Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital Schleswig-Holstein
About this trial
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.
Eligibility criteria
Qualifiers
Localised, histopathologically confirmed Prostate Cancer (cT1-T2c N0 M0)
Gleason-grade ≤7, ISUP Grade Group 1-3
Guideline-based staging
Age ≥ 18 years
Disqualifiers
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
Trial design
Treatments tested in this trial
- Hypofractionated Radiosurgery
Treatment groups
175 Participants
are divided into 1 treatment groupSponsors and collaborators
University Hospital Schleswig-Holstein
Lead sponsor
University of Luebeck
Collaborator
Source ClinicalTrials.gov