Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-25 @ 7:58 PM
Study NCT ID:
NCT06355050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2024-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2032-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-04-06', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life (EPIC 26)', 'timeFrame': 'longitudinally: before + during RT and during follow up (5 years, at least bi-annually)', 'description': 'Expanded Prostate Cancer Index Composite 26 (questionnaire)'}], 'secondaryOutcomes': [{'measure': 'Toxicity (CTCAE v5.0)', 'timeFrame': 'longitudinally: before + during RT and during follow up (5 years, at least bi-annually)', 'description': 'Common Terminology Criteria for Adverse Events v5.0'}, {'measure': 'Planning parameters', 'timeFrame': 'for every fraction, total: 5x (1 week)', 'description': 'Dose constraints per organ, Conformity Indices, Quality of adaptive planning'}, {'measure': 'Dose constraints', 'timeFrame': 'for every fraction, total: 5x (1 week)', 'description': 'Dose constraints for organs at risk and target volumes per fraction'}, {'measure': 'Conformity indices', 'timeFrame': 'for every fraction, total: 5x (1 week)', 'description': 'Conformity indices for target volumes, per fraction'}, {'measure': 'Quality of adaptive planning', 'timeFrame': 'for every fraction, total: 5x (1 week)', 'description': 'Semi-quantitative score to evaluate the quality of the adaptive plan and if revisions would be required'}, {'measure': 'PSA-value', 'timeFrame': 'longitudinally: before + during RT and during follow up (5 years, at least bi-annually)', 'description': 'endpoint: Prostate-specific antigene (PSA)-recurrence free survival'}, {'measure': 'Overall survival', 'timeFrame': '5 Years'}, {'measure': 'Recurrence free survival', 'timeFrame': '5 Years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adaptive Radiotherapy', 'Quality of Life', 'Ultra-hypofractionation'], 'conditions': ['Prostate Cancer', 'Adaptive Radiotherapy', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* low / intermediate risk prostate cancer\n* prostate volume \\< 100 ccm', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no androgen deprivation therapy within the last 2 months prior to RT\n* good performance status (Eastern Cooperative Oncology Group, ECOG, 0/1)\n* no secondary malignancy'}, 'identificationModule': {'nctId': 'NCT06355050', 'acronym': 'ultraHART', 'briefTitle': 'Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jena University Hospital'}, 'officialTitle': 'Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer - Ultra-HART', 'orgStudyIdInfo': {'id': 'UKJ-ultraHART'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients receiving ultrahypofractionated radiotherapy'}, {'label': 'Retrospective reference cohort', 'description': "reference cohort of patients who underwent normofractionated radiotherapy or moderately hypofractionated radiotherapy earlier.\n\nmatching 1:1:1 by tumor stage and risk profile (d'Amico)"}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jena', 'country': 'Germany', 'contacts': [{'name': 'Klaus Pietschmann, MD', 'role': 'CONTACT', 'email': 'klaus.pietschmann@med.uni-jena.de'}, {'name': 'Georg Wurschi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Radiotherapy and Radiation Oncology, Jena University Hospital', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'centralContacts': [{'name': 'Klaus Pietschmann, MD. MBa. LLM.', 'role': 'CONTACT', 'email': 'strahlentherapie@med.uni-jena.de', 'phone': '00 - 49 03641 - 9-328401'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jena University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, {'name': 'Klinikum Stuttgart', 'class': 'OTHER'}, {'name': 'University Medical Center Göttingen', 'class': 'UNKNOWN'}, {'name': 'Kantonsspital Aarau', 'class': 'OTHER'}, {'name': 'Hirslanden Stephanshorn', 'class': 'UNKNOWN'}, {'name': 'Universitätsklinik Würzburg', 'class': 'UNKNOWN'}, {'name': 'Radiologische Allianz Hamburg', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Georg Wurschi', 'investigatorAffiliation': 'Jena University Hospital'}}}}