Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)
NCT03795337 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 475
Last updated 2024-03-20
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.
Conditions
Interventions
- RADIATION
-
Hypofractionated Radiosurgery
Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife
Sponsors & Collaborators
-
University of Luebeck
collaborator OTHER -
Saphir Radiosurgery Center Northern Germany
collaborator UNKNOWN -
University Hospital Schleswig-Holstein
lead OTHER
Principal Investigators
-
Juergen Dunst, Prof. · University Hospital Schleswig-Holstein
-
Alexander Muacevic, Prof. · European CyberKnife Center Munich
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 60 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-05
- Primary Completion
- 2024-03-04
- Completion
- 2025-12-31
Countries
- Germany
Study Locations
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