '46 Years', 'genderBased': True, 'genderDescription': 'Informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* well-informed men with the wish for prostate cancer screening\n* prostate biopsy naïve\n* life expectancy \\> 10 years\n* men \\> 50 years of age\n* men \\> 45 years of age with a family history of prostate cancer\n* African-Americans \\> 45 years of age\n\nExclusion Criteria:\n\n* prostate biopsy performed prior to study\n* life expectancy \\< 10 years\n* acute urinary tract infection\n* NIH-CPSI score 19 (leads to initiation of urologic diagnostics and treatment)\n* IPSS score 20 (leads to initiation of urologic diagnostics and treatment)\n\nContraindications for MRI:\n\n* Heart pacemaker\n* Artificial heart valves (some types are eligible)\n* Cochlea implant\n* ICD\n* Metallic foreign bodies/devices/implants (neuro-stimulator, pain or insulin pump, etc.)\n* Severe claustrophobia'}, 'identificationModule': {'nctId': 'NCT03749993', 'acronym': 'VISIONING', 'briefTitle': 'Evaluation of a MRI-based Prostate Cancer Screening Program', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Evaluation of a MRI-based Prostate Cancer Screening Program', 'orgStudyIdInfo': {'id': 'VISIONING1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Screening Arm', 'description': 'Screening', 'interventionNames': ['Other: Screening']}], 'interventions': [{'name': 'Screening', 'type': 'OTHER', 'description': 'Use of bpMRI for opportunistic prostate cancer screening.', 'armGroupLabels': ['Screening Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel, Clinic of Urology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Cyrill Rentsch, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}