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| Name | Class |
|---|---|
| Klinikum Stuttgart | OTHER |
| University Medical Center Göttingen | UNKNOWN |
| Kantonsspital Aarau | OTHER |
| Hirslanden Stephanshorn |
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In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving ultrahypofractionated radiotherapy | |||
| Retrospective reference cohort | reference cohort of patients who underwent normofractionated radiotherapy or moderately hypofractionated radiotherapy earlier. matching 1:1:1 by tumor stage and risk profile (d'Amico) |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (EPIC 26) | Expanded Prostate Cancer Index Composite 26 (questionnaire) | longitudinally: before + during RT and during follow up (5 years, at least bi-annually) |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity (CTCAE v5.0) | Common Terminology Criteria for Adverse Events v5.0 | longitudinally: before + during RT and during follow up (5 years, at least bi-annually) |
| Planning parameters | Dose constraints per organ, Conformity Indices, Quality of adaptive planning |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klaus Pietschmann, MD. MBa. LLM. | Contact | 00 - 49 03641 - 9-328401 | strahlentherapie@med.uni-jena.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiotherapy and Radiation Oncology, Jena University Hospital | Recruiting | Jena | Germany |
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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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| UNKNOWN |
| Radiologische Allianz Hamburg | UNKNOWN |
| University Hospital Freiburg | OTHER |
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| for every fraction, total: 5x (1 week) |
| Dose constraints | Dose constraints for organs at risk and target volumes per fraction | for every fraction, total: 5x (1 week) |
| Conformity indices | Conformity indices for target volumes, per fraction | for every fraction, total: 5x (1 week) |
| Quality of adaptive planning | Semi-quantitative score to evaluate the quality of the adaptive plan and if revisions would be required | for every fraction, total: 5x (1 week) |
| PSA-value | endpoint: Prostate-specific antigene (PSA)-recurrence free survival | longitudinally: before + during RT and during follow up (5 years, at least bi-annually) |
| Overall survival | 5 Years |
| Recurrence free survival | 5 Years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |