Clinical trial · Interventional
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
NCT06914544CI-TRIAL-00109714HYPOSTAT-IIIrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated Radiosurgery
- description
- 3 fractions with 9.5-10.5 Gy, total dose 28.5-31.5 Gy
- interventionNames
- Radiation: Hypofractionated Radiosurgery
Primary outcomes (1)
- measure
- GU and GI Toxicity
- timeFrame
- 12-15 months after radiotherapy
- description
- Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
Secondary outcomes (5)
- measure
- Acute toxicity
- timeFrame
- Through study completion
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDKrug D, Imhoff D, Haidenberger A, Hessler N, Schafer J, Huttenlocher S, Chatzikonstantinou G, Furweger C, Ramm U, Konig IR, Chun F, Staehler M, Rodel C, Muacevic A, Vonthein R, Dunst J, Blanck O. Robotic stereotactic body radiotherapy for localized prostate cancer: final analysis of the German HYPOSTAT trial. Strahlenther Onkol. 2023 Jun;199(6):565-573. doi: 10.1007/s00066-023-02044-2. Epub 2023 Feb 9. PMID 36757424