Clinical trial · Interventional
Hypofractionated Radiosurgery for Localised Prostate Cancer
NCT02635256CI-TRIAL-00075266HYPOSTATcompletedN/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 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, who are ineligible for the "PREFERE trial" under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 1 year amounts 2,8% and is significant lower than 17.5%.
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
- 12-15 months after radiotherapy
Secondary outcomes (4)
- measure
- Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.
- timeFrame
- through study completion
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Localised, histopathologically confirmed Prostate Cancer (cT1-3 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: * 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 (2)
- BACKGROUNDJiang P, Krockenberger K, Vonthein R, Tereszczuk J, Schreiber A, Liebau S, Huttenlocher S, Imhoff D, Balermpas P, Keller C, Dellas K, Baumann R, Rodel C, Hildebrandt G, Junemann KP, Merseburger AS, Katz A, Ziegler A, Blanck O, Dunst J. Hypo-fractionated SBRT for localized prostate cancer: a German bi-center single treatment group feasibility trial. Radiat Oncol. 2017 Aug 18;12(1):138. doi: 10.1186/s13014-017-0872-2. PMID 28821268
- RESULTKrug 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