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

Primary Purpose

Prostate Cancer

Status
Recruiting
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, long-term toxicity

Eligibility Criteria

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

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

Sites / Locations

  • Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK)Recruiting
  • University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and RadiotherapyRecruiting
  • Saphir Radiosurgery Center Frankfurt am Main
  • University Hospital Frankfurt, Department of Radiation Therapy and OncologyRecruiting
  • Saphir Radiosurgery Center Northern Germany
  • University Medical Center Schleswig-HolsteinRecruiting
  • European Cyberknife Center MunichRecruiting

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 19, 2018
Last Updated
March 31, 2022
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
NCT03795337
Brief Title
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)
Acronym
HYPOSTAT-II
Official Title
Hypofractionated Radiosurgery for Localised Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

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

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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 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.
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).

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, long-term toxicity

7. Study Design

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

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
3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juergen Dunst, Prof.
Phone
+494315973011
Ext
3011
Email
Juergen.Dunst@uksh.de
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Blanck, Dr.
Phone
+4943123989970
Ext
0
Email
blanck@saphir-rc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juergen Dunst, Prof.
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Muacevic, Prof.
Organizational Affiliation
European CyberKnife Center Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arne Grün, Dr.
First Name & Middle Initial & Last Name & Degree
David Kaul, Dr.
Facility Name
University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Baues, Dr.
First Name & Middle Initial & Last Name & Degree
Karolina Jablonska, Dr.
Facility Name
Saphir Radiosurgery Center Frankfurt am Main
City
Frankfurt am Main
ZIP/Postal Code
60528
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Frankfurt, Department of Radiation Therapy and Oncology
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgios Chatzikonstantinou, Dr.
First Name & Middle Initial & Last Name & Degree
Detlef Imhoff, Dr.
Facility Name
Saphir Radiosurgery Center Northern Germany
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
University Medical Center Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juergen Dunst, Prof.
First Name & Middle Initial & Last Name & Degree
Krug David, Dr.
First Name & Middle Initial & Last Name & Degree
Schulz Christian, Dr.
Facility Name
European Cyberknife Center Munich
City
Munich
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Muacevic, Prof.
First Name & Middle Initial & Last Name & Degree
Alfred Haidenberger, Dr.
First Name & Middle Initial & Last Name & Degree
Markus Kufeld, Dr.

12. IPD Sharing Statement

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Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)

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