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Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02635256
Recruitment Status : Completed
First Posted : December 18, 2015
Last Update Posted : January 30, 2020
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, who are ineligible for the "PREFERE trial" under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 1 year amounts 2,8% and is significant lower than 17.5%.


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 four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 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 : December 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2019

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: 12-15 months after radiotherapy ]

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

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

Inclusion Criteria:

  • Localised, histopathologically confirmed Prostate Cancer (cT1-3 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:

  • 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): NCT02635256


Locations
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Germany
Saphir Radiosurgery Center Frankfurt am Main
Frankfurt am Main, Germany, 60528
University Hospital Frankfurt, Department of Radiation Therapy and Oncology
Frankfurt am Main, Germany, 60590
Saphir Radiosurgery Center Northern Germany
Güstrow, Germany, 18273
University Medical Center Schleswig-Holstein
Kiel, Germany, 24105
European Cyberknife Center Munich
Munich, Germany, 81377
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
More Information
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Publications:

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Responsible Party: Juergen Dunst, Prof., Prof. Dr. med. Juergen Dunst, University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT02635256    
Other Study ID Numbers: ZKS-121-003
ARO-2016-5 ( Other Identifier: German Cancer Society )
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Keywords provided by Juergen Dunst, Prof., University Hospital Schleswig-Holstein:
hypofractionation
prostate cancer
radiotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases