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

H

Hospital of Macerata

Status

Enrolling

Conditions

Prostate Cancer

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

534 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

534 participants in 3 patient groups

For ARON-3S: Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa
Description:
Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa treated with ADT+ARSI or ADT+ARSI+docetaxel
For ARON-3Lu: Patients receiving Lutetium-177 PSMA for castration resistant PC (CRPC)
For ARON-3GEN: Patients treated with PARP inhibitors (alone or plus ARSI) for CRPC

Trial contacts and locations

1

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Central trial contact

Matteo Santoni

Data sourced from clinicaltrials.gov

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