ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital of Macerata

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients aged >18y

Cytological or Histologically confirmed diagnosis of PC

Histologically or radiologically confirmed diagnosis of metastatic disease and

HRD POSITIVE STATUS

Disqualifiers

Patients without histologically confirmed diagnosis of PC

Patients without histologically or radiologically confirmed metastatic disease and

HRD NEGATIVE STATUS

Patients treated with PARP inhibitors alone or in combination regimens not included in the ARON-3GEN study

Trial 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

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

534 Participants
are grouped into 3 trial groups
Group A: For ARON-3S: Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa
Group B: For ARON-3Lu: Patients receiving Lutetium-177 PSMA for castration resistant PC (CRPC)
Group C: For ARON-3GEN: Patients treated with PARP inhibitors (alone or plus ARSI) for CRPC

Trial outcomes

Primary outcomes

1

Overall Survival (OS) of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel

Time frame
January 31h, 2024- May 31th, 2024
2

Progression-Free Survival of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel

Time frame
January 31h, 2024- May 31th, 2024
3

Overall Response Rate of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel

Time frame
January 31h, 2024- May 31th, 2024
4

Overall Survival (OS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy

Time frame
January 31h, 2024- May 31th, 2024

Secondary outcomes

1

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

Time frame
January 31h, 2024- May 31th, 2024
2

prognostic role of lifestyle and concomitant medications

Statistical analysis of data obtained by medical charts related to lifestyle and concomitant medications

Time frame
January 31h, 2024- May 31th, 2024

Other outcomes

Sponsors and contacts

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