Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:19 AM
Study NCT ID:
NCT07485257
Status:
COMPLETED
Last Update Posted:
2026-03-20
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Profiling of MRI-PSMA PET Discordance in Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of omic alterations distinguishing MRI-PSMA PET discordant lesions from concordant lesions within the same cohort.', 'timeFrame': 'At the time of biopsy'}, {'measure': 'Distribution of molecular profiles across discordant versus concordant lesions.', 'timeFrame': 'At the time of biopsy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Molecular Imaging', 'Transcriptomics', 'RNA', 'PSMA PET/CT']}, 'descriptionModule': {'briefSummary': 'MRI and PSMA-PET are highly sensitive imaging tools for prostate cancer, yet they often detect different lesions. These discordant findings pose clinical uncertainty because their biological significance is unclear. This project aims to molecularly characterize MRI-PSMA PET discordant lesions using high-quality biobanked samples from patients enrolled in an institutional study (NCT06187870). By integrating imaging and molecular data, the study will clarify whether these lesions represent indolent disease, aggressive subclones, or biologically distinct entities, and will assess their clinical implications.', 'detailedDescription': 'Magnetic Resonance Imaging and PSMA-PET are currently the most sensitive imaging modalities for prostate cancer, yet they do not always provide concordant results. Discordant lesions, those detected by one modality but not the other, represent a significant clinical challenge, as their biological nature and implications remain poorly understood. A molecular characterization of these lesions may clarify whether they correspond to indolent clones missed due to imaging limitations, aggressive subclones with distinct molecular features, or biologically different disease entities. We aim to investigate prostate cancer lesions that are discordant between MRI and PSMA-PET, with the specific objective of elucidating their molecular characteristics and clinical implications. Molecular omic analyses will be performed on existing biobank samples from patients enrolled at our institution who have already provided informed consent for research use. This resource provides access to high-quality biospecimens linked with imaging data, enabling a comprehensive evaluation of MRI-PSMA PET discordant prostate cancer lesions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of male patients with a histologically confirmed diagnosis of prostate cancer who previously underwent both multiparametric MRI and PSMA-PET imaging at our institution. All participants have provided informed consent for inclusion in our institutional biobank, from which archived tissue samples will be selected. Eligible samples must be of sufficient quality for molecular analyses. Patients are retrospectively identified from existing biobank material; no new patient enrollment or prospective procedures are required', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* PCa diagnosis\n* Available samples\n* Performed both PSMA PET and MRI\n\nExclusion Criteria:\n\n* Low quality samples availability'}, 'identificationModule': {'nctId': 'NCT07485257', 'acronym': 'MP-PET-MRI', 'briefTitle': 'Molecular Profiling of MRI-PSMA PET Discordance in Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Molecular Profiling of Prostate Cancer Lesions With MRI-PSMA PET Discordance', 'orgStudyIdInfo': {'id': 'MP-PET-MRI'}}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Milan', 'country': 'Italy', 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full professor', 'investigatorFullName': 'Prof. Alberto Briganti', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}