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Brief Title: Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)
Official Title: Hypofractionated Radiosurgery for Localised Prostate Cancer
Study ID: NCT03795337
Brief Summary: 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 under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% currently.
Detailed Description: 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 eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter after last day of radiation).
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK), Berlin, , Germany
University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy, Cologne, , Germany
CyberKnife Centrum Mitteldeutschland, Erfurt, , Germany
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, Kiel, , Germany
University Medical Center Schleswig-Holstein, Kiel, , Germany
European Cyberknife Center Munich, Munich, , Germany
Name: Juergen Dunst, Prof.
Affiliation: University Hospital Schleswig-Holstein
Role: PRINCIPAL_INVESTIGATOR
Name: Alexander Muacevic, Prof.
Affiliation: European CyberKnife Center Munich
Role: PRINCIPAL_INVESTIGATOR