NCT02635256

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%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

5 active sites

Status
completed

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

Study Start

First participant enrolled

December 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

3.1 years

First QC Date

December 8, 2015

Last Update Submit

March 19, 2024

Conditions

Prostate Cancer

Keywords

hypofractionationprostate cancerradiotherapy

Outcome Measures

Primary Outcomes (1)

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

    12-15 months after radiotherapy

Secondary Outcomes (4)

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

    through study completion

  • Prostate Specific Antigen (PSA)

    At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy

  • International Prostate Symptom Score (IPSS)

    Screening and 3, 6-9 and 12-15 months after radiotherapy

  • EORTC Quality of Life Questionnaire (QLQ) C30

    At the time of inclusion and 12-15 months 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
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 (5)

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

Güstrow, 18273, Germany

Location

University Medical Center Schleswig-Holstein

Kiel, 24105, Germany

Location

European Cyberknife Center Munich

Munich, 81377, Germany

Location

Related Publications (2)

  • 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.

    PMID: 28821268BACKGROUND

  • Krug D, Imhoff D, Haidenberger A, Hessler N, Schafer J, Huttenlocher S, Chatzikonstantinou G, Furweger C, Ramm U, Konig IR, Chun F, Staehler M, Rodel C, Muacevic A, Vonthein R, Dunst J, Blanck O. Robotic stereotactic body radiotherapy for localized prostate cancer: final analysis of the German HYPOSTAT trial. Strahlenther Onkol. 2023 Jun;199(6):565-573. doi: 10.1007/s00066-023-02044-2. Epub 2023 Feb 9.

    PMID: 36757424RESULT

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

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
Prof. Dr. med. Juergen Dunst

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 18, 2015

Study Start

December 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations

DE(5)