Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)

Last updated: March 19, 2024
Sponsor: University Hospital Schleswig-Holstein
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Urologic Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

Hypofractionated Radiosurgery

Clinical Study ID

NCT03795337
ZKS-121-08
ARO-2018-4
  • Ages > 60
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 475
Treatment Group(s): 1
Primary Treatment: Hypofractionated Radiosurgery
Phase:
Study Start date:
March 05, 2019
Estimated Completion Date:
December 31, 2025

Study 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).

Connect with a study center

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

    Berlin, 13353
    Germany

    Site Not Available

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

    Cologne, 50937
    Germany

    Site Not Available

  • CyberKnife Centrum Mitteldeutschland

    Erfurt, 99089
    Germany

    Site Not Available

  • Saphir Radiosurgery Center Frankfurt am Main

    Frankfurt am Main, 60528
    Germany

    Site Not Available

  • University Hospital Frankfurt, Department of Radiation Therapy and Oncology

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • Saphir Radiosurgery Center Northern Germany

    Güstrow, 18273
    Germany

    Site Not Available

  • Saphir Radiosurgery Center Northern Germany

    Kiel, 24105
    Germany

    Site Not Available

  • University Medical Center Schleswig-Holstein

    Kiel, 24105
    Germany

    Site Not Available

  • European Cyberknife Center Munich

    Munich, 81377
    Germany

    Site Not Available

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