Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-04 @ 1:04 PM
Study NCT ID:
NCT02899104
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064129', 'term': 'Prostatic Neoplasms, Castration-Resistant'}], 'ancestors': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581106', 'term': 'radium Ra 223 dichloride'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2016-09-08', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determining factors that drive physician decision for treatment selection.', 'timeFrame': 'Up to 9 months', 'description': 'The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD), testosterone, pain, symptoms, bone lesions, disease progression.'}], 'secondaryOutcomes': [{'measure': 'Most common treatment sequences', 'timeFrame': 'Up to 9 months', 'description': 'Description of what treatments are given to treat mCRPC in first, second, third, and fourth line.'}, {'measure': 'Integration of Xofigo into the common treatment sequences, monotherapy or in combination.', 'timeFrame': 'Up to 9 months', 'description': 'Describe where is Xofigo given in the treatment paradigm, whether is given in combination with hormonals or chemotherapy or given as a monotherapy'}, {'measure': 'Mean Xofigo dose', 'timeFrame': 'Up to 9 months', 'description': 'Mean dose of each treatment received in the respective sequence'}, {'measure': 'Duration of Xofigo treatment', 'timeFrame': 'Up to 9 months', 'description': 'Mean number of treatment cycles'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 9 months', 'description': 'Collect outcomes for patients following treatment for mCRPC including changes in overall survival'}, {'measure': 'Time to radiographic progression', 'timeFrame': 'Up to 9 months', 'description': 'Collect outcomes for patients following treatment for mCRPC including changes in time to radiographic progression'}, {'measure': 'Time to PSA (Prostate specific antigen) progression', 'timeFrame': 'Up to 9 months', 'description': 'Collect outcomes for patients following treatment for mCRPC including changes in PSA progression'}, {'measure': 'Most common SRE (Skeletal Related Event)', 'timeFrame': 'Up to 9 months', 'description': 'The SRE occurring in the highest number of participants will be described.'}, {'measure': 'Most common clinical intervention', 'timeFrame': 'Up to 9 months', 'description': 'Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery.'}, {'measure': 'Time to first SSE(Symptomatic Skeletal Events)', 'timeFrame': 'Up to 9 months', 'description': 'Time to first SSE outcome will be analysed using the Kaplan Meier method'}, {'measure': 'Reasons for discontinuation', 'timeFrame': 'Up to 9 months', 'description': 'The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD)), testosterone, pain, symptoms, bone lesions, disease progression.'}, {'measure': 'Change in laboratory values from baseline', 'timeFrame': 'Up to 9 months', 'description': 'for hemoglobin, platelets, neutrophils'}, {'measure': 'Radiological progression free survival (rPFS)', 'timeFrame': 'Up to 9 months', 'description': 'change in laboratory values from baseline for radiological progression free survival (rPFS)'}, {'measure': 'Time to alkaline phosphatase (ALP) progression', 'timeFrame': 'Up to 9 months', 'description': 'change in laboratory values from baseline for ALP'}, {'measure': 'Time to visceral metastasis', 'timeFrame': 'Up to 9 months', 'description': 'time from baseline to the appearance of visceral metastasis'}, {'measure': 'Time to onset of first subsequent treatment', 'timeFrame': 'Up to 9 months', 'description': 'or start of any other treatment for mCRPC'}, {'measure': 'Pain', 'timeFrame': 'Up to 9 months', 'description': 'Based on chart reported pain'}, {'measure': 'Most common symptoms', 'timeFrame': 'Up to 9 months', 'description': 'The participant and the treating physician should select out of the following list: fatigue, hypertension, cognitive disorder, seizures, edema, hypokalemia, cardiac disorders, hepatotoxicity, anemia, neutropenia, febrile neutropenia, thrombocytopenia'}, {'measure': 'Type of physician', 'timeFrame': 'Up to 9 months', 'description': 'Define type of physicians that treat of mCRPC'}, {'measure': 'Change in PSA from baseline to 12 weeks, and baseline to discontinuation', 'timeFrame': 'Baseline and 12 weeks,Baseline and through study completion, an average of 1 year', 'description': 'Measure PSA closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation'}, {'measure': 'Resource utilization', 'timeFrame': 'Up to 9 months', 'description': 'Number of outpatient, inpatient and emergency room visits as well as number of hospitalizations'}, {'measure': 'Change in ALP from baseline to 12 weeks, and baseline to discontinuation', 'timeFrame': 'Baseline and 12 weeks,Baseline and through study completion, an average of 1 year', 'description': 'Measure ALP closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation'}, {'measure': 'Change in LDH from baseline to 12 weeks, and baseline to discontinuation', 'timeFrame': 'Baseline and 12 weeks,Baseline and through study completion, an average of 1 year', 'description': 'Measure LDH values closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostatic Neoplasms, Castration-Resistant']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicaltrials.bayer.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.', 'detailedDescription': 'This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'mCRPC patients treated with Xofigo from 10 centers in the US', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC) per medical chart.\n* Patients were at least 18 years of age as of the first diagnosis for mCRPC.\n* Patients must have received at least one intravenous injection of Radium-223 (Xofigo).\n* First injection of Radium-223 must have started between periods\n\n 1-January-2014 to 30-June-2014 or 15-November-2014 to present.\n* Patients must have a minimum of 12 months documented follow-up records following last Radium-223 treatment or death within 12 months of last dose.\n\nExclusion Criteria:\n\n* Patients who received Radium-223 as part in an interventional clinical trial\n* Actively treated, or expect to be treated, in 6 months before last follow-up, for any other malignancy with the exception of non-metastatic skin cancer or low-grade superficial bladder cancer.'}, 'identificationModule': {'nctId': 'NCT02899104', 'acronym': 'Navigant', 'briefTitle': 'Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Current Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients Treated With Radium-223', 'orgStudyIdInfo': {'id': '18919'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radium-223 dichloride', 'description': 'Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC), at least 18 years of age, must have received at least one intravenous injection of Radium-223.', 'interventionNames': ['Drug: Xofigo (Radium-223 dichloride, BAY88-8223)']}], 'interventions': [{'name': 'Xofigo (Radium-223 dichloride, BAY88-8223)', 'type': 'DRUG', 'description': 'Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.', 'armGroupLabels': ['Radium-223 dichloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07981', 'city': 'Whippany', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Whippany', 'geoPoint': {'lat': 40.82454, 'lon': -74.4171}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}