Three-fraction prostate radiosurgery for localized prostate cancer
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
This trial will test whether giving prostate radiosurgery in three high-dose sessions is safe and causes fewer late urinary and bowel side effects for men with localized, low- to intermediate-risk prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital Schleswig-Holstein Academic / other |
| Drugs / interventions | radiation |
| Locations | 6 sites (Frankfurt am Main, Hesse and 5 other locations) |
| Trial ID | NCT06914544 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men aged 18 or older with localized (cT1–T2c N0 M0) prostate cancer, Gleason ≤7 (ISUP 1–3), PSA <20 ng/mL, prostate volume <80 cm³, IPSS ≤12, and who can undergo MRI and fiducial placement are ideal candidates.
Not a fit: Patients with prior pelvic radiotherapy, prior transurethral prostate surgery or ablation, contraindications to MRI or fiducial markers, significant comorbidity affecting compliance, or high-risk/advanced disease are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce late urinary and bowel side effects and shorten the overall treatment course to three visits, improving convenience for patients.
How similar studies have performed: Five-fraction SBRT is an established option for localized prostate cancer, while three-fraction radiosurgery has appeared in smaller series and early trials but is not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Frankfurt am Main, Hesse and 5 other locations
- Saphir Radiosurgery Center Frankfurt am Main — Frankfurt am Main, Hesse, Germany (Recruiting)
- University Hospital Frankfurt — Frankfurt am Main, Hesse, Germany (Suspended)
- European Radiosurgery Center Munich — Munich, Hesse, Germany (Recruiting)
- Saphir Radiosurgery Center Norther Germany — Kiel, Schleswig-Holstein, Germany (Active_not_recruiting)
- University Medical Center Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany (Recruiting)
- CyberKnife Centrum Mitteldeutschland — Erfurt, Thuringia, Germany (Recruiting)
Study contacts
- Principal investigator: David Krug, MD — University Hospital Schleswig-Holstein
- Study coordinator: Oliver Blanck, PhD
- Email: oliver.blanck@uksh.de
- Phone: +4943150026666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.