Citations 2
Biparametric vs Multiparametric MRI for Prostate Cancer Diagnosis
Ng, Alexander , Asif, Aqua , Gómez‐Gómez, Enrique , Budäus, Lars, Barrett, Tristan , Radtke, Jan Philipp , Kesch, Claudia, Pham, Tho, Tewari, Ash , Cabello, M.A. Rodríguez , Mynderse, Lance A. , Borghi, Marcelo, Boesen, Lars , Singh, Paras B. , Renard‐Penna, Raphaële , Leow, Jeffrey J. , Pecoraro, Martina , Giannarini, Gianluca , Perlis, Nathan , López-Ruiz, Daniel, Rossiter, Marimo , Khetrapal, Pramit , Chan, Vinson Wai‐Shun , Haider, Aiman , Clarke, Caroline S. , Dickinson, Louise , Mitra, Anita, Margolis, Daniel J. A., Takwoingi, Yemisi , Emberton, Mark , Allen, Clare, Moore, Caroline M. , Kasivisvanathan, Veeru , Collaborators, PRIME Study Group, Briganti, Alberto , Evangelista, Alex, Freeman, Alex , Kirkham, Alex, Zlotta, Alexandre R. , Grey, Alistair, Ryan, Andrew, Borrelli, Antonella , Andrews, Antonette, Finelli, Antonio , Sancho, Arturo Platas, Baring, Ashley, Roy, Ashoke, Issa, Balqiisa, Israël, Bas , González, Carolina Aulló, English, Caroline, Zuiani, Chiara , Amate, Cristina, Yong, Daniel , Rozze, Davide, Lomas, Derek J. , Cannoletta, Donato , Chang, Eileen Wang, Chun, Felix, Zussino, Gaia , Antoch, Gerald , Gandaglia, Giorgio, Sauter, Guido , Thevarajah, Harini, Sorrell, Harriet, McBain, Hazel, Reis, Henning , Pita, Hernando Ríos , Potyka, Ingrid , Collavino, Jeanlou, Koshy, Jincy, Weng, Jing Yi , Withington, John, Egmond, Joke van, Piper, Jon, O’Brien, Jonathan , Rosa, José Valero, Sanz, Juan Luis , Quesada, Juan Mesa, Jannusch, Kai , Corr, Kateri , Haines, Kenneth, Umutlu, Lale , Quarta, Leonardo, Casarotto, Letizia, Gimeno, Linda , Moretti, Lucas, Laschena, Ludovica , Drewes, Lukas, Ostos, Manuel Sanchez, Peris, M., Volpacchio, Mariano , Prentice, Mark, Graefen, Markus , Soligo, Matteo, Boschheidgen, Matthias , Singhera, M., Wenzel, Mike, Fatterpekar, Monali, Al‐Nader, Mulham , Kachanov, Mykyta , Shaida, Nadeem , Muirhead, Nicola , Vasdev, Nikhil , Sanmugalingam, Nimalan , Nørgaard, Nis , Vicente, Pete, Incze, Peter , Ryan, Philip, Rouvier, Philippe , Mead, Phoebe, Mozer, Pierre, Viana, Públio César Cavalcante , Jiménez, Rafael E. , Novotta, Réka, Huang, Richard, O’Sullivan, Richard, Jepsen, Rikke Karlin , Frese, Robert, Clow, Rosemary, Al‐Monajjed, Rouvier , Lewis, Sara , Cashman, Sophia, Pizzolitto, Stefano, Lelie, S., Lindner, Sydney, Al‐Hammouri, Tarek , Sánchez, Teresa González, Reid, Thomas, McClure, Timothy, Maurer, Tobias , Peruzzi, Valeria, Tan, Wei Phin, Nahas, William Carlos, Chong, Yew Lam, Agarwal, Ridhi , Panebianco, Valeria , Girometti, Rossano , Ghai, Sangeet , COBELLI, Francesco DE , Pham, Tho, Taneja, Samir S. , Hu, Jim C. , Dias, Adriano Basso , Falkenbach, Fabian , Kastner, Christof , Schimmöller, Lars , Nathan, Arjun , Punwani, Shonit , Brew‐Graves, Chris , Brembilla, Giorgio , Margolis, Daniel , Giganti, Francesco , Collaborators, PRIME Study Group, Crestani, Alessandro , Sciarra, Alessandro , Evangelista, Alex, Kirkham, Alex P. S. , Grey, Alistair, Blanca, Ana , Bjartell, Anders , Tong, Angela , Warren, Anne Y. , Ciardi, Antonio , Rannikko, Antti , Stabile, Armando , Villers, Arnauld A. , Issa, Balqiisa, Hadaschik, Boris Alexander , English, Caroline L, Lee, Chau Hung , Caris, Christien T.M. , Stempel, Conrad von , Rozze, Davide, Messina, Emanuele , Chun, Felix, Gandaglia, Giorgio, Robert, G. , Caglič, Iztok , Theysohn, Jens Matthias , Grummet, Jeremy , Koshy, Jincy, Wilkinson, John, Withington, John, Egmond, Joke van, Deeks, Jonathan J , O'Brien, Jonathan, Quesada, Juan Mesa, Quarta, Leonardo , Orecchia, Luca , Moretti, Lucas, Rooij, Maarten de , Bicchetti, Marco , Gatti, Marco , Peris, María de los Desamparados Esteban, Roethke, Matthias Claudius , Monte, Maurizio Del, Wenzel, Mike, Takahashi, Naoki , Fleshner, Neil , Albers, Peter , Mead, Phoebe, Visschere, Pieter De , Huang, Richard, Shah, Syed Ahmar , Sanchez, Teresa González, Bathala, Tharakeswara K , Kwast, Theodorus van der , Reid, Thomas, Løgager, Vibeke , Prabhu, Vinay , Wagaskar, Vinayak Gorakhnath , Tan, Wei Phin, Nahas, William Carlos, Witjes, Wim P.J. , Chong, Yew Lam
JAMA | September 10, 2025 | Volume: 334 | Issue: 13 | Pages: 1170
