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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00036292 | Registry Identifier | DRKS - Deutsches Register Klinischer Studien |
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| Name | Class |
|---|---|
| University of Luebeck | OTHER |
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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.
Experimental radiosurgery of the prostate with 3 fractions each with 9.5 -10.5 Gy (total application rate of 28.5-31.5 Gy) based on risk grading.
Planned visits are: Baseline, visits at every radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Radiosurgery | Experimental | 3 fractions with 9.5-10.5 Gy, total dose 28.5-31.5 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiosurgery | Radiation | Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife |
|
| Measure | Description | Time Frame |
|---|---|---|
| GU and GI Toxicity | Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score | 12-15 months after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports | Through study completion |
| PSA | Prostate Specific Antigen (PSA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oliver Blanck, PhD | Contact | +4943150026666 | oliver.blanck@uksh.de | |
| Frauke Walther-Clausnizer | Contact | +4943150026581 | Frauke.Walther-Clausnizer@uksh.de |
| Name | Affiliation | Role |
|---|---|---|
| David Krug, MD | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saphir Radiosurgery Center Frankfurt am Main | Recruiting | Frankfurt am Main | Hesse | 60528 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36757424 | Background | Krug 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy |
| IPSS | International Prostate Symptom Score (IPSS) on a scale 0-35 with lower being better | Screening and 3, 6-9 and 12-15 months after radiotherapy |
| Quality of Life Score | EORTC Quality of Life Questionnaire (QLQ) C30 on a scale 0-100 with higher being better | At the time of inclusion and 12-15 months after radiotherapy |
| Decision Regret Score | Decision Regret Score on a scale 0-100 with lower being lower regret | At the time of inclusion and 12-15 months after radiotherapy |
| University Hospital Frankfurt | Suspended | Frankfurt am Main | Hesse | 60528 | Germany |
| European Radiosurgery Center Munich | Recruiting | Munich | Hesse | 81377 | Germany |
|
| Saphir Radiosurgery Center Norther Germany | Active, not recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
| University Medical Center Schleswig-Holstein | Recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
|
| CyberKnife Centrum Mitteldeutschland | Recruiting | Erfurt | Thuringia | 99089 | Germany |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |