Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT)

NCT07538791 | Not Yet Recruiting

• 1 other identifier: 85/2026/OSS/IRCCSRE
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Pheochromocytomas; Paragangliomas

Keywords

PPGL; PRRT; PHEO; PGL; Somatostatin receptors; Peptide Receptor Radionuclide Therapy

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  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 Outcomes (2)

• Progression-Free Survival (PFS)

  baseline, 12 months

• Overall Survival (OS)

  12 months

Study Arms (3)

MONO 177Lu

Patients treated with PRRT using ¹⁷⁷Lu only.

Radiation: Peptide Receptor Radionuclide Therapy (PRRT)

MONO 90Y

Patients treated with PRRT using ⁹⁰Y only.

Radiation: Peptide Receptor Radionuclide Therapy (PRRT)

TANDEM 177Lu + 90Y

Patients treated with PRRT using a combination (sequential or concomitant) of ¹⁷⁷Lu and ⁹⁰Y.

Radiation: Peptide Receptor Radionuclide Therapy (PRRT)

Interventions

Peptide Receptor Radionuclide Therapy (PRRT) RADIATION

PRRT with radiolabeled somatostatin analogues (¹⁷⁷Lu and/or ⁹⁰Y), according to clinical practice.

MONO 177Lu; MONO 90Y; TANDEM 177Lu + 90Y

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (10)

Policlinico di Bari

Bari, Italy

Location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

Location

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Italy

Location

Irst Irccs

Meldola, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Italy

Location

Istituto Europeo di Oncologia

Milan, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Italy

Location

Università degli Studi di Napoli Federico II

Naples, Italy

Location

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy

Location

Related Publications (5)

• Su D, Yang H, Qiu C, Chen Y. Peptide receptor radionuclide therapy in advanced Pheochromocytomas and Paragangliomas: a systematic review and meta-analysis. Front Oncol. 2023 Jul 6;13:1141648. doi: 10.3389/fonc.2023.1141648. eCollection 2023.

  PMID: 37483516 BACKGROUND

• Aygun N, Uludag M. Pheochromocytoma and Paraganglioma: From Epidemiology to Clinical Findings. Sisli Etfal Hastan Tip Bul. 2020 Jun 3;54(2):159-168. doi: 10.14744/SEMB.2020.18794. eCollection 2020.

  PMID: 32617052 BACKGROUND

• Saavedra T JS, Nati-Castillo HA, Valderrama Cometa LA, Rivera-Martinez WA, Asprilla J, Castano-Giraldo CM, Sanchez S L, Heredia-Espin M, Arias-Intriago M, Izquierdo-Condoy JS. Pheochromocytoma: an updated scoping review from clinical presentation to management and treatment. Front Endocrinol (Lausanne). 2024 Dec 13;15:1433582. doi: 10.3389/fendo.2024.1433582. eCollection 2024.

  PMID: 39735644 BACKGROUND

• Cascon A, Calsina B, Monteagudo M, Mellid S, Diaz-Talavera A, Curras-Freixes M, Robledo M. Genetic bases of pheochromocytoma and paraganglioma. J Mol Endocrinol. 2023 Jan 24;70(3):e220167. doi: 10.1530/JME-22-0167. Print 2023 Apr 1.

  PMID: 36520714 BACKGROUND

• Welander J, Soderkvist P, Gimm O. Genetics and clinical characteristics of hereditary pheochromocytomas and paragangliomas. Endocr Relat Cancer. 2011 Dec 1;18(6):R253-76. doi: 10.1530/ERC-11-0170. Print 2011 Dec.

  PMID: 22041710 BACKGROUND

MeSH Terms

Conditions

Pheochromocytoma; Paraganglioma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Central Study Contacts

Angelina Filice, MD

CONTACT

0522 296313; angelina.filice@ausl.re.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 30, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

IT (10)