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The ProtecT trial: analysis of the patient cohort, baseline risk stratification and disease progression
Author(s) -
Bryant Richard J.,
Oxley Jon,
Young Grace J.,
Lane Janet A.,
Metcalfe Chris,
Davis Michael,
Turner Emma L.,
Martin Richard M.,
Goepel John R.,
Varma Murali,
Griffiths David F.,
Grigor Ken,
Mayer Nick,
Warren Anne Y.,
Bhattarai Selina,
Dormer John,
Mason Malcolm,
Staffurth John,
Walsh Eleanor,
Rosario Derek J.,
Catto James W.F.,
Neal David E.,
Donovan Jenny L.,
Hamdy Freddie C.
Publication year - 2020
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.14987
Subject(s) - medicine , prostate cancer , pathological , perineural invasion , cohort , hazard ratio , stage (stratigraphy) , proportional hazards model , disease , prostatectomy , biochemical recurrence , cancer , oncology , confidence interval , biology , paleontology
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.