TY - JOUR
T1 - Diagnostic Pathway with Multiparametric Magnetic Resonance Imaging Versus Standard Pathway
T2 - Results from a Randomized Prospective Study in Biopsy-naïve Patients with Suspected Prostate Cancer
AU - Porpiglia, Francesco
AU - Manfredi, Matteo
AU - Mele, Fabrizio
AU - Cossu, Marco
AU - Bollito, Enrico
AU - Veltri, Andrea
AU - Cirillo, Stefano
AU - Regge, Daniele
AU - Faletti, Riccardo
AU - Passera, Roberto
AU - Fiori, Cristian
AU - De Luca, Stefano
PY - 2016
Y1 - 2016
N2 - Background: An approach based on multiparametric magnetic resonance imaging (mpMRI) might increase the detection rate (DR) of clinically significant prostate cancer (csPCa). Objective: To compare an mpMRI-based pathway with the standard approach for the detection of prostate cancer (PCa) and csPCa. Design, setting, and participants: Between November 2014 and April 2016, 212 biopsy-naïve patients with suspected PCa (prostate specific antigen level ≤15 ng/ml and negative digital rectal examination results) were included in this randomized clinical trial. Patients were randomized into a prebiopsy mpMRI group (arm A, . n =107) or a standard biopsy (SB) group (arm B, . n =105). Intervention: In arm A, patients with mpMRI evidence of lesions suspected for PCa underwent mpMRI/transrectal ultrasound fusion software-guided targeted biopsy (TB) (n =81). The remaining patients in arm A (n =26) with negative mpMRI results and patients in arm B underwent 12-core SB. Outcomes measurements and statistical analysis: The primary end point was comparison of the DR of PCa and csPCa between the two arms of the study; the secondary end point was comparison of the DR between TB and SB. Results and limitations: The overall DRs were higher in arm A versus arm B for PCa (50.5% vs 29.5%, respectively; . p =0.002) and csPCa (43.9% vs 18.1%, respectively; . p . <. 0.001). Concerning the biopsy approach, that is, TB in arm A, SB in arm A, and SB in arm B, the overall DRs were significantly different for PCa (60.5% vs 19.2% vs 29.5%, respectively; . p . <. 0.001) and for csPCa (56.8% vs 3.8% vs 18.1%, respectively; . p . <. 0.001). The reproducibility of the study could have been affected by the single-center nature. Conclusions: A diagnostic pathway based on mpMRI had a higher DR than the standard pathway in both PCa and csPCa. Patient summary: In this randomized trial, a pathway for the diagnosis of prostate cancer based on multiparametric magnetic resonance imaging (mpMRI) was compared with the standard pathway based on random biopsy. The mpMRI-based pathway had better performance than the standard pathway. This randomized trial included 212 biopsy-naïve patients with suspected prostate cancer (PCa) who were randomized to prebiopsy multiparametric magnetic resonance imaging (mpMRI) or standard biopsy. The detection rates of PCa and clinically significant PCa in the mpMRI group were higher than those in the standard biopsy group.
AB - Background: An approach based on multiparametric magnetic resonance imaging (mpMRI) might increase the detection rate (DR) of clinically significant prostate cancer (csPCa). Objective: To compare an mpMRI-based pathway with the standard approach for the detection of prostate cancer (PCa) and csPCa. Design, setting, and participants: Between November 2014 and April 2016, 212 biopsy-naïve patients with suspected PCa (prostate specific antigen level ≤15 ng/ml and negative digital rectal examination results) were included in this randomized clinical trial. Patients were randomized into a prebiopsy mpMRI group (arm A, . n =107) or a standard biopsy (SB) group (arm B, . n =105). Intervention: In arm A, patients with mpMRI evidence of lesions suspected for PCa underwent mpMRI/transrectal ultrasound fusion software-guided targeted biopsy (TB) (n =81). The remaining patients in arm A (n =26) with negative mpMRI results and patients in arm B underwent 12-core SB. Outcomes measurements and statistical analysis: The primary end point was comparison of the DR of PCa and csPCa between the two arms of the study; the secondary end point was comparison of the DR between TB and SB. Results and limitations: The overall DRs were higher in arm A versus arm B for PCa (50.5% vs 29.5%, respectively; . p =0.002) and csPCa (43.9% vs 18.1%, respectively; . p . <. 0.001). Concerning the biopsy approach, that is, TB in arm A, SB in arm A, and SB in arm B, the overall DRs were significantly different for PCa (60.5% vs 19.2% vs 29.5%, respectively; . p . <. 0.001) and for csPCa (56.8% vs 3.8% vs 18.1%, respectively; . p . <. 0.001). The reproducibility of the study could have been affected by the single-center nature. Conclusions: A diagnostic pathway based on mpMRI had a higher DR than the standard pathway in both PCa and csPCa. Patient summary: In this randomized trial, a pathway for the diagnosis of prostate cancer based on multiparametric magnetic resonance imaging (mpMRI) was compared with the standard pathway based on random biopsy. The mpMRI-based pathway had better performance than the standard pathway. This randomized trial included 212 biopsy-naïve patients with suspected prostate cancer (PCa) who were randomized to prebiopsy multiparametric magnetic resonance imaging (mpMRI) or standard biopsy. The detection rates of PCa and clinically significant PCa in the mpMRI group were higher than those in the standard biopsy group.
KW - Diagnosis
KW - Magnetic resonance imaging
KW - Prostate cancer
KW - Systematic random biopsy
KW - Targeted biopsy
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U2 - 10.1016/j.eururo.2016.08.041
DO - 10.1016/j.eururo.2016.08.041
M3 - Article
AN - SCOPUS:84994071552
JO - European Urology
JF - European Urology
SN - 0302-2838
ER -