Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resonance Imaging (ART-Pro): A Study Protocol for a Multicenter, Multinational Trial Evaluating Biparametric Magnetic Resonance Imaging and Advanced, Quantitative Diffusion Magnetic Resonance Imaging for the Detection of Prostate Cancer
Multiparametric magnetic resonance imaging (mpMRI) is strongly recommended by current clinical guidelines for improved detection of clinically significant prostate cancer (csPCa). However, the major limitations are the need for intravenous (IV) contrast and dependence on reader expertise. Efforts to...
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2025-01-01
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| author | Madison T. Baxter Christopher C. Conlin Aditya Bagrodia Tristan Barrett Hauke Bartsch Anja Brau Matthew Cooperberg Anders M. Dale Arnaud Guidon Michael E. Hahn Mukesh G. Harisinghani Juan F. Javier-DesLoges Sophia C. Kamran Christopher J. Kane Joshua M. Kuperman Daniel J.A. Margolis Paul M. Murphy Nabih Nakrour Michael A. Ohliger Rebecca Rakow-Penner Ahmed Shabaik Jeffry P. Simko Clare M. Tempany Natasha Wehrli Sean A. Woolen Jingjing Zou Tyler M. Seibert |
| author_facet | Madison T. Baxter Christopher C. Conlin Aditya Bagrodia Tristan Barrett Hauke Bartsch Anja Brau Matthew Cooperberg Anders M. Dale Arnaud Guidon Michael E. Hahn Mukesh G. Harisinghani Juan F. Javier-DesLoges Sophia C. Kamran Christopher J. Kane Joshua M. Kuperman Daniel J.A. Margolis Paul M. Murphy Nabih Nakrour Michael A. Ohliger Rebecca Rakow-Penner Ahmed Shabaik Jeffry P. Simko Clare M. Tempany Natasha Wehrli Sean A. Woolen Jingjing Zou Tyler M. Seibert |
| author_sort | Madison T. Baxter |
| collection | DOAJ |
| description | Multiparametric magnetic resonance imaging (mpMRI) is strongly recommended by current clinical guidelines for improved detection of clinically significant prostate cancer (csPCa). However, the major limitations are the need for intravenous (IV) contrast and dependence on reader expertise. Efforts to address these issues include use of biparametric magnetic resonance imaging (bpMRI) and advanced, quantitative magnetic resonance imaging (MRI) techniques. One such advanced technique is the Restriction Spectrum Imaging restriction score (RSIrs), an imaging biomarker that has been shown to improve quantitative accuracy of patient-level csPCa detection. Advanced Restriction imaging and reconstruction Technology for Prostate MRI (ART-Pro) is a multisite, multinational trial that aims to evaluate whether IV contrast can be avoided in the setting of standardized, state-of-the-art image acquisition, with or without addition of RSIrs. Additionally, RSIrs will be evaluated as a stand-alone, quantitative, objective biomarker. ART-Pro will be conducted in two stages and will include a total of 500 patients referred for multiparametric prostate MRI with a clinical suspicion of prostate cancer at the participating sites. ART-Pro-1 will evaluate bpMRI, mpMRI, and RSIrs on the accuracy of expert radiologists’ detection of csPCa and will evaluate RSIrs as a stand-alone, quantitative, objective biomarker. ART-Pro-2 will evaluate the same MRI techniques on the accuracy of nonexpert radiologists’ detection of csPCa, and findings will be evaluated against the expertly created dataset from ART-Pro-1. The primary endpoint is to evaluate whether bpMRI is noninferior to mpMRI among expert (ART-Pro-1) and nonexpert (ART-Pro-2) radiologists for the detection of grade group ≥2 csPCa. This trial is registered in the US National Library of Medicine Trial Registry (NCT number: NCT06579417) at ClinicalTrials.gov. Patient accrual at the first site (UC San Diego) began in December 2023. Initial results are anticipated by the end of 2026. |
| format | Article |
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| institution | Kabale University |
