Riccardo Schiavina1, Matteo Droghetti2, Giacomo Novara3, Lorenzo Bianchi1, Caterina Gaudiano4, Valeria Panebianco5, Marco Borghesi1, Pietro Piazza1, Federico Mineo Bianchi1, Marco Guerra1, Beniamino Corcioni4, Michelangelo Fiorentino6, Francesca Giunchi6, Paolo Verze7, Cristian Pultrone1, Rita Golfieri4, Angelo Porreca8, Vincenzo Mirone9, Eugenio Brunocilla1. 1. Department of Urology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy. 2. Department of Urology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy. Electronic address: droghet@gmail.com. 3. Department of Surgery, Oncology, and Gastroenterology - Urology Clinic University of Padua, Padua, Italy. 4. Department of Radiology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy. 5. Department of Radiology, University of Rome "La Sapienza", Rome, Italy. 6. Department of Pathology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy. 7. Department of Medicine, Surgery, Dentistry "Scuola Medica Salernitana", University of Salerno, Salerno, Italy. 8. Department of Urology, Policlinico Abano Terme, Abano Terme, Italy. 9. Department of Urology, University of Naples, Federico II, Naples, Italy.
Abstract
BACKGROUND: We aim to evaluate the impact of multiparametric magnetic resonance imaging and fusion-target biopsy for early reclassification of patients with low-risk Prostate Cancer in a randomized trial. MATERIALS AND METHODS: Between 2015 and 2018, patients diagnosed with Prostate Cancer after random biopsy fulfilling PRIAS criteria were enrolled and centrally randomized (1:1 ratio) to study group or control group. Patients randomized to study group underwent multiparametric magnetic resonance imaging at 3 months from enrollment: patients with positive findings (PIRADS-v2>2) underwent fusion-target biopsy; patients with negative multiparametric magnetic resonance imaging or confirmed ISUP - Grade Group 1 at fusion-target biopsy were managed according to PRIAS schedule and 12-core random biopsy was performed at 12 months. Patients in control group underwent PRIAS protocol, including a confirmatory 12-core random biopsy at 12 months. Primary endpoint was a reduction of reclassification rate at 12-month random biopsy in study group at least 20% less than controls. Reclassification was defined as biopsy ISUP Grade Group 1 in >2 biopsy cores or disease upgrading. RESULTS: A total of 124 patients were randomized to study group (n = 62) or control group (n = 62). Around 21 of 62 patients (34%) in study group had a positive multiparametric magnetic resonance imaging, and underwent fusion-target biopsy, with 11 (17.7%) reclassifications. Considering the intention-to-treat population, reclassification rate at 12-month random biopsy was 6.5% for study group and 29% for control group, respectively (P < 0.001). CONCLUSIONS: The early employment of multiparametric magnetic resonance imaging for active surveillance patients enrolled after random biopsy consents to significantly reduce reclassifications at 12-month random biopsy.
BACKGROUND: We aim to evaluate the impact of multiparametric magnetic resonance imaging and fusion-target biopsy for early reclassification of patients with low-risk Prostate Cancer in a randomized trial. MATERIALS AND METHODS: Between 2015 and 2018, patients diagnosed with Prostate Cancer after random biopsy fulfilling PRIAS criteria were enrolled and centrally randomized (1:1 ratio) to study group or control group. Patients randomized to study group underwent multiparametric magnetic resonance imaging at 3 months from enrollment: patients with positive findings (PIRADS-v2>2) underwent fusion-target biopsy; patients with negative multiparametric magnetic resonance imaging or confirmed ISUP - Grade Group 1 at fusion-target biopsy were managed according to PRIAS schedule and 12-core random biopsy was performed at 12 months. Patients in control group underwent PRIAS protocol, including a confirmatory 12-core random biopsy at 12 months. Primary endpoint was a reduction of reclassification rate at 12-month random biopsy in study group at least 20% less than controls. Reclassification was defined as biopsy ISUP Grade Group 1 in >2 biopsy cores or disease upgrading. RESULTS: A total of 124 patients were randomized to study group (n = 62) or control group (n = 62). Around 21 of 62 patients (34%) in study group had a positive multiparametric magnetic resonance imaging, and underwent fusion-target biopsy, with 11 (17.7%) reclassifications. Considering the intention-to-treat population, reclassification rate at 12-month random biopsy was 6.5% for study group and 29% for control group, respectively (P < 0.001). CONCLUSIONS: The early employment of multiparametric magnetic resonance imaging for active surveillance patients enrolled after random biopsy consents to significantly reduce reclassifications at 12-month random biopsy.
Authors: Rocco S Flammia; Benedikt Hoeh; Lukas Hohenhorst; Gabriele Sorce; Francesco Chierigo; Andrea Panunzio; Zhe Tian; Fred Saad; Costantino Leonardo; Alberto Briganti; Alessandro Antonelli; Carlo Terrone; Shahrokh F Shariat; Umberto Anceschi; Markus Graefen; Felix K H Chun; Francesco Montorsi; Michele Gallucci; Pierre I Karakiewicz Journal: Int Urol Nephrol Date: 2022-07-15 Impact factor: 2.266