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

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

Hypofractionated Radiosurgery for Localised Prostate Cancer

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.

Study Overview

Status

Active, not recruiting

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 eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter after last day of radiation).

Study Type

Interventional

Enrollment (Actual)

475

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 Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK)
      • Cologne, Germany, 50937
        • University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy
      • Erfurt, Germany, 99089
        • CyberKnife Centrum Mitteldeutschland
      • 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
      • Kiel, Germany, 24105
        • University Medical Center Schleswig-Holstein
      • Kiel, Germany, 24105
        • Saphir Radiosurgery Center Northern Germany
      • 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

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy
3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
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
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
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
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
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
At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years 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
  • Principal Investigator: Alexander Muacevic, Prof., European Cyberknife Center Munich

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)

March 5, 2019

Primary Completion (Actual)

March 4, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

January 4, 2019

First Posted (Actual)

January 7, 2019

Study Record Updates

Last Update Posted (Actual)

March 20, 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-121-08
  • ARO-2018-4 (Other Identifier: German Cancer Society)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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