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NCT Number: NCT06914544

Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Saphir Radiosurgery Center Frankfurt am Main, Frankfurt am Main, Hesse, Germany

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About this study

Experimental radiosurgery of the prostate with 3 fractions each with 9.5 -10.5 Gy (total application rate of 28.5-31.5 Gy) based on risk grading.

Planned visits are: Baseline, visits at every radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Hypofractionated Radiosurgery

Radiation

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

Primary outcomes

  1. GU and GI Toxicity

    Time frame: 12-15 months after radiotherapy

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

Secondary outcomes

  1. Acute toxicity

    Time frame: Through study completion

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

  2. PSA

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

    Prostate Specific Antigen (PSA)

  3. IPSS

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

    International Prostate Symptom Score (IPSS) on a scale 0-35 with lower being better

  4. Quality of Life Score

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

    EORTC Quality of Life Questionnaire (QLQ) C30 on a scale 0-100 with higher being better

  5. Decision Regret Score

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

    Decision Regret Score on a scale 0-100 with lower being lower regret

Study contacts

Contact information is provided by the study sponsor or research team.

Frauke Walther-Clausnizer

CONTACT

[email protected]

+4943150026581

Oliver Blanck, PhD

CONTACT

[email protected]

+4943150026666

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • University of Luebeck

Registry information

Acronym: HYPOSTAT-III

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 6, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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