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Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hypofractionated Radiosurgery
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring hypofractionation, prostate cancer, radiotherapy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Saphir Radiosurgery Center Frankfurt am Main
  • University Hospital Frankfurt, Department of Radiation Therapy and Oncology
  • Saphir Radiosurgery Center Northern Germany
  • University Medical Center Schleswig-Holstein
  • European Cyberknife Center Munich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypofractionated Radiosurgery

Arm Description

5 fractions with 7 Gy, total dose 35 Gy

Outcomes

Primary Outcome Measures

Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score

Secondary Outcome Measures

Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.
Prostate Specific Antigen (PSA)
International Prostate Symptom Score (IPSS)
EORTC Quality of Life Questionnaire (QLQ) C30

Full Information

First Posted
December 8, 2015
Last Updated
January 29, 2020
Sponsor
University Hospital Schleswig-Holstein
Collaborators
University of Luebeck, Saphir Radiosurgery Center Northern Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02635256
Brief Title
Hypofractionated Radiosurgery for Localised Prostate Cancer
Acronym
HYPOSTAT
Official Title
Hypofractionated Radiosurgery for Localised Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
Collaborators
University of Luebeck, Saphir Radiosurgery Center Northern Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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%.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
hypofractionation, prostate cancer, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypofractionated Radiosurgery
Arm Type
Experimental
Arm Description
5 fractions with 7 Gy, total dose 35 Gy
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Radiosurgery
Intervention Description
Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife
Primary Outcome Measure Information:
Title
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
Time Frame
12-15 months after radiotherapy
Secondary Outcome Measure Information:
Title
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.
Time Frame
through study completion
Title
Prostate Specific Antigen (PSA)
Time Frame
At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy
Title
International Prostate Symptom Score (IPSS)
Time Frame
Screening and 3, 6-9 and 12-15 months after radiotherapy
Title
EORTC Quality of Life Questionnaire (QLQ) C30
Time Frame
At the time of inclusion and 12-15 months after radiotherapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juergen Dunst, Prof.
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saphir Radiosurgery Center Frankfurt am Main
City
Frankfurt am Main
ZIP/Postal Code
60528
Country
Germany
Facility Name
University Hospital Frankfurt, Department of Radiation Therapy and Oncology
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Saphir Radiosurgery Center Northern Germany
City
Güstrow
ZIP/Postal Code
18273
Country
Germany
Facility Name
University Medical Center Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
European Cyberknife Center Munich
City
Munich
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28821268
Citation
Jiang P, Krockenberger K, Vonthein R, Tereszczuk J, Schreiber A, Liebau S, Huttenlocher S, Imhoff D, Balermpas P, Keller C, Dellas K, Baumann R, Rodel C, Hildebrandt G, Junemann KP, Merseburger AS, Katz A, Ziegler A, Blanck O, Dunst J. Hypo-fractionated SBRT for localized prostate cancer: a German bi-center single treatment group feasibility trial. Radiat Oncol. 2017 Aug 18;12(1):138. doi: 10.1186/s13014-017-0872-2.
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Hypofractionated Radiosurgery for Localised Prostate Cancer

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