NCT06914544 Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
| NCT ID | NCT06914544 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Schleswig-Holstein |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 175 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 175 participants in total. It began in 2025-12-10 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
David Krug, MD
PRINCIPAL INVESTIGATOR
University Hospital Schleswig-Holstein
Frequently Asked Questions
Who can join the NCT06914544 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06914544 currently recruiting?
Yes, NCT06914544 is actively recruiting participants. Contact the research team at oliver.blanck@uksh.de for enrollment information.
Where is the NCT06914544 trial being conducted?
This trial is being conducted at Frankfurt am Main, Germany, Frankfurt am Main, Germany, Munich, Germany, Kiel, Germany and 2 additional locations.
Who is sponsoring the NCT06914544 clinical trial?
NCT06914544 is sponsored by University Hospital Schleswig-Holstein. The principal investigator is David Krug, MD at University Hospital Schleswig-Holstein. The trial plans to enroll 175 participants.
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