• Chris C Parker, Nicholas D James, Christopher D Brawley, Noel W Clarke, Adnan Ali, Claire L Amos, Gerhardt Attard, Simon Chowdhury, Adrian Cook, William Cross, David P Dearnaley, Hassan Douis, Duncan C Gilbert, Clare Gilson, Silke Gillessen, Alex Hoyle, Rob J Jones, Ruth E Langley, Zafar I Malik, Malcolm D Mason, David Matheson, Robin Millman, Mary Rauchenberger, Hannah Rush, J Martin Russell, Hannah Sweeney, Amit Bahl, Alison Birtle, Lisa Capaldi, Omar Din, Daniel Ford, Joanna Gale, Ann Henry, Peter Hoskin, Mohammed Kagzi, Anna Lydon, Joe M O'Sullivan, Sangeeta A Paisey, Omi Parikh, Delia Pudney, Vijay Ramani, Peter Robson, Narayanan Nair Srihari, Jacob Tanguay, ParmarMahesh K BMKB0000-0003-0166-1700MRC Clinical Trials Unit at UCL, UCL, London, United Kingdom., Matthew R Sydes, and STAMPEDE Trial Collaborative Group.
• The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, London, United Kingdom.
• PLoS Med. 2022 Jun 1; 19 (6): e1003998e1003998.

BackgroundSTAMPEDE 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 FindingsPatients 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.ConclusionsProstate 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 RegistrationClinicalTrials.gov NCT00268476, ISRCTN.com ISRCTN78818544.

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