The ProtecT randomised trial cost-effectiveness analysis comparing active monitoring, surgery, or radiotherapy for prostate cancer

Sian Noble ,Owen Hughes,Tim J Peters,Vincent Gnanapragasam,J Athene Lane,David E Neal,Richard M Martin,Jon Oxley,Prasad Bollina,Joanna Thorn ,Howard Kynaston,Eleanor Walsh ,James W.f Catto ,Malcolm David Mason ,Freddie C Hamdy,Emma L Turner ,Chris Metcalfe,Kirsty Garfield,Edward Rowe,Michael J Davis ,Alan Paul,Derek J Rosario,Roger Kockelbergh,Edgar Páez ,John Staffurth,Alan Doherty,Jenny Donovan

doi:10.1038/s41416-020-0978-4

Abstract

BackgroundThere is limited evidence relating to the cost-effectiveness of treatments for localised prostate cancer.MethodsThe cost-effectiveness of active monitoring, surgery, and radiotherapy was evaluated within the Prostate Testing for Cancer and Treatment (ProtecT) randomised controlled trial from a UK NHS perspective at 10 years’ median follow-up. Prostate cancer resource-use collected from hospital records and trial participants was valued using UK reference-costs. QALYs (quality-adjusted-life-years) were calculated from patient-reported EQ-5D-3L measurements. Adjusted mean costs, QALYs, and incremental cost-effectiveness ratios were calculated; cost-effectiveness acceptability curves and sensitivity analyses addressed uncertainty; subgroup analyses considered age and disease-risk.ResultsAdjusted mean QALYs were similar between groups: 6.89 (active monitoring), 7.09 (radiotherapy), and 6.91 (surgery). Active monitoring had lower adjusted mean costs (£5913) than radiotherapy (£7361) and surgery (£7519). Radiotherapy was the most likely (58% probability) cost-effective option at the UK NICE willingness-to-pay threshold (£20,000 per QALY). Subgroup analyses confirmed radiotherapy was cost-effective for older men and intermediate/high-risk disease groups; active monitoring was more likely to be the cost-effective option for younger men and low-risk groups.ConclusionsLonger follow-up and modelling are required to determine the most cost-effective treatment for localised prostate cancer over a man’s lifetime.Trial registrationCurrent Controlled Trials number, ISRCTN20141297: http://isrctn.org (14/10/2002); ClinicalTrials.gov number, NCT02044172: http://www.clinicaltrials.gov (23/01/2014).

Highlights

There is limited evidence relating to the cost-effectiveness of treatments for localised prostate cancer
The Prostate Testing for Cancer and Treatment (ProtecT) randomised treatment trial showed there was no evidence of a difference in prostate cancer mortality at a median of 10 years’ follow-up between 3D-conformal radiotherapy with neo-adjuvant androgen deprivation therapy (ADT), radical surgery, and active monitoring in men with clinically localised prostate cancer.[1]
This paper presents an individual patient data economic evaluation of the ProtecT trial in terms of costs to the UK NHS and Quality-Adjusted-Life-Years (QALYs) at a median of 10 years’ follow-up, the prespecified time point for the primary analysis.[1]

Summary

Introduction

There is limited evidence relating to the cost-effectiveness of treatments for localised prostate cancer. METHODS: The cost-effectiveness of active monitoring, surgery, and radiotherapy was evaluated within the Prostate Testing for Cancer and Treatment (ProtecT) randomised controlled trial from a UK NHS perspective at 10 years’ median follow-up. The ProtecT randomised treatment trial showed there was no evidence of a difference in prostate cancer mortality at a median of 10 years’ follow-up between 3D-conformal radiotherapy with neo-adjuvant androgen deprivation therapy (ADT), radical surgery, and active monitoring in men with clinically localised prostate cancer.[1] Men randomised to surgery and radiotherapy had half the rate of prostate cancer progression and metastasis compared with the active monitoring group, but they experienced greater levels of treatment side effects, including urinary incontinence, erectile dysfunction and bowel symptoms.[2].

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