A prospective randomised phase III study of observation versus screening MRI and preemptive treatment in castrate resistant prostate cancer patients with spinal metastasis

Phase 3

Completed

• Conditions: Prostate Cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN74112318
• Lead Sponsor: Institute of Cancer Research Experimental Cancer Medicine Centre

Brief Summary

Results article in https://pubmed.ncbi.nlm.nih.gov/35279270/ (added 14/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-29
• Study Completion: 2015-05-01
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 541

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified