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MR (Magnetic Resonance Imaging) - based IGRT (image-guided radiotherapy) for patients with prostate carcinoma.
Single arm, phase II study, MR (Magnetic Resonance Imaging) - based IGRT (Image-guided radiotherapy) of prostate cancer.
Primary endpoint: Grade 2+ GI (gastrointestinal) and genitourinary (GU) toxicity after 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation | Other | IGRT 5x 2Gy/week, total dose: 78 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGRT | Radiation | MR-based IGRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| G2+gastrointestinal and genitourinary toxicity at 2 years | Number of participants with G2+-treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 2 years | Total trial treatment duration: 4 years, Duration for individual patient:Study treatment 9 months, Follow-up: 2 years for primary endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term GU-GI toxicity | Measurement of treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 10 years | 10 years after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arndt-Christian Müller, Dr. | Contact | 497071/2986142 | Arndt-Christian.Mueller@med.uni-tuebingen.de | |
| Daniel Zips, Prof. | Contact | 497071/2982165 | Daniel.Zips@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Arndt-Christian Müller, Dr. | Department of Radiation Oncology, University of Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Müller Arndt-Christian | Recruiting | Tübingen | 72076 | 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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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |