European urology open science · 2026
Progression-free Survival Following Primary Staging with [18F]PSMA-1007-PET/ceCT Versus Na[18F]F-PET/ceCT in Prostate Cancer: Results from the PRISMA-PET Randomized Controlled Trial.
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Buch-Olsen Karen M, Hansen Steinbjørn, Vilstrup Mie H, Poulsen Mads H, Holdgaard Paw C, Zieger Karsten E A, Asmussen Jon T, Holm Jorun, Pedersen Kasper T, Hess Søren, Madsen Søren S, Eiber Matthias, Gerke Oke, Hildebrandt Malene G
Аннотация
OBJECTIVE: 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.
DESIGN SETTING AND PARTICIPANTS: 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.
RESULTS AND LIMITATIONS: 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.
CONCLUSIONS: 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.
DESIGN SETTING AND PARTICIPANTS: 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.
RESULTS AND LIMITATIONS: 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.
CONCLUSIONS: 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.