Phase III study of F-PSMA-1007 versus F-fluorocholine PET/CT for localization of prostate cancer biochemical recurrence: a prospective, randomized, cross-over, multicenter study.
Fiche publication
Date publication
novembre 2022
Journal
Journal of nuclear medicine : official publication, Society of Nuclear Medicine
Auteurs
Membres identifiés du Cancéropôle Est :
Pr OLIVIER Pierre
Tous les auteurs :
Olivier P, Giraudet AL, Skanjeti A, Merlin C, Weinmann P, Rudolph I, Hoepping A, Gauthé M
Lien Pubmed
Résumé
To compare F-PSMA-1007 and F-fluorocholine PET/CT for localization of prostate cancer (PCa) biochemical recurrence. 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 F-PSMA-1007 and F-fluorocholine PET/CT (102 received F-PSMA-1007 first and 88 received F-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. A total of 190 patients were included. The primary endpoint was met. Overall correct detection rate of F-PSMA-1007 was 0.82 vs 0.65 for F-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 F-PSMA-1007 contributed more than F-fluorocholine in 93. In 122 patients, PET/CT led to an adequate diagnosis which benefited the patient, among whom F-PSMA-1007 contributed more than F-fluorocholine in 88 patients. F-PSMA-1007 PET/CT is superior to F-fluorocholine PET/CT in localization of PCa recurrence. Decision making was more adequate when based on F-PSMA-1007 PET/CT results.
Mots clés
Genitourinary, Oncology: GU, PET/CT, Positron Emission Tomography Computed Tomography, decision making, prostate-specific antigen, prostatic neoplasms
Référence
J Nucl Med. 2022 11 23;: