Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT06473259
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C572045', 'term': 'apalutamide'}, {'id': 'C540278', 'term': 'enzalutamide'}, {'id': 'D000069501', 'term': 'Abiraterone Acetate'}, {'id': 'C000607739', 'term': 'darolutamide'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D017329', 'term': 'Triptorelin Pamoate'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'rate of patients with an objective response', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'rate of patients who experienced a reduction of at least 30% of measurable lesions'}], 'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': 'From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months', 'description': 'the projected rate over the time of patients without progressive disease'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months', 'description': 'the projected rate over the time of alive patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Hormone Sensitive Prostate Cancer', 'Metastatic Tumor']}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to evaluate the clinical outcomes of treatment with docetaxel, ARTA (alone or in combination) or with radiotherapy on the primary tumor for mCSPC, in an unselected population, in clinical practice'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with mCSPC who initiated treatment with docetaxel, ARPI (alone or in combination) or with radiotherapy on the primary tumor in addition to ADT within clinical practice or expanded access programs in Italian hospitals from January 2015 to December 2027 will be studied.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. histologically confirmed diagnosis of adenocarcinoma of the prostate, metastatic, not undergoing previous treatment (except hormone therapy initiated no more than 4-6 months prior to docetaxel) for metastatic disease\n2. treatment with docetaxel, ARPI (alone or in combination) or with radiation therapy on the primary tumor in combination with ADT within normal clinical practice or expanded access programs initiated between January 2015 and December 2027.\n3. availability of inpatient and/or outpatient medical records for clinical data collection\n\nExclusion Criteria:\n\n1. histological diagnosis other than adenocarcinoma\n2. patients who have received multiple lines of ADT for mCSPC\n3. patients who have received docetaxel or ARTA for metastatic castration-resistant disease'}, 'identificationModule': {'nctId': 'NCT06473259', 'acronym': 'ECHOS', 'briefTitle': 'Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Santa Chiara Hospital'}, 'officialTitle': 'Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Therapy (Alone or in Combination) or Radiotherapy on the Primary Tumor in Combination With Androgen Deprivation Therapy in Metastatic Hormone-sensitive Prostate Cancer: Multicenter Observational Study of Patients Undergoing Treatment in Clinical Practice in Italian Hospitals', 'orgStudyIdInfo': {'id': 'A349'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ADT + docetaxel', 'description': 'mHSPC patients treated with ADT + docetaxel', 'interventionNames': ['Drug: Docetaxel', 'Drug: Triptorelin']}, {'label': 'ADT + ARPI', 'description': 'mHSPC patients treated with ADT + ARPI', 'interventionNames': ['Drug: Apalutamide Oral Tablet', 'Drug: Enzalutamide Oral Tablet', 'Drug: Abiraterone acetate tablets', 'Drug: Triptorelin']}, {'label': 'ADT + ARPI + docetaxel', 'description': 'mHSPC patients treated with ADT + docetaxel + ARPI', 'interventionNames': ['Drug: Docetaxel', 'Drug: Darolutamide Oral Tablet', 'Drug: Triptorelin']}, {'label': 'ADT + radiotherapy on primary tumor', 'description': 'mHSPC patients treated with ADT + radiotherapy on primary tumor', 'interventionNames': ['Radiation: radiotherapy', 'Drug: Triptorelin']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'description': '6 courses of docetaxel 75 mg/sqm iv', 'armGroupLabels': ['ADT + ARPI + docetaxel', 'ADT + docetaxel']}, {'name': 'Apalutamide Oral Tablet', 'type': 'DRUG', 'description': '240 mg /daily orally', 'armGroupLabels': ['ADT + ARPI']}, {'name': 'Enzalutamide Oral Tablet', 'type': 'DRUG', 'description': '600 mg /daily orally', 'armGroupLabels': ['ADT + ARPI']}, {'name': 'Abiraterone acetate tablets', 'type': 'DRUG', 'description': '1000 mg /daily orally', 'armGroupLabels': ['ADT + ARPI']}, {'name': 'Darolutamide Oral Tablet', 'type': 'DRUG', 'description': '600 mg/daily orally', 'armGroupLabels': ['ADT + ARPI + docetaxel']}, {'name': 'radiotherapy', 'type': 'RADIATION', 'description': 'radical radiotherapy on primary tumor', 'armGroupLabels': ['ADT + radiotherapy on primary tumor']}, {'name': 'Triptorelin', 'type': 'DRUG', 'description': '3,75 mg im/4 w', 'armGroupLabels': ['ADT + ARPI', 'ADT + ARPI + docetaxel', 'ADT + docetaxel', 'ADT + radiotherapy on primary tumor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10043', 'city': 'Orbassano', 'state': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Consuelo Buttigliero, MD, PhD', 'role': 'CONTACT', 'email': 'consuelo.buttigliero@unito.it', 'phone': '+390116705492'}, {'name': 'Consuelo Buttigliero, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera San Luigi', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '35128', 'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Umberto Basso, MD', 'role': 'CONTACT', 'email': 'umberto.basso@iov.veneto.it', 'phone': '+39-049-8215953'}, {'name': 'Basso Umberto', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Oncologico Veneto', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '38122', 'city': 'Trento', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Orazio Caffo, MD', 'role': 'CONTACT', 'email': 'orazio.caffo@apss.tn.it', 'phone': '+39 046190212'}, {'name': 'Orazio Caffo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Santa Chiara Hospital', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}], 'centralContacts': [{'name': 'Orazio Caffo, MD', 'role': 'CONTACT', 'email': 'orazio.caffo@apss.tn.it', 'phone': '+390461904416'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santa Chiara Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Orazio Caffo', 'investigatorAffiliation': 'Santa Chiara Hospital'}}}}