NCT03795337

Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)

Hypofractionated Radiosurgery for Localised Prostate Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: Male
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible. Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% currently.

Detailed description

Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy). Planned visits are: Baseline, visits at every radiation day and eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter 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: 2019-03-05
• Primary completion: 2024-03-04
• Completion: 2025-12-31
• First posted: 2019-01-07
• Last updated: 2024-03-20

Locations

8 sites across 1 country: Germany