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Recruiting

NCT Number: NCT06200558

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale di Macerata

Province of Macerata, Macerata, 62100, Italy

Location status: Recruiting

Location contact

Matteo Santoni, MD, PhD

CONTACT

[email protected]

+3907332573752

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  5. Progression-Free Survival (PFS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy

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

  6. Overall Response Rate (ORR) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy

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

  7. 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

  8. 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

  9. 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 outcomes

  1. Time to progression of patients with different metastatic sites treated by the distinct combinations

    Time frame: 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

  2. prognostic role of lifestyle and concomitant medications

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Matteo Santoni

CONTACT

[email protected]

+39 07332573752

Sponsors and collaborators

Lead sponsor

Hospital of Macerata

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2028
First posted
Jan 11, 2024
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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