Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-29 @ 4:24 AM
Study NCT ID:
NCT04733768
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-PSMA-1007 PET/CT Imaging in Patients with Biochemically Recurrent or High-risk 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2021-01-27', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - immediate', 'timeFrame': 'Immediately (within 15 minutes) after 18F-PSMA-1007 injection', 'description': 'Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site'}, {'measure': 'Safety - post scan', 'timeFrame': '2.5 hours after 18F-PSMA-1007 injection', 'description': 'Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site'}, {'measure': 'Safety - delayed', 'timeFrame': '6 months after 18F-PSMA-1007 injection', 'description': 'Questionnaire (open-ended) to referring physicians to document any perceived delayed adverse events related to 18F-PSMA-1007 tracer injection'}, {'measure': 'Biodistribution', 'timeFrame': 'Within 5 days of scan', 'description': 'Evaluation of whether tracer distribution is as expected based on published normal distribution and known disease'}, {'measure': 'Diagnostic Accuracy', 'timeFrame': '1 year after 18F-PSMA-1007 PET/CT scan', 'description': 'Lesion by lesion comparison to conventional imaging (bone scan and CT scan) performed 2-10 days after the 18F-PSMA-1007 PET/CT scan. Reference standard based on lesion pathology (if available) or 1 year clinical/imaging following (using criteria published by Lawhn-Heath et al., AJR 2019;213:1-8.'}], 'secondaryOutcomes': [{'measure': 'Clinical Efficacy', 'timeFrame': '6 months after the 18F-PSMA-1007 PET/CT scan', 'description': 'Questionnaire completed by referring physicians evaluating the perceived clinical effect of the 18F-PSMA-1007 PET/CT on patient management'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in patients with biochemically recurrent or high-risk prostate cancer. Safety, biodistribution, clinical efficacy, and diagnostic accuracy will be assessed. For diagnostic accuracy comparison will be made to a contemporary (within 10 days) conventional imaging study (bone scan and CT scan).', 'detailedDescription': 'A single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in specific patient populations:\n\n1. Adult patients (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) \\> 0.2 µg/L\n2. Adult patients (≥ 18 years old) with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of \\< 9 months\n3. Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score \\> 7, serum PSA \\> 20 µg/L, OR minimum clinical T-stage T2c.\n\nAll patients will have a comparison conventional imaging study performed within 10 days of the investigational PET/CT scan. The conventional imaging study will include a 99mTc -MDP bone scan including whole body planar imaging (top of skull to toes) as well as SPECT/CT imaging of the trunk (including clavicles to pelvis). In the absence of contraindications (renal failure with eGFR \\< 40 mL/min/1.73m2 or history of IV contrast allergy), all scans will include an IV-contrast enhanced CT scan of the chest, abdomen, and pelvis. In the presence of contraindications to IV contrast, a non-IV contrast enhanced CT scan of the chest, abdomen, and pelvis will be performed.\n\nThe biodistribution of 18F-PSMA-1007 produced by the Edmonton PET Centre will be evaluated in 2 ways:\n\n* by comparing the biodistribution of tracer on the scans to an expected normal distribution.\n* for any identified abnormal distribution, a lesion-by-lesion comparison to the conventional imaging study will be performed with lesions classified as follows:\n\n * A - lesion identified on the investigational imaging study but not on the conventional imaging study\n * B - matching lesions on both the investigational and conventional imaging studies\n * C - lesion identified on the conventional imaging study but not on the investigational imaging study\n\nThe clinical efficacy of 18F-PSMA-1007 will be evaluated as follows:\n\n• a follow-up questionnaire will be sent to referring clinicians 6 months after the scan to determine if the scans were of perceived clinical benefit.\n\nThe safety of 18F-PSMA-1007 produced by Edmonton PET Centre will be evaluated in 3 ways:\n\n* the patients will be screened for adverse effects immediately post-injection as well as after the scan (approximately 2.5 hours after injection)\n* the patients will be provided an information sheet and contact information for self-reporting of delayed adverse events (1-7 days post injection)\n* a 6 month follow-up questionnaire will be sent to referring clinicians to determine if there were any perceived adverse events related to the injection\n\nThe diagnostic accuracy of 18F-PSMA-1007PET/CT produced by Edmonton PET Centre will be evaluated as follows:\n\n* All lesions categorized as "A", "B", or "C" will be compared with a reference standard to determine sensitivity and specificity on both a per lesion and per patient level\n* The reference standard will be defined a minimum of 1 year after completion of both scans based on available clinical data\n* Lesional histopathology results will be used as the reference standard when available\n* When pathology is unavailable, criteria for determining lesional positivity for metastatic disease will be based on recently published methodology (Lawhn-Heath et al., AJR 2019;213:1-8)\n* If lesion the criteria for determining lesion positivity are not met, the lesion will be considered unevaluable and will be excluded from assessment of accuracy'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) \\> 0.2 µg/L\n2. Adult patients (≥ 18 years old) with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of \\< 9 months\n3. Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score \\> 7, serum PSA \\> 20 µg/L, OR minimum clinical T-stage T2c.\n\nExclusion Criteria:\n\n1. Unable to obtain consent\n2. Weight \\>225 kg (weight limitation of PET/CT scanner)\n3. Unable to lie flat for 30 minutes to complete the PET-CT imaging session\n4. Lack of intravenous access\n5. Both CT scan of the chest, abdomen, and pelvis and 99mTc-MDP bone scan within 3 months\n6. History of allergic reaction to 18F-PSMA-1007 or 99mTc-MDP'}, 'identificationModule': {'nctId': 'NCT04733768', 'briefTitle': '18F-PSMA-1007 PET/CT Imaging in Patients with Biochemically Recurrent or High-risk Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': '18F-PSMA-1007 PET/CT Imaging in Patients with Biochemically Recurrent or High-risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'CC-20-0281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-PSMA-1007 PET/CT scan', 'description': 'Single Arm study - all enrolled patients will undergo an experimental 18F-PSMA-1007 PET/CT scan', 'interventionNames': ['Diagnostic Test: 18F-PSMA-1007']}], 'interventions': [{'name': '18F-PSMA-1007', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['[18F]PSMA-1007'], 'description': '18f-PSMA-1007 PET/CT scan', 'armGroupLabels': ['18F-PSMA-1007 PET/CT scan']}]}, '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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}