Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
NCT ID: NCT06914544
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
175 participants
INTERVENTIONAL
2025-07-01
2029-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hypofractionated Radiosurgery
3 fractions with 9.5-10.5 Gy, total dose 28.5-31.5 Gy
Hypofractionated Radiosurgery
Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife
Interventions
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Hypofractionated Radiosurgery
Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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University of Luebeck
OTHER
University Hospital Schleswig-Holstein
OTHER
Responsible Party
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Principal Investigators
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David Krug, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Schleswig-Holstein
Locations
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Saphir Radiosurgery Center Frankfurt am Main
Frankfurt am Main, Hesse, Germany
University Hospital Frankfurt
Frankfurt am Main, Hesse, Germany
European Radiosurgery Center Munich
Munich, Hesse, Germany
Saphir Radiosurgery Center Norther Germany
Kiel, Schleswig-Holstein, Germany
University Medical Center Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
CyberKnife Centrum Mitteldeutschland
Erfurt, Thuringia, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Krug D, Imhoff D, Haidenberger A, Hessler N, Schafer J, Huttenlocher S, Chatzikonstantinou G, Furweger C, Ramm U, Konig IR, Chun F, Staehler M, Rodel C, Muacevic A, Vonthein R, Dunst J, Blanck O. Robotic stereotactic body radiotherapy for localized prostate cancer: final analysis of the German HYPOSTAT trial. Strahlenther Onkol. 2023 Jun;199(6):565-573. doi: 10.1007/s00066-023-02044-2. Epub 2023 Feb 9.
Other Identifiers
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DRKS00036292
Identifier Type: REGISTRY
Identifier Source: secondary_id
ARO-2024-3
Identifier Type: -
Identifier Source: org_study_id
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