PheochromocytomasPRRT-PGL-PHEONCT07538791
Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT)
An observational study of Pheochromocytomas and Paragangliomas, run by Azienda USL Reggio Emilia - IRCCS at 10 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pheochromocytomas, Paragangliomas
- What is being tested?
- Peptide Receptor Radionuclide Therapy (PRRT)
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 10 sitesItaly
- Study dates
- 30 Aug 2026to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sporadic or hereditary paraganglioma and pheochromocytoma (PPGL) with unresectable or metastatic disease, treated with peptide receptor radionuclide therapy (PRRT).
Who may be able to join
- 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.
Who cannot join
- Patients who did not receive at least one cycle of peptide receptor radionuclide therapy (PRRT).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Italy10 sites
Policlinico di Bari
Bari
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara
Irst Irccs
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan
Istituto Europeo di Oncologia
Milan
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples
Università degli Studi di Napoli Federico II
Naples
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia
About this study
Official title: 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.
Read the 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.
- Conditions
- Pheochromocytomas, Paragangliomas
- Being tested
- Peptide Receptor Radionuclide Therapy (PRRT)
- Keywords
- PPGL, PRRT, PHEO, PGL, Somatostatin receptors, Peptide Receptor Radionuclide Therapy
- Medical subject headings
- Pheochromocytoma, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide Receptor Radionuclide Therapy (PRRT)Radiation
PRRT with radiolabeled somatostatin analogues (¹⁷⁷Lu and/or ⁹⁰Y), according to clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| MONO 177Lu | Patients treated with PRRT using ¹⁷⁷Lu only. Receives: Radiation: Peptide Receptor Radionuclide Therapy (PRRT) | |
| MONO 90Y | Patients treated with PRRT using ⁹⁰Y only. Receives: Radiation: Peptide Receptor Radionuclide Therapy (PRRT) | |
| TANDEM 177Lu + 90Y | Patients treated with PRRT using a combination (sequential or concomitant) of ¹⁷⁷Lu and ⁹⁰Y. Receives: Radiation: Peptide Receptor Radionuclide Therapy (PRRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline, 12 months
Secondary outcomes (2)
Progression-Free Survival (PFS)
To evaluate progression-free survival (PFS) after PRRT in the overall population and by line of treatment (early vs late).
Measured: baseline, 12 months
Overall Survival (OS)
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PheochromocytomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538791
- Sponsor's protocol ID
- 85/2026/OSS/IRCCSRE
- Acronym
- PRRT-PGL-PHEO
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
Publications
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.
PubMed 37483516Aygun 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.
PubMed 32617052Saavedra 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.
PubMed 39735644Cascon 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.
PubMed 36520714Welander 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.
PubMed 22041710
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT) in Pheochromocytomas and Paragangliomas: a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT07538791
- Acronym / sponsor ID
- PRRT-PGL-PHEO / 85/2026/OSS/IRCCSRE
- Conditions
- Pheochromocytomas, Paragangliomas
- Keywords
- PPGL, PRRT, PHEO, PGL, Somatostatin receptors, Peptide Receptor Radionuclide Therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MONO 177Lu | – | Radiation: Peptide Receptor Radionuclide Therapy (PRRT)Patients treated with PRRT using ¹⁷⁷Lu only. |
| MONO 90Y | – | Radiation: Peptide Receptor Radionuclide Therapy (PRRT)Patients treated with PRRT using ⁹⁰Y only. |
| TANDEM 177Lu + 90Y | – | Radiation: Peptide Receptor Radionuclide Therapy (PRRT)Patients treated with PRRT using a combination (sequential or concomitant) of ¹⁷⁷Lu and ⁹⁰Y. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sporadic or hereditary paraganglioma and pheochromocytoma (PPGL) with unresectable or metastatic disease, treated with peptide receptor radionuclide therapy (PRRT).
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who did not receive at least one cycle of peptide receptor radionuclide therapy (PRRT).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peptide Receptor Radionuclide Therapy (PRRT)PRRT with radiolabeled somatostatin analogues (¹⁷⁷Lu and/or ⁹⁰Y), according to clinical practice. | Radiation | MONO 177Lu, MONO 90Y, TANDEM 177Lu + 90Y |
Primary outcome
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).
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: baseline, 12 months
Overall Survival (OS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 37483516Su 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.
- Background: PubMed 32617052Aygun 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.
- Background: PubMed 39735644Saavedra 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.
- Background: PubMed 36520714Cascon 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.
- Background: PubMed 22041710Welander 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pheochromocytomas and Paragangliomas, run by Azienda USL Reggio Emilia - IRCCS at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelina Filice, MD (0522 296313, angelina.filice@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (DCR) (time frame: baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07538791, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.