Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 4:08 PM
Study NCT ID:
NCT06238661
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-04
First Post:
2024-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prostate Cancer Screening: a Pilot Study
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': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4500}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2024-01-25', 'studyFirstSubmitQcDate': '2024-01-25', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rate of clinically significant prostate cancer (Gleason Group ≥2)', 'timeFrame': '24 months', 'description': 'No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial'}, {'measure': 'Comparison of the detection rate of clinically significant prostate cancer with and without screening', 'timeFrame': '24 months', 'description': 'No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial compared to the same proportion of men calculated in the 2-year period before the introduction of the screening protocol'}, {'measure': 'Verify that the detection rate of clinically significant prostate cancer with the screening strategy is not inferior to that of the Italian cohort in the ERSPC study', 'timeFrame': '24 months', 'description': 'No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial compared to the same proportion of men included in the Italian cohort of the ERSPC study screened using PSA only'}], 'secondaryOutcomes': [{'measure': 'Changes in number of biopsy procedures', 'timeFrame': '24 months', 'description': 'Estimation of the number of biopsy that could be avoided using the new screening strategy compared to the use of PSA only.'}, {'measure': 'Assessment of positive and negative predictive values', 'timeFrame': '24 months', 'description': 'Definition of positive and negative predictive values of the proposed screening strategy and comparison with those obtained in the ERSPC screening study with PSA only'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'PSA', 'Risk Calculator', 'Magnetic Resonance Imaging', 'Prostate biopsy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Prostate Cancer (PCa) is the second most frequently diagnosed tumour and the third most lethal among men in Europe. The lack of precise tools and examinations to precisely diagnose PCa has caused overtreatment of indolent and low-aggressive PCa, while in some other cases, with aggressive disease, diagnosis and treatment are dangerously delayed because cancer could be potentially missed. The present trial aims to study a new pathway to early diagnose PCa with Magnetic Resonance Imaging (MRI) to identify men who will not need treatment and those who will benefit from radical treatment, thus improving disease control and quality of life.', 'detailedDescription': 'Men aged 55-65 years with neither previous biopsy nor prostate diseases will be invited in the screening protocol and will perform an initial PSA test. Those cases with PSA ≥ 3 ng/ml will be invited to undergo a urologic examination with computed risk assessment and an MRI, which is a non-invasive test with high positive and negative predictive value in identifying clinically significant prostate cancer. Then, only men with medium-high risk of harbouring clinically significant prostate cancer will be invited to undergo a prostate biopsy to indentify cancer presence and its aggressiveness.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '55 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 55-65 years;\n* asymptomatic or paucisymptomatic from a urological point of view;\n* no previous prostate biopsy;\n* living in the ASL TO5 (Piedmont, Italy);\n* signed written informed consent.\n\nExclusion Criteria:\n\n* positive oncologic anamnesis for prostate cancer;\n* previous biopsy or prostate surgery;\n* previous radiotherapy of the pelvis;\n* any contraindication to MRI examination;\n* claustrophobic or uncollaborative subjects.'}, 'identificationModule': {'nctId': 'NCT06238661', 'acronym': 'ProScreenMRI', 'briefTitle': 'Prostate Cancer Screening: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': "Fondazione del Piemonte per l'Oncologia"}, 'officialTitle': 'Prostate Cancer Screening With PSA, Risk Calculator and Multiparametric MRI: a Pilot Study', 'orgStudyIdInfo': {'id': 'ProScreenMRI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects with PSA ≥ 3 ng/ml', 'description': '* Urologic examination\n* Risk calculation (ERSPC no.6)\n* Magnetic resonance imaging\n* (optional) biopsy', 'interventionNames': ['Diagnostic Test: Urology visit with Risk Calculator and MRI']}], 'interventions': [{'name': 'Urology visit with Risk Calculator and MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients with PSA ≥3 ng/ml will undergo urology visit with risk calculator and MRI assessment of the prostate', 'armGroupLabels': ['Subjects with PSA ≥ 3 ng/ml']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10060', 'city': 'Candiolo', 'state': 'Italy', 'country': 'Italy', 'facility': "Fondazione del Piemonte per l'Oncologia", 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}], 'overallOfficials': [{'name': 'Daniele Regge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fondazione del Piemonte per l'Oncologia"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione del Piemonte per l'Oncologia", 'class': 'OTHER'}, 'collaborators': [{'name': 'San Luigi Gonzaga Hospital', 'class': 'OTHER'}, {'name': 'Epidemiology and Screening Unit - CPO, Turin, Italy', 'class': 'UNKNOWN'}, {'name': 'ASL TO5', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}