Radiotherapy to the prostate for men with metastatic prostate cancer in the UK and Switzerland: Long-term results from the STAMPEDE randomised controlled trial

Parker, C. C. et al. (2022) Radiotherapy to the prostate for men with metastatic prostate cancer in the UK and Switzerland: Long-term results from the STAMPEDE randomised controlled trial. PLoS Medicine, 19(6), e1003998. (doi: 10.1371/journal.pmed.1003998) (PMID:35671327) (PMCID:PMC9173627)

Abstract

Background: STAMPEDE has previously reported that radiotherapy (RT) to the prostate improved overall survival (OS) for patients with newly diagnosed prostate cancer with low metastatic burden, but not those with high-burden disease. In this final analysis, we report long-term findings on the primary outcome measure of OS and on the secondary outcome measures of symptomatic local events, RT toxicity events, and quality of life (QoL). Methods and findings: Patients were randomised at secondary care sites in the United Kingdom and Switzerland between January 2013 and September 2016, with 1:1 stratified allocation: 1,029 to standard of care (SOC) and 1,032 to SOC+RT. No masking of the treatment allocation was employed. A total of 1,939 had metastatic burden classifiable, with 42% low burden and 58% high burden, balanced by treatment allocation. Intention-to-treat (ITT) analyses used Cox regression and flexible parametric models (FPMs), adjusted for stratification factors age, nodal involvement, the World Health Organization (WHO) performance status, regular aspirin or nonsteroidal anti-inflammatory drug (NSAID) use, and planned docetaxel use. QoL in the first 2 years on trial was assessed using prospectively collected patient responses to QLQ-30 questionnaire. Patients were followed for a median of 61.3 months. Prostate RT improved OS in patients with low, but not high, metastatic burden (respectively: 202 deaths in SOC versus 156 in SOC+RT, hazard ratio (HR) = 0·64, 95% CI 0.52, 0.79, p < 0.001; 375 SOC versus 386 SOC+RT, HR = 1.11, 95% CI 0.96, 1.28, p = 0·164; interaction p < 0.001). No evidence of difference in time to symptomatic local events was found. There was no evidence of difference in Global QoL or QLQ-30 Summary Score. Long-term urinary toxicity of grade 3 or worse was reported for 10 SOC and 10 SOC+RT; long-term bowel toxicity of grade 3 or worse was reported for 15 and 11, respectively. Conclusions: Prostate RT improves OS, without detriment in QoL, in men with low-burden, newly diagnosed, metastatic prostate cancer, indicating that it should be recommended as a SOC. Trial registration: ClinicalTrials.gov NCT00268476, ISRCTN.com ISRCTN78818544.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Russell, Dr Martin and Jones, Professor Robert

Creator Roles

Jones, R.: Data curation, Investigation, Supervision
Russell, M.: Data curation, Investigation, Writing – review and editing

• Authors: Parker, C. C., James, N. D., Brawley, C. D., Clarke, N. W., Ali, A., Amos, C. L., Attard, G., Chowdhury, S., Cook, A., Cross, W., Dearnaley, D. P., Douis, H., Gilbert, D. C., Gilson, C., Gillessen, S., Hoyle, A., Jones, R. J., Langley, R. E., Malik, Z. I., Mason, M. D., Matheson, D., Millman, R., Rauchenberger, M., Rush, H., Russell, J. M., Sweeney, H., Bahl, A., Birtle, A., Capaldi, L., Din, O., Ford, D., Gale, J., Henry, A., Hoskin, P., Kagzi, M., Lydon, A., O’Sullivan, J. M., Paisey, S. A., Parikh, O., Pudney, D., Ramani, V., Robson, P., Srihari, N. N., Tanguay, J., Parmar, M. K. B., and Sydes, M. R.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences
• Journal Name: PLoS Medicine
• Publisher: Public Library of Science
• ISSN: 1549-1277
• ISSN (Online): 1549-1676
• Copyright Holders: Copyright © 2022 Parker et al.
• First Published: First published in PLoS Medicine 19(6):e1003998
• Publisher Policy: Reproduced under a Creative Commons licence