Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ARO-2018-4 | Other Identifier | German Cancer Society |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Luebeck | OTHER |
| Saphir Radiosurgery Center Northern Germany | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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 eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter after last day of radiation).
Not provided
Not provided
Not provided
Not provided
| 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 | 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports. | 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy | |
| Prostate Specific Antigen (PSA) | At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juergen Dunst, Prof. | University Hospital Schleswig-Holstein | Principal Investigator |
| Alexander Muacevic, Prof. | European CyberKnife Center Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK) | Berlin | 13353 | Germany | |||
| University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| International Prostate Symptom Score (IPSS) | At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy |
| EORTC Quality of Life Questionnaire (QLQ) C30 | At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy |
| Cologne |
| 50937 |
| Germany |
| CyberKnife Centrum Mitteldeutschland | Erfurt | 99089 | Germany |
| Saphir Radiosurgery Center Frankfurt am Main | Frankfurt am Main | 60528 | Germany |
| University Hospital Frankfurt, Department of Radiation Therapy and Oncology | Frankfurt am Main | 60590 | Germany |
| Saphir Radiosurgery Center Northern Germany | Kiel | 24105 | Germany |
| University Medical Center Schleswig-Holstein | Kiel | 24105 | Germany |
| European Cyberknife Center Munich | Munich | 81377 | Germany |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |