0a88d980500808bad34827c879c3cf9f pmc_10890536.pdf 19e49b9024f4c2ab8a999f9eb6a70f426129f033 pmc_10890536.pdf cd35296429c21a6149002d70d2eafb8218d35ab52f51b63d8f0878f162717ea6 pmc_10890536.pdf Title: Investigating Efficient Risk-Stratified Pathways for the Early Detection of Clinically Significant Prostate Cancer Subject: Risk-stratified pathways (RSPs) are recommended by the European Association of Uro-logy (EAU) to improve the early detection of clinically significant prostate cancer (csPCa). RSPs can reduce magnetic resonance imaging (MRI) demand, prostate biopsies, and the over-detection of insignificant PCa (iPCa). Our goal is to analyze the efficacy and cost-effectiveness of several RSPs by using sequential stratifications from the serum prostate-specific antigen level and digital rectal examination, the Barcelona risk calculators (BCN-RCs), MRI, and Proclarix™. In a cohort of 567 men with a serum PSA level above 3.0 ng/mL who underwent multiparametric MRI (mpMRI) and targeted and/or systematic biopsies, the risk of csPCa was retrospectively assessed using Proclarix™ and BCN-RCs 1 and 2. Six RSPs were compared with those recommended by the EAU that, stratifying men from MRI, avoided 16.7% of prostate biopsies with a prostate imaging–reporting and data system score of <3, with 2.6% of csPCa cases remaining undetected. The most effective RSP avoided mpMRI exams in men with a serum PSA level of >10 ng/mL and suspicious DRE, following stratifications from BCN-RC 1, mpMRI, and Proclarix™. The demand for mpMRI decreased by 19.9%, prostate biopsies by 19.8%, and over-detection of iPCa by 22.7%, while 2.6% of csPCa remained undetected as in the recommended RSP. Cost-effectiveness remained when the Proclarix™ price was assumed to be below EUR 200. Keywords: screening; prostate cancer; Barcelona risk calculator; Proclarix; risk-stratified pathway Author: Juan Morote, Ángel Borque-Fernando, Luis M. Esteban, Ana Celma, Miriam Campistol, Berta Miró, Olga Méndez and Enrique Trilla Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Thu Jan 25 05:14:59 2024 CET ModDate: Thu Jan 25 05:16:55 2024 CET Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 15 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 3129087 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- MIDETX+VnURWPalladioL-Bold Type 1 Custom yes yes yes 10 0 OFFFCG+VnURWPalladioL Type 1 Custom yes yes yes 16 0 BLTUJY+URWPalladioL-Bold Type 1 Custom yes yes yes 21 0 ZIZTJN+URWPalladioL-Roma Type 1 Custom yes yes yes 27 0 TNJHWR+URWPalladioL-Ital Type 1 Custom yes yes yes 32 0 UIJACC+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 48 0 BSDWLC+TimesNewRomanPSMT Type 1C WinAnsi yes yes no 51 0 AHSHLD+CMSY10 Type 1 Builtin yes yes yes 71 0 CKBPVA+EURM10 Type 1 Builtin yes yes yes 76 0 WABLSD+SFRM1000 Type 1 Custom yes yes yes 87 0 LCNHPJ+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 104 0 LCNHPF+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 107 0 LCNHPH+PalatinoLinotype TrueType WinAnsi yes yes no 110 0 LCNKEP+Calibri CID TrueType Identity-H yes yes yes 125 0 LCNHPF+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 131 0 LCNHPH+PalatinoLinotype TrueType WinAnsi yes yes no 134 0 LCNHPJ+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 137 0 LCNKDO+Calibri,Bold CID TrueType Identity-H yes yes yes 140 0 LCNKEP+Calibri CID TrueType Identity-H yes yes yes 154 0 LCNHPF+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 160 0 LCNHPH+PalatinoLinotype TrueType WinAnsi yes yes no 163 0 LCNHPJ+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 166 0 LCNKDO+Calibri,Bold CID TrueType Identity-H yes yes yes 169 0 LCNHPF+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 186 0 LCNHPH+PalatinoLinotype TrueType WinAnsi yes yes no 189 0 LCNHPJ+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 192 0 LCNHPF+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 206 0 LCNHPH+PalatinoLinotype TrueType WinAnsi yes yes no 209 0 LCNHPJ+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 212 0 LCNHPF+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 229 0 LCNHPH+PalatinoLinotype TrueType WinAnsi yes yes no 232 0 LCNHPJ+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 235 0 LCNHPF+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 248 0 LCNHPH+PalatinoLinotype TrueType WinAnsi yes yes no 251 0 LCNHPJ+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 254 0 LCNHPF+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 270 0 LCNHPH+PalatinoLinotype TrueType WinAnsi yes yes no 273 0 LCNHPJ+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 276 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2024-12-18 02:49:27 CET RepresentationInformation: pmc_10890536.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2024-12-12 02:29:45 CET Size: 3129087 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 464 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Materials and Methods Destination: section.2 Children: Item: Title: Design, Setting, and Participants Destination: subsection.2.1 Item: Title: Intervention Destination: subsection.2.2 Item: Title: MpMRI Technique and Evaluation Destination: subsection.2.3 Item: Title: Prostate Biopsy Procedure and Pathologic Analysis Destination: subsection.2.4 Item: Title: Proclarix™ Assessment Destination: subsection.2.5 Item: Title: BCN-RC 1 and BCN-RC 2 Risk of csPCa Assessment Destination: subsection.2.6 Item: Title: Proposed Risk-Stratified Pathways for Analysis Destination: subsection.2.7 Item: Title: Endpoint Variables Destination: subsection.2.8 Item: Title: Statistical Analysis Destination: subsection.2.9 Item: Title: Results Destination: section.3 Children: Item: Title: Characteristics of the Study Cohort Destination: subsection.3.1 Item: Title: Discrimination Ability for csPCa of Tools Used for Stratifications of Men Suspected of Having PCa Destination: subsection.3.2 Item: Title: Behavior and Clinical Effectiveness of Proposed RSPs Destination: subsection.3.3 Item: Title: Efficacy of Proposed RSPs Destination: subsection.3.4 Item: Title: Cost-Effectiveness Approximative Analysis Destination: subsection.3.5 Item: Title: Discussion Destination: section.4 Item: Title: Conclusions Destination: section.5 Item: Title: References Destination: section.6 Info: Title: Investigating Efficient Risk-Stratified Pathways for the Early Detection of Clinically Significant Prostate Cancer Author: Juan Morote, Ángel Borque-Fernando, Luis M. Esteban, Ana Celma, Miriam Campistol, Berta Miró, Olga Méndez and Enrique Trilla Subject: Risk-stratified pathways (RSPs) are recommended by the European Association of Uro-logy (EAU) to improve the early detection of clinically significant prostate cancer (csPCa). RSPs can reduce magnetic resonance imaging (MRI) demand, prostate biopsies, and the over-detection of insignificant PCa (iPCa). Our goal is to analyze the efficacy and cost-effectiveness of several RSPs by using sequential stratifications from the serum prostate-specific antigen level and digital rectal examination, the Barcelona risk calculators (BCN-RCs), MRI, and Proclarix™. In a cohort of 567 men with a serum PSA level above 3.0 ng/mL who underwent multiparametric MRI (mpMRI) and targeted and/or systematic biopsies, the risk of csPCa was retrospectively assessed using Proclarix™ and BCN-RCs 1 and 2. Six RSPs were compared with those recommended by the EAU that, stratifying men from MRI, avoided 16.7% of prostate biopsies with a prostate imaging reporting and data system score of <3, with 2.6% of csPCa cases remaining undetected. The most effective RSP avoided mpMRI exams in men with a serum PSA level of >10 ng/mL and suspicious DRE, following stratifications from BCN-RC 1, mpMRI, and Proclarix™. The demand for mpMRI decreased by 19.9%, prostate biopsies by 19.8%, and over-detection of iPCa by 22.7%, while 2.6% of csPCa remained undetected as in the recommended RSP. Cost-effectiveness remained when the Proclarix™ price was assumed to be below EUR 200. 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