Research Article 2026-04-21 under-review v1

Follow-up Analysis of Intermediate-risk Prostate Cancer Patients Staged With Psma PET/CT

S
Sara Damiani Humanitas University
P
Priscilla Guglielmo Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
G
Guya Mansi Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
S
Sara Calzolai Lettieri Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
G
Giulia Giacoppo Nuclear Medicine Unit, Humanitas Istituto Clinico Catanese, Catania, Italy
D
Demetrio Aricò Nuclear Medicine Unit, Humanitas Istituto Clinico Catanese, Catania, Italy
L
Lucia Setti Nuclear Medicine Unit, Humanitas Gavazzeni, Bergamo, Italy
A
Alessia Artesani Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
G
Giovanni Lughezzani Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
A
Angelo Porreca Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
A
Antonio Selvaggio Nuclear Medicine Unit, Humanitas Istituto Clinico Catanese, Catania, Italy
L
Laura Evangelista Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy

Abstract

Objective. Radiolabelled PSMA PET/CT has demonstrated high diagnostic accuracy in staging patients with intermediate-risk prostate cancer (PCa). However, its role on long-term prognosis and outcome prediction in this risk-group remains poorly defined. This study aimed to evaluate survival outcomes and identify prognostic factors in intermediate-risk PCa patients staged with PSMA PET/CT before primary treatment. Methods. This is a retrospective, multicenter study of patients diagnosed with intermediate-risk PCa, both favourable (FIR) and unfavorable (UIR), who were staged using radiolabeled PSMA PET/CT to evaluate the extent of the disease before initiating appropriate treatment (either surgery, radiotherapy or systemic treatment), in the period between 2021 and 2024. Primary endpoints were biochemical recurrence (BCR) and radiological recurrence (RR). Survival was assessed using Kaplan-Meier analysis and log-rank tests. The event-free survival was established by using the time between PET/CT examination and the occurrence of the events. All statistical analyses were performed with MedCalc® version 23.3.7 and STATA 18.0/SE. Results. A total of 148 patients were enrolled across all the centers, 112 patients were treated exclusively with local treatment strategies (n = 84 surgery, n = 28 radiotherapy) and 36 with the addition or only with systemic treatment. After a median follow-up of 25 months, 30 (20.3%) patients experienced BCR and 15 (10.1%) RR. UIR patients showed significantly higher PSMA-positivity (20.8% vs 5.6%, p = 0.007) and significantly shorter BCR-free survival compared to FIR (p = 0.039). Extraprostatic PET-positivity (N + or M+) was associated with a trend toward poorer BCR and RR outcomes (p = 0.08). Within the intraprostatic PRIMARY score, score 5 nearly doubled the RR rate compared to score 4 (15.9% vs 8.2%). Main limitations include the retrospective design and relatively short follow-up. Conclusions. PSMA PET/CT may provide early prognostic information in patients with intermediate risk PCa. While its yield in FIR is marginal, molecular staging in UIR effectively identifies aggressive phenotypes at higher risk for early treatment failure, supporting its use to guide treatment intensification in this subgroup.

Citation Information

@article{saradamiani2026,
  title={Follow-up Analysis of Intermediate-risk Prostate Cancer Patients Staged With Psma PET/CT},
  author={Sara Damiani and Priscilla Guglielmo and Guya Mansi and Sara Calzolai Lettieri and Giulia Giacoppo and Demetrio Aricò and Lucia Setti and Alessia Artesani and Giovanni Lughezzani and Angelo Porreca and Antonio Selvaggio and Laura Evangelista},
  journal={Annals of Nuclear Medicine},
  year={2026},
  doi={https://doi.org/10.21203/rs.3.rs-9347158/v1}
}
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