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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06200558
• Other study ID #: ARON-3
• Status: Not yet recruiting
• Start date: January 31, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2023
• Source: Hospital of Macerata
• Contact: Matteo Santoni
• Phone: +39 07332573752
• Email: sorgentoni.giulia[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 534
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Italy	Ospedale di Macerata	Macerata

Sponsors (1)

Lead Sponsor	Collaborator
Hospital of Macerata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS) of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel		January 31h, 2024- May 31th, 2024
Primary	Progression-Free Survival of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel		January 31h, 2024- May 31th, 2024
Primary	Overall Response Rate of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel		January 31h, 2024- May 31th, 2024
Primary	Overall Survival (OS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy		January 31h, 2024- May 31th, 2024
Primary	Progression-Free Survival (PFS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy		January 31h, 2024- May 31th, 2024
Primary	Overall Response Rate (ORR) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy		January 31h, 2024- May 31th, 2024
Primary	Overall Survival (OS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens		January 31h, 2024- May 31th, 2024
Primary	Progression-Free Survival (PFS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens		January 31h, 2024- May 31th, 2024
Primary	Overall Response Rate (ORR) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens		January 31h, 2024- May 31th, 2024
Secondary	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	January 31h, 2024- May 31th, 2024
Secondary	prognostic role of lifestyle and concomitant medications	Statistical analysis of data obtained by medical charts related to lifestyle and concomitant medications	January 31h, 2024- May 31th, 2024