Pd19-11 Interim Analysis of the Fast—study Frozen Section Analysis Assisted Mri-Targeted Biopsy for Prostate Cancer Diagnosis—a Prospective, Randomized Study

You have accessJournal of UrologyProstate Cancer: Detection & Screening II (PD19)1 May 2024PD19-11 INTERIM ANALYSIS OF THE FAST—STUDY FROZEN SECTION ANALYSIS ASSISTED MRI-TARGETED BIOPSY FOR PROSTATE CANCER DIAGNOSIS—A PROSPECTIVE, RANDOMIZED STUDY Matthias Jahnen, Juergen Gschwend, Andreas Sauter, Kristina Schwamborn, and Thomas Amiel Matthias JahnenMatthias Jahnen , Juergen GschwendJuergen Gschwend , Andreas SauterAndreas Sauter , Kristina SchwambornKristina Schwamborn , and Thomas AmielThomas Amiel View All Author Informationhttps://doi.org/10.1097/01.JU.0001009448.41537.64.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The contemporary diagnostic evaluation for patients suspicious of prostate cancer (PCa) is mpMRI of the prostate followed by MRI targeted (TB) plus systematic 12-core (SB) prostate biopsy in the case of suspicious MRI lesions. However, to reduce complications and discomfort it is of increasing interest to establish `targeted biopsy-only approaches´ in men suspicious of PCa. The aim of this prospective randomized study is to demonstrate the feasibility of a reduction of unnecessary extracted systematic biopsy cores while preserving an equal detection rate of significant PCa by performing primarily a TB followed by immediate frozen section analysis (FSA) and omitting SB when detecting clinically significant PCa (csPCa). METHODS: Since August 2022 patient accrual has started at the primary study site Klinikum rechts der Isar, School of Medicine, Technical University of Munich. Patients over the age of 50 undergoing prostate MRI fusion biopsy with a PIRADS≥4 lesion according to PIRADS V2.0 protocol are assessed for eligibility. Eligible patients are randomized in equal parts to either a TB + SB biopsy (Arm A; standard of care) or a primary TB with immediate FSA of the extracted cores (Arm B). In arm B no further cores will be extracted if FSA detects significant PCa (ISUP≥2). If no csPCa is detected these patients will undergo additional SB. FSA results are confirmed with an additionally extracted core for paraffin embedding followed by HE staining. The primary Endpoint is the non-inferiority of arm B compared to arm A regarding the detection of csPCa (ISUP≥2), while reducing the total number of extracted cores by around 70%. RESULTS: So far 117 men have been screened. N=92 men (PIRADS 4: 48; PIRADS 5: 44) have been randomized and biopsy has been performed according to protocol (Arm A: n=44, Arm B: n=48). 25 men have been excluded due to low MRI quality or MRI downgrading by the reference radiology. Mean age (Arm A: 67.7±7.5 years; Arm B: 70.4±8.3 years), mean PSA value (Arm A: 9.8±6.4 ng/ml; Arm B: 10.7±5.1 ng/ml), and prostate volume (Arm A: 50.3±23.7 ml; Arm B: 46.7±23.4 ml), has so far been comparable between Arm A and B (p>0.1). The overall clinically significant PCa detection rate (≥ISUP 2) in Arm A has been 93% (41/44) and 96% (46/48) in Arm B. The total number of extracted cores in Arm A has been 623 (14.2 cores per biopsy) and 218 (4.5 cores per biopsy) in Arm B. An immediate additional SB was performed following a negative FSA in 10% (5/48) of men in Arm B. In 60% (3/5) of these men, csPCa was detected after additional SB and HE staining. CONCLUSIONS: An FSA-assisted prostate biopsy in men suspicious of PCa in mpMRI seems feasible, leading to a significant reduction in extracted biopsy cores while maintaining a non-inferior detection rate of csPCa. Source of Funding: No external funding © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e444 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Matthias Jahnen More articles by this author Juergen Gschwend More articles by this author Andreas Sauter More articles by this author Kristina Schwamborn More articles by this author Thomas Amiel More articles by this author Expand All Advertisement PDF downloadLoading ...