Hormone-refractory Prostate Cancer
Conditions
Brief summary
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
Please refer to uploaded Study Protocol
Interventions
RADIATIONPalliative radiotherapy
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
Sponsors
University Hospital Schleswig-Holstein
Zealand University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Feasibility study
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with hormone refractory biopsy proven prostate cancer 2. Presenting with a dominating debilitating symptom 3. Expected median survival of 12 months 4. Focal irradiation of lesion is feasible 5. Systemic therapy according to guidelines 6. age ≥18 years 7. Legal capacity, able to understand consequences of the trial 8. Written informed consent
Exclusion criteria
1. Relevant comorbidity (limiting radiotherapy according to protocol) 2. Prior radiotherapy limitations to administer radiotherapy according to protocol 3. No large metal implants in vicinity of lesion 4. Department dose constraints for normal tissue can't be met 5. Large bony lesions with extensive osseous destruction 6. Patients symptoms do not correlate with MR findings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of study participants that complete the study | 6 months | Proportion of study participants that complete radiotherapy with ≥ 90% of prescribed dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response in dominating symptom score (short form McGill pain Questionnaire) | Baseline, 1,3 and 6 months after radiotherapy | Patient score symptom/pain using the short form McGill pain Questionnaire version 2 |
| Acute radiation toxicity score using CTCAE | Baseline, 1,3 and 6 months after radiotherapy | Doctor score acute radiation toxicity using the CTCAE version 4 |
| Quality of life score using EORTC QLQ-C30 | Baseline and 6 months after radiotherapy | Patient fill out EORTC quality of life Questionnaire form C30 |
Countries
Denmark, Germany
Contacts
Primary ContactRedas Trepiakas, MD
Backup ContactK F E
Outcome results
None listed