NCT03795337

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
475

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 5, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2024

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

5 years

First QC Date

December 19, 2018

Last Update Submit

March 19, 2024

Conditions

Prostate Cancer

Keywords

HypofractionationProstate CancerRadiotherapylong-term toxicity

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (4)

  • Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.

    4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy

  • Prostate Specific Antigen (PSA)

    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)

    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

    At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy

Study Arms (1)

Hypofractionated Radiosurgery

EXPERIMENTAL

5 fractions with 7 Gy, total dose 35 Gy

Radiation: Hypofractionated Radiosurgery

Interventions

Hypofractionated RadiosurgeryRADIATION

Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife

Hypofractionated Radiosurgery

Eligibility Criteria

Age60 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK)

Berlin, 13353, Germany

Location

University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy

Cologne, 50937, Germany

Location

CyberKnife Centrum Mitteldeutschland

Erfurt, 99089, Germany

Location

Saphir Radiosurgery Center Frankfurt am Main

Frankfurt am Main, 60528, Germany

Location

University Hospital Frankfurt, Department of Radiation Therapy and Oncology

Frankfurt am Main, 60590, Germany

Location

Saphir Radiosurgery Center Northern Germany

Kiel, 24105, Germany

Location

University Medical Center Schleswig-Holstein

Kiel, 24105, Germany

Location

European Cyberknife Center Munich

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Juergen Dunst, Prof.

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

  • Alexander Muacevic, Prof.

    European CyberKnife Center Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Director, Head of Department

Study Record Dates

First Submitted

December 19, 2018

First Posted

January 7, 2019

Study Start

March 5, 2019

Primary Completion

March 4, 2024

Study Completion

December 31, 2025

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations

DE(8)