Impact of dutasteride treatment on the detection of clinically significant prostate cancer in patients with PI-RADS 3 lesions: a single-center observational study

Impacto del tratamiento con dutasteride en la detección de cáncer de próstata clínicamente significativo en pacientes con lesiones PIRADS 3: un estudio observacional unicéntrico

Background: Multiparametric magnetic resonance imaging (mpMRI) has become a key tool for the detection and risk stratification of prostate cancer. Prostate Imaging Reporting and Data System (PI-RADS) 3 lesions remain a diagnostic challenge because of their intermediate probability of malignancy. Whether prior dutasteride treatment affects the detection of clinically significant prostate cancer in this patient group remains unclear. The objective is to determine whether treatment with dutasteride for ≥6 months is associated with the detection of clinically significant prostate cancer International Society of Urological Pathology (ISUP ≥2) in patients with PI-RADS 3 lesions identified on mpMRI. Methods: A single-center retrospective study including 203 patients with PI-RADS 3 lesions was conducted. Demographic and clinical data (including dutasteride treatment), biochemical parameters (total prostate-specific antigen (PSA) and corrected prostate-specific antigen density (PSAD)), and prostate biopsy histopathological results were collected. Descriptive analyses and multivariable logistic regression including age, corrected PSAD ≥0.15 ng/mL/cc and dutasteride treatment were performed. Results: Clinically significant prostate cancer was identified in 16/170 (9.4%) untreated patients and in 5/33 (15.2%) patients treated with dutasteride (Fisher’s exact test, p = 0.348). In multivariable logistic regression, PSAD ≥0.15 (Odds ratio (OR) 4.52; 95% Confidence interval (CI) 1.56–13.05; p = 0.005) and age (OR 1.08; 95% CI 1.00–1.16; p = 0.044) were independently associated with clinically significant prostate cancer. Dutasteride treatment was not independently associated with clinically significant prostate cancer detection (OR 1.16; 95% CI 0.36–3.69; p = 0.806). Conclusions: In this single-center cohort of patients with PI-RADS 3 lesions, treatment with dutasteride for ≥6 months was not independently associated with the detection of clinically significant prostate cancer. However, given the limited statistical power and wide confidence intervals, these findings should be interpreted with caution and considered hypothesis-generating. Corrected PSAD and age remained independent predictors of clinically significant disease.

Resumen
Antecedentes: La resonancia magnética multiparamétrica (mpRMN) se ha consolidado como herramienta clave en la detección y estratificación del riesgo de cáncer de próstata. Las lesiones Prostate Imaging Reporting and Data System (PIRADS) 3 representan un desafío diagnóstico debido a su probabilidad intermedia de malignidad. Se desconoce si el tratamiento previo con dutasteride altera la detección de cáncer clínicamente significativo en este grupo de pacientes. El objetivo es determinar si el tratamiento con dutasteride durante ≥6 meses se asocia con la detección de cáncer de próstata clínicamente significativo International Society of Urological Pathology (ISUP ≥2) en pacientes con lesiones PIRADS 3 a resonancia magnética multiparamétrica (mpRMN). Métodos: Estudio retrospectivo unicéntrico de 203 pacientes con lesiones PIRADS 3. Se recogieron datos demográficos, clínicos (tratamiento con dutasteride), parámetros bioquímicos (antígeno prostático específico (PSA) total y antígeno prostático específico densidad (PSAD) corregida) y resultados histológicos de biopsia prostática. Se realizó análisis descriptivo y regresión logística multivariante incluyendo edad, PSAD corregida ≥0.15 ng/mL/cc y tratamiento con dutasteride. Resultados: El cáncer clínicamente significativo fue identificado en 16/170 (9.4%) pacientes no tratados y 5/33 (15.2%) pacientes tratados con dutasteride (Fisher p = 0.348). En la regresión logística, la densidad de PSA (PSAD) ≥0.15 ng/mL/cc: Odds ratio (OR) 4.52; intervalo de confianza del 95% (IC95%) 1.56–13.05; p = 0.005 y edad: OR 1.08; IC95% 1.00–1.16; p = 0.044, se asociaron de forma independiente con cáncer significativo. El tratamiento con dutasteride no mostró asociación independiente con cáncer clínicamente significativo (OR 1.16; IC95% 0.36–3.69; p = 0.806). Conclusiones: En pacientes con lesiones PIRADS 3, dutasteride ≥6 meses no se asoció de forma independiente con cáncer de próstata clínicamente significativo. La PSAD corregida y la edad siguen siendo predictores relevantes. No obstante, debido a la limitada potencia estadística y a la amplitud de los intervalos de confianza, estos resultados deben interpretarse con cautela y considerarse generadores de hipótesis.

Prostate cancer; PI-RADS 3; Dutasteride; PSA density; Prostate biopsy

Palabras Clave
Cáncer de próstata; PIRADS 3; Dutasteride; Densidad de PSA; Biopsia prostática

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