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
To evaluate the impact of staging with Na[18F]F-PET/ceCT (NaF) vs. [18F]PSMA-1007-PET/ceCT (PSMA) on clinical decision-making and patient outcome in patients with newly diagnosed prostate cancer (PCa).
Materials & Methods
Newly diagnosed high-risk and unfavorable intermediate-risk PCa patients were enrolled in the multicenter, randomized, controlled clinical trial, PRISMA-PET (EudraCT 2021-000123-12, NCT05123300). All participants gave consent and underwent staging with NaF or PSMA following 1:1 randomization. The study followed the Intention-to-treat principle. Patient management adhered to routine clinical practice. After a minimum of one year of follow-up, we extracted data on time to progression or death from the patient records. Progression-free survival (PFS) was compared between the groups as the primary endpoint using Cox proportional hazards regression, and model-based Kaplan-Meier plots were generated. Secondary endpoints included a group comparison of pelvic lymph node (N) and metastatic (M) stage and treatment allocation.
Results
We enrolled 385 patients from October 2021 to January 2025; 11 were excluded, leaving 186 in the NaF group and 188 in the PSMA group. Baseline characteristics were balanced. Progression occurred more often in the NaF group (43, 23%) than in the PSMA group (34, 18%; p=0.25). The adjusted hazard ratio was 0.74 (95% CI: 0.47–1.16; p=0.19), indicating a trend favoring [18F]PSMA-1007-PET/ceCT. Model-based Kaplan-Meier plots showed similar PFS during the first 2 years, with a subsequent tendency toward longer PFS in the PSMA group in high-risk patients (Figure 1). We found pelvic lymph node metastases (N+) and distant metastases (M+) in 30 (16%) and 25 (13%) patients in the NaF group, respectively, and in 50 (27%) and 36 (19%) patients in the PSMA group (p=0.016 and 0.16). The number of patients treated with curative intent was 117 in the PSMA group compared to 122 in the NaF group.
Conclusions
Staging with [18F]PSMA-1007-PET/ceCT affected disease stage and treatment allocation compared with Na[18F]F-PET/CT in newly diagnosed PCa. Although PFS did not differ significantly between groups, a late-emerging trend suggested a potential long-term benefit for high-risk patients staged with [18F]PSMA-1007-PET/ceCT.
Karen M. Buch-Olsena, Steinbjørn Hansen, Mie H. Vilstrup, Mads H. Poulsen, Paw C. Holdgaard, Karsten E.A. Zieger, Jon T. Asmussen, Jorun Holm, Kasper T. Pedersen, Søren Hessa, 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 Oncology, Odense University Hospital, Odense, Denmark; Department of Radiology and Nuclear Medicine, Esbjerg and Grindsted Hospitals, University of Southern Denmark, Esbjerg, Denmark; Department of Urology, 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 Nuclear Medicine, Technical University of Münich, Münich, Germany
Source: Buch-Olsena KM, Hansen S, Vilstrup MH. et al. 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. European Urology Open Science 89. 2026. 23–31. https://doi.org/10.1016/j.euros.2026.05.013.