Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-25 @ 1:38 PM
Study NCT ID:
NCT04266392
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2020-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand
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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-04', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of PET PSMA and Conventional Imaging', 'timeFrame': 'Within 1 year from the PET Imaging study', 'description': 'Compare \\[18F\\]DCFPyL PET imaging combined with whole body magnetic resonance imaging (MRI) and multiparametric pelvic/prostate MRI to conventional imaging modalities (CIM)--such as 99mTc-methylene diphosphonate bone scan (BS) and contrast-enhanced CT (CECT) of the abdomen and pelvis, or a newly approved PET imaging agent F-18 Fluciclovine, for the localization and determination of extent of recurrent/metastatic disease in patients with biochemical recurrence of prostate cancer or evidence of recurrence on CIM.'}, {'measure': 'Sensitivity and Specificity of PET/MRI PSMA in biochemical recurrence', 'timeFrame': 'Within 1 year from the PET Imaging study', 'description': 'Determine the sensitivity and specificity of \\[18F\\]-DCFPyL PET/MRI for extent of recurrent/metastatic disease in patients with biochemical recurrence.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '26493203', 'type': 'BACKGROUND', 'citation': 'Rowe SP, Macura KJ, Ciarallo A, Mena E, Blackford A, Nadal R, Antonarakis ES, Eisenberger MA, Carducci MA, Ross AE, Kantoff PW, Holt DP, Dannals RF, Mease RC, Pomper MG, Cho SY. Comparison of Prostate-Specific Membrane Antigen-Based 18F-DCFBC PET/CT to Conventional Imaging Modalities for Detection of Hormone-Naive and Castration-Resistant Metastatic Prostate Cancer. J Nucl Med. 2016 Jan;57(1):46-53. doi: 10.2967/jnumed.115.163782. Epub 2015 Oct 22.'}, {'pmid': '25896814', 'type': 'BACKGROUND', 'citation': 'Szabo Z, Mena E, Rowe SP, Plyku D, Nidal R, Eisenberger MA, Antonarakis ES, Fan H, Dannals RF, Chen Y, Mease RC, Vranesic M, Bhatnagar A, Sgouros G, Cho SY, Pomper MG. Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Mol Imaging Biol. 2015 Aug;17(4):565-74. doi: 10.1007/s11307-015-0850-8.'}, {'pmid': '22042970', 'type': 'BACKGROUND', 'citation': 'Chen Y, Pullambhatla M, Foss CA, Byun Y, Nimmagadda S, Senthamizhchelvan S, Sgouros G, Mease RC, Pomper MG. 2-(3-1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. Clin Cancer Res. 2011 Dec 15;17(24):7645-53. doi: 10.1158/1078-0432.CCR-11-1357. Epub 2011 Oct 31.'}, {'pmid': '26013479', 'type': 'BACKGROUND', 'citation': 'Dietlein M, Kobe C, Kuhnert G, Stockter S, Fischer T, Schomacker K, Schmidt M, Dietlein F, Zlatopolskiy BD, Krapf P, Richarz R, Neubauer S, Drzezga A, Neumaier B. Comparison of [(18)F]DCFPyL and [ (68)Ga]Ga-PSMA-HBED-CC for PSMA-PET Imaging in Patients with Relapsed Prostate Cancer. Mol Imaging Biol. 2015 Aug;17(4):575-84. doi: 10.1007/s11307-015-0866-0.'}, {'pmid': '27094471', 'type': 'BACKGROUND', 'citation': 'Tan H, Joseph D, Loh NK, McCarthy M, Leong E, Siew T, Segard T, Morandeau L, Trevenen M, Francis RJ. A pilot study of the utility of choline PET-CT in prostate cancer biochemical relapse following radical prostatectomy. J Med Imaging Radiat Oncol. 2016 Jun;60(3):374-81. doi: 10.1111/1754-9485.12455. Epub 2016 Apr 20.'}, {'pmid': '14716746', 'type': 'BACKGROUND', 'citation': "O'Keefe DS, Bacich DJ, Heston WD. Comparative analysis of prostate-specific membrane antigen (PSMA) versus a prostate-specific membrane antigen-like gene. Prostate. 2004 Feb 1;58(2):200-10. doi: 10.1002/pros.10319."}, {'pmid': '16985927', 'type': 'BACKGROUND', 'citation': 'Chang SS. Overview of prostate-specific membrane antigen. Rev Urol. 2004;6 Suppl 10(Suppl 10):S13-8.'}, {'pmid': '23707439', 'type': 'BACKGROUND', 'citation': 'Thompson IM, Valicenti RK, Albertsen P, Davis BJ, Goldenberg SL, Hahn C, Klein E, Michalski J, Roach M, Sartor O, Wolf JS Jr, Faraday MM. Adjuvant and salvage radiotherapy after prostatectomy: AUA/ASTRO Guideline. J Urol. 2013 Aug;190(2):441-9. doi: 10.1016/j.juro.2013.05.032. Epub 2013 May 21.'}, {'pmid': '25007963', 'type': 'BACKGROUND', 'citation': 'van der Pol CB, Schweitzer ME, Di Primio G, Sampaio ML, Kielar A, Clemons M, Jaberi A. Breast cancer and bone metastases: the association of axial skeleton MRI findings with skeletal-related events and survival. Breast Cancer Res Treat. 2014 Aug;146(3):583-9. doi: 10.1007/s10549-014-3046-z. Epub 2014 Jul 10.'}, {'pmid': '27080322', 'type': 'BACKGROUND', 'citation': 'Rowe SP, Macura KJ, Mena E, Blackford AL, Nadal R, Antonarakis ES, Eisenberger M, Carducci M, Fan H, Dannals RF, Chen Y, Mease RC, Szabo Z, Pomper MG, Cho SY. PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. Mol Imaging Biol. 2016 Jun;18(3):411-9. doi: 10.1007/s11307-016-0957-6.'}]}, 'descriptionModule': {'briefSummary': 'Eligible patients have prostate cancer that was treated with surgery or radiation therapy for localized disease and there is evidence of biochemical recurrence and/or metastases on conventional imaging.The objective of this study is to assess the performance in detection of prostate cancer of a new positron emission tomography (PET) radiotracer for prostate cancer (\\[18F\\]-DCFPyl) combined with magnetic resonance imaging (MRI). Results of tracer uptake and MRI image features as whole body PET/MRI and dedicated pelvic/prostate PET/MRI, alone and together, will be correlated and compared to detection of lesions on conventional imaging modalities. Additionally, if the patient undergoes a biopsy as standard of care, image features will correlate directly with histopathological findings.Validation of this radiotracer can potentially lead to its use as a standard of care for future imaging and improve diagnosis and treatment guidance.This drug is not approved by the Food and Drug Administration (FDA) and is therefore considered experimental.There will be 20 subjects enrolled in this study; all of these patients will be enrolled at Stony Brook University Medical Center.', 'detailedDescription': "The study objective is to assess the performance of \\[18F\\]-DCFPyl PET with whole-body MRI and multiparametric pelvic/prostate MRI for PCa detection in men with recurrence as determined by biochemical PSA level or evidence on CIM. Results of tracer uptake and MRI image features on whole body PET/MRI and dedicated pelvic/prostate PET/MRI, alone and together, will be correlated and compared to detection of lesions on CIM that usually includes bone scan (BS) and CT scan of the abdomen and pelvis, or PET imaging with F-18 Fluciclovine. In addition, in patients who undergo a biopsy when performed as standard of care, image features will correlate directly with histopathological findings on lesion biopsy to directly demonstrate that 'radiotracer and/or MRI positive' lesions contain tumor cells.\n\nTo test the hypothesis, this study is being proposed using the \\[18F\\]-DCFPyL PET tracer for the detection of PCa in patients with biochemical recurrence or evidence on CIM. The \\[18F\\]-DCFPyL PET tracer will be provided by the company Progenics Pharmaceuticals, Inc. (New York, New York) and conducted under an investigational new drug (IND) approval received by Stony Brook University."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject has prostate cancer treated with surgery, radiation therapy and/or chemotherapy for localized disease\n* subject has biochemical recurrence defined in postsurgical patients as a PSA value = \\> 0.2 ng/mL followed by a subsequent confirmatory PSA value = \\>0.2 ng/mL according to the American Urological Association (AUA) guidelines, or three consecutive rises above the nadir in patients following radiation therapy according to the American Society for Radiation Therapy and Oncology (ASTRO).\n* in most cases, it will be required that the patient has had a prior CIM scan (such as a BS, MRI, CT or PET with F-18 Fluciclovine) performed before enrollment in this study; the only exception would be if the PSA level of the patient is remarkably high indicating apparent recurrence.\n\nExclusion Criteria:\n\n* less than 18 years of age (prostate cancer is not prevalent in the pediatric population);\n* any contraindications to MRI imaging such as electrical implants, cardiac pacemakers or perfusion pumps;\n* ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or ferromagnetic objects such as jewelry or metal clips in clothing;\n* is unable to lie comfortably on a bed inside the scanner for 60 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis);\n* if they have had treatment with investigational drug within 30 days prior to trial enrollment;\n* if they had administration of another radioisotope within five physical half-lives of trial enrollment;\n* if they had radiation or chemotherapy within 4 weeks prior to trial enrollment;\n\nEligibility will be determined by a screening interview. All subjects recruited for the study will be able to withdraw from the study at any time.'}, 'identificationModule': {'nctId': 'NCT04266392', 'briefTitle': 'Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand', 'orgStudyIdInfo': {'id': '889520'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: [18F]-DCFPyl Ligand']}], 'interventions': [{'name': '[18F]-DCFPyl Ligand', 'type': 'DRUG', 'description': "To assess the performance of \\[18F\\]-DCFPyl PET with whole-body MRI and multiparametric pelvic/prostate MRI for PCa detection in men with recurrence as determined by biochemical PSA level or evidence on CIM. Results of tracer uptake and MRI image features on whole body PET/MRI and dedicated pelvic/prostate PET/MRI, alone and together, will be correlated and compared to detection of lesions on CIM that usually includes bone scan (BS) and CT scan of the abdomen and pelvis, or PET imaging with F-18 Fluciclovine.In addition, in patients who undergo biopsy when performed as standard of care, we will correlate image features directly with histopathological findings on lesion biopsy to directly demonstrate that 'radiotracer and/or MRI positive' lesions contain tumor cells.", 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794-7263', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'Dinko Franceschi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Progenics Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Dinko Franceschi', 'investigatorAffiliation': 'Stony Brook University'}}}}