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| ID | Type | Description | Link |
|---|---|---|---|
| ARO-2016-5 | Other Identifier | German Cancer Society |
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| Name | Class |
|---|---|
| University of Luebeck | OTHER |
| Saphir Radiosurgery Center Northern Germany | UNKNOWN |
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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%.
Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy).
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 | 5 fractions with 7 Gy, total dose 35 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 |
|---|---|---|
| Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score | 12-15 months after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports. | through study completion | |
| Prostate Specific Antigen (PSA) | At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juergen Dunst, Prof. | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saphir Radiosurgery Center Frankfurt am Main | Frankfurt am Main | 60528 | Germany | |||
| University Hospital Frankfurt, Department of Radiation Therapy and Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28821268 | Background | Jiang 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. | |
| 36757424 |
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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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| International Prostate Symptom Score (IPSS) | Screening and 3, 6-9 and 12-15 months after radiotherapy |
| EORTC Quality of Life Questionnaire (QLQ) C30 | At the time of inclusion and 12-15 months after radiotherapy |
| Frankfurt am Main |
| 60590 |
| Germany |
| Saphir Radiosurgery Center Northern Germany | Güstrow | 18273 | Germany |
| University Medical Center Schleswig-Holstein | Kiel | 24105 | Germany |
| European Cyberknife Center Munich | Munich | 81377 | Germany |
| Result |
| 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |