Status:
ACTIVE_NOT_RECRUITING
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)
Lead Sponsor:
University Hospital Schleswig-Holstein
Collaborating Sponsors:
University of Luebeck
Saphir Radiosurgery Center Northern Germany
Conditions:
Prostate Cancer
Eligibility:
MALE
60+ years
Phase:
NA
Brief 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 (to...
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 we...
Eligibility Criteria
Inclusion
- non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 N0 M0
- 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
- Age ≤ 60 years
- 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
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT03795337
Start Date
March 5 2019
End Date
December 31 2025
Last Update
March 20 2024
Active Locations (8)
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1
Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK)
Berlin, Germany, 13353
2
University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy
Cologne, Germany, 50937
3
CyberKnife Centrum Mitteldeutschland
Erfurt, Germany, 99089
4
Saphir Radiosurgery Center Frankfurt am Main
Frankfurt am Main, Germany, 60528