Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT07258056
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2038-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rate of clinically significant prostate cancer (csPCa) for PSMA guided biopsies vs systematic biopsies', 'timeFrame': 'From enrollment to pathology report is ready, assessed up to 2 years', 'description': 'CsPCa is defined as "International Society of Urological Pathology" (ISUP) grade ≥ 2.\n\nThe ISUP grade scale ranges from 1 to 5, where grade 1 is low-risk / indolent / non-significant prostate cancer and grade 5 is the most aggressive prostate cancer form with worse outcome.'}], 'secondaryOutcomes': [{'measure': 'High negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2)', 'timeFrame': 'From enrollment to pathology report, assessed up to 2 years', 'description': 'A high negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2) means that biopsies can safely be avoided in patients with PRIMARY 1-2 lesions only.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PSMA', 'PET/MRI', 'Prostate cancer', 'biopsy guidance'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to test the performance of PSMA PET/MRI-guided biopsies against systematic biopsies in men with negative MRI scan (PI-RADS 1-2) of the prostate with continuous suspicion of clinically significant prostate cancer (csPCa) due to PSAd \\> 0.20. The main questions it aims to answer are:\n\nCan biopsies safely be avoided at PRIMARY score 1-2 without missing csPCa? Does targeted PSMA PET/MRI-guided biopsies have a higher detection rate of csPCa compared to systematic biopsies?\n\nParticipants will undergo both transperineal MRI/ultrasound fusion target biopsies from PRIMARY score 3-5 lesions on PSMA PET and systematic biopsies irrespective of the PRIMARY-lesion.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PSAdensity \\> 0.20\n* Negative MRI (PI-RADS 1-2) or negative biopsy from MRI-target\n* MRI within 6 months\n* Read and understand danish\n* Expected remaining lifetime \\> 10 years\n\nExclusion Criteria:\n\n* Known prostate cancer\n* MRI contraindications'}, 'identificationModule': {'nctId': 'NCT07258056', 'acronym': 'GUIDE PSMA PET', 'briefTitle': 'GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies (GUIDE PSMA PET/MRI)', 'orgStudyIdInfo': {'id': '1-10-72-109-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PSMA-guided and systematic biopsies', 'description': 'Both PSMA-guided and systematic biopsies are performed', 'interventionNames': ['Diagnostic Test: PSMA-guided and systematic biopsies']}], 'interventions': [{'name': 'PSMA-guided and systematic biopsies', 'type': 'DIAGNOSTIC_TEST', 'description': 'Both PSMA-guided and systematic biopsies are performed', 'armGroupLabels': ['PSMA-guided and systematic biopsies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'state': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mads R Jochumsen, MD, Ph.D.', 'role': 'CONTACT', 'email': 'madsjoch@rm.dk', 'phone': '78456270'}, {'role': 'CONTACT', 'email': 'madsjoch@rm.dk'}, {'name': 'Mads R. Jochumsen, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Morten H Andersen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '7400', 'city': 'Herning', 'state': 'Herning', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Kasper D Berg, MD, Ph.D.', 'role': 'CONTACT', 'email': 'KASPBG@rm.dk', 'phone': '45 + 78439450'}, {'name': 'Kasper D Berg, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Goedstrup Hospital', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'centralContacts': [{'name': 'Mads R Jochumsen, MD, Ph.D.', 'role': 'CONTACT', 'email': 'madsjoch@rm.dk', 'phone': '+45 + 78456270'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Relevant data from the study will be made avilable and published, but the investigators do not have permission to share individual participant data with external researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mads Ryo Jochumsen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.D.', 'investigatorFullName': 'Mads Ryo Jochumsen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}