ProtecT study group (Including: Parashar, D.). (2017) Mortality among men with advanced prostate cancer excluded from the ProtecT Trial. European Urology, 71 (3). pp. 381-388. doi:10.1016/j.eururo.2016.09.040 ISSN 0302-2838.

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Abstract

Background
Early detection and treatment of asymptomatic men with advanced and high-risk prostate cancer (PCa) may improve survival rates.

Objective
To determine outcomes for men diagnosed with advanced PCa following prostate-specific antigen (PSA) testing who were excluded from the ProtecT randomised trial.

Design, setting, and participants
Mortality was compared for 492 men followed up for a median of 7.4 yr to a contemporaneous cohort of men from the UK Anglia Cancer Network (ACN) and with a matched subset from the ACN.

Outcome measurements and statistical analysis
PCa-specific and all-cause mortality were compared using Kaplan-Meier analysis and Cox's proportional hazards regression.

Results and limitations
Of the 492 men excluded from the ProtecT cohort, 37 (8%) had metastases (N1, M0 = 5, M1 = 32) and 305 had locally advanced disease (62%). The median PSA was 17 μg/l. Treatments included radical prostatectomy (RP; n = 54; 11%), radiotherapy (RT; n = 245; 50%), androgen deprivation therapy (ADT; n = 122; 25%), other treatments (n = 11; 2%), and unknown (n = 60; 12%). There were 49 PCa-specific deaths (10%), of whom 14 men had received radical treatment (5%); and 129 all-cause deaths (26%). In matched ProtecT and ACN cohorts, 37 (9%) and 64 (16%), respectively, died of PCa, while 89 (22%) and 103 (26%) died of all causes. ProtecT men had a 45% lower risk of death from PCa compared to matched cases (hazard ratio 0.55, 95% confidence interval 0.38–0.83; p = 0.0037), but mortality was similar in those treated radically. The nonrandomised design is a limitation.

Conclusions
Men with PSA-detected advanced PCa excluded from ProtecT and treated radically had low rates of PCa death at 7.4-yr follow-up. Among men who underwent nonradical treatment, the ProtecT group had a lower rate of PCa death. Early detection through PSA testing, leadtime bias, and group heterogeneity are possible factors in this finding.

Item Type:	Journal Article
Subjects:	R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Prostate -- Cancer -- Treatment -- East Anglia (England)
Journal or Publication Title:	European Urology
Publisher:	Elsevier BV
ISSN:	0302-2838
Official Date:	March 2017
Dates:	Date Event March 2017 Published 7 October 2016 Available 26 September 2016 Accepted
Volume:	71
Number:	3
Page Range:	pp. 381-388
DOI:	10.1016/j.eururo.2016.09.040
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
Date of first compliant deposit:	19 October 2016
Date of first compliant Open Access:	7 October 2017
Funder:	National Institute for Health Research (Great Britain). Technology Assessment Programme (NIHR TAP), University of Oxford, Collaborations for Leadership in Applied Health Research and Care (CLAHRC), University Hospitals Bristol NHS Trust, Oxford Biomedical Research Centre, Cancer Research UK (CRUK)
Grant number:	Projects 96/20/06, 96/20/99 (NIHT TAP)

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