To compare progression-free survival (PFS) in newly diagnosed prostate cancer (PCa) staged with prostate-specific membrane antigen prostate-specific membrane antigen 1007 ([18F]PSMA-1007)-positron emission tomography/contrast-enhanced computed tomography (PET/ceCT) versus sodium fluoride (Na[18F]F)-PET/ceCT.
Patients with newly diagnosed PCa were enrolled in the multicenter, randomized controlled clinical Primary Staging of Prostate Cancer: A Randomized Controlled Trial Comparing [ 18 F]PSMA -1007 PET /CT to Conventional Imaging (PRISMA-PET) trial. Patients were staged with Na[18F]F-PET/ceCT or [18F]PSMA-1007-PET/ceCT following 1:1 randomization. Patient management followed routine clinical practice. After a minimum of 1 yr follow-up, data on PFS events were extracted from patient files. PFS was defined per the European Association of Urology guidelines (prostate-specific antigen increase) for curative treatment regimens; for noncurative treatments, PFS was defined as a change of treatment. PFS was compared using Cox proportional hazards regression.
We enrolled 385 patients from October 2021 to January 2025. The intention-to-treat principle was followed. Fewer patients were classified as nonmetastatic when staged with [18F]PSMA-1007-PET/ceCT (n = 130, 69%) than with Na[18F]F-PET/ceCT (n = 143, 77%). Fewer patients staged with [18F]PSMA-1007-PET/ceCT experienced a PFS event: 34 (18%) versus 43 (23%). PFS did not differ between the groups (hazard ratio [HR]: 0.74, 95% confidence interval [CI]: 0.47-1.16; p = 0.19), although the point estimate favored the [18F]PSMA-1007-PET/ceCT group. The exploratory stratified Kaplan-Meier plots suggested a visually longer PFS in the [18F]PSMA-1007-PET/ceCT group for patients with high-risk disease. The main limitation was the variation in types of PFS events between the two groups.
Staging with [18F]PSMA-1007-PET/ceCT affected disease stage and level of progression compared with Na[18F]F-PET/ceCT in newly diagnosed PCa. PFS did not differ significantly between groups, and an exploratory visual long-term benefit for patients with high-risk disease staged with [18F]PSMA-1007-PET/ceCT warrants longer follow-up.
European urology open science. 2026 May 27*** epublish ***
Karen M Buch-Olsen, Steinbjørn Hansen, Mie H Vilstrup, Mads H Poulsen, Paw C Holdgaard, Karsten E A Zieger, Jon T Asmussen, Jorun Holm, Kasper T Pedersen, Søren Hess, Søren S Madsen, Matthias Eiber, Oke Gerke, Malene G Hildebrandt
Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark., Department of Clinical Research, University of Southern Denmark, Odense, Denmark., Department of Radiology and Nuclear Medicine, Esbjerg and Grindsted Hospitals, University of Southern Denmark, Esbjerg, Denmark., Department of Nuclear Medicine, Lillebaelt Hospital - University Hospital of Southern Denmark, Vejle, Denmark., Department of Urology, Lillebaelt Hospital - University Hospital of Southern Denmark, Vejle, Denmark., Department of Radiology, Odense University Hospital, Odense, Denmark., Department of Urology, Esbjerg and Grindsted Hospitals, University of Southern Denmark, Esbjerg, Denmark., Department of Nuclear Medicine, Technical University of Münich, Münich, Germany.