Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
University Hospital Schleswig-Holstein
175 participants
Dec 10, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria5
- 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
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Interventions
Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife
Locations(6)
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NCT06914544