Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT06200558
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2023-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 534}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2023-12-03', 'studyFirstSubmitQcDate': '2023-12-28', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS) of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel', 'timeFrame': 'January 31h, 2024- May 31th, 2024'}, {'measure': 'Progression-Free Survival of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel', 'timeFrame': 'January 31h, 2024- May 31th, 2024'}, {'measure': 'Overall Response Rate of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel', 'timeFrame': 'January 31h, 2024- May 31th, 2024'}, {'measure': 'Overall Survival (OS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy', 'timeFrame': 'January 31h, 2024- May 31th, 2024'}, {'measure': 'Progression-Free Survival (PFS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy', 'timeFrame': 'January 31h, 2024- May 31th, 2024'}, {'measure': 'Overall Response Rate (ORR) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy', 'timeFrame': 'January 31h, 2024- May 31th, 2024'}, {'measure': 'Overall Survival (OS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens', 'timeFrame': 'January 31h, 2024- May 31th, 2024'}, {'measure': 'Progression-Free Survival (PFS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens', 'timeFrame': 'January 31h, 2024- May 31th, 2024'}, {'measure': 'Overall Response Rate (ORR) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens', 'timeFrame': 'January 31h, 2024- May 31th, 2024'}], 'secondaryOutcomes': [{'measure': 'Time to progression of patients with different metastatic sites treated by the distinct combinations', 'timeFrame': 'January 31h, 2024- May 31th, 2024', 'description': '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'}, {'measure': 'prognostic role of lifestyle and concomitant medications', 'timeFrame': 'January 31h, 2024- May 31th, 2024', 'description': 'Statistical analysis of data obtained by medical charts related to lifestyle and concomitant medications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mCSPC', 'Lutetium-177 PSMA', 'PARP inhibitors', 'ADT', 'ARSI'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Study wants to explore real-world data in three distinct settings\n\n* Patients with metachronous or de novo mCSPC treated with ADT+ARSI or ADT+ARSI+docetaxel \\_ARON-3S\n* Patients receiving Lutetium-177 PSMA for mCRPC \\_ ARON-3Lu\n* Patients treated with PARP inhibitors (alone or combined with ARSI) for CRPC \\_ ARON-3GEN'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'treatment of patients with metastatic PCa. In the ARON-3 Study the investigators focused on three different settings:\n\n* ARON-3S: Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa treated with ADT + ARSI or ADT + ARSI + docetaxel\n* ARON-3Lu: Patients receiving Lutetium-177 PSMA for castration resistant PC (CRPC)\n* ARON-3GEN: Patients treated with PARP inhibitors (alone or plus ARSI) for CRPC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged \\>18y\n* Cytological or Histologically confirmed diagnosis of PC\n* Histologically or radiologically confirmed diagnosis of metastatic disease and\n\nFor ARON-3S\n\n▪ 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)\n\nFor ARON-3Lu\n\n▪ Treatment with Luthetium-177-PSMA therapy for castration resistant PC\n\nFor ARON-3GEN\n\n* HRD POSITIVE STATUS\n* 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\n\nExclusion Criteria:\n\n* Patients without histologically confirmed diagnosis of PC\n* Patients without histologically or radiologically confirmed metastatic disease and\n\nFor ARON-3S\n\n▪ Patients treated with doublets or triplets not included in the list reported in the Inclusion Criteria Section\n\nFor ARON-3Lu\n\n▪ Patients treated with Luthetium-177-PSMA therapy for hormone/castration sensitive PC\n\nFor ARON-3GEN\n\n* HRD NEGATIVE STATUS\n* Patients treated with PARP inhibitors alone or in combination regimens not included in the ARON-3GEN study'}, 'identificationModule': {'nctId': 'NCT06200558', 'briefTitle': 'ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa', 'organization': {'class': 'OTHER', 'fullName': 'Hospital of Macerata'}, 'officialTitle': 'ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa', 'orgStudyIdInfo': {'id': 'ARON-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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'}, {'label': 'For ARON-3Lu: Patients receiving Lutetium-177 PSMA for castration resistant PC (CRPC)'}, {'label': 'For ARON-3GEN: Patients treated with PARP inhibitors (alone or plus ARSI) for CRPC'}]}, 'contactsLocationsModule': {'locations': [{'zip': '62100', 'city': 'Macerata', 'state': 'Macerata', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo Santoni, MD, PhD', 'role': 'CONTACT', 'email': 'sorgentoni.giulia@gmail.com', 'phone': '+3907332573752'}], 'facility': 'Ospedale di Macerata', 'geoPoint': {'lat': 43.29789, 'lon': 13.45293}}], 'centralContacts': [{'name': 'Matteo Santoni', 'role': 'CONTACT', 'email': 'sorgentoni.giulia@gmail.com', 'phone': '+39 07332573752'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital of Macerata', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Principal Investigator', 'investigatorFullName': 'Matteo Santoni', 'investigatorAffiliation': 'Hospital of Macerata'}}}}