Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-27 @ 8:22 PM
Study NCT ID:
NCT03471650
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-10
First Post:
2018-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572626', 'term': '2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-03-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2018-03-02', 'studyFirstSubmitQcDate': '2018-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of 18F-DCFPyL PET/CT to detect clinically significant prostate cancer on prostate biopsy relative to serum prostate specific antigen (PSA)', 'timeFrame': '4 years', 'description': 'Measure the diagnostic accuracy of 18F-DCFPyL PET/CT and compare it with serum PSA for detecting clinically significant prostate cancer on prostate biopsy'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of 18F-DCFPyL PET/CT relative to PSA', 'timeFrame': '4 years', 'description': 'Measure the diagnostic accuracy of 18F-DCFPyL PET/CT relative to serum PSA for detecting clinically significant prostate cancer as defined by the following alternative definitions: Gleason score ≥4+3=7; Gleason score ≥3+4 or \\>50% involvement of ≥1 core with Gleason score ≥3+3=6 prostate cancer; Gleason score ≥3+4 or \\>70% involvement of ≥1 core with Gleason score ≥3+3=6 prostate cancer; Gleason score ≥3+4=7, or \\>2 cores with Gleason score ≥3+3=6, or \\>50% involvement of ≥1 core with Gleason score ≥3+3=6 prostate cancer.'}, {'measure': 'Sensitivity of 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer relative to mpMRI', 'timeFrame': '4 years', 'description': 'Measure the diagnostic accuracy of 18F-DCFPyL PET/CT relative to mpMRI for detecting clinically significant prostate cancer by the various tested definitions'}, {'measure': 'Sensitivity and diagnostic accuracy of 18F-DCFPyL PET/CT relative to the phi blood test for detecting clinically significant prostate cancer by the various tested definitions', 'timeFrame': '4 years', 'description': 'Measure the diagnostic accuracy of 18F-DCFPyL PET/CT relative to the phi blood test for detecting clinically significant prostate cancer by the various tested definitions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['J17149', 'PSMA', '18F-DCFPyL PET/CT'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population.', 'detailedDescription': 'This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population. 150 biopsy-naïve patients with an elevated PSA (2-10 ng/mL) will be enrolled in this study.\n\nWithin 28 days of informed consent, patients will undergo an 18F-DCFPyL PET/CT. All scans will be read by a single experienced radiologist who will identify regions of interest (ROI) with discrete radiotracer uptake. The maximum SUV value (SUVmax) of each ROI will be recorded. For patients without a detectable ROI, the mean SUV (SUVmean) of a 1-2 cm volume of the prostate will instead be recorded.\n\nOne to 28 days following PET/CT imaging, a systematic 12 to 14 core TRUS-guided prostate biopsy will be performed. Immediately following completion of systematic TRUS biopsies, fusion-targeted biopsies of all PET and/or MRI visible lesions will be performed, taking an additional 2 to 3 cores from each radiographic ROI. All biopsy cores will be assessed for Gleason score and percent cancer involvement.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Study is For Prostate Cancer in Men', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* PSA of 2-10 ng/mL\n* Clinical stage T1c-T2a on digital rectal exam\n* Elect to undergo TRUS-guided prostate biopsy as part of routine clinical care\n* Willingness to sign informed consent and comply with all protocol requirements\n\nExclusion Criteria:\n\n* History of prior prostate biopsy\n* Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT\n* Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT\n* Administered oral contrast medium ≤120 hours prior to the date of study PET/CT\n* Any medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectives'}, 'identificationModule': {'nctId': 'NCT03471650', 'briefTitle': 'Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'A Phase II Study to Evaluate the Performance of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer in Men With an Elevated PSA', 'orgStudyIdInfo': {'id': 'J17149'}, 'secondaryIdInfos': [{'id': 'IRB00139990', 'type': 'OTHER', 'domain': 'JHMIRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-DCFPyL Injection', 'description': 'A bolus of \\~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.', 'interventionNames': ['Drug: 18F-DCFPyL Injection']}], 'interventions': [{'name': '18F-DCFPyL Injection', 'type': 'DRUG', 'otherNames': ['PyL'], 'description': 'A bolus of \\~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.', 'armGroupLabels': ['18F-DCFPyL Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'SKCCC', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Mohamad Allaf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'Progenics Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}