Abstract

BackgroundDiagnosis of prostate cancer at an early stage can potentially identify tumours when intervention may improve treatment options and survival.AimTo develop and validate an equation to predict absolute risk of prostate cancer in asymptomatic men with prostate specific antigen (PSA) tests in primary care.Design and settingCohort study using data from English general practices, held in the QResearch database.MethodRoutine data were collected from 1098 QResearch English general practices linked to mortality, hospital, and cancer records for model development. Two separate sets of practices were used for validation. In total, there were 844 455 men aged 25–84 years with PSA tests recorded who were free of prostate cancer at baseline in the derivation cohort; the validation cohorts comprised 292 084 and 316 583 men. The primary outcome was incident prostate cancer. Cox proportional hazards models were used to derive 10-year risk equations. Measures of performance were determined in both validation cohorts.ResultsThere were 40 821 incident cases of prostate cancer in the derivation cohort. The risk equation included PSA level, age, deprivation, ethnicity, smoking status, serious mental illness, diabetes, BMI, and family history of prostate cancer. The risk equation explained 70.4% (95% CI = 69.2 to 71.6) of the variation in time to diagnosis of prostate cancer (R2) (D statistic 3.15, 95% CI = 3.06 to 3.25; Harrell’s C-index 0.917, 95% CI = 0.915 to 0.919). Two-step approach had higher sensitivity than a fixed PSA threshold at identifying prostate cancer cases (identifying 68.2% versus 43.9% of cases), high-grade cancers (49.2% versus 40.3%), and deaths (67.0% versus 31.5%).ConclusionThe risk equation provided valid measures of absolute risk and had higher sensitivity for incident prostate cancer, high-grade cancers, and prostate cancer mortality than a simple approach based on age and PSA threshold.

Highlights

  • Prostate cancer affects an estimated 1 million men worldwide, with >300 000 dying from the disease each year.[1]

  • The risk equation provided valid measures of absolute risk and had higher sensitivity for incident prostate cancer, high-grade cancers, and prostate cancer mortality than a simple approach based on age and prostate specific antigen (PSA) threshold

  • Diagnosing prostate cancer early can potentially identify tumours when they are at an early stage and intervention might improve treatment options and survival; studies have suggested that PSA alone has poor senstivity to determine the presence of prostate cancer for any risk stratification category.[2]

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Summary

Introduction

Prostate cancer affects an estimated 1 million men worldwide, with >300 000 dying from the disease each year.[1] Prostate specific antigen (PSA) is a biomarker that is widely used to help detect prostate cancer before symptoms develop or at an early stage. Diagnosing prostate cancer early can potentially identify tumours when they are at an early stage and intervention might improve treatment options and survival; studies have suggested that PSA alone has poor senstivity to determine the presence of prostate cancer for any risk stratification category.[2]. Diagnosis of prostate cancer at an early stage can potentially identify tumours when intervention may improve treatment options and survival

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