Clinical trial · Interventional
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)
Hypofractionated Radiosurgery for Localised Prostate Cancer
- 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 has been investigated in a few trials and appears to be safe and feasible. Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% 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
- 5 fractions with 7 Gy, total dose 35 Gy
- interventionNames
- Radiation: Hypofractionated Radiosurgery
Primary outcomes (1)
- measure
- Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
- timeFrame
- 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy
Secondary outcomes (4)
- measure
- Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.
- timeFrame
- 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 N0 M0 * Gleason-grade ≤7 * Guideline-based staging * Age ≥ 60 years * PSA \< 15 ng / ml * Volume of the prostate \< 80 cm³ * IPSS-Score ≤ 12 * Written informed consent Exclusion Criteria: * Age ≤ 60 years * History of prior pelvic radiotherapy * Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold), * Immunosuppressive therapy * Relevant comorbidity thought to adversely affect treatment compliance, * Legal incapacity or lack of informed consent
References
Publications (0)
Data not yet available