ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa
1 other identifier
observational
534
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2023
CompletedFirst Posted
Study publicly available on registry
January 11, 2024
CompletedStudy Start
First participant enrolled
January 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
ExpectedNovember 26, 2025
November 1, 2025
4 months
December 3, 2023
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Overall Survival (OS) of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
January 31h, 2024- May 31th, 2024
Progression-Free Survival of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
January 31h, 2024- May 31th, 2024
Overall Response Rate of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
January 31h, 2024- May 31th, 2024
Overall Survival (OS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
January 31h, 2024- May 31th, 2024
Progression-Free Survival (PFS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
January 31h, 2024- May 31th, 2024
Overall Response Rate (ORR) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
January 31h, 2024- May 31th, 2024
Overall Survival (OS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
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
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
January 31h, 2024- May 31th, 2024
Secondary Outcomes (2)
Time to progression of patients with different metastatic sites treated by the distinct combinations
January 31h, 2024- May 31th, 2024
prognostic role of lifestyle and concomitant medications
January 31h, 2024- May 31th, 2024
Study Arms (3)
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
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Patients without histologically confirmed diagnosis of PC
- Patients without histologically or radiologically confirmed metastatic disease and
- For ARON-3S
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale di Macerata
Macerata, Macerata, 62100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, Principal Investigator
Study Record Dates
First Submitted
December 3, 2023
First Posted
January 11, 2024
Study Start
January 31, 2024
Primary Completion
May 31, 2024
Study Completion (Estimated)
February 1, 2028
Last Updated
November 26, 2025
Record last verified: 2025-11