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Recruiting NCT06200558

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

— Observational Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • Overall Survival (OS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy [Time frame: January 31h, 2024- May 31th, 2024]
  • Progression-Free Survival (PFS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy [Time frame: January 31h, 2024- May 31th, 2024]
  • Overall Response Rate (ORR) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy [Time frame: January 31h, 2024- May 31th, 2024]
  • Overall Survival (OS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens [Time frame: 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 [Time frame: January 31h, 2024- May 31th, 2024]
  • Overall Response Rate (ORR) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens [Time frame: January 31h, 2024- May 31th, 2024]
Secondary outcome measures (2)
  • Time to progression of patients with different metastatic sites treated by the distinct combinations [Time frame: January 31h, 2024- May 31th, 2024]
  • prognostic role of lifestyle and concomitant medications [Time frame: January 31h, 2024- May 31th, 2024]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • Ospedale di Macerata — Province of Macerata

Identifiers

NCT: NCT06200558 · ARON-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