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Prospective study of diagnostic accuracy in the detection of high‐grade prostate cancer in biopsy‐naïve patients with clinical suspicion of prostate cancer who underwent the Select MDx test
Author(s) -
LendínezCano Guillermo,
OjedaClaro Ana Victoria,
GómezGómez Enrique,
Morales Jimenez Pedro,
Flores Martin José,
Dominguez Juan Francisco,
Amores Javier,
Cozar Jose Manuel,
Bachiller Jaime,
Juárez Alvaro,
Linares Ramón,
Garcia Galisteo Emilio,
Alvarez Ossorio Jose Luis,
Requena Tapia Maria José,
Moreno Jimenez Juan,
Medina Lopez Rafael Antonio
Publication year - 2021
Publication title -
the prostate
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.295
H-Index - 123
eISSN - 1097-0045
pISSN - 0270-4137
DOI - 10.1002/pros.24182
Subject(s) - medicine , rectal examination , prostate cancer , prospective cohort study , prostate , prostate specific antigen , biopsy , prostate biopsy , predictive value of tests , magnetic resonance imaging , cancer , likelihood ratios in diagnostic testing , radiology , urology , receiver operating characteristic
Objectives This study aimed to externally validate the diagnostic accuracy of the Select MDx test for Significant prostate cancer (Sig PCa) (ISUP > 1), in a contemporaneous, prospective, multicenter cohort with a prostate‐specific antigen (PSA) between 3 and 10 ng/ml and a non‐suspicious digital rectal examination. Methods and Participants For all enrolled patients, the Select Mdx test, the risk calculator ERSPC3 + DRE, and a prostatic magnetic resonance imaging (MRI) were carried out. Subsequently, a systematic 12‐core trans‐rectal biopsy and a targeted biopsy, in the case of a prostate imaging–reporting and data system (PIRADS) > 2 lesion (max three lesions), were performed. To assess the accuracy of the Select MDx test in the detection of clinically Sig PCa, the test sensitivity was evaluated. Secondary objectives were specificity, negative predictive value (NPV), positive predictive value (PPV), and area under the curve (AUC). A direct comparison with the ERSPC + DRE risk calculator and MRI were also performed. We also studied the predictive ability to diagnose Sig PCa from the combination of the Select MDx test with MRI using clinical decision‐curve analysis. Results There were 163 patients enrolled after meeting the inclusion criteria and study protocol. The Select MDx test showed a sensitivity of 76.9% (95% CI, 63.2–87.5), 49.6% specificity (95% CI, 39.9–59.2), 82.09% (95% CI, 70.8–90.4) NPV, and 41.67% (95% CI, 31.7–52.2) PPV for the diagnosis of Sig PCa. COR analysis was also performed, which showed an AUC of 0.63 (95% CI, 0.56–0.71). There were no differences in the accuracy of Select MDx, ERSPC + DRE, or MRI. The combination of Select MDX + MRI showed the highest impact in the decision‐curve analysis, with an NPV of 93%. Conclusion Our study showed a worse performance for the SelectMdx test than previously reported, within a cohort of patients with a PSA 3–10 ng/ml and a normal DRE, with results similar to those from ERSPC + DRE RC and MRI, but with an improvement in the usual PSA pathway. A combination of the Select Mdx test and MRI could improve accuracy, but studies specifically evaluating this scenario with a cost‐effective analysis are needed.