NCT06914544

Brief Summary

Hypofractionated radiosurgery with 5 fractions is considered standard of care for localized prostate cancer. The investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 3 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late GU and GI toxicity ≥ grade 2 after 1 year amounts to 8.4% and 1.3% and is significant lower than 16.4% and 5.7% currently.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
44mo left

Started Dec 2025

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

6 active sites

Status
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

Study Progress10%
Dec 2025Dec 2029

First Submitted

Initial submission to the registry

March 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

March 31, 2025

Last Update Submit

April 28, 2026

Conditions

Prostate Cancer

Keywords

Prostate CancerSBRTCyberKnifeRadiosurgeryHYPOSTAT

Outcome Measures

Primary Outcomes (1)

  • GU and GI Toxicity

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

    12-15 months after radiotherapy

Secondary Outcomes (5)

  • Acute toxicity

    Through study completion

  • PSA

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

  • IPSS

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

  • Quality of Life Score

    At the time of inclusion and 12-15 months after radiotherapy

  • Decision Regret Score

    At the time of inclusion and 12-15 months after radiotherapy

Study Arms (1)

Hypofractionated Radiosurgery

EXPERIMENTAL

3 fractions with 9.5-10.5 Gy, total dose 28.5-31.5 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

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Localised, histopathologically confirmed Prostate Cancer (cT1-T2c N0 M0)
  • Gleason-grade ≤7, ISUP Grade Group 1-3
  • Guideline-based staging
  • Age ≥ 18 years
  • PSA \< 20 ng/ml
  • Volume of the prostate \< 80 cm³
  • IPSS-Score ≤ 12
  • Written informed consent

You may not qualify if:

  • History of prior pelvic radiotherapy
  • Previous transurethral resection, laser enucleation or prostate ablation
  • Contraindication to MRI or Fiducial marker implantation (e.g. gold allergy)
  • 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 (6)

Saphir Radiosurgery Center Frankfurt am Main

Frankfurt am Main, Hesse, 60528, Germany

RECRUITING

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60528, Germany

SUSPENDED

European Radiosurgery Center Munich

Munich, Hesse, 81377, Germany

RECRUITING

Saphir Radiosurgery Center Norther Germany

Kiel, Schleswig-Holstein, 24105, Germany

ACTIVE NOT RECRUITING

University Medical Center Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

CyberKnife Centrum Mitteldeutschland

Erfurt, Thuringia, 99089, Germany

RECRUITING

Related Publications (1)

  • 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: 36757424BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • David Krug, MD

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Blanck, PhD

CONTACT

+4943150026666oliver.blanck@uksh.de

Frauke Walther-Clausnizer

CONTACT

+4943150026581Frauke.Walther-Clausnizer@uksh.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 6, 2025

Study Start

December 10, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

DE(6)