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Original Investigation
March 2016

Failure-Free Survival and Radiotherapy in Patients With Newly Diagnosed Nonmetastatic Prostate Cancer: Data From Patients in the Control Arm of the STAMPEDE Trial

Author Affiliations
  • 1Warwick Medical School, University of Warwick, Coventry, United Kingdom
  • 2University Hospitals Birmingham NHS Foundation Trust, The Medical School, University of Birmingham, Birmingham, United Kingdom
  • 3Medical Research Council Clinical Trials Unit, University College, London, United Kingdom
  • 4Department of Urology, Christie NHS Foundation Trust, Manchester, United Kingdom
  • 5Institute of Cancer Research and Royal Marsden NHS Foundation Trust, London, United Kingdom
  • 6Velindre Hospital, Cardiff, United Kingdom
  • 7Institute of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom
  • 8Royal Preston Hospital, Preston, United Kingdom
  • 9Cantonal Hospital St Gallen, St Gallen, Switzerland
  • 10Greater Manchester Group, Manchester, United Kingdom
  • 11Leeds Beckett University, Leeds, United Kingdom
  • 12Belfast City Hospital, Belfast, United Kingdom
  • 13Singleton Hospital, Swansea, United Kingdom
  • 14Royal Shrewsbury Hospital, Shrewsbury, United Kingdom
  • 15Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom
  • 16Velindre Hospital, Cardiff, United Kingdom
  • 17CCO Liverpool Warrington Aintree, Liverpool, United Kingdom
JAMA Oncol. 2016;2(3):348-357. doi:10.1001/jamaoncol.2015.4350

Importance  The natural history of patients with newly diagnosed high-risk nonmetastatic (M0) prostate cancer receiving hormone therapy (HT) either alone or with standard-of-care radiotherapy (RT) is not well documented. Furthermore, no clinical trial has assessed the role of RT in patients with node-positive (N+) M0 disease. The STAMPEDE Trial includes such individuals, allowing an exploratory multivariate analysis of the impact of radical RT.

Objective  To describe survival and the impact on failure-free survival of RT by nodal involvement in these patients.

Design, Setting, and Participants  Cohort study using data collected for patients allocated to the control arm (standard-of-care only) of the STAMPEDE Trial between October 5, 2005, and May 1, 2014. Outcomes are presented as hazard ratios (HRs) with 95% CIs derived from adjusted Cox models; survival estimates are reported at 2 and 5 years. Participants were high-risk, hormone-naive patients with newly diagnosed M0 prostate cancer starting long-term HT for the first time. Radiotherapy is encouraged in this group, but mandated for patients with node-negative (N0) M0 disease only since November 2011.

Exposures  Long-term HT either alone or with RT, as per local standard. Planned RT use was recorded at entry.

Main Outcomes and Measures  Failure-free survival (FFS) and overall survival.

Results  A total of 721 men with newly diagnosed M0 disease were included: median age at entry, 66 (interquartile range [IQR], 61-72) years, median (IQR) prostate-specific antigen level of 43 (18-88) ng/mL. There were 40 deaths (31 owing to prostate cancer) with 17 months’ median follow-up. Two-year survival was 96% (95% CI, 93%-97%) and 2-year FFS, 77% (95% CI, 73%-81%). Median (IQR) FFS was 63 (26 to not reached) months. Time to FFS was worse in patients with N+ disease (HR, 2.02 [95% CI, 1.46-2.81]) than in those with N0 disease. Failure-free survival outcomes favored planned use of RT for patients with both N0M0 (HR, 0.33 [95% CI, 0.18-0.61]) and N+M0 disease (HR, 0.48 [95% CI, 0.29-0.79]).

Conclusions and Relevance  Survival for men entering the cohort with high-risk M0 disease was higher than anticipated at study inception. These nonrandomized data were consistent with previous trials that support routine use of RT with HT in patients with N0M0 disease. Additionally, the data suggest that the benefits of RT extend to men with N+M0 disease.

Trial Registration  clinicaltrials.gov Identifier: NCT00268476; ISRCTN78818544