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

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ClinicalTrials.gov Identifier: NCT03795337
Recruitment Status : Not yet recruiting
First Posted : January 7, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborators:
University of Luebeck
Saphir Radiosurgery Center Northern Germany
Information provided by (Responsible Party):
Juergen Dunst, Prof., University of Schleswig-Holstein

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Radiosurgery for Localised Prostate Cancer
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




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 ]


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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

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
Contact: Juergen Dunst, Prof. +494315973011 ext 3011 Juergen.Dunst@uksh.de
Contact: Oliver Blanck, Dr. +49384334599 ext 0 blanck@saphir-rc.com

Locations
Germany
Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK) Not yet 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 Not yet recruiting
Cologne, Germany, 50937
Principal Investigator: Christian Baues, Dr.         
Sub-Investigator: Karolina Jablonska, Dr.         
Saphir Radiosurgery Center Frankfurt am Main Not yet recruiting
Frankfurt am Main, Germany, 60528
Principal Investigator: Christian Keller, Dr.         
Sub-Investigator: Detlef Imhoff, Dr.         
University Hospital Frankfurt, Department of Radiation Therapy and Oncology Not yet recruiting
Frankfurt am Main, Germany, 60590
Principal Investigator: Christian Keller, Dr.         
Sub-Investigator: Detlef Imhoff, Dr.         
Saphir Radiosurgery Center Northern Germany Not yet recruiting
Güstrow, Germany, 18273
Principal Investigator: David Krug, Dr.         
Sub-Investigator: Stefan Wurster, Dr.         
University Medical Center Schleswig-Holstein Not yet recruiting
Kiel, Germany, 24105
Principal Investigator: Juergen Dunst, Prof.         
Sub-Investigator: Krug David, Dr.         
Sub-Investigator: Schulz Christian, Dr.         
Sub-Investigator: Setter Cornelia, Dr.         
European Cyberknife Center Munich Not yet recruiting
Munich, Germany, 81377
Principal Investigator: Alexander Muacevic, Prof.         
Sub-Investigator: Alfred Haidenberger, Dr.         
Sub-Investigator: Markus Kufeld, Dr.         
Sponsors and Collaborators
University of Schleswig-Holstein
University of Luebeck
Saphir Radiosurgery Center Northern Germany
Investigators
Principal Investigator: Juergen Dunst, Prof. University of Schleswig-Holstein
Principal Investigator: Alexander Muacevic, Prof. European CyberKnife Center Munich

Responsible Party: Juergen Dunst, Prof., Clinical Professor, Director, Head of Department, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03795337     History of Changes
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 8, 2019
Last Verified: January 2019

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 of Schleswig-Holstein:
Hypofractionation
Prostate Cancer
Radiotherapy
long-term toxicity

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases