Abstract
PSMA-targeted imaging with 18 F-DCFPyL-PET/CT in patients (pts) withbiochemically recurrent prostate cancer (PCa): A phase 3 study (CONDOR)—A subanalysis of correct localization rate (CLR) and positive predictive value (PPV) by standard of truth
Journal of clinical oncology, Vol.39(15_suppl), pp.5023-5023
05/20/2021
DOI: 10.1200/JCO.2021.39.15_suppl.5023
Abstract
5023
Background: PSMA-targeted PET/CT is superior to conventional imaging modalities to localize biochemically recurrent (BCR) PCa after local therapy, particularly in pts with low PSA ( < 2 ng/mL). However, few studies have reported PSMA-targeted PET/CT accuracy compared to a pre-specified rigorous standard of truth (SOT) including histopathology, correlative imaging or treatment response in this population. Here, we report the CLR and PPV of PSMA-targeted
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F-DCFPyLPET/ CT, for each of the pre-defined SOT criteria for the CONDOR prospective phase 3 study. Methods: The study enrolled men with rising PSA after definitive therapy and negative or equivocal standard of care imaging (e.g., CT/MRI, bone scintigraphy, F-18 fluciclovine). A single 9 mCi (333 MBq) ± 20% dose of
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F-DCFPyL was injected, followed by PET/CT 1-2 hours later. Pts with positive
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F-DCFPyL-PET/CT scans based on local interpretation were scheduled for follow up within 60 days to verify suspected lesion(s) using a composite SOT. The primary endpoint was CLR defined as PPV with the requirement of anatomic lesion co-localization between
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F-DCFPyL-PET/CT and the SOT. The SOT consisted of, in descending priority: 1) histopathology, 2) subsequent correlative imaging findings determined by twocentral readers, or 3) post-radiation PSA response. The trial was successful if the lower bound of the 95% confidence interval for CLR exceeded 20% for at least two of three independent, blinded central
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F-DCFPyL-PET/CT reviewers. Results: 208 men (median PSA 0.8 ng/mL) underwent
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F-DCFPyL-PET/CT and the study achieved its primary endpoint: CLR was between 84.8% to 87.0% (lower bound of 95% CI: 77.8%-80.4%) among the three
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F-DCFPyL-PET/CT readers, against the composite SOT. The performance of
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F-DCFPyL-PET/CT by CLR (≥1 lesion co-localized) and PPV (≥1 lesion confirmed) was maintained through all 3 SOT categories. Histopathology (N = 31): 78.6-82.8% and 92.9-93.3% for CLR and PPV, respectively; correlative imaging (N = 100): 86.1-88.6% and 87.0-89.5% for CLR and PPV, respectively; and PSA response (N = 1): 100% for both CLR and PPV. Further analyses of the correlative imaging results showed CLR remained high across the different modalities used a)
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F-fluciclovine-PET/CT (N = 71): (86.8-90.9%); b) MRI (N = 23): (80.0-86.7%); and c) CT (n = 6): (80.0-100%). Conclusions: PSMA-targeted
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F-DCFPyL-PET/CT detected and localized metastatic lesions with high CLR and PPV regardless of which criterion defined CLR that was used, in men with BCR who had negative or equivocal baseline imaging. Clinicaltrials.gov: NCT03739684 Clinical trial information: NCT03739684.
Details
- Title: Subtitle
- PSMA-targeted imaging with 18 F-DCFPyL-PET/CT in patients (pts) withbiochemically recurrent prostate cancer (PCa): A phase 3 study (CONDOR)—A subanalysis of correct localization rate (CLR) and positive predictive value (PPV) by standard of truth
- Creators
- Frederic Pouliot - Université LavalMichael A. Gorin - Johns Hopkins University School of MedicineSteven P. Rowe - Johns Hopkins University School of MedicineLawrence Saperstein - Yale School of MedicineDavid Josephson - Tower Urology, Los Angeles, CAPeter R. Carroll - University of California, San FranciscoJeffrey Y.C. Wong - City Of Hope National Medical CenterAustin R. Pantel - University of PennsylvaniaSteve Y. Cho - University of Wisconsin SMPH, Department of Radiology, University of Wisconsin Carbone Cancer Center, Madison, WIKenneth L. Gage - Moffitt Cancer CenterMorand Piert - University of Michigan–Ann ArborAndrei Iagaru - Stanford UniversityJanet H. Pollard - University of IowaVivien Wong - Progenics PharmaceuticalsJessica Jensen - Progenics PharmaceuticalsNancy Stambler - Progenics PharmaceuticalsMichael J. Morris - Memorial Sloan Kettering Cancer CenterBarry A. Siegel - Washington University School of Medicine in St. Louis, St. Louis, MO
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.39(15_suppl), pp.5023-5023
- DOI
- 10.1200/JCO.2021.39.15_suppl.5023
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Grant note
- DOI: 10.13039/100016542, name: Progenics Pharmaceuticals, Inc
- Language
- English
- Date published
- 05/20/2021
- Academic Unit
- Radiology
- Record Identifier
- 9984320083902771
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