Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 8:23 PM
Study NCT ID:
NCT03880851
Status:
UNKNOWN
Last Update Posted:
2019-03-20
First Post:
2019-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MR-based Hypofractionated Adaptive IGRT of Prostate Cancer (M-base HyPro 2.0)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Phase II, Intervention: Plan adaption in case of significant changes of organ at risk or target volumes measured in weekly MRIs'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2019-03-16', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with gastrointestinal "GI" and genitourinary "GU" toxicity of >/= G2', 'timeFrame': '2 years', 'description': 'Hypothesis: reduction of GI/GU-toxicity (CTC-criteria 4.0, RTOG) from 20% to 10% at 2 years, power 80%'}], 'secondaryOutcomes': [{'measure': 'Number of participants completing at least 2 of 4 MRI-examinations during course of IGRT', 'timeFrame': '6 months', 'description': 'Feasibility and tolerability of completing at least 2 of 4 MRIs during treatment'}, {'measure': 'Rate of participants achieving local control', 'timeFrame': '2, 5, 10 years', 'description': 'In case of PSA progress: No evidence of local recurrence detected by MRI'}, {'measure': 'Rate of participants achieving regional control', 'timeFrame': '2, 5, 10 years', 'description': 'In case of PSA progress: No evidence of regional recurrence detected by MRI'}, {'measure': 'Rate of participants achieving Distant-metastasis-free survival "DMFS"', 'timeFrame': '2, 5, 10 years', 'description': 'No evidence of distant metastases diagnosed by cross-sectional imaging including bone scan, MRI, CT and PET'}, {'measure': 'Number of Participants with biochemical no evidence of disease "bNED"', 'timeFrame': '2, 5, 10 years', 'description': 'biochemical no evidence of disease according to Phoenix definition: nadir + 2ng/ml'}, {'measure': 'Time without secondary treatment "TWIST"', 'timeFrame': '2, 5, 10 years', 'description': 'Time without secondary treatment calculated from start of IGRT'}, {'measure': 'CTC-Proctitis', 'timeFrame': '2, 5, 10 years', 'description': 'CTC 4.0'}, {'measure': 'CTC-Incontinence', 'timeFrame': '2, 5, 10 years', 'description': 'CTC 4.0'}, {'measure': 'Progression-free survival "PFS"', 'timeFrame': '2, 5, 10 years', 'description': 'progression-free survival is defined as any progression (biochemical or other recurrences) or death or initiation of secondary treatment, calculation from start of IGRT'}, {'measure': 'Overall survival "OS"', 'timeFrame': '2, 5, 10 years', 'description': 'Overall survival is calculated from start of IGRT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypofractionation', 'MR-based IGRT', 'Mbase HyPro'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Single-centre single-armed, non-randomized interventional phase II-study of hypofractionated image-guided radiotherapy "IGRT" with weekly magnetic resonance imagings "MRI" for personalized adaptation of the treatment plan depending on individual MR-anatomy of prostate/organ at risks "OAR" during course of IGRT.', 'detailedDescription': 'IGRT-schedule: 20 fractions to a total dose of 60 Gy\n\nPersonalized adaption of treatment plan dependning on volume-/ and constraint-thresholds and evaluation of biomarkers (multiparametric MRI, blood, tissue, stool, urine).\n\nTreatment at MR-Linac allowed'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* biopsy-proven prostate cancer with indication for RT\n* cT1b-cT3a cN0 cM0\n* ECOG Performance score 0-2\n* IPSS≤12 (before planning computed tomography i.e. reached after neoadjuvant androgen deprivation therapy or tamsulosin)\n* age\\>18 years\n* Informed consent\n\nExclusion Criteria:\n\n* not fulfilled inclusion criteria\n* contraindication against curative RT\n* age\\<18 years\n* previous pelvic radiotherapy or planned pelvic radiotherapy\n* comorbidities interfering with image-guided radiotherapy\n* contraindications against multiparametric MRI (like hio prosthesis, pacer, allergy against contrast media)\n* prior transurethral resection, highly focussed ultrasound or other pre-treatment of prostate'}, 'identificationModule': {'nctId': 'NCT03880851', 'acronym': 'Mbase_HyPro', 'briefTitle': 'MR-based Hypofractionated Adaptive IGRT of Prostate Cancer (M-base HyPro 2.0)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Single-arm Phase (II) Study on MR-based Hypofractionated Adaptive Image-guided Radiation Therapy for Prostate Cancer', 'orgStudyIdInfo': {'id': 'Mbase HyPro 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hypofractionated image-guided radiotherapy', 'description': 'Hypofractionated image-guided radiotherapy "IGRT" to a total dose of 60 Gy (20 fractions) is performed.\n\nWeekly MRI are used to estimate volume/deformation changes of OAR and target volume.\n\nIntervention: In case of a significant change of target volume or OARs (threshold based) the radiation treatment plan is adapted on individual MR-anatomy.', 'interventionNames': ['Radiation: Plan adaptation of Radiation Treatment in case of anatomical changes']}], 'interventions': [{'name': 'Plan adaptation of Radiation Treatment in case of anatomical changes', 'type': 'RADIATION', 'description': 'Image guided radiotherapy is given to 60Gy in 20 fractions. Intervention: Radiation treatment plan adaption in case of volume changes of target volume or not meeting OAR constraints due to volume changes.', 'armGroupLabels': ['Hypofractionated image-guided radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Arndt-Christian Müller', 'role': 'CONTACT', 'email': 'arndt-christian.mueller@med.uni-tuebingen.de', 'phone': '070712986143'}], 'facility': 'Müller Arndt-Christian', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Silke Theden', 'role': 'CONTACT', 'email': 'silke.theden@med.uni-tuebingen.de', 'phone': '+49707183420'}, {'name': 'Arndt-Christian Müller', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Head of the Department of Radiation Oncology', 'investigatorFullName': 'Arndt-Christian Mueller', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}