Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT)

Overview

This multicenter retrospective Italian study evaluates the efficacy and safety of PRRT in patients with advanced, unresectable or metastatic pheochromocytomas and paragangliomas (PPGL). Data from \~210 patients treated between 2000 and 2024 will be analyzed. The primary endpoint is disease control rate (DCR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), and prognostic factors.

Pheochromocytomas (PHEO) and paragangliomas (PGL), collectively referred to as PPGL, are rare neuroendocrine tumors, sometimes secreting catecholamines, with variable clinical presentations and a risk of advanced/metastatic disease. In patients not eligible for curative treatment or with progressive disease, multimodal strategies may be used, including systemic and radiometabolic therapies, although shared therapeutic algorithms are difficult to define. In particular, in PPGL with somatostatin receptor expression documented by functional imaging, PRRT (Peptide Receptor Radionuclide Therapy) represents a therapeutic option used in an experimental/off-label setting, within authorized clinical protocols or clinical trials, as reported in the literature. Between 2000 and 2024, several centers in Italy treated PPGL patients with PRRT using different regimens (radionuclide, number of cycles, and timing), depending on experimental protocols, technological availability, and clinical characteristics. This heterogeneity, combined with the rarity of the disease, highlights the relevance of a structured national collection of real-world data to describe the efficacy and safety of PRRT in this setting. This is a retrospective, multicenter, non-profit observational pharmacological study including adult patients (≥18 years) with documented PPGL and advanced/unresectable or metastatic disease who received at least one cycle of PRRT within the study period. Patients must have available essential data to document treatment exposure and outcomes, including at least one post-treatment evaluation for disease control and minimum data for progression-free survival assessment. PRRT exposure includes treatments administered within completed clinical trials or authorized protocols at participating centers. Data collected will include type of radionuclide(s), number of planned and administered cycles, treatment intervals, and reasons for treatment modifications or discontinuation, where available.

Conditions

Interventions

Eligibility

Locations (10)

Outcomes

Central Contacts