|

Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)

RECRUITINGN/ASponsored by University Hospital Schleswig-Holstein
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital Schleswig-Holstein
Started2025-12-10
Est. completion2028-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06914544

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 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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

Browse More Trials

Cancer trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.