A Prospective Study on (18)F-DCFPyL PSMA PET/CT Imaging in Biochemical Recurrence of Prostate Cancer

(18)F-DCFPyL (2-(3-{1-carboxy-5-[(6-(18)F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid), a prostate-specific membrane antigen–targeting radiotracer, has shown promise as a prostate cancer imaging radiotracer. We evaluated the safety, sensitivity, and impact on patient management of (18)F-DCFPyL in the setting of biochemical recurrence of prostate cancer. Methods: Subjects with prostate cancer and biochemical recurrence after radical prostatectomy or curative-intent radiotherapy were included in this prospective study. The subjects underwent (18)F-DCFPyL PET/CT imaging. The localization and number of lesions were recorded. The uptake characteristics of the 5 most active lesions were measured. A pre- and posttest questionnaire was sent to treating physicians to assess the impact on management. Results: One hundred thirty subjects were evaluated. (18)F-DCFPyL PET/CT localized recurrent prostate cancer in 60% of cases with a prostate-specific antigen (PSA) level of ≥0.4 to <0.5, 78% with a level of ≥0.5 to <1.0, 72% with a level of ≥1.0 to <2.0, and 92% with a level of ≥2.0. Many subjects had few lesions (1 lesion in 40.8%, 2 in 8.5%, and 3 in 4.6%). The number of lesions was significantly related to PSA by ANOVA, but there was a large overlap in the PSA values for number of lesion categories. Total lesion uptake was also significantly related to PSA level. A change in treatment intent occurred in 65.5% of subjects, disease stage changed in 65.5%, and management plans changed in 87.3%. Twenty-two subjects reported mild adverse events after the scan; all resolved completely. Conclusion: (18)F-DCFPyL PET/CT is safe and sensitive for the localization of biochemical recurrence of prostate cancer. This test improved decision making for referring oncologists and changed management for most subjects.