Journal article
Diagnostic Performance of F-18-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study
Clinical cancer research, Vol.27(13), pp.3674-3682
07/01/2021
DOI: 10.1158/1078-0432.CCR-20-4573
PMCID: PMC8382991
PMID: 33622706
Abstract
Purpose Current FDA-approved imaging modalities are inadequate for localizing prostate cancer biochemical recurrence (BCR). F-18-DCFPyL is a highly selective, small-molecule prostate-specific membrane antigen-targeted PET radiotracer. CONDOR was a prospective study designed to determine the performance of F-18-DCFPyL-PET/CT in patients with BCR and uninformative standard imaging.
Experimental Design: Men with rising PSA >= 0.2 ng/mL after prostatectomy or >= 2 ng/mL above nadir after radiotherapy were eligible. The primary endpoint was correct localization rate (CLR), defined as positive predictive value with an additional requirement of anatomic lesion colocalization between (FDCFPyL)-F-18-PET/Cr and a composite standard of truth (SOT). The SOT consisted of, in descending priority (i) histopathology, (ii) subsequent correlative imaging findings, or (iii) post-radiation PSA response. The trial was considered a success if the lower bound of the 95% confidence interval (CI) for CLR exceeded 20% for two of three F-18-DCFPyL-PET/CT readers. Secondary endpoints included change in intended management and safety.
Results: A total of 208 men with a median baseline PSA of 0.8 ng/mL (range: 0.2-98.4 ng/mL) underwent F-18-DCFPyL-PET/CT. The CLR was 84.8%-87.0% (lower bound of 95% CI: 77.8-80.4). A total of 63.9% of evaluable patients had a change in intended management after F-18-DCFPyL-PET/CT. The disease detection rate was 59% to 66% (at least one lesion detected per patient by F-18-DCFPyL-PET/CT by central readers).
Conclusions: Performance of F-18-DCFPyL-PET/CT achieved the study's primary endpoint, demonstrating disease localization in the setting of negative standard imaging and providing clinically meaningful and actionable information. These data further support the utility of F-18-DCFPyL-PET/CT to localize disease in men with recurrent prostate cancer.
Details
- Title: Subtitle
- Diagnostic Performance of F-18-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study
- Creators
- Michael J. Morris - Memorial Sloan Kettering Cancer CenterSteven P. Rowe - Johns Hopkins UniversityMichael A. Gorin - Johns Hopkins MedicineLawrence Saperstein - Yale UniversityFrederic Pouliot - Université LavalDavid Josephson - Cedars-Sinai Medical CenterJeffrey Y. C. Wong - City Of Hope National Medical CenterAustin R. Pantel - Hospital of the University of PennsylvaniaSteve Y. Cho - University of Wisconsin–MadisonKenneth L. Gage - Moffitt Cancer CenterMorand Piert - University of Michigan–Ann ArborAndrei Iagaru - Stanford UniversityJanet H. Pollard - University of IowaVivien Wong - Progenics PharmaceuticalsJessica Jensen - Progenics PharmaceuticalsTess Lin - Progenics PharmaceuticalsNancy Stambler - Progenics PharmaceuticalsPeter R. Carroll - University of California, San FranciscoBarry A. Siegel - MallinckrodtCONDOR Study Group
- Resource Type
- Journal article
- Publication Details
- Clinical cancer research, Vol.27(13), pp.3674-3682
- DOI
- 10.1158/1078-0432.CCR-20-4573
- PMID
- 33622706
- PMCID
- PMC8382991
- NLM abbreviation
- Clin Cancer Res
- ISSN
- 1078-0432
- eISSN
- 1557-3265
- Publisher
- Amer Assoc Cancer Research
- Number of pages
- 9
- Grant note
- Progenics Pharmaceuticals, Inc.; Takeda Pharmaceutical Company Ltd
- Language
- English
- Date published
- 07/01/2021
- Academic Unit
- Radiology
- Record Identifier
- 9984318689202771
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