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Inicio Actas Urológicas Españolas (English Edition) Initial experience with SelectMDx® in the diagnosis of prostate cancer in a rea...
Journal Information
Vol. 44. Issue 6.
Pages 400-407 (July - August 2020)
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Vol. 44. Issue 6.
Pages 400-407 (July - August 2020)
Original article
Initial experience with SelectMDx® in the diagnosis of prostate cancer in a real-world evidence clinical practice setting
Experiencia inicial del uso de SelectMDx® en el diagnóstico de cáncer de próstata en un entorno de práctica clínica habitual «real-world evidence»
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L.M. Quintanaa, E. Fernández Pascuala,b, E. Linares Espinósa,b,
Corresponding author
elinares@lyxurologia.com

Corresponding author.
, C. Martinez-Ballesterosb,c, C. Martin-Vivasb, D. Rengifo Abbadb,c, N. D’Anna Carusob, A. Allonad, J.I. Martínez-Salamancab,c
a Servicio de Urología, Hospital Universitario La Paz, Universidad Autónoma de Madrid, Madrid, Spain
b Instituto Lyx Urología, Universidad Francisco de Vitoria, Madrid, Spain
c Servicio de Urología, Hospital Universitario Puerta de Hierro-Majadahonda, Universidad Autónoma de Madrid, Madrid, Spain
d Servicio de Urología, Hospital Ruber Internacional, Madrid, Spain
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Figures (2)
Tables (3)
Table 1. Baseline characteristics of the patients in the sample.
Table 2. Stratified results according to diagnostic process and risk percentage.
Table 3. Characteristics of the molecular tests available on the market.
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Abstract
Introduction

The use of biomarkers in the detection of prostate cancer (PC) can decrease overdiagnosis and overtreatment of non-significant PC. We analyze the usefulness and applicability of the SelectMDx® marker in a routine clinical practice setting.

Material and methods

Retrospective study of 48 patients evaluated by the SelectMDx® test between July 2017 and April 2019. Patients were stratified into two groups according to the risk estimated by the clinically significant CP test (CS-PC): <2% or "very low risk", and >2%. Results were expressed based on previous prostate biopsy (PB) and MRI outcomes.

Results

Patients with negative PB and normal/doubtful MRI had <2% risk in 7/9 cases. Patients without PB and normal/doubtful MRI had <2% risk in 12/18 cases, and 2/6 cases with a >2% risk presented CS-PC. Of the 14 patients with no previous PB or MRI, 9 had <2% risk, and 2 cases were diagnosed with PC from the group of patients (5) with risk >2%. The number of patients in the remaining subgroups is too small to draw any conclusions. In all cases with pathological digital rectal examination, the test showed a >2% PC risk.

Conclusion

SelectMDx® is a promising test for detecting patients with a very low risk of CS-PC, especially in patients with suspected PC, with or without negative PB, with normal/doubtful MRI. The presence of a pathological digital rectal examination may condition the result of the test.

Keywords:
Prostate cancer
Diagnosis
Biomarker
Resumen
Introducción

El uso de biomarcadores en la detección del cáncer de próstata (CP) puede disminuir el sobrediagnóstico y sobretratamiento de CP no significativos. Analizamos la utilidad y aplicabilidad del marcador SelectMDx® en un entorno de práctica clínica habitual.

Material y métodos

Estudio retrospectivo de 48 pacientes evaluados mediante el test SelectMDx® entre julio de 2017 y abril de 2019. Los pacientes se estratificaron en dos grupos según el riesgo estimado por el test de CP clínicamente significativo (CP-CS): <2% o “muy bajo riesgo”, y >2%. Los resultados se expresaron en función de los antecedentes de biopsia prostática (BP) y RMmp.

Resultados

En pacientes con BP negativa y RMmp normal/dudosa el riesgo fue <2% en 7/9 casos. En pacientes sin BP y RMmp normal/dudosa el riesgo fue <2% en 12/18 casos, y 2/6 casos con un riesgo >2% presentaron un CP-CS. De los 14 pacientes sin BP ni RMmp previas, 9 presentaron un riesgo <2%, con 2 casos diagnosticados de CP en los 5 pacientes con riesgo >2%. En el resto de subgrupos el número de pacientes es pequeño como para poder extraer conclusiones. En todos los casos con tacto rectal patológico el test demostraba un riesgo de padecer CP > 2%.

Conclusión

SelectMDx® es un test prometedor para detectar pacientes con un riesgo muy bajo de CP-CS, especialmente en pacientes con sospecha de CP con o sin BP negativas, en los que la RMmp muestre un resultado normal/dudoso. La presencia de un tacto rectal patológico puede condicionar el resultado del test.

Palabras clave:
Cáncer de próstata
Diagnóstico
Marcador

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