RT Journal Article SR Electronic T1 Phase III study of 18F-PSMA-1007 versus 18F-fluorocholine PET/CT for localization of prostate cancer biochemical recurrence: a prospective, randomized, cross-over, multicenter study JF Journal of Nuclear Medicine JO J Nucl Med FD Society of Nuclear Medicine SP jnumed.122.264743 DO 10.2967/jnumed.122.264743 A1 Pierre Olivier A1 Anne-Laure Giraudet A1 Andrea Skanjeti A1 Charles Merlin A1 Pierre Weinmann A1 Ines Rudolph A1 Alexander Hoepping A1 Mathieu Gauthé YR 2022 UL http://jnm.snmjournals.org/content/early/2022/11/23/jnumed.122.264743.abstract AB Objective: To compare 18F-PSMA-1007 and 18F-fluorocholine PET/CT for localization of prostate cancer (PCa) biochemical recurrence. Methods: This prospective, open-label, randomized, cross-over, multicenter study, included prostate cancer patients with prior definitive therapy and suspicion of PCa recurrence. All men underwent both 18F-PSMA-1007 and 18F-fluorocholine PET/CT (102 received 18F-PSMA-1007 first and 88 received 18F-fluorocholine PET/CT first). All images were assessed independently by three readers blinded to all clinical information using a 3-point qualitative scale (0-no-recurrence; 1-undetermined; 2-recurrence). Patients were followed for approximately 6 months. An independent panel with a urologist, radiologist, and nuclear physician reviewed all clinical data, including imaging and response to therapy but blinded to PET/CT information, and acting in consensus, determined a patient-based and region-based composite standard of truth for PCa lesions. The “correct detection rate” of PCa lesions on a patient-basis for each radiopharmaceutical was compared for the three readers individually and for the average reader. Secondary objectives included determining if PET/CT findings impact diagnostic thinking (impact of a test result on post-test versus pre-test probability of a correct diagnosis), therapeutic decision making (description and quantification of impact of diagnostic information gained with both radiopharmaceuticals on patient management), and adequacy of management changes. Results: A total of 190 patients were included. The primary endpoint was met. Overall correct detection rate of 18F-PSMA-1007 was 0.82 vs 0.65 for 18F-fluorocholine (p<0.0001) when considering undetermined findings as positive for malignancy, and 0.77 vs 0.57 respectively (p<0.0001) when considering undetermined findings as negative for malignancy. A change in diagnostic thinking due to PET/CT was reported in 149 patients among whom 18F-PSMA-1007 contributed more than 18F-fluorocholine in 93. In 122 patients, PET/CT led to an adequate diagnosis which benefited the patient, among whom 18F-PSMA-1007 contributed more than 18F-fluorocholine in 88 patients. Conclusion: 18F-PSMA-1007 PET/CT is superior to 18F-fluorocholine PET/CT in localization of PCa recurrence. Decision making was more adequate when based on 18F-PSMA-1007 PET/CT results.