Condition: Prostate Cancer · Sponsor: University Hospital Schleswig-Holstein
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Hypofractionated radiosurgery with 5 fractions is considered standard of care for localized prostate cancer. The investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 3 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late GU and GI toxicity ≥ grade 2 after 1 year amounts to 8.4% and 1.3% and is significant lower than 16.4% and 5.7% currently.
This description comes directly from the study's public registry record.
Oliver Blanck, PhD · +4943150026666 · oliver.blanck@uksh.de
Frauke Walther-Clausnizer · +4943150026581 · Frauke.Walther-Clausnizer@uksh.de
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Inclusion Criteria: * Localised, histopathologically confirmed Prostate Cancer (cT1-T2c N0 M0) * Gleason-grade ≤7, ISUP Grade Group 1-3 * Guideline-based staging * Age ≥ 18 years * PSA \< 20 ng/ml * Volume of the prostate \< 80 cm³ * IPSS-Score ≤ 12 * Written informed consent Exclusion Criteria: * History of prior pelvic radiotherapy * Previous transurethral resection, laser enucleation or prostate ablation * Contraindication to MRI or Fiducial marker implantation (e.g. gold allergy) * Relevant comorbidity thought to adversely affect treatment compliance * Legal incapacity or lack of informed consent
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Saphir Radiosurgery Center Frankfurt am Main | Frankfurt am Main, Hesse, Germany | Recruiting |
| University Hospital Frankfurt | Frankfurt am Main, Hesse, Germany | Suspended |
| European Radiosurgery Center Munich | Munich, Hesse, Germany | Recruiting |
| Saphir Radiosurgery Center Norther Germany | Kiel, Schleswig-Holstein, Germany | Active Not Recruiting |
| University Medical Center Schleswig-Holstein | Kiel, Schleswig-Holstein, Germany | Recruiting |
| CyberKnife Centrum Mitteldeutschland | Erfurt, Thuringia, Germany | Recruiting |
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