Status:
NOT_YET_RECRUITING
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
Lead Sponsor:
University Hospital Schleswig-Holstein
Collaborating Sponsors:
University of Luebeck
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 feasibil...
Detailed Description
Experimental radiosurgery of the prostate with 3 fractions each with 9.5 -10.5 Gy (total application rate of 28.5-31.5 Gy) based on risk grading. Planned visits are: Baseline, visits at every radiati...
Eligibility Criteria
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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT06914544
Start Date
July 1 2025
End Date
December 31 2029
Last Update
April 10 2025
Active Locations (6)
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1
Saphir Radiosurgery Center Frankfurt am Main
Frankfurt am Main, Hesse, Germany, 60528
2
University Hospital Frankfurt
Frankfurt am Main, Hesse, Germany, 60528
3
European Radiosurgery Center Munich
Munich, Hesse, Germany, 81377
4
Saphir Radiosurgery Center Norther Germany
Kiel, Schleswig-Holstein, Germany, 24105