Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Ms Shama Hassan
ORCID ID
Contact details
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
-
prompts-icrctsu@icr.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13129
Study information
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
Acronym
PROMPTS
Study hypothesis
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
12/LO/1109
Study design
Randomised; Interventional; Design type: Screening
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
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
Phase
Phase III
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/12/2012
Overall trial end date
01/05/2015
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Planned Sample Size: 541; UK Sample Size: 541
Participant 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
Recruitment start date
30/12/2012
Recruitment end date
01/05/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
Sponsor information
Organisation
Institute of Cancer Research Experimental Cancer Medicine Centre
Sponsor details
Cancer Research
123 Old Brompton Road
London
SW7 3RP
United Kingdom
Sponsor type
Research organisation
Website
http://www.ecmcnetwork.org.uk/network-centres/london-institute-cancer-research/
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK) Grant Codes: C8262/A13749
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary