Abstract
BackgroundProstate cancer (PCa) represents a significant healthcare problem. The critical clinical question is the need for a biopsy. Accurate risk stratification of patients before a biopsy can allow for individualised risk stratification thus improving clinical decision making. This study aims to build a risk calculator to inform the need for a prostate biopsy.MethodsUsing the clinical information of 4801 patients an Irish Prostate Cancer Risk Calculator (IPRC) for diagnosis of PCa and high grade (Gleason ≥7) was created using a binary regression model including age, digital rectal examination, family history of PCa, negative prior biopsy and Prostate-specific antigen (PSA) level as risk factors. The discrimination ability of the risk calculator is internally validated using cross validation to reduce overfitting, and its performance compared with PSA and the American risk calculator (PCPT), Prostate Biopsy Collaborative Group (PBCG) and European risk calculator (ERSPC) using various performance outcome summaries. In a subgroup of 2970 patients, prostate volume was included. Separate risk calculators including the prostate volume (IPRCv) for the diagnosis of PCa (and high-grade PCa) was created.ResultsIPRC area under the curve (AUC) for the prediction of PCa and high-grade PCa was 0.6741 (95% CI, 0.6591 to 0.6890) and 0.7214 (95% CI, 0.7018 to 0.7409) respectively. This significantly outperforms the predictive ability of cancer detection for PSA (0.5948), PCPT (0.6304), PBCG (0.6528) and ERSPC (0.6502) risk calculators; and also, for detecting high-grade cancer for PSA (0.6623) and PCPT (0.6804) but there was no significant improvement for PBCG (0.7185) and ERSPC (0.7140). The inclusion of prostate volume into the risk calculator significantly improved the AUC for cancer detection (AUC = 0.7298; 95% CI, 0.7119 to 0.7478), but not for high-grade cancer (AUC = 0.7256; 95% CI, 0.7017 to 0.7495). The risk calculator also demonstrated an increased net benefit on decision curve analysis.ConclusionThe risk calculator developed has advantages over prior risk stratification of prostate cancer patients before the biopsy. It will reduce the number of men requiring a biopsy and their exposure to its side effects. The interactive tools developed are beneficial to translate the risk calculator into practice and allows for clarity in the clinical recommendations.
Highlights
Prostate cancer (PCa) represents a significant healthcare problem
This study aims to build an Irish risk calculator and compare it with Prostate Specific Antigen (PSA), the Prostate Cancer Prevention Trial (PCPT) and ERSPC risk calculator and assessed using a number of performance indicators with the purpose to reduce the number of men going for a biopsy without missing significant cancer
PSA, Digital Rectal Examination (DRE) and previous negative biopsy were significant for predicting highgrade cancer; there was no significant individual effect of family history on detecting high-grade cancer
Summary
Prostate cancer (PCa) represents a significant healthcare problem. The critical clinical question is the need for a biopsy. Prostate Cancer (PCa) is the most common non-cutaneous cancer in men in Ireland [1] and internationally [2] This disease causes significant morbidity and mortality; every year over 500 men in Ireland die from this disease [3]. The decision to proceed to prostate biopsy, an essential step in the accurate diagnosis of PCa lacks an appropriate sensitivity and specificity based on these parameters. This has led to the diagnosing clinically insignificant cancer and treatment of disease exposing a large number of men to unnecessary biopsies (false positives), anxiety about their diagnosis and treatment impacts on their quality of life. There are a large number of men who are diagnosed with low-grade PCa (Gleason 6), who need not have been diagnosed, as their disease is unlikely to lead to an impact on their life span
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