Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-04 @ 10:18 PM
Study NCT ID:
NCT03658434
Status:
UNKNOWN
Last Update Posted:
2018-09-12
First Post:
2018-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-01', 'size': 1667617, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-29T07:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Feasibility study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2018-07-30', 'studyFirstSubmitQcDate': '2018-09-03', 'lastUpdatePostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of study participants that complete the study', 'timeFrame': '6 months', 'description': 'Proportion of study participants that complete radiotherapy with ≥ 90% of prescribed dose'}], 'secondaryOutcomes': [{'measure': 'Response in dominating symptom score (short form McGill pain Questionnaire)', 'timeFrame': 'Baseline, 1,3 and 6 months after radiotherapy', 'description': 'Patient score symptom/pain using the short form McGill pain Questionnaire version 2'}, {'measure': 'Acute radiation toxicity score using CTCAE', 'timeFrame': 'Baseline, 1,3 and 6 months after radiotherapy', 'description': 'Doctor score acute radiation toxicity using the CTCAE version 4'}, {'measure': 'Quality of life score using EORTC QLQ-C30', 'timeFrame': 'Baseline and 6 months after radiotherapy', 'description': 'Patient fill out EORTC quality of life Questionnaire form C30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hormone-refractory Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '30630502', 'type': 'DERIVED', 'citation': 'Carl J, Rades D, Doemer C, Setter C, Dunst J, Hollander NH. Palliative radiotherapy to dominant symptomatic lesion in patients with hormone refractory prostate cancer (PRADO). Radiat Oncol. 2019 Jan 10;14(1):3. doi: 10.1186/s13014-019-1209-0.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present feasibility study of a new short palliative radiotherapy regime that apply to patients with metastatic hormone refractory prostate cancer (HRPC) presenting with a dominating debilitating symptom. Diffusion weighted magnetic resonance imaging (DWI) will apply to identify both the lesion and the most aggressive part of the lesion. The symptomatic lesions will be treated with a dose of 4 x 5 Gy, while for the most aggressive part of the lesion the dose will be escalated to 4 x 7 Gy using a simultaneous integrated boost (SIB) technique.', 'detailedDescription': 'Please refer to uploaded Study Protocol'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with hormone refractory biopsy proven prostate cancer\n2. Presenting with a dominating debilitating symptom\n3. Expected median survival of 12 months\n4. Focal irradiation of lesion is feasible\n5. Systemic therapy according to guidelines\n6. age ≥18 years\n7. Legal capacity, able to understand consequences of the trial\n8. Written informed consent\n\nExclusion Criteria:\n\n1. Relevant comorbidity (limiting radiotherapy according to protocol)\n2. Prior radiotherapy limitations to administer radiotherapy according to protocol\n3. No large metal implants in vicinity of lesion\n4. Department dose constraints for normal tissue can't be met\n5. Large bony lesions with extensive osseous destruction\n6. Patients symptoms do not correlate with MR findings"}, 'identificationModule': {'nctId': 'NCT03658434', 'acronym': 'PRADO', 'briefTitle': 'Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer', 'orgStudyIdInfo': {'id': 'PRADO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'feasibilty', 'description': 'Palliative Radiotherapy', 'interventionNames': ['Radiation: Palliative radiotherapy']}], 'interventions': [{'name': 'Palliative radiotherapy', 'type': 'RADIATION', 'otherNames': ['PRADO'], 'description': 'Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer', 'armGroupLabels': ['feasibilty']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-4700', 'city': 'Næstved', 'state': 'Region Sjælland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Redas Trepiakas', 'role': 'CONTACT', 'email': 'rtr@regionsjaelland.dk', 'phone': '+4556513231', 'phoneExt': '+4556513231'}, {'name': 'K F E', 'role': 'CONTACT', 'email': 'laml@regionsjaelland.dk', 'phone': '+ 45 56 51 31 17'}], 'facility': 'Dep. Radiation Oncology, Zealand University Hospital', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}, {'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Juergen Dunst, MD', 'role': 'CONTACT', 'email': 'juergen.dunst@uksh.de', 'phone': '0049 431 500-26500'}], 'facility': 'University Hospital Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dirk Rades, MD', 'role': 'CONTACT', 'email': 'dirk.rades@uksh.de', 'phone': '0049 451-500-45400'}], 'facility': 'University Hospital Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'centralContacts': [{'name': 'Redas Trepiakas, MD', 'role': 'CONTACT', 'email': 'rtr@regionsjaelland.dk', 'phone': '+45 56 51 3231'}, {'name': 'K F E', 'role': 'CONTACT', 'email': 'laml@regionsjaelland.dk', 'phone': '+ 45 56 51 31 17'}], 'overallOfficials': [{'name': 'Jesper H Carl, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Oncology, Zealand University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '1\\. august 2018', 'ipdSharing': 'YES', 'description': 'Defined in Partner Agreement Contract', 'accessCriteria': 'Innocan Partners'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}