A prospective randomised phase III study of observation versus screening MRI and pre-emptive treatment in castrate resistant prostate cancer patients with spinal metastasis.
Disease site: Prostate cancer, urological cancers
Intervention and treatment: MRI scan, followed by pre-emptive radiotherapy and/or surgery if needed
PROMPTS is a prospective, randomised, phase III, interventional study to determine whether detection of radiological spinal cord compression (SCC) using screening MRI of the spine and pre-emptive treatment could reduce the incidence of clinical SCC in asymptomatic castrate resistant prostate cancer patients with spinal metastasis.
541 patients will be recruited from UK sites over a 2–3 year period and randomised into one of two groups. Patients in the intervention group will receive a baseline screening MRI and pre-emptive treatment to any sites of radiological SCC; following the pre-emptive treatment, patients will receive an MRI scan every 6 months. Patients in the control group will be followed up as per standard practice. All participants will be followed up for a further 3 years.
Chief Investigator: Professor David Dearnaley, The Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific Lead: Dr Emma Hall
Trial management contact: [email protected]
Sponsor: The Institute of Cancer Research
Funding: Cancer Research UK (CRUK/11/053)
View PROMPTS on the National Institute for Health Research website: NIHR - Be Part Of Research
Patient friendly information is available from Cancer Research UK.
Publications and presentations
Dearnaley D, Hinder V, Hijab A, Horan G, Srihari N, Rich P, Houston GJ, Henry AM, Gibbs S, Venkitaraman R, Crickshank C, Hassan S, Miners A, Mason M, Pedley I, Payne H, Brock S, Wade R, Robinson A, Din O, Lees K, Graham J, Worlding J, Murray J, Parker C, Griffin C, Sohaib A, Hall E on behalf of the PROMPTS investigators. Observation versus screening spinal MRI and pre-emptive treatment for spinal cord compression in patients with castration-resistant prostate cancer and spinal metastases in the UK (PROMPTS): an open-label, randomised, controlled, phase 3 trial. Lancet Oncol 2022; 23: 501-513