The study design for CONDOR is as follows:
For this study, a single 9 mCi (333 MBq) ± 20% dose of 18F-DCFPyL was injected, followed by PET/CT 1-2 hours later. Patients with positive 18F-DCFPyL-PET/CT scans based on local interpretation were scheduled for follow-up within 60 days to verify suspected lesion(s) using a composite standard of truth. The primary endpoint was the correct localization rate defined as positive predictive value with the requirement of anatomic lesion co-localization between 18F-DCFPyL-PET/CT and the standard of truth. The standard of truth consisted of, in descending priority:
- Subsequent correlative imaging findings determined by two central readers
- Post-radiation PSA response.
There were 208 men (with a median PSA of 0.8 ng/mL) that underwent 18F-DCFPyL-PET/CT and the study achieved its primary endpoint: correct localization rate was between 84.8% to 87.0% (lower bound of 95% CI: 77.8%-80.4%) among the three 18F-DCFPyL-PET/CT readers, against the composite standard of truth. The performance of 18F-DCFPyL-PET/CT by correct localization rate (≥1 lesion co-localized) and positive predictive value (≥1 lesion confirmed) was maintained through all 3 standards of truth categories:
- Histopathology (n = 31): 78.6-82.8% and 92.9-93.3% for correct localization rate and positive predictive value, respectively
- Correlative imaging (n = 100): 86.1-88.6% and 87.0-89.5% for correct localization rate and positive predictive value, respectively
- PSA response (n = 1): 100% for both correct localization rate and positive predictive value
Further analyses of the correlative imaging results showed correct localization rate remained high across the different modalities used 18F-fluciclovine-PET/CT (N = 71): (86.8-90.9%); MRI (N = 23): (80.0-86.7%); and CT (n = 6): (80.0-100%).
Dr. Pouliot concluded this updated subanalysis of the CONDOR study with the following take-home/concluding messages:
- The CONDOR study met the novel FDA recommended primary endpoint of correct localization rate, as the lower limit of the 95% CI greatly exceeded 20% by all 3 readers
- PSMA-targeted 18F-DCFPyL-PET/CT detected and localized metastatic lesions with high correct localization rate and positive predictive value regardless of which criterion defined correct localization rate that was used
- Novel standard of truth criteria based on correlative imaging shows similar performance when compared to histopathological standard of truth. Therefore, it can be used to determine correct localization rate and positive predictive value in future studies where biopsy is not possible
Clinical trial information: NCT03739684
Presented By: Frederic Pouliot, MD, Ph.D., FRCSC, Cancer Research Center, Centre Hospitalier Universitaire (CHU) de Québec-Université Laval, Québec City, Canada
Written By: Zachary Klaassen, MD, MSc, Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia Twitter: @zklaassen_md at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, Virtual Annual Meeting #ASCO21, June, 4-8, 2021
- Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study. Clin Cancer Res. 2021 Feb 23 [Epub ahead of print].
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CONDOR: Study of 18F-DCFPyL PET/CT Imaging in Patients with Suspected Recurrence of Prostate Cancer - Michael J. Morris