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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife
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
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
Time frame: 12-15 months after radiotherapy
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.
Time frame: through study completion
Prostate Specific Antigen (PSA)
Time frame: At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy
International Prostate Symptom Score (IPSS)
Time frame: Screening and 3, 6-9 and 12-15 months after radiotherapy
EORTC Quality of Life Questionnaire (QLQ) C30
Time frame: At the time of inclusion and 12-15 months after radiotherapy
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European Cyberknife Center Munich
Munich, Germany