Mp74-08 [68ga]psma Pet/Ct vs. Mpmri in Patients With Suspicion of Prostate Cancer and Previous Negative Biopsy: Results of the Prospet-Bx Trial

You have accessJournal of UrologyProstate Cancer: Detection & Screening VI (MP74), Moderated Poster 741 May 2024MP74-08 [68GA]PSMA PET/CT VS. MPMRI IN PATIENTS WITH SUSPICION OF PROSTATE CANCER AND PREVIOUS NEGATIVE BIOPSY: RESULTS OF THE PROSPET-BX TRIAL Vittorio Fasulo, Davide Maffei, Paola Arena, Pier Paolo Avolio, Luca Disconzi, Piergiuseppe Colombo, Alberto Rosario Saita, Rodolfo Fausto Hurle, Giorgio Ferruccio Guazzoni, Luca Balzarini, Marcello Rodari, Paolo Casale, Nicolò Maria Buffi, Massimo Lazzeri, Egesta Lopci, and Giovanni Lughezzani Vittorio FasuloVittorio Fasulo , Davide MaffeiDavide Maffei , Paola ArenaPaola Arena , Pier Paolo AvolioPier Paolo Avolio , Luca DisconziLuca Disconzi , Piergiuseppe ColomboPiergiuseppe Colombo , Alberto Rosario SaitaAlberto Rosario Saita , Rodolfo Fausto HurleRodolfo Fausto Hurle , Giorgio Ferruccio GuazzoniGiorgio Ferruccio Guazzoni , Luca BalzariniLuca Balzarini , Marcello RodariMarcello Rodari , Paolo CasalePaolo Casale , Nicolò Maria BuffiNicolò Maria Buffi , Massimo LazzeriMassimo Lazzeri , Egesta LopciEgesta Lopci , and Giovanni LughezzaniGiovanni Lughezzani View All Author Informationhttps://doi.org/10.1097/01.JU.0001008632.59099.b9.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Increasing evidence on PSMA PET/CT has emerged regarding its ability to detect intraprostatic foci of prostate cancer (PCa). As such, it represents an exciting opportunity for disease localization, particularly in men unsuitable for MRI or with negative standard imaging. Herein we present the results of the interim analyses of our prospective trial (Identifier: NCT05297162), designed to compare [68Ga]PSMA PET/CT with mpMRI in men with a high suspicion of prostate cancer (PCa) after at least one previous negative biopsy. METHODS: From April 2022 until October 2023, overall, 98 patients were screened, 82 were enrolled and 65 completed all study investigations. Inclusion criteria: PSA >4.0ng/ml; free-to-total PSA ratio <20%; progressive rise of PSA levels in two consecutive samples; at least one previous negative biopsy; negative digital rectal examination [1]. [68Ga]PSMA PET/CT and 3T mpMRI were performed within one month, followed by TRUS-fusion prostate biopsy. Target lesions were defined based on PI-RADS v2.1 for mpMRI and Primary Score, SUVmax and SUVratio [2-4] for [68Ga]PSMA PET/CT, then correlated to pathology findings. RESULTS: Median age was 64 years (range 51-83) and median PSA 10.2 ng/ml (range 4.3-25,9). Most patients (51; 78.5%) had one previous negative biopsy. According to re-biopsy results, 10 patients presented with clinically significant PCa (csPCa), 4 with GS 6, while the majority had a negative biopsy (78.5%). mpMRI results were: 40 patients with PI-RADS 2 (61.5%), 3 with PI-RADS 3 (4.6%), 16 with PI-RADS 4 (24.6%), and 6 with PI-RADS 5 (9.2%). Primary scores were: 46 score 1-2 (70.8%), and 20 score 3-5. PI-RADS and Primary scores were significantly correlated (p=0.0006). Median SUVmax and SUVratio were 3.7 and 1.35 for benign versus 8.9 and 3 for malignancy, respectively (p<0.001). ROC analyses identified optimal cut-off points for csPCA, with SUVmax >7.48 (AUC 0.756; 95%CI 0.633-0.855) and SUVratio >2.79 (AUC 0.748; 95%CI 0.624-0.848). PI-RADS, Primary score, SUVmax and SUVratio proved significantly associated to biopsy results. When combining [68Ga]PSMA PET/CT with mpMRI data, the detection rate was 90% for csPCa, and the combination of both modalities could spare 96% of unnecessary re-biopsies. CONCLUSIONS: In these interim results, [68Ga]PSMA PET/CT parameters predicts biopsy results as mpMRI in patients candidate to rebiopsy; the combination of both modalities can spare most unnecessary re-biopsies, by granting a 90% detection rate for csPCa. Source of Funding: The study was financially supported by the Italian Ministry of Health (Ministero della Salute) with the Grant GR-2018-12366240 © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1196 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Vittorio Fasulo More articles by this author Davide Maffei More articles by this author Paola Arena More articles by this author Pier Paolo Avolio More articles by this author Luca Disconzi More articles by this author Piergiuseppe Colombo More articles by this author Alberto Rosario Saita More articles by this author Rodolfo Fausto Hurle More articles by this author Giorgio Ferruccio Guazzoni More articles by this author Luca Balzarini More articles by this author Marcello Rodari More articles by this author Paolo Casale More articles by this author Nicolò Maria Buffi More articles by this author Massimo Lazzeri More articles by this author Egesta Lopci More articles by this author Giovanni Lughezzani More articles by this author Expand All Advertisement PDF downloadLoading ...