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| Name | Class |
|---|---|
| University Hospital Schleswig-Holstein | OTHER |
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The aim of the present feasibility study of a new short palliative radiotherapy regime that apply to patients with metastatic hormone refractory prostate cancer (HRPC) presenting with a dominating debilitating symptom. Diffusion weighted magnetic resonance imaging (DWI) will apply to identify both the lesion and the most aggressive part of the lesion. The symptomatic lesions will be treated with a dose of 4 x 5 Gy, while for the most aggressive part of the lesion the dose will be escalated to 4 x 7 Gy using a simultaneous integrated boost (SIB) technique.
Please refer to uploaded Study Protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| feasibilty | Experimental | Palliative Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative radiotherapy | Radiation | Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of study participants that complete the study | Proportion of study participants that complete radiotherapy with ≥ 90% of prescribed dose | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response in dominating symptom score (short form McGill pain Questionnaire) | Patient score symptom/pain using the short form McGill pain Questionnaire version 2 | Baseline, 1,3 and 6 months after radiotherapy |
| Acute radiation toxicity score using CTCAE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Redas Trepiakas, MD | Contact | +45 56 51 3231 | rtr@regionsjaelland.dk | |
| K F E | Contact | + 45 56 51 31 17 | laml@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jesper H Carl, Phd | Oncology, Zealand University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. Radiation Oncology, Zealand University Hospital | Recruiting | Næstved | Region Sjælland | DK-4700 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30630502 | Derived | Carl J, Rades D, Doemer C, Setter C, Dunst J, Hollander NH. Palliative radiotherapy to dominant symptomatic lesion in patients with hormone refractory prostate cancer (PRADO). Radiat Oncol. 2019 Jan 10;14(1):3. doi: 10.1186/s13014-019-1209-0. |
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Defined in Partner Agreement Contract
1. august 2018
Innocan Partners
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2018 | Jul 29, 2018 | Prot_000.pdf |
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Feasibility study
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Doctor score acute radiation toxicity using the CTCAE version 4 |
| Baseline, 1,3 and 6 months after radiotherapy |
| Quality of life score using EORTC QLQ-C30 | Patient fill out EORTC quality of life Questionnaire form C30 | Baseline and 6 months after radiotherapy |
| University Hospital Schleswig-Holstein | Not yet recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
|
| University Hospital Schleswig-Holstein | Not yet recruiting | Lübeck | Schleswig-Holstein | 23538 | Germany |
|