Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-06-28 @ 8:13 PM
Study NCT ID:
NCT02635256
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2015-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypofractionated Radiosurgery for Localised 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2015-12-08', 'studyFirstSubmitQcDate': '2015-12-15', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score', 'timeFrame': '12-15 months after radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.', 'timeFrame': 'through study completion'}, {'measure': 'Prostate Specific Antigen (PSA)', 'timeFrame': 'At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy'}, {'measure': 'International Prostate Symptom Score (IPSS)', 'timeFrame': 'Screening and 3, 6-9 and 12-15 months after radiotherapy'}, {'measure': 'EORTC Quality of Life Questionnaire (QLQ) C30', 'timeFrame': 'At the time of inclusion and 12-15 months after radiotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypofractionation', 'prostate cancer', 'radiotherapy'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '28821268', 'type': 'BACKGROUND', 'citation': 'Jiang P, Krockenberger K, Vonthein R, Tereszczuk J, Schreiber A, Liebau S, Huttenlocher S, Imhoff D, Balermpas P, Keller C, Dellas K, Baumann R, Rodel C, Hildebrandt G, Junemann KP, Merseburger AS, Katz A, Ziegler A, Blanck O, Dunst J. Hypo-fractionated SBRT for localized prostate cancer: a German bi-center single treatment group feasibility trial. Radiat Oncol. 2017 Aug 18;12(1):138. doi: 10.1186/s13014-017-0872-2.'}, {'pmid': '36757424', 'type': 'RESULT', 'citation': 'Krug D, Imhoff D, Haidenberger A, Hessler N, Schafer J, Huttenlocher S, Chatzikonstantinou G, Furweger C, Ramm U, Konig IR, Chun F, Staehler M, Rodel C, Muacevic A, Vonthein R, Dunst J, Blanck O. Robotic stereotactic body radiotherapy for localized prostate cancer: final analysis of the German HYPOSTAT trial. Strahlenther Onkol. 2023 Jun;199(6):565-573. doi: 10.1007/s00066-023-02044-2. Epub 2023 Feb 9.'}]}, 'descriptionModule': {'briefSummary': 'Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible.\n\nInvestigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer, who are ineligible for the "PREFERE trial" under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 1 year amounts 2,8% and is significant lower than 17.5%.', 'detailedDescription': 'Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy).\n\nPlanned visits are: Baseline, visits at every radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Localised, histopathologically confirmed Prostate Cancer (cT1-3 N0 M0)\n* Gleason-grade ≤7\n* Guideline-based staging\n* Age ≥ 60 years\n* PSA \\< 15 ng/ml\n* Volume of the prostate \\<80 cm³\n* IPSS-Score ≤12\n* Written informed consent\n\nExclusion Criteria:\n\n* History of prior pelvic radiotherapy\n* Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold),\n* Immunosuppressive therapy\n* Relevant comorbidity thought to adversely affect treatment compliance,\n* Legal incapacity or lack of informed consent'}, 'identificationModule': {'nctId': 'NCT02635256', 'acronym': 'HYPOSTAT', 'briefTitle': 'Hypofractionated Radiosurgery for Localised Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Hypofractionated Radiosurgery for Localised Prostate Cancer', 'orgStudyIdInfo': {'id': 'ZKS-121-003'}, 'secondaryIdInfos': [{'id': 'ARO-2016-5', 'type': 'OTHER', 'domain': 'German Cancer Society'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypofractionated Radiosurgery', 'description': '5 fractions with 7 Gy, total dose 35 Gy', 'interventionNames': ['Radiation: Hypofractionated Radiosurgery']}], 'interventions': [{'name': 'Hypofractionated Radiosurgery', 'type': 'RADIATION', 'description': 'Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife', 'armGroupLabels': ['Hypofractionated Radiosurgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60528', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Saphir Radiosurgery Center Frankfurt am Main', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'University Hospital Frankfurt, Department of Radiation Therapy and Oncology', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '18273', 'city': 'Güstrow', 'country': 'Germany', 'facility': 'Saphir Radiosurgery Center Northern Germany', 'geoPoint': {'lat': 53.7972, 'lon': 12.17337}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'University Medical Center Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'European Cyberknife Center Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Juergen Dunst, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Schleswig-Holstein'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Luebeck', 'class': 'OTHER'}, {'name': 'Saphir Radiosurgery Center Northern Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Juergen Dunst', 'investigatorFullName': 'Juergen Dunst, Prof.', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}