Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06914544

Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)

Led by University Hospital Schleswig-Holstein · Updated on 2026-04-29

175

Participants Needed

6

Research Sites

211 weeks

Total Duration

On this page

Sponsors

U

University Hospital Schleswig-Holstein

Lead Sponsor

U

University of Luebeck

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Localised, histopathologically confirmed Prostate Cancer (cT1-T2c N0 M0)
  • Gleason-grade �3d7, ISUP Grade Group 1-3
  • Guideline-based staging
  • Age �3e= 18 years
  • PSA < 20 ng/ml
  • Volume of the prostate < 80 cm�b3
  • IPSS-Score �3c= 12
  • Written informed consent
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Saphir Radiosurgery Center Frankfurt am Main

Frankfurt am Main, Hesse, Germany, 60528

Actively Recruiting

2

University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany, 60528

Suspended

3

European Radiosurgery Center Munich

Munich, Hesse, Germany, 81377

Actively Recruiting

4

Saphir Radiosurgery Center Norther Germany

Kiel, Schleswig-Holstein, Germany, 24105

Active, Not Recruiting

5

University Medical Center Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany, 24105

Actively Recruiting

6

CyberKnife Centrum Mitteldeutschland

Erfurt, Thuringia, Germany, 99089

Actively Recruiting

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Research Team

O

Oliver Blanck, PhD

CONTACT

F

Frauke Walther-Clausnizer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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