Importance Multiparametric magnetic resonance imaging (MRI), with or without prostate biopsy, has become the standard of care for diagnosing clinically significant prostate cancer. Resource capacity limits widespread adoption. Biparametric MRI, which omits the gadolinium contrast sequence, is a shorter and cheaper alternative offering time-saving capacity gains for health systems globally. Objective To assess whether biparametric MRI is noninferior to multiparametric MRI for diagnosis of clinically significant prostate cancer. Design, Setting, and Participants A prospective, multicenter, within-patient, noninferiority trial of biopsy-naive men from 22 centers (12 countries) with clinical suspicion of prostate cancer (elevated prostate-specific antigen [PSA] level and/or abnormal digital rectal examination findings) from April 2022 to September 2023, with the last follow-up conducted on December 3, 2024. Interventions Participants underwent multiparametric MRI, comprising T2-weighted, diffusion-weighted, and dynamic contrast–enhanced (DCE) sequences. Radiologists reported abbreviated biparametric MRI first (T2-weighted and diffusion-weighted), blinded to the DCE sequence. After unblinding, radiologists reported the full multiparametric MRI. Patients underwent a targeted biopsy with or without systematic biopsy if either biparametric MRI or multiparametric MRI was suggestive of clinically significant prostate cancer. Main outcomes and measures The primary outcome was the proportion of men with clinically significant prostate cancer. Secondary outcomes included the proportion of men with clinically insignificant cancer. The noninferiority margin was 5%. Results Of 555 men recruited, 490 were included for primary outcome analysis. Median age was 65 (IQR, 59-70) years and median PSA level was 5.6 (IQR, 4.4-8.0) ng/mL. The proportion of patients with abnormal digital rectal examination findings was 12.7%. Biparametric MRI was noninferior to multiparametric MRI, detecting clinically significant prostate cancer in 143 of 490 men (29.2%), compared with 145 of 490 men (29.6%) (difference, −0.4 [95% CI, −1.2 to 0.4] percentage points; P = .50). Biparametric MRI detected clinically insignificant cancer in 45 of 490 men (9.2%), compared with 47 of 490 men (9.6%) with the use of multiparametric MRI (difference, −0.4 [95% CI, −1.2 to 0.4] percentage points). Central quality control demonstrated that 99% of scans were of adequate diagnostic quality. Conclusion and relevance In men with suspected prostate cancer, provided image quality is adequate, an abbreviated biparametric MRI scan, with or without targeted biopsy, could become the new standard of care for prostate cancer diagnosis. With approximately 4 million prostate MRIs performed globally annually, adopting biparametric MRI could substantially increase scanner throughput and reduce costs worldwide. Trial registration ClinicalTrials.gov Identifier: NCT04571840
A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial
George, Arvin K. , Miocinovic, Ranko, Lomas, Derek J. , Chen, David Y. T., Rastinehad, Ardeshir R. , Schwartz, Michael J. , Uchio, Edward , Sidana, Abhinav , Gahan, Jeffrey , Yu, Alice , Vourganti, Srinivas , Barqawi, Al B. , Brisbane, Wayne , Wysock, James , Polascik, Thomas J. , McClure, Timothy, Rastinehad, Ardeshir R , Schwartz, Michael J , Patel, Amit R. , Correa, Andres F. , Chen, David Y.T. , Helfand, Brian T. , Polascik, Thomas J. , Coleman, Jonathan
Cancers | June 10, 2024 | Volume: 16 | Issue: 12 | Pages: 2178
The PRESERVE study (NCT04972097) aims to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue in patients with intermediate-risk prostate cancer (PCa). The NanoKnife uses irreversible electroporation (IRE) to deliver high-voltage electrical pulses to change the permeability of cell membranes, leading to cell death. A total of 121 subjects with organ-confined PCa ≤ T2c, prostate-specific antigens (PSAs) ≤ 15 ng/mL, and a Gleason score of 3 + 4 or 4 + 3 underwent focal ablation of the index lesion. The primary endpoints included negative in-field biopsy and adverse event incidence, type, and severity through 12 months. At the time of analysis, the trial had completed accrual with preliminary follow-up available. Demographics, disease characteristics, procedural details, PSA responses, and adverse events (AEs) are presented. The median (IQR) age at screening was 67.0 (61.0–72.0) years and Gleason distribution 3 + 4 (80.2%) and 4 + 3 (19.8%). At 6 months, all patients with available data (n = 74) experienced a median (IQR) percent reduction in PSA of 67.6% (52.3–82.2%). Only ten subjects (8.3%) experienced a Grade 3 adverse event; five were procedure-related. No Grade ≥ 4 AEs were reported. This study supports prior findings that IRE prostate ablation with the NanoKnife System can be performed safely. Final results are required to fully assess oncological, functional, and safety outcomes.