Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Apr;125(4):506-514.
doi: 10.1111/bju.14987. Epub 2020 Feb 12.

The ProtecT trial: analysis of the patient cohort, baseline risk stratification and disease progression

Richard J Bryant  1 , Jon Oxley  2 , Grace J Young  3   4 , Janet A Lane  3   4 , Chris Metcalfe  3   4 , Michael Davis  3 , Emma L Turner  3 , Richard M Martin  3 , John R Goepel  5 , Murali Varma  6 , David F Griffiths  6 , Ken Grigor  7 , Nick Mayer  8 , Anne Y Warren  9 , Selina Bhattarai  10 , John Dormer  8 , Malcolm Mason  11 , John Staffurth  12 , Eleanor Walsh  3 , Derek J Rosario  13 , James W F Catto  13 , David E Neal  1   14 , Jenny L Donovan  3   15 , Freddie C Hamdy  1 ; ProtecT Study Group
Collaborators, Affiliations

The ProtecT trial: analysis of the patient cohort, baseline risk stratification and disease progression

Richard J Bryant et al. BJU Int. 2020 Apr.

Abstract

Objective: To test the hypothesis that the baseline clinico-pathological features of the men with localized prostate cancer (PCa) included in the ProtecT (Prostate Testing for Cancer and Treatment) trial who progressed (n = 198) at a 10-year median follow-up were different from those of men with stable disease (n = 1409).

Patients and methods: We stratified the study participants at baseline according to risk of progression using clinical disease stage, pathological grade and PSA level, using Cox proportional hazard models.

Results: The findings showed that 34% of participants (n = 505) had intermediate- or high-risk PCa, and 66% (n = 973) had low-risk PCa. Of 198 participants who progressed, 101 (51%) had baseline International Society of Urological Pathology Grade Group 1, 59 (30%) Grade Group 2, and 38 (19%) Grade Group 3 PCa, compared with 79%, 17% and 5%, respectively, for 1409 participants without progression (P < 0.001). In participants with progression, 38% and 62% had baseline low- and intermediate-/high-risk disease, compared with 69% and 31% of participants with stable disease (P < 0.001). Treatment received, age (65-69 vs 50-64 years), PSA level, Grade Group, clinical stage, risk group, number of positive cores, tumour length and perineural invasion were associated with time to progression (P ≤ 0.005). Men progressing after surgery (n = 19) were more likely to have a higher Grade Group and pathological stage at surgery, larger tumours, lymph node involvement and positive margins.

Conclusions: We demonstrate that one-third of the ProtecT cohort consists of people with intermediate-/high-risk disease, and the outcomes data at an average of 10 years' follow-up are generalizable beyond men with low-risk PCa.

Keywords: Prostate cancer; pathology; risk stratification.

PubMed Disclaimer

Conflict of interest statement

F.C.H. and J.W.F.C. have attended an Advisory board for Steba Biotech. R.J.B. has undertaken consultancy for Owen Mumford Ltd. M.M. has received a speaker’s fee from Janssen. J.D. has undertaken pathology reporting at Spire and Nuffield Health Hospitals, Leicester. M.V. has received consultancy fees from Roche Products Ltd and AstraZeneca. J.S. has received honoraria from, and advised, Bayer. D.J.R. has received honoraria from Ferring and Research Funding from Bayer. R.J.B. reports grants from Cancer Research UK, The Urology Foundation, and UCARE. D.F.G. reports grants from UK National Institute for Health Research Health Technology Assessment Program. R.M.M. reports grants from Cancer Research UK during the conduct of the study.

Figures

Figure 1
Figure 1
Cumulative incidence of disease progression by International Society of Urological Pathology Grade Group (GG) and clinical stage, based on intention to treat groups. AM, active monitoring.
Figure 2
Figure 2
Cumulative incidence of disease progression by age and PSA level, based on intention‐to‐treat groups. AM, active monitoring.
See this image and copyright information in PMC

Comment in

References

    1. Hamdy FC, Donovan JL, Lane JA et al. 10‐Year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer. N Engl J Med 2016; 375: 1415–24 - PubMed
    1. Rodrigues G, Warde P, Pickles T et al. Pre‐treatment risk stratification of prostate cancer patients: a critical review. Can Urol Assoc J 2012; 6: 121–7 - PMC - PubMed
    1. D’Amico AV, Whittington R, Malkowicz SB et al. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA 1998; 280: 969–74 - PubMed
    1. Donovan JL, Hamdy FC, Lane JA et al. Patient‐reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer. N Engl J Med 2016; 375: 1425–37 - PMC - PubMed
    1. Lane JA, Donovan JL, Davis M et al. Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial. Lancet Oncol 2014; 15: 1109–18 - PubMed

Publication types