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Search / Trial NCT06914544

Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)

Launched by UNIVERSITY HOSPITAL SCHLESWIG-HOLSTEIN · Mar 31, 2025

Trial Information

Current as of June 27, 2025

Not yet recruiting

Keywords

Prostate Cancer Sbrt Cyber Knife Radiosurgery Hypostat

ClinConnect Summary

The HYPOSTAT-III trial is studying a type of treatment for localized prostate cancer called hypofractionated radiosurgery. This method typically involves delivering radiation in five smaller doses over time. However, this trial is investigating whether giving the treatment in just three smaller doses is safe and effective. Researchers want to see if this approach results in fewer side effects, particularly issues related to the urinary and gastrointestinal systems, after one year.

To be eligible for this trial, participants must be adult males aged 18 or older with confirmed localized prostate cancer that meets certain criteria, such as a specific cancer grade and prostate size. Participants will need to provide written consent and must not have had previous pelvic radiation or certain other medical conditions that could interfere with the study. While the trial is not yet recruiting, it aims to offer insights into potentially improving treatment for localized prostate cancer with fewer side effects. If you or someone you know is considering this option, it could be a chance to contribute to important research in cancer care.

Gender

MALE

Eligibility criteria

  • 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

About University Hospital Schleswig Holstein

University Hospital Schleswig-Holstein (UKSH) is a leading academic medical center in Germany, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution, UKSH integrates cutting-edge medical research with comprehensive patient care, fostering an environment that promotes the development of novel therapeutic strategies. With a multidisciplinary approach and a strong emphasis on collaboration, UKSH is dedicated to enhancing clinical outcomes and contributing to the global medical community through rigorous scientific inquiry and the translation of research findings into practice.

Locations

Munich, Ba, Germany

Frankfurt, He, Germany

Frankfurt, He, Germany

Kiel, Sh, Germany

Kiel, Sh, Germany

Erfurt, Th, Germany

Patients applied

0 patients applied

Trial Officials

David Krug, MD

Principal Investigator

University Hospital Schleswig-Holstein

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported