Three-fraction prostate radiosurgery for localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective phase II trial testing hypofractionated radiosurgery delivered in three fractions of 9.5–10.5 Gy (total 28.5–31.5 Gy) for patients with localized prostate cancer. Eligible men have cT1–T2c N0 M0 disease, Gleason ≤7 (ISUP 1–3), PSA <20 ng/mL, prostate volume <80 cm³ and IPSS ≤12. Treatment includes baseline assessment, visits on each radiation day, and follow-ups at 4–6 weeks, 3 months, 6 months and 1 year to record acute and late genitourinary and gastrointestinal toxicity. The trial tests the hypothesis that rates of late GU and GI toxicity ≥ grade 2 at one year will be substantially lower than historical rates seen with five-fraction schedules.

Why it matters

Who can join: the full rules

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

Where it's running

• Saphir Radiosurgery Center Frankfurt am Main
  Frankfurt am Main, Hesse, Germany Recruiting
• European Radiosurgery Center Munich
  Munich, Hesse, Germany Recruiting
• University Medical Center Schleswig-Holstein
  Kiel, Schleswig-Holstein, Germany Recruiting
• CyberKnife Centrum Mitteldeutschland
  Erfurt, Thuringia, Germany Recruiting
• University Hospital Frankfurt
  Frankfurt am Main, Hesse, Germany Suspended
• Saphir Radiosurgery Center Norther Germany
  Kiel, Schleswig-Holstein, Germany Active not recruiting

Study contacts

• Principal investigator: David Krug, MD — University Hospital Schleswig-Holstein
• Study coordinator: Oliver Blanck, PhD
• Email: oliver.blanck@uksh.de
• Phone: +4943150026666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.