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NCT06200558 | RECRUITING | Prostate Cancer


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

Hospital of Macerata

Information provided by (Responsible Party):

Matteo Santoni

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

Condition or disease

Prostate Cancer

Study Type : OBSERVATIONAL
Estimated Enrollment : 534 participants
Official Title : ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa
Actual Study Start Date : 2024-01-31
Estimated Primary Completion Date : 2024-05-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT06200558


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Locations


RECRUITING

Italy,

Macerata hospital

Macerate, Italy, 62100

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