A prospective randomised phase III study of observation versus screening MRI and preemptive treatment in castrate resistant prostate cancer patients with spinal metastasis
| ISRCTN | ISRCTN74112318 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74112318 |
| Protocol serial number | 13129 |
| Sponsor | Institute of Cancer Research Experimental Cancer Medicine Centre |
| Funder | Cancer Research UK (UK) Grant Codes: C8262/A13749 |
- Submission date
- 28/11/2012
- Registration date
- 29/11/2012
- Last edited
- 14/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Shama Hassan
Scientific
Scientific
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
| prompts-icrctsu@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Screening |
| Secondary study design | Randomised controlled trial |
| Scientific title | A prospective randomised phase III study of observation versus screening MRI and preemptive treatment in castrate resistant prostate cancer patients with spinal metastasis |
| Study acronym | PROMPTS |
| Study objectives | Does detection of radiological spinal cord compression (rSCC) by screening magnetic resonance imaging (MRI) of the spine and pre-emptive treatment reduce the incidence of clinical spinal cord compression (SCC) in asymptomatic castrate resistant prostate cancer (CRPC) patients with spinal metastasis? More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13129 |
| Ethics approval(s) | 12/LO/1109 |
| Health condition(s) or problem(s) studied | Prostate Cancer |
| Intervention | 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 neurological deficit or significant spinal pain with treatment given if there is overt SCC on MRI. Intervention Group, Baseline screening MRI and pre-emptive treatment to sites of radiological (r) SCC; following pre-emptive treatment patients will receive an MRI scan every 6 months (rSCC is defined as radiological spinal cord compromise). |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 541 |
| Key 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 patients 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) |
| Key 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 |
| Date of first enrolment | 30/12/2012 |
| Date of final enrolment | 01/05/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/03/2022 | Yes | No |
Editorial Notes
14/03/2022: Publication reference added.
24/07/2020: No publications found.
14/05/2018: No publications found, verifying study status with principal investigator.
10/02/2016: No publications found, verifying study status with principal investigator
