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Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II) (HYPOSTAT-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03795337
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 25, 2021
Sponsor:
Collaborators:
University of Luebeck
Saphir Radiosurgery Center Northern Germany
Information provided by (Responsible Party):
Juergen Dunst, Prof., University Hospital Schleswig-Holstein

Study Description
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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 (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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Hypofractionated Radiosurgery Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Radiosurgery for Localised Prostate Cancer
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Hypofractionated Radiosurgery
5 fractions with 7 Gy, total dose 35 Gy
 Radiation: Hypofractionated Radiosurgery
Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife


Outcome Measures
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Primary Outcome Measures :
  1. Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score [ Time Frame: 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy ]

Secondary Outcome Measures :
  1. Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports. [ Time Frame: 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy ]
  2. Prostate Specific Antigen (PSA) [ Time Frame: At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy ]
  3. International Prostate Symptom Score (IPSS) [ Time Frame: At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy ]
  4. EORTC Quality of Life Questionnaire (QLQ) C30 [ Time Frame: At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795337


Contacts
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Contact: Juergen Dunst, Prof. +494315973011 ext 3011 Juergen.Dunst@uksh.de
Contact: Oliver Blanck, Dr. +4943123989970 ext 0 blanck@saphir-rc.com

Locations
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Germany
Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK) Recruiting
Berlin, Germany, 13353
Principal Investigator: Arne Grün, Dr.         
Sub-Investigator: David Kaul, Dr.         
University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy Recruiting
Cologne, Germany, 50937
Principal Investigator: Christian Baues, Dr.         
Sub-Investigator: Karolina Jablonska, Dr.         
Saphir Radiosurgery Center Frankfurt am Main Active, not recruiting
Frankfurt am Main, Germany, 60528
University Hospital Frankfurt, Department of Radiation Therapy and Oncology Recruiting
Frankfurt am Main, Germany, 60590
Principal Investigator: Georgios Chatzikonstantinou, Dr.         
Sub-Investigator: Detlef Imhoff, Dr.         
Saphir Radiosurgery Center Northern Germany Active, not recruiting
Kiel, Germany, 24105
University Medical Center Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Principal Investigator: Juergen Dunst, Prof.         
Sub-Investigator: Krug David, Dr.         
Sub-Investigator: Schulz Christian, Dr.         
European Cyberknife Center Munich Recruiting
Munich, Germany, 81377
Principal Investigator: Alexander Muacevic, Prof.         
Sub-Investigator: Alfred Haidenberger, Dr.         
Sub-Investigator: Markus Kufeld, Dr.         
Sponsors and Collaborators
University Hospital Schleswig-Holstein
University of Luebeck
Saphir Radiosurgery Center Northern Germany
Investigators
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Principal Investigator: Juergen Dunst, Prof. University Hospital Schleswig-Holstein
Principal Investigator: Alexander Muacevic, Prof. European CyberKnife Center Munich
More Information
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Responsible Party: Juergen Dunst, Prof., Clinical Professor, Director, Head of Department, University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03795337    
Other Study ID Numbers: ZKS-121-08
ARO-2018-4 ( Other Identifier: German Cancer Society )
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juergen Dunst, Prof., University Hospital Schleswig-Holstein:
Hypofractionation
Prostate Cancer
Radiotherapy
long-term toxicity
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases