Clinical trial NCT06200558: ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa
Official title: ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: mCSPC
Lutetium-177 PSMA
PARP inhibitors
ADT
ARSI
Lead sponsor: Hospital of Macerata
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS) of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
timeFrame: January 31h, 2024- May 31th, 2024
measure: Progression-Free Survival of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
timeFrame: January 31h, 2024- May 31th, 2024
measure: Overall Response Rate of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
timeFrame: January 31h, 2024- May 31th, 2024
measure: Overall Survival (OS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
timeFrame: January 31h, 2024- May 31th, 2024
measure: Progression-Free Survival (PFS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
timeFrame: January 31h, 2024- May 31th, 2024
measure: Overall Response Rate (ORR) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
timeFrame: January 31h, 2024- May 31th, 2024
measure: Overall Survival (OS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
timeFrame: January 31h, 2024- May 31th, 2024
measure: Progression-Free Survival (PFS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
timeFrame: January 31h, 2024- May 31th, 2024
measure: Overall Response Rate (ORR) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
timeFrame: January 31h, 2024- May 31th, 2024
Secondary outcomes:
measure: Time to progression of patients with different metastatic sites treated by the distinct combinations
timeFrame: January 31h, 2024- May 31th, 2024
measure: prognostic role of lifestyle and concomitant medications
timeFrame: January 31h, 2024- May 31th, 2024
Other outcomes:
Locations:
city: Macerata
country: Italy
facility: Ospedale di Macerata
Study officials:
References: