Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-28 @ 7:05 PM
Study NCT ID:
NCT04742361
Status:
COMPLETED
Last Update Posted:
2025-07-15
First Post:
2021-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2021-02-04', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT)', 'timeFrame': 'Within 6 months after PET/CT'}, {'measure': 'Patient-level correct detection rate of [18F]PSMA-1007', 'timeFrame': 'Within 6 months after PET/CT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Prostate Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'This study evaluates the diagnostic performance and safety of \\[18F\\]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy\n* Suspicion of recurrence or persistence\n\n * after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)\n * after prostatectomy, PSA \\> 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association)\n* For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment.\n* Life expectancy of 6 months or more as judged by the investigator\n* Willing and able to undergo all study procedures\n* Informed consent in writing\n\nExclusion Criteria:\n\n* Age: less than18 years\n* Contraindications to any of the ingredients of \\[18F\\]PSMA-1007\n* Close affiliation with the investigational site\n* At the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial\n* Having been previously enrolled in this clinical trial\n* Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial\n* Being clinically unstable or requiring emergency treatment\n* Patients who are unwilling to consider a biopsy if clinically recommended\n* Patients who are unable to undergo a PET/CT scan\n* Patients for whom systemic therapy is the most likely course regardless of PET findings.'}, 'identificationModule': {'nctId': 'NCT04742361', 'briefTitle': 'Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'ABX advanced biochemical compounds GmbH'}, 'officialTitle': 'Phase III Study of [18F]PSMA-1007 Positron Emission Tomography for the Detection of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer', 'orgStudyIdInfo': {'id': 'ABX-CT-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[18F]PSMA-1007', 'description': 'single intravenous administration of \\[18F\\]PSMA-1007 for Positron Emission Tomography (PET) scan', 'interventionNames': ['Drug: [18F]PSMA-1007']}], 'interventions': [{'name': '[18F]PSMA-1007', 'type': 'DRUG', 'description': 'diagnostic radiopharmaceutical for PET scan', 'armGroupLabels': ['[18F]PSMA-1007']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77042', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Excel Diagnostics and Nuclear Oncology Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'RUMC', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital, Universitätsspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ABX advanced biochemical compounds GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}