Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT) (PRRT-PGL-PHEO)

April 21, 2026 updated by: Azienda USL Reggio Emilia - IRCCS

Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT) in Pheochromocytomas and Paragangliomas: a Retrospective Analysis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bari, Italy
        • Policlinico di Bari
      • Bologna, Italy
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
      • Ferrara, Italy
        • Azienda Ospedaliero-Universitaria di Ferrara
      • Meldola, Italy
        • Irst Irccs
      • Milan, Italy
        • Istituto Europeo di Oncologia
      • Milan, Italy
        • Fondazione IRCCS Istituto Nazionale dei tumori di Milano
      • Modena, Italy
        • Azienda Ospedaliero-Universitaria Policlinico di Modena
      • Naples, Italy
        • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
      • Naples, Italy
        • Università degli Studi di Napoli Federico II
      • Reggio Emilia, Italy
        • Azienda USL IRCCS Di Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with sporadic or hereditary paraganglioma and pheochromocytoma (PPGL) with unresectable or metastatic disease, treated with peptide receptor radionuclide therapy (PRRT).

Description

Inclusion Criteria:

  • Documented diagnosis of pheochromocytoma or paraganglioma (PPGL) (sporadic or hereditary forms) with unresectable or metastatic disease.
  • Treatment with peptide receptor radionuclide therapy (PRRT) administered with ⁷⁷Lu and/or ⁹⁰Y (including combination regimens), with t0 (first PRRT administration) between January 1, 2000 and February 28, 2024.
  • Availability of essential data required by the protocol to document exposure (PRRT) and outcomes, including: PRRT start date (t0) and treatment details (radioisotope(s), number of cycles and/or cycles actually administered, intervals when available), At least one post-treatment evaluation suitable for determining disease control rate (DCR) (morphological imaging by CT/MRI ± functional imaging by PET/CT, and available clinical data), Follow-up information suitable for determining progression-free survival (PFS) within the predefined time window.
  • Availability of follow-up up to 12 months from end of treatment (EoT), or documentation of progression and/or death occurring within 12 months.
  • Required data and source documents are available at the enrolling center or obtainable from other Italian centers (e.g., PRRT-administering center or centers performing imaging/evaluations) through formal data transfer agreements (e.g., DTA) in compliance with applicable regulations.
  • Privacy/consent requirements (general framework):

For living and contactable patients, consent for personal data processing will be managed according to the requirements/assessment of the Ethics Committee.

For deceased or non-contactable patients after reasonable documented efforts, inclusion may occur without consent, as it falls under situations of "impossibility to inform the subjects," in accordance with applicable regulations (Article 110 of the Italian Privacy Code and subsequent amendments), subject to Ethics Committee evaluation/opinion and implementation of appropriate safeguards.

Exclusion Criteria:

  • Patients who did not receive at least one cycle of peptide receptor radionuclide therapy (PRRT).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MONO 177Lu
Patients treated with PRRT using ¹⁷⁷Lu only.
Radiation: Peptide Receptor Radionuclide Therapy (PRRT)
PRRT with radiolabeled somatostatin analogues (¹⁷⁷Lu and/or ⁹⁰Y), according to clinical practice.
MONO 90Y
Patients treated with PRRT using ⁹⁰Y only.
Radiation: Peptide Receptor Radionuclide Therapy (PRRT)
PRRT with radiolabeled somatostatin analogues (¹⁷⁷Lu and/or ⁹⁰Y), according to clinical practice.
TANDEM 177Lu + 90Y
Patients treated with PRRT using a combination (sequential or concomitant) of ¹⁷⁷Lu and ⁹⁰Y.
Radiation: Peptide Receptor Radionuclide Therapy (PRRT)
PRRT with radiolabeled somatostatin analogues (¹⁷⁷Lu and/or ⁹⁰Y), according to clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: baseline, 12 months
To describe the effectiveness of PRRT in terms of disease control rate (DCR) in the overall population and by line of treatment (early vs late).
baseline, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: baseline, 12 months
To evaluate progression-free survival (PFS) after PRRT in the overall population and by line of treatment (early vs late).
baseline, 12 months
Overall Survival (OS)
Time Frame: 12 months
To evaluate overall survival (OS) at 1 year after completion of PRRT, including analysis by response category (complete response, partial response, stable disease, progressive disease).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Reggio Emilia - IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85/2026/OSS/IRCCSRE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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