Status:
RECRUITING
ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa
Lead Sponsor:
Hospital of Macerata
Conditions:
Prostate Cancer
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT06200558
Start Date
January 31 2024
End Date
February 1 2028
Last Update
November 26 2025
Active Locations (1)
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1
Ospedale di Macerata
Macerata, Macerata, Italy, 62100