Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
Recruiting · NCT06914544 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Schleswig-Holstein
View the official record on ClinicalTrials.gov →Interventions studied
Hypofractionated Radiosurgery
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
6 locations listed.
- Saphir Radiosurgery Center Frankfurt am Main - Frankfurt am Main, Hesse, Germany
- University Hospital Frankfurt - Frankfurt am Main, Hesse, Germany
- European Radiosurgery Center Munich - Munich, Hesse, Germany
- Saphir Radiosurgery Center Norther Germany - Kiel, Schleswig-Holstein, Germany
- University Medical Center Schleswig-Holstein - Kiel, Schleswig-Holstein, Germany
- CyberKnife Centrum Mitteldeutschland - Erfurt, Thuringia, Germany