RecruitingNot Applicable

Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)

Germany175 participantsStarted 2025-12-10

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

GU and GI Toxicity

Timeframe: 12-15 months after radiotherapy

Trial details

NCT IDNCT06914544

SponsorUniversity Hospital Schleswig-Holstein

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Oliver Blanck, PhD

+4943150026666 oliver.blanck@uksh.de

View on ClinicalTrials.gov More Prostate Cancer trials