Prostate Cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
Control Group: Patients followed up as per standard practice i.e. in accordance with National Institute of Clinical Excellence (NICE) guidelines, MRI spine performed if patient develops clinical neuro
following pre-emptive treatment patients will receive an MRI scan every 6 months (rSCC is defined as radiological spinal cord compromise).
Sponsors
Institute of Cancer Research Experimental Cancer Medicine Centre
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically / cytologically confirmed adenocarcinoma of the prostate or clinical diagnosis of prostate cancer with osteoblastic bone metastases and Prostate-specific antigen (PSA) = 100ng/ml 2. Castrate resistant disease* 3. One or more spinal metastasis on imaging (technetium bone scan with confirmatory X-ay as appropriate clinically) undertaken at any time during the patient?s illness 4. Life expectancy of 6 months or more 5. Eastern Cooperative Oncology Group (ECOG) performance status 02 6. Written, informed consent *(rising PSA (> 5 ng /ml and >50% rise from nadir) after luteinizing hormone releasing hormone agonist (LHRHa) therapy or orchidectomy with or without antiandrogen)
Exclusion criteria
Exclusion criteria: 1. Back pain related to metastatic cancer, requiring regular (daily) analgesics 2. Previous active malignancy within the last 5 years other than basal cell carcinoma or low grade superficial bladder cancer 3. Current or previous spinal cord compression (SCC) or neurologic deficit 4. Brain metastasis 5. Spinal MRI within last 12 months 6. CT or PET CT scan of thorax AND abdomen within the last 6 months 7. Previous external beam radiotherapy to the vertebra or spinal surgery with the primary aim to prevent or treat SCC+ 8. Serious or uncontrolled coexistent non-malignant diseases 9. Any contra indications for MRI 10. Inability to comply with neurologic and Quality of Life (QoL) assessments 11. Previous palliative radiotherapy to painful spinal metastases in now asymptomatic patients is permissible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
England, United Kingdom
Outcome results
None listed