NCT06914544Recruiting
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 175 (estimated)
- First submitted
- 31 Mar 2025
- Start date
- 10 Dec 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University Hospital Schleswig-Holstein
- Diseases
- Prostate cancer
- NCT number
- NCT06914544
What you commit to
- Study type: Interventional
- Planned participants: 175
- From 10 Dec 2025 to the primary completion date, 31 Dec 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior pelvic radiotherapy
- Previous transurethral resection, laser enucleation or prostate ablation
Other illness
- Contraindication to MRI or Fiducial marker implantation (e.g. gold allergy)
Other
- Relevant comorbidity thought to adversely affect treatment compliance
- Legal incapacity or lack of informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CyberKnife Centrum Mitteldeutschland Coordinator of this site? Confirm its status | Erfurt | Germany | Recruiting |
| University Hospital Frankfurt Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Suspended |
| Saphir Radiosurgery Center Frankfurt am Main Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Saphir Radiosurgery Center Norther Germany Coordinator of this site? Confirm its status | Kiel | Germany | Active, not recruiting |
| University Medical Center Schleswig-Holstein Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| European Radiosurgery Center Munich Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.