Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT04839367
Status:
COMPLETED
Last Update Posted:
2023-01-17
First Post:
2021-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-04-07', 'lastUpdatePostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5', 'timeFrame': '11 weeks', 'description': 'Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.'}, {'measure': 'Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology', 'timeFrame': '11 weeks', 'description': 'Efficacy will be measured by the proportion of 64Cu-SAR-bisPSMA PET/CT scans assessed as True Positive or False Negative for primary Prostate Cancer, as confirmed by histopathology.'}], 'secondaryOutcomes': [{'measure': 'Comparison of image quality at varying dose levels of 64CuSAR-bisPSMA for each dose cohort (100 MBq, 150 MBq and 200 MBq).', 'timeFrame': '11 weeks', 'description': 'Image quality will be assessed by 2 blinded central readers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostatic Neoplasms']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.', 'detailedDescription': 'This is a multi-centre, blinded review, dose ranging, non-randomized study of 64Cu-SAR-bisPSMA administered to participants with confirmed Prostate Cancer. 30 eligible participants will be allocated (1:1:3) to 1 of 3 dosing cohorts to be administered with 64Cu-SAR-bisPSMA 100 MBq, 150 MBq or 200 MBq. PET/CT scan images will be sent to blinded central readers to assess the capacity of 64Cu-SAR-bisPSMA to detect primary Prostate Cancer, to assess image quality of the various dose cohorts, and to assess the PET/CT scan features of 64Cu-SAR-bisPSMA in comparison standard of care.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent;\n* ≥18 years of age;\n* Life expectancy \\>3 months;\n* Confirmation of Prostate Cancer by histopathology and planned radical prostatectomy;\n* Have ≥1 of the following intermediate- to high-risk features:\n\n 1. PSA level greater than or equal to 10.0 ng/ml within 12 weeks prior to enrolment;\n 2. International Society of Urological Pathology (ISUP) Grade Group 3 (i.e. Gleason score of 7 (4+3) or above;\n 3. Clinical stage greater than or equal to T2b;\n* Participants must have adequate renal function;\n* Sexually active participants who have female partners of childbearing potential: Partner and/or participant must agree to use an acceptable form of contraception. Further participants must refrain from donating sperm;\n* A 68Ga-PSMA-11 PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SAR-bisPSMA.\n\nExclusion Criteria:\n\n* Prior prostatectomy or any other treatment for Prostate Cancer, including Androgen Deprivation Therapy and radiation therapy;\n* Previous treatment with PSMA-targeted therapy within 3 months prior to enrolment, and administration of other investigational agents within 4 weeks prior to entering the study (except 68Ga-PSMA-11);\n* Known hypersensitivity to the components of 64Cu-SAR-bisPSMA;\n* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;\n* Any serious medical condition which the Investigator feels may interfere with the procedures or evaluations of the study;\n* Patients unwilling or unable to comply with protocol or with a history of noncompliance or inability to grant informed consent.'}, 'identificationModule': {'nctId': 'NCT04839367', 'acronym': 'PROPELLER', 'briefTitle': 'Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clarity Pharmaceuticals Ltd'}, 'officialTitle': 'Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study', 'orgStudyIdInfo': {'id': 'CLP03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA', 'description': 'Participants will receive a single administration, a bolus injection of 100 MBq 64Cu-SAR-bisPSMA.', 'interventionNames': ['Drug: 64Cu-SAR-bisPSMA']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA', 'description': 'Participants will receive a single administration, a bolus injection of 150 MBq 64Cu-SAR-bisPSMA.', 'interventionNames': ['Drug: 64Cu-SAR-bisPSMA']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA', 'description': 'Participants will receive a single administration, a bolus injection of 200 MBq 64Cu-SAR-bisPSMA.', 'interventionNames': ['Drug: 64Cu-SAR-bisPSMA']}], 'interventions': [{'name': '64Cu-SAR-bisPSMA', 'type': 'DRUG', 'description': '64Cu-SAR-bisPSMA', 'armGroupLabels': ['Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA', 'Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA', 'Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2751', 'city': 'Kingswood', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Nepean Hospital', 'geoPoint': {'lat': -33.75614, 'lon': 150.72346}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '6150', 'city': 'Murdoch', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'GenesisCare CTA, SJOG Medical Clinic', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clarity Pharmaceuticals Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}