Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)
NCT ID: NCT03795337
Last Updated: 2024-03-20
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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ACTIVE_NOT_RECRUITING
NA
475 participants
INTERVENTIONAL
2019-03-05
2025-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hypofractionated Radiosurgery
5 fractions with 7 Gy, total dose 35 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
* Guideline-based staging
* Age ≥ 60 years
* PSA \< 15 ng / ml
* Volume of the prostate \< 80 cm³
* IPSS-Score ≤ 12
* Written informed consent
Exclusion Criteria
* History of prior pelvic radiotherapy
* Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold),
* Immunosuppressive therapy
* Relevant comorbidity thought to adversely affect treatment compliance,
* Legal incapacity or lack of informed consent
60 Years
MALE
No
Sponsors
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University of Luebeck
OTHER
Saphir Radiosurgery Center Northern Germany
UNKNOWN
University Hospital Schleswig-Holstein
OTHER
Responsible Party
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Juergen Dunst, Prof.
Clinical Professor, Director, Head of Department
Principal Investigators
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Juergen Dunst, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Schleswig-Holstein
Alexander Muacevic, Prof.
Role: PRINCIPAL_INVESTIGATOR
European CyberKnife Center Munich
Locations
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Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK)
Berlin, , Germany
University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy
Cologne, , Germany
CyberKnife Centrum Mitteldeutschland
Erfurt, , Germany
Saphir Radiosurgery Center Frankfurt am Main
Frankfurt am Main, , Germany
University Hospital Frankfurt, Department of Radiation Therapy and Oncology
Frankfurt am Main, , Germany
Saphir Radiosurgery Center Northern Germany
Kiel, , Germany
University Medical Center Schleswig-Holstein
Kiel, , Germany
European Cyberknife Center Munich
Munich, , Germany
Countries
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Other Identifiers
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ARO-2018-4
Identifier Type: OTHER
Identifier Source: secondary_id
ZKS-121-08
Identifier Type: -
Identifier Source: org_study_id
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