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
Secondary identifying numbers	13129

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

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-mri-scans-pick-up-early-signs-prostate-cancer-pressing-spine-prompts

Contact information

Ms Shama Hassan
Scientific

15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Email	prompts-icrctsu@icr.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Screening
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
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	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	30/12/2012
Completion date	01/05/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	Planned Sample Size: 541; UK Sample Size: 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

England
United Kingdom

Study participating centre

15 Cotswold Road

Sutton
SM2 5NG
United Kingdom

Sponsor information

Institute of Cancer Research Experimental Cancer Medicine Centre
Research organisation

Cancer Research
123 Old Brompton Road
London
SW7 3RP
United Kingdom

Website	http://www.ecmcnetwork.org.uk/network-centres/london-institute-cancer-research/
"ROR"	https://ror.org/043jzw605

Funders

Funder type

Charity

Cancer Research UK (UK) Grant Codes: C8262/A13749
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
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