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| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-4d83ed1c3d234d46864d870ea6653c6a2025-01-17T04:52:23ZengElsevierEuropean Urology Open Science2666-16832025-01-0171132143Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resonance Imaging (ART-Pro): A Study Protocol for a Multicenter, Multinational Trial Evaluating Biparametric Magnetic Resonance Imaging and Advanced, Quantitative Diffusion Magnetic Resonance Imaging for the Detection of Prostate CancerMadison T. Baxter0Christopher C. Conlin1Aditya Bagrodia2Tristan Barrett3Hauke Bartsch4Anja Brau5Matthew Cooperberg6Anders M. Dale7Arnaud Guidon8Michael E. Hahn9Mukesh G. Harisinghani10Juan F. Javier-DesLoges11Sophia C. Kamran12Christopher J. Kane13Joshua M. Kuperman14Daniel J.A. Margolis15Paul M. Murphy16Nabih Nakrour17Michael A. Ohliger18Rebecca Rakow-Penner19Ahmed Shabaik20Jeffry P. Simko21Clare M. Tempany22Natasha Wehrli23Sean A. Woolen24Jingjing Zou25Tyler M. Seibert26Department of Radiation Medicine and Applied Sciences, University of California San Diego School of Medicine, La Jolla, CA, USADepartment of Radiology, University of California San Diego School of Medicine, La Jolla, CA, USADepartment of Urology, University of California San Diego School of Medicine, La Jolla, CA, USADepartment of Radiology, Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UKDepartment of Radiology, University of California San Diego School of Medicine, La Jolla, CA, USAGE Healthcare, Chicago, IL, USADepartment of Urology, University of California San Francisco, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, CA, USADepartment of Radiology, University of California San Diego School of Medicine, La Jolla, CA, USA; Department of Neurosciences, University of California San Diego School of Medicine, La Jolla, CA, USA; Halıcıoğlu Data Science Institute, University of California San Diego, La Jolla, CA, USAGE Healthcare, Chicago, IL, USADepartment of Radiology, University of California San Diego School of Medicine, La Jolla, CA, USADepartment of Radiology, Massachusetts General Hospital, Boston, MA, USADepartment of Urology, University of California San Diego School of Medicine, La Jolla, CA, USADepartment of Radiation Oncology, Massachusetts General Hospital, Boston, MA, USADepartment of Urology, University of California San Diego School of Medicine, La Jolla, CA, USADepartment of Radiology, University of California San Diego School of Medicine, La Jolla, CA, USADepartment of Radiology, Weill Cornell Medical College, New York, NY, USADepartment of Radiology, University of California San Diego School of Medicine, La Jolla, CA, USADepartment of Radiology, Massachusetts General Hospital, Boston, MA, USADepartment of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, USADepartment of Radiology, University of California San Diego School of Medicine, La Jolla, CA, USADepartment of Pathology, UC San Diego School of Medicine, La Jolla, CA, USADepartment of Urology, University of California San Francisco, San Francisco, CA, USA; Department of Pathology, University of California San Francisco, San Francisco, CA, USADepartment of Radiology, Massachusetts General Hospital, Boston, MA, USADepartment of Radiology, Weill Cornell Medical College, New York, NY, USADepartment of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, USADepartment of Biostatistics, Herbert Wertheim School of Public Health & Human Longevity Science, University of California San Diego, La Jolla, CA, USADepartment of Radiation Medicine and Applied Sciences, University of California San Diego School of Medicine, La Jolla, CA, USA; Department of Radiology, University of California San Diego School of Medicine, La Jolla, CA, USA; Department of Urology, University of California San Diego School of Medicine, La Jolla, CA, USA; Department of Bioengineering, University of California San Diego Jacobs School of Engineering, La Jolla, CA, USA; Corresponding author. Altman Clinical and Translational Research Institute, 9500 Gilman Drive, #0861, La Jolla, CA 92093, USA. Tel. +1 (858) 246-5988; Fax: +1 (844) 321-6610Multiparametric magnetic resonance imaging (mpMRI) is strongly recommended by current clinical guidelines for improved detection of clinically significant prostate cancer (csPCa). However, the major limitations are the need for intravenous (IV) contrast and dependence on reader expertise. Efforts to address these issues include use of biparametric magnetic resonance imaging (bpMRI) and advanced, quantitative magnetic resonance imaging (MRI) techniques. One such advanced technique is the Restriction Spectrum Imaging restriction score (RSIrs), an imaging biomarker that has been shown to improve quantitative accuracy of patient-level csPCa detection. Advanced Restriction imaging and reconstruction Technology for Prostate MRI (ART-Pro) is a multisite, multinational trial that aims to evaluate whether IV contrast can be avoided in the setting of standardized, state-of-the-art image acquisition, with or without addition of RSIrs. Additionally, RSIrs will be evaluated as a stand-alone, quantitative, objective biomarker. ART-Pro will be conducted in two stages and will include a total of 500 patients referred for multiparametric prostate MRI with a clinical suspicion of prostate cancer at the participating sites. ART-Pro-1 will evaluate bpMRI, mpMRI, and RSIrs on the accuracy of expert radiologists’ detection of csPCa and will evaluate RSIrs as a stand-alone, quantitative, objective biomarker. ART-Pro-2 will evaluate the same MRI techniques on the accuracy of nonexpert radiologists’ detection of csPCa, and findings will be evaluated against the expertly created dataset from ART-Pro-1. The primary endpoint is to evaluate whether bpMRI is noninferior to mpMRI among expert (ART-Pro-1) and nonexpert (ART-Pro-2) radiologists for the detection of grade group ≥2 csPCa. This trial is registered in the US National Library of Medicine Trial Registry (NCT number: NCT06579417) at ClinicalTrials.gov. Patient accrual at the first site (UC San Diego) began in December 2023. Initial results are anticipated by the end of 2026.http://www.sciencedirect.com/science/article/pii/S2666168324014344Biparametric magnetic resonance imagingClinical trialMultiparametric magnetic resonance imagingProstate cancerRestriction Spectrum ImagingRestriction Spectrum Imaging restriction score |
| spellingShingle | Madison T. Baxter Christopher C. Conlin Aditya Bagrodia Tristan Barrett Hauke Bartsch Anja Brau Matthew Cooperberg Anders M. Dale Arnaud Guidon Michael E. Hahn Mukesh G. Harisinghani Juan F. Javier-DesLoges Sophia C. Kamran Christopher J. Kane Joshua M. Kuperman Daniel J.A. Margolis Paul M. Murphy Nabih Nakrour Michael A. Ohliger Rebecca Rakow-Penner Ahmed Shabaik Jeffry P. Simko Clare M. Tempany Natasha Wehrli Sean A. Woolen Jingjing Zou Tyler M. Seibert Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resonance Imaging (ART-Pro): A Study Protocol for a Multicenter, Multinational Trial Evaluating Biparametric Magnetic Resonance Imaging and Advanced, Quantitative Diffusion Magnetic Resonance Imaging for the Detection of Prostate Cancer European Urology Open Science Biparametric magnetic resonance imaging Clinical trial Multiparametric magnetic resonance imaging Prostate cancer Restriction Spectrum Imaging Restriction Spectrum Imaging restriction score |
| title | Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resonance Imaging (ART-Pro): A Study Protocol for a Multicenter, Multinational Trial Evaluating Biparametric Magnetic Resonance Imaging and Advanced, Quantitative Diffusion Magnetic Resonance Imaging for the Detection of Prostate Cancer |
| title_full | Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resonance Imaging (ART-Pro): A Study Protocol for a Multicenter, Multinational Trial Evaluating Biparametric Magnetic Resonance Imaging and Advanced, Quantitative Diffusion Magnetic Resonance Imaging for the Detection of Prostate Cancer |
| title_fullStr | Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resonance Imaging (ART-Pro): A Study Protocol for a Multicenter, Multinational Trial Evaluating Biparametric Magnetic Resonance Imaging and Advanced, Quantitative Diffusion Magnetic Resonance Imaging for the Detection of Prostate Cancer |
| title_full_unstemmed | Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resonance Imaging (ART-Pro): A Study Protocol for a Multicenter, Multinational Trial Evaluating Biparametric Magnetic Resonance Imaging and Advanced, Quantitative Diffusion Magnetic Resonance Imaging for the Detection of Prostate Cancer |
| title_short | Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resonance Imaging (ART-Pro): A Study Protocol for a Multicenter, Multinational Trial Evaluating Biparametric Magnetic Resonance Imaging and Advanced, Quantitative Diffusion Magnetic Resonance Imaging for the Detection of Prostate Cancer |
| title_sort | advanced restriction imaging and reconstruction technology for prostate magnetic resonance imaging art pro a study protocol for a multicenter multinational trial evaluating biparametric magnetic resonance imaging and advanced quantitative diffusion magnetic resonance imaging for the detection of prostate cancer |
| topic | Biparametric magnetic resonance imaging Clinical trial Multiparametric magnetic resonance imaging Prostate cancer Restriction Spectrum Imaging Restriction Spectrum Imaging restriction score |
| url | http://www.sciencedirect.com/science/article/pii/S2666168324014344 |
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