NCT06914544

Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Hypofractionated Radiosurgery	Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2025-04-06
• Last updated: 2025-04-10

Locations

6 sites across 1 country: Germany