Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:48 AM
Study NCT ID:
NCT07432360
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detecting Clinically Significant Prostate Cancer With Advanced MRI Protocols and Extensive Histopathology
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of different microstructure models in the performance of detecting csPCa', 'timeFrame': 'Upon study completion since data from all subjects need to be included (Until 6 months after the last patient got included)'}]}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'In recent years, new and promising approaches have emerged in the field of MRI imaging of the prostate. These approaches usually aim to visualise the so-called "microstructures" of the tissue and are intended to offer greater accuracy in the diagnosis of prostate cancer than the current mpMRI examination. To this end, mathematical microstructure models are calculated that determine the proportional presence of histological substructures in specific MRI volumes. Additional new MRI sequences that are not routinely recorded are required to calculate the microstructure models. In order to further investigate the possibilities of these new MRI sequences, this study will compare different mathematical models. In addition, a histopathological examination of the tissue will be performed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at the Instituto do Câncer do Estado de São Paulo', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Humans with a prostate ≥18 years of age.\n* Patients with biopsy-proven PCa who are scheduled for an RPE.\n* Signed informed consent form (ICF) that demonstrates study participant understands the purpose of and procedures necessary for the study.\n* Willingness, ability, and legal capacity to participate in the study.\n* Ability to adhere to the prohibitions and restrictions defined in this protocol.\n\nExclusion Criteria:\n\n* Inability to give consent.\n* Prior hormone treatment (i.e., androgen deprivation treatment (ADT) and/or 5-ɑ-reductase inhibitors).\n* Prior PCa treatment.\n* Prior transurethral resection of the prostate (TUR-P) or other prostate surgery.\n* Prior total hip arthroplasty on one or both sides or other metal implants that interfere with the MRI acquisition of the hip region.\n* General contraindications for an MRI scan (i.e., pacemaker, relevant metal implants, etc.).'}, 'identificationModule': {'nctId': 'NCT07432360', 'briefTitle': 'Detecting Clinically Significant Prostate Cancer With Advanced MRI Protocols and Extensive Histopathology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Virdx, Inc.'}, 'officialTitle': 'Bridging Imaging and Pathology: Using Advanced MRI Protocols in Correlation With Extensive Histopathology to Detect Clinically Significant Prostate Cancer', 'orgStudyIdInfo': {'id': 'VIRDX 2025_BR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with biopsy-proven PCa who are scheduled for RPE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Instituto do Câncer do Estado de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Sina Knapp, PhD', 'role': 'CONTACT', 'email': 'sina.knapp@virdx.com', 'phone': '+4917680891277'}], 'overallOfficials': [{'name': 'Marcelo Araujo Queiroz, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto do Câncer do Estado de São Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virdx, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}