Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
Study NCT ID:
NCT04232761
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2020-01-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Gather Information on the Safety and How Radium-223 Dichloride, an Alpha Particle-emitting Radioactive Agent, Works Under Routine Clinical Practice in Taiwan in Patients With Castration-resistant Prostate Cancer (CRPC) Which Has Spread to the Bone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C581106', 'term': 'radium Ra 223 dichloride'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 7 months'}, {'measure': 'Incidence of drug-related TEAEs', 'timeFrame': 'Up to 7 months'}, {'measure': 'Descriptive analysis of long-term safety information during the extended follow-up period', 'timeFrame': 'Up to 2 years', 'description': 'This safety information may include e.g. hematological adverse events, bone fractures or osteoporosis.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 2 years'}, {'measure': 'Time to the first symptomatic skeletal event (SSE)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Proportion of patients with total ALP (tALP) response', 'timeFrame': 'Up to 2 years', 'description': 'ALP - Alkaline Phosphatase tALP - Total Alkaline Phosphatase'}, {'measure': 'Proportion of patients with PSA response', 'timeFrame': 'Up to 2 years', 'description': 'PSA - Prostate Specific Antigen'}, {'measure': 'Change in pain status', 'timeFrame': 'Up to 2 years', 'description': 'Pain status is assessed through analgesic utility that is calculated by WHO analgesic scores (0 - none, 1 - non-opioid, 2 - opioid for mild to moderate pain, 3 - opioid for moderate to severe pain)'}, {'measure': 'Change in ECOG-PS', 'timeFrame': 'Up to 2 years', 'description': 'The Cooperative Oncology Group-Performance Status (ECOG-PS) score ranks the performance status from 0 (perfect health) to 5 (death).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bone metastases', 'Radium-223 dichloride'], 'conditions': ['Castration-resistant Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.'}]}, 'descriptionModule': {'briefSummary': 'In this observational study researchers want to gather more information about safety and survival in patients suffering from castration-resistant prostate cancer (CRPC) which has spread to the bone and were treated with radium-223 in routine clinical practice in Taiwan. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).', 'detailedDescription': 'The primary objective of the study is to describe the safety profile of radium-223 dichloride in patients having castration-resistent prostate cancer with symptomatic bone metastases and who are treated in routine clinical practice in Taiwan.\n\nThe secondary objective is to assess the effectiveness of radium-223 dichloride in these patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male patients in routine clinical practice from Taiwan', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate with bone metastases\n* Treatment decision for Radium-223 according to local label needs to be made independent from and before patient enrollment in the study by the investigator\n* No contra-indications according to the local marketing authorization\n\nExclusion Criteria:\n\n* Previously treated with Radium-223 for any reason\n* Currently treated in clinical trials including other Radium-223 studies or planned participation in an investigational program with interventions outside of routine clinical practice during the study period'}, 'identificationModule': {'nctId': 'NCT04232761', 'acronym': 'RAPIT', 'briefTitle': 'Study to Gather Information on the Safety and How Radium-223 Dichloride, an Alpha Particle-emitting Radioactive Agent, Works Under Routine Clinical Practice in Taiwan in Patients With Castration-resistant Prostate Cancer (CRPC) Which Has Spread to the Bone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Safety and Effectiveness of Xofigo® (Radium-223 Dichloride) in Routine Clinical Practice Settings in Taiwan', 'orgStudyIdInfo': {'id': '21124'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CRPC patients', 'description': 'Patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases who are treated with radium-223 dichloride in routine clinical practice in Taiwan', 'interventionNames': ['Drug: Radium-223 dichloride (Xofigo, BAY88-8223)']}], 'interventions': [{'name': 'Radium-223 dichloride (Xofigo, BAY88-8223)', 'type': 'DRUG', 'description': 'Drug administration as determined by treating physician', 'armGroupLabels': ['CRPC patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Taiwan', 'facility': 'Many locations'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will later be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nInterested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}