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Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible. Investigators 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%.
Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy). Planned 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).
Age
60 - No limit years
Sex
MALE
Healthy Volunteers
No
Saphir Radiosurgery Center Frankfurt am Main
Frankfurt am Main, Germany
University Hospital Frankfurt, Department of Radiation Therapy and Oncology
Frankfurt am Main, Germany
Saphir Radiosurgery Center Northern Germany
Güstrow, Germany
University Medical Center Schleswig-Holstein
Kiel, Germany
European Cyberknife Center Munich
Munich, Germany
Start Date
December 1, 2015
Primary Completion Date
December 31, 2018
Completion Date
December 31, 2019
Last Updated
March 21, 2024
85
ACTUAL participants
Hypofractionated Radiosurgery
RADIATION
Lead Sponsor
University Hospital Schleswig-Holstein
Collaborators
NCT04550494
NCT05691465
Data Source & Attribution
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