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Clinical Trial
. 2021 Jul 1;27(13):3674-3682.
doi: 10.1158/1078-0432.CCR-20-4573. Epub 2021 Feb 23.

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study

Michael J Morris #  1 , Steven P Rowe #  2 , Michael A Gorin  3 , Lawrence Saperstein  4 , Frédéric Pouliot  5 , David Josephson  6 , Jeffrey Y C Wong  7 , Austin R Pantel  8 , Steve Y Cho  9 , Kenneth L Gage  10 , Morand Piert  11 , Andrei Iagaru  12 , Janet H Pollard  13 , Vivien Wong  14 , Jessica Jensen  14 , Tess Lin  14 , Nancy Stambler  14 , Peter R Carroll  15 , Barry A Siegel; CONDOR Study Group
Collaborators, Affiliations
Clinical Trial

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study

Michael J Morris et al. Clin Cancer Res. .

Abstract

Purpose: Current FDA-approved imaging modalities are inadequate for localizing prostate cancer biochemical recurrence (BCR). 18F-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 18F-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 18F-DCFPyL-PET/CT 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 18F-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 18F-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 18F-DCFPyL-PET/CT. The disease detection rate was 59% to 66% (at least one lesion detected per patient by 18F-DCFPyL-PET/CT by central readers).

Conclusions: Performance of 18F-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 18F-DCFPyL-PET/CT to localize disease in men with recurrent prostate cancer.See related commentary by True and Chen, p. 3512.

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Conflict of interest statement

Conflict of interest statement: COI’s have been submitted electronically.

Figures

Figure 1.
Figure 1.. STARD flow diagram with Composite Standard of Truth (SOT) Validation
*Includes patients who withdrew from the study or did not have follow-up assessment due to negative 18F-DCFPyL-PET/CT per local read; EBRT = external beam radiation therapy
Figure 2.
Figure 2.. CLR (A) and detection rate (B) by baseline PSA levels
*Median (95% CI) for each group of three readers provided Abbreviations: CLR: Correct localization rate; PSA: Prostate-specific antigen
Figure 3.
Figure 3.. PPV by anatomic region (A) and extra-pelvic region (B)
*Median (95% CI) for each group of three readers provided; PPV: Positive predictive value
Figure 4.
Figure 4.
Change in Planned Medical Management
See this image and copyright information in PMC

Comment in

References

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