Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
Key facts
- Where
- Erfurt, Frankfurt am Main, Kiel és Munich, NémetországSee the 6 sites
Where in Németország
- CyberKnife Centrum MitteldeutschlandErfurt, NémetországTaking people
- Saphir Radiosurgery Center Frankfurt am MainFrankfurt am Main, NémetországTaking people
- University Hospital FrankfurtFrankfurt am Main, NémetországNo longer taking part
- University Medical Center Schleswig-HolsteinKiel, NémetországTaking people
- Saphir Radiosurgery Center Norther GermanyKiel, NémetországNo longer taking part
- European Radiosurgery Center MunichMunich, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Schleswig-Holstein
- Trial code
- NCT06914544
- Record updated
- 2026. április 29.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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.