Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)

NCT03795337 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2024-03-20

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Hypofractionated Radiosurgery

Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife

Sponsors & Collaborators

  • University of Luebeck

    collaborator OTHER
  • Saphir Radiosurgery Center Northern Germany

    collaborator UNKNOWN
  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Juergen Dunst, Prof. · University Hospital Schleswig-Holstein

  • Alexander Muacevic, Prof. · European CyberKnife Center Munich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-05
Primary Completion
2024-03-04
Completion
2025-12-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03795337 on ClinicalTrials.gov