Prostate CancerPrediction of Prostate Cancer Risk: The Role of Prostate Volume and Digital Rectal Examination in the ERSPC Risk Calculators
Introduction
It is widely recognized that too many men undergo prostate biopsy if prostate-specific antigen (PSA) alone is used for screening. Multivariable risk calculators (RCs) are essential tools for improved risk stratification. The goal is to identify men at increased risk of having a potentially life-threatening prostate cancer (PCa) as candidates for biopsy [1]. Based on data from the European Randomized Study of Screening for Prostate Cancer (ERSPC) Rotterdam, a multistep PCa RC was developed (www.prostatecancer-riskcalulator.com) [2], [3]. The RC is meant as a decision aid for laypeople, general practitioners, and urologists that provides estimates of current risk on having a biopsy-detectable PCa based on age, family history, and urinary complaints (calculator 1), PSA level (calculator 2), and PSA in combination with digital rectal examination (DRE), transrectal ultrasound (TRUS), prostate volume (PV), and previous biopsy status (calculators 3–5). RC 6 calculates the probability of having a potentially indolent PCa and can be used to aid treatment choice.
The ERSPC RCs 3–5 require information from TRUS, including PV and the presence of hypoechoic lesions. Because the PSA level is related to PV [4], [5], it is reasonable to include PV in PCa prediction models. However, including parameters that require invasive procedures could limit the clinical application of the RC. DRE has a reasonable ability to discriminate correctly between TRUS-assessed PV ± 40 cm3 [6] and performs well for volumes >50 cm3 [7]. We aimed to develop and validate a DRE-based RC that includes information on PV but avoids the need for TRUS before biopsy.
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Materials and methods
ERSPC Rotterdam recruited 42 176 men (aged 55–74 yr) randomized into intervention and control arms. Of the 21 210 men randomized to the intervention arm, 19 970 were actually screened. Rescreening was scheduled every 4 yr. Details on biopsy indication are described elsewhere [8]. Men with a biopsy indication first underwent DRE followed by biplanar TRUS using a Bruel and Kjaer model 1846 mainframe and a 7-MHz biplanar endorectal transducer (B&K Medical Systems, Marlborough, MA, USA) in the left
Results
Among the 885 PCa cases detected at first screening, 431 (48.7%) were classified as HG PCa using our criteria. At repeat screening, 131 (23.9%) of the 547 PCa cases were classified as HG PCa (Table 1).
PSA and DRE were both positively correlated with the presence of PCa and HG PCa. A large PV and a previous negative biopsy reduced the likelihood of a biopsy-detectable (HG) PCa (Table 2). An abnormal DRE at the initial screening was highly predictive for HG PCa (odds ratio: 6.1), a direct
Discussion
Multivariable tools have increasingly been developed and validated for use in the primary screening setting. As described earlier, our group previously developed several RCs to aid in the decision for biopsy or to predict indolent disease to help guide management [2], [3] (www.prostatecancer-riskcalculator.com). These RCs have been validated in external populations and shown to have superior discrimination for the prediction of PCa as compared with the PCPT RC, which does not include PV [12],
Conclusions
Risk assessment on the basis of PSA alone is not optimal. It can be improved by adding the outcome of DRE. Additional improvement can easily be obtained, however, by adding information on PV. Realizing that invasive procedures before risk assessment are suboptimal, we developed a DRE-based prediction tool that still contains information on PV and therefore is not only more accurate in risk prediction but also easily implemented into daily urologic practice and therefore also suitable to be used
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