Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT)

March 19, 2024 updated by: Juergen Dunst, Prof., University Hospital Schleswig-Holstein

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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
Time Frame: 12-15 months after radiotherapy
12-15 months after radiotherapy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Collaborators

University of Luebeck
Saphir Radiosurgery Center Northern Germany

Investigators

  • Principal Investigator: Juergen Dunst, Prof., University Hospital Schleswig-Holstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimated)

December 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZKS-121-003
  • ARO-2016-5 (Other Identifier: German Cancer Society)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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