Prostate Cancer
Conditions
Keywords
mCSPC, Lutetium-177 PSMA, PARP inhibitors, ADT, ARSI
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
Interventions
None listed
Sponsors
Hospital of Macerata
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prognostic role of lifestyle and concomitant medications | January 31h, 2024- May 31th, 2024 | Statistical analysis of data obtained by medical charts related to lifestyle and concomitant medications |
| Time to progression of patients with different metastatic sites treated by the distinct combinations | 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 |
Countries
Italy
Contacts
Primary ContactMatteo Santoni
Outcome results
None listed