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Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial

Parker, CC; James, ND; Brawley, CD; Clarke, NW; Hoyle, AP; Ali, A; Ritchie, AWS; ... Systemic Therapy for Advanced or Metastatic Prostate cancer, .; + view all (2018) Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial. Lancet , 392 (10162) pp. 2353-2366. 10.1016/S0140-6736(18)32486-3. Green open access

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Abstract

BACKGROUND: Local treatment of the prostate might not only improve local control, but also slow the progression of metastatic disease. We hypothesised that radiotherapy (RT) to the prostate would improve overall survival in men presenting with metastatic prostate cancer (PCa) and that the survival benefit would be greater in men with a lower metastatic burden. METHOD: STAMPEDE is a multi-arm multi-stage platform protocol that included a randomised phase III comparison to test the above hypotheses. Standard-of-care (SOC) was lifelong ADT, with up-front docetaxel permitted from Dec-2015. Stratified randomisation within 12 weeks on ADT allocated pts 1:1 to SOC or SOC+RT. Men allocated to RT received daily (55Gy/20f over 4 weeks) or weekly (36Gy/6f over 6 weeks) RT, started ≤8 weeks after randomisation or completion of docetaxel. The RT schedule was nominated before randomisation. The primary outcome measure was death from any cause; secondary outcome measures included failure-free survival (FFS). Comparison of SOC vs SOC+RT for survival had 90% power at 2.5% 1-sided alpha for hazard ratio (HR) of 0.75, requiring approximately 267 control arm deaths. Analyses used Cox proportional hazards & flexible parametric models, adjusted for stratification factors. A pre-specified subgroup analysis tested the effects of prostate RT by baseline metastatic burden. RESULTS: 2061 men with newly-diagnosed M1 PCa were randomised from Jan 2013 to Sep 2016. Randomised groups were well balanced: median age 68yrs; median PSA 97ng/ml; 18% early docetaxel; metastatic burden: 40% lower metastatic burden, 54% higher metastatic burden, 6% unknown in the group as a whole. Prostate RT improved FFS (HR=0.76, 95%CI 0.68, 0.84; p=3.36x10-7 60 ) but not overall survival (HR=0.92, 95%CI 0.80, 1.06; p=0.266). Pre-specified subgroup analysis showed 62 improved overall survival for prostate RT in 819 men with a lower metastatic burden 63 (HR=0.68, 95%CI 0.52, 0.90; p=0.007) but not in 1120 men with a higher metastatic burden (HR=1.07, 95%CI 0.90, 1.28; p=0.300). RT was well-tolerated during (G3-4 5% SOC+RT) and after treatment (G3-4 <1% SOC, 4% SOC+RT). CONCLUSIONS: Radiotherapy to the prostate did not improve survival for unselected patients with newly-diagnosed metastatic prostate cancer, but, in a pre-specified subgroup analysis, did improve survival in men with a lower metastatic burden. Therefore, prostate radiotherapy should be a standard treatment option for men with oligometastatic disease.

Type: Article
Title: Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/S0140-6736(18)32486-3
Publisher version: https://doi.org/10.1016/S0140-6736(18)32486-3
Language: English
Additional information: © 2018 The Author(s). This is an Open Access article under the CC BY 4.0 license (https://creativecommons.org/licenses/by/4.0/)
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Oncology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10058568
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