ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa

November 19, 2025 updated by: Matteo Santoni, Hospital of Macerata

Study wants to explore real-world data in three distinct settings

  • Patients with metachronous or de novo mCSPC treated with ADT+ARSI or ADT+ARSI+docetaxel _ARON-3S
  • Patients receiving Lutetium-177 PSMA for mCRPC _ ARON-3Lu
  • Patients treated with PARP inhibitors (alone or combined with ARSI) for CRPC _ ARON-3GEN

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

534

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
    • Macerata
      • Macerata, Macerata, Italy, 62100

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

treatment of patients with metastatic PCa. In the ARON-3 Study the investigators focused on three different settings:

  • ARON-3S: Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa treated with ADT + ARSI or ADT + ARSI + docetaxel
  • ARON-3Lu: Patients receiving Lutetium-177 PSMA for castration resistant PC (CRPC)
  • ARON-3GEN: Patients treated with PARP inhibitors (alone or plus ARSI) for CRPC

Description

Inclusion Criteria:

  • Patients aged >18y
  • Cytological or Histologically confirmed diagnosis of PC
  • Histologically or radiologically confirmed diagnosis of metastatic disease and

For ARON-3S

▪ Treatment with ADT + Apalutamide or ADT + enzalutamide or ADT + Abiraterone or ADT + Abiraterone + Docetaxel or ADT + Darolutamide + Docetaxel (patients treated with previous docetaxel - CHAARTED - resulted eligible)

For ARON-3Lu

▪ Treatment with Luthetium-177-PSMA therapy for castration resistant PC

For ARON-3GEN

  • HRD POSITIVE STATUS
  • Treatment with PARP inhibitors for castration resistant PC. Treatment included: olaparib (as 1st, 2nd or 3rd line therapy), olaparib + abiraterone (as 1st line therapy) or niraparib + abiraterone (as 1st line therapy) or talazoparib + enzalutamide

Exclusion Criteria:

  • Patients without histologically confirmed diagnosis of PC
  • Patients without histologically or radiologically confirmed metastatic disease and

For ARON-3S

▪ Patients treated with doublets or triplets not included in the list reported in the Inclusion Criteria Section

For ARON-3Lu

▪ Patients treated with Luthetium-177-PSMA therapy for hormone/castration sensitive PC

For ARON-3GEN

  • HRD NEGATIVE STATUS
  • Patients treated with PARP inhibitors alone or in combination regimens not included in the ARON-3GEN study

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
For ARON-3S: Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa
Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa treated with ADT+ARSI or ADT+ARSI+docetaxel
For ARON-3Lu: Patients receiving Lutetium-177 PSMA for castration resistant PC (CRPC)
For ARON-3GEN: Patients treated with PARP inhibitors (alone or plus ARSI) for CRPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS) of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
Time Frame: January 31h, 2024- May 31th, 2024
January 31h, 2024- May 31th, 2024
Progression-Free Survival of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
Time Frame: January 31h, 2024- May 31th, 2024
January 31h, 2024- May 31th, 2024
Overall Response Rate of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
Time Frame: January 31h, 2024- May 31th, 2024
January 31h, 2024- May 31th, 2024
Overall Survival (OS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
Time Frame: January 31h, 2024- May 31th, 2024
January 31h, 2024- May 31th, 2024
Progression-Free Survival (PFS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
Time Frame: January 31h, 2024- May 31th, 2024
January 31h, 2024- May 31th, 2024
Overall Response Rate (ORR) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
Time Frame: January 31h, 2024- May 31th, 2024
January 31h, 2024- May 31th, 2024
Overall Survival (OS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
Time Frame: January 31h, 2024- May 31th, 2024
January 31h, 2024- May 31th, 2024
Progression-Free Survival (PFS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
Time Frame: January 31h, 2024- May 31th, 2024
January 31h, 2024- May 31th, 2024
Overall Response Rate (ORR) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
Time Frame: January 31h, 2024- May 31th, 2024
January 31h, 2024- May 31th, 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression of patients with different metastatic sites treated by the distinct combinations
Time Frame: January 31h, 2024- May 31th, 2024
Statistical analysis of data obtained by medical charts related to disease metastatic sites, treatment performed and period of time from the start of treatment until the radiological progression disease
January 31h, 2024- May 31th, 2024
prognostic role of lifestyle and concomitant medications
Time Frame: January 31h, 2024- May 31th, 2024
Statistical analysis of data obtained by medical charts related to lifestyle and concomitant medications
January 31h, 2024- May 31th, 2024

Collaborators and Investigators

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

Sponsor

Hospital of Macerata

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 (Actual)

January 31, 2024

Primary Completion (Actual)

May 31, 2024

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

December 3, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARON-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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