ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa
Recruiting · NCT06200558 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hospital of Macerata
View the official record on ClinicalTrials.gov →What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Ospedale di Macerata - Province of Macerata, Macerata, Italy