Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Please refer to uploaded Study Protocol

Official Title
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Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer

Conditions
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Hormone-refractory Prostate Cancer

Intervention / Treatment
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* Radiation: Palliative radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hormone refractory biopsy proven prostate cancer Presenting with a dominating debilitating symptom Expected median survival of 12 months Focal irradiation of lesion is feasible Systemic therapy according to guidelines age ≥18 years Legal capacity, able to understand consequences of the trial Written informed consent Exclusion Criteria: Relevant comorbidity (limiting radiotherapy according to protocol) Prior radiotherapy limitations to administer radiotherapy according to protocol No large metal implants in vicinity of lesion Department dose constraints for normal tissue can't be met Large bony lesions with extensive osseous destruction Patients symptoms do not correlate with MR findings

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: feasibilty<br>Palliative Radiotherapy | Radiation: Palliative radiotherapy<br>* Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer<br>* Other names: PRADO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |