Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 4:30 PM
Study NCT ID:
NCT05141760
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2021-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients
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': 'D011877', 'term': 'Radionuclide Imaging'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2021-11-09', 'studyFirstSubmitQcDate': '2021-11-18', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor T-staging', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Differentiate Unilateral vs. Bilateral Tumor (i.e. T2a vs. T2b), Identify extracapsular extension (T3a) or Seminal vesicle invasion (T3b)'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of PSMA-1007 PET', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Compare final histology against PSMA-1007 PET'}, {'measure': 'Sensitivity of MRI', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Compare final histology against MR imaging'}, {'measure': 'Specificity of PSMA-1007 PET', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Compare final histology against PSMA-1007 PET'}, {'measure': 'Specificity of MRI', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Compare final histology against MR imaging'}, {'measure': 'Negative Predictive Value of PSMA-1007 PET', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Compare final histology against PSMA-1007 PET'}, {'measure': 'Negative Predictive Value of MRI', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Compare final histology against MR imaging'}, {'measure': 'Positive Predictive Value of PSMA-1007 PET', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Compare final histology against PSMA-1007 PET'}, {'measure': 'Positive Predictive Value of MRI', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Compare final histology against MRI'}, {'measure': 'Nodal Staging', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Accuracy of nodal disease on PSMA-1007 PET and MRI compared to bone scan + CT'}, {'measure': 'Metastatic Staging', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Accuracy of PSMA-1007 PET and MRI compared to bone scan + CT'}, {'measure': 'Longest Tumor diameter', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Compare final histology against PSMA-1007 PET and MRI measurements'}, {'measure': 'Identification of dominant lesion', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Compare rate of dominant lesion identification of PSMA-1007 PET and MRI against final histology'}, {'measure': 'Identification of non-dominant lesion', 'timeFrame': 'Through study completion, this is expected to be reviewed within 1 year of imaging', 'description': 'Compare rate of non-dominant lesion identification of PSMA-1007 PET and MRI against final histology'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This prospective phase II study assesses the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007)) and multiparametric magnetic resonance imaging (MRI) for locoregional staging of clinically significant prostate cancer in men undergoing radical prostatectomy and bilateral pelvic lymph node dissection. The design will be a multicenter validating-paired cohort study using radical prostatectomy and pelvic lymph node dissection as the gold standard comparator. Each patient will undergo both 18F-PSMA-1007 PET and 3T MRI allowing comparison of each imaging modality within each subject. Furthermore, PET and MRI will be compared to standard-of-care imaging techniques (CT abdomen/pelvis and 99mTc-MDP Bone scan).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients or their legal medical decision makers will sign an informed consent prior to entering the study.\n2. Adult patient (≥ 18 years old) with a diagnosis of at least Gleason Grade Group 2 prostate cancer.\n3. Appropriate staging investigations have been performed prior to the participation in the study (i.e. CT abdomen/pelvis and 99mTc-MDP bone scan)\n\nExclusion Criteria:\n\n1. Unable to obtain consent\n2. Weight \\>250 kg (weight limitation of scanners)\n3. Unable to lie flat for 30 minutes to complete the PET or MRI imaging\n4. Severe claustrophobia precluding image acquisition\n5. Lack of intravenous access\n6. Non-MRI compatible pacemaker or hardware\n7. eGFR \\< 40 mL/min/1.73 m2 and/or a history of a severe reaction to MRI contrast\n8. Prior androgen deprivation therapy'}, 'identificationModule': {'nctId': 'NCT05141760', 'briefTitle': '18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients', 'orgStudyIdInfo': {'id': 'HREBA.CC-21-0073'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Additional staging PET and MRI scan prior to prostatectomy and lymph node dissection'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Urological Association Scholarship Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}