Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-02-26 @ 5:44 PM
Study NCT ID:
NCT03223727
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Extra blood will be collected at baseline, 1st, 2nd, 3rd and 6th (or last) Radium-223 treatment. Changes in serum and blood levels of biomarkers of bone metabolism and levels of blood osteoclast precursors in Radium-223 treated patients will e evaluated for their potential to predict treatment outcome.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-07-17', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of treatment on pain outcomes, as mentioned by the patient', 'timeFrame': 'through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)', 'description': 'Evaluate Radium-223 treatment efficacy by patient, by several questionnaires (FACT-P, BPI-S and use of painmedication).'}, {'measure': 'Efficacy of treatment by patient records', 'timeFrame': 'through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)', 'description': 'But also by patient records (records of bonescans, CT scans, blood measurements, out-patient clinic visits).\n\nAll of these assessments will be combined to come to a final reported value (Progressive disease, stable disease, partial remission or complete remission)'}], 'secondaryOutcomes': [{'measure': 'Symptomatic Skeletal Event', 'timeFrame': 'through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)', 'description': 'To evaluate the efficacy of Radium-223 treatment in a nonstudy population by effects on Symptomatic Skeletal Event (SSE). Through patient records and questionnairs (FACT-P, BPI-S and use of painmedication).'}, {'measure': 'Clinical Parameters assessed by the WHO PS.', 'timeFrame': 'through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)', 'description': 'Evaluate Radium-223 treatment efficacy in a non-study population of CRPC patients by clinical parameters, through patient records (WHO PS)'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)', 'description': 'Evaluate Radium-223 treatment tolerability in a non-study population of CRPC patients, through patient records (using the CTCAE v4.03 for adverse events).'}, {'measure': 'Subsequent therapy after Radium-223: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)', 'description': 'Evaluate of the treatment after Radium-223 the treatment tolerability in a non-study population of CRPC patients, through patient records (using the CTCAE v4.03 for adverse events).'}, {'measure': 'Biomarkers', 'timeFrame': 'through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)', 'description': 'Identification of predictive clinical and explorative biomarkers of Radium-223 efficacy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radium-223'], 'conditions': ['Prostate Cancer Metastatic', 'Bone Metastases']}, 'descriptionModule': {'briefSummary': "This registry aims to evaluate the efficacy of Rad-223 treatment in a non-study population of CRPC patients treated earlier with Docetaxel and patients not treated earlier with Docetaxel and efficacy of the first subsequent therapy. The indication for treatment with Radium-223 will be at the physician's decision. All patients treated with Radium-223 can be included in this registry. The registry only dictates the collection of base line characteristics, expansion of regular blood tests and patient reported pain scores.", 'detailedDescription': 'Serum and blood markers of bone metabolism will be evaluated at Base Line, 1st, 2nd, 3rd and 6th (or last) Radium- 223 treatment. Every blood draw prior to Radium-223 treatment At baseline, tests include (but not restricted to): Testosterone, vitamin D-25-OH (Calciferol), C-reactive protein, Rank Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centres). Before 2nd, 3rd, 4th and 6th (or last) Radium-223 treatment, tests include (but not restricted to): C-reactive protein, Rank, Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centers).\n\nMoreover, levels of osteoclast precursors (CD34+) will be evaluated (10 ml heparinized blood) prior to the first Radium-223 treatment, 3rd and last treatment (Limited to 100 patients in selected centres).\n\nAll above-mentioned blood collections will be from the same venipuncture as standard clinical labs. Experimental assessments will be evaluated for their value as biomarkers of treatment outcome.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men with prostate cancer and bone metastasis, which are to be treated with Radium-223.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At the physicians discretion\n* Age 18 year and older.\n* Written informed consent\n\nExclusion Criteria:\n\n* Previous treatment with Radium-223.\n* Participation in another Radium-223 study.'}, 'identificationModule': {'nctId': 'NCT03223727', 'acronym': 'ROTOR', 'briefTitle': 'Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'Registry of Treatment Outcomes in a Non-study Population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223', 'orgStudyIdInfo': {'id': 'm15RTO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood tests for several bone markers (see summary)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'The Netherlands Cancer Intitute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Franciscus Gasthuis & Vlietland', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Andre Bergman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Netherlands Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}