Prostate Cancer Clinical Trial
Official title:
ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa
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
| Status | Not yet recruiting |
| Enrollment | 534 |
| Est. completion date | July 31, 2024 |
| Est. primary completion date | May 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ospedale di Macerata | Macerata |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital of Macerata |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel | January 31h, 2024- May 31th, 2024 | ||
| Primary | Progression-Free Survival of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel | January 31h, 2024- May 31th, 2024 | ||
| Primary | Overall Response Rate of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel | January 31h, 2024- May 31th, 2024 | ||
| Primary | Overall Survival (OS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy | January 31h, 2024- May 31th, 2024 | ||
| Primary | Progression-Free Survival (PFS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy | January 31h, 2024- May 31th, 2024 | ||
| Primary | Overall Response Rate (ORR) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy | January 31h, 2024- May 31th, 2024 | ||
| Primary | Overall Survival (OS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens | January 31h, 2024- May 31th, 2024 | ||
| Primary | 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 | ||
| Primary | 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 | Time to progression of patients with different metastatic sites treated by the distinct combinations | 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 | |
| Secondary | prognostic role of lifestyle and concomitant medications | Statistical analysis of data obtained by medical charts related to lifestyle and concomitant medications | January 31h, 2024- May 31th, 2024 |
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