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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
| University of California, San Francisco | OTHER |
| Massachusetts General Hospital | OTHER |
| Weill Medical College of Cornell University |
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This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate cancer (csPCa). The study will enroll 500 participants at 5 clinical centers (100 participants per center). The current standard MRI technique for prostate cancer screening is multiparametric MRI (mpMRI), but two drawbacks include need for intravenous (IV) contrast and dependence on radiologist expertise. The investigators expect that the combination of two other techniques, biparametric MRI (bpMRI) and Restriction Spectrum Imaging restriction score (RSIrs), will help non-expert radiologists achieve similar performance to expert radiologists using bpMRI or mpMRI for detection of csPCa, while avoiding the drawbacks that are present when using mpMRI.
ART-Pro will be conducted in two phases (ART-Pro-1 and ART-Pro-2) and will evaluate bpMRI, mpMRI, and RSIrs (an advanced quantitative diffusion technique), for detection of csPCa. ART-Pro-1 will evaluate these techniques prospectively, by having each patients' MRI exam read by 2 expert radiologists, both using different subsets of the images to evaluate the different techniques. ART-Pro-1 will additionally evaluate RSIrs as a stand-alone quantitative biomarker. ART-Pro-2 will evaluate these same techniques retrospectively using radiologists of varying experience levels (novice, basic, and expert), and findings will be evaluated against the expertly created dataset from ART-Pro-1. Patients will be followed after initial enrollment for the purpose of extracting relevant medical outcomes, such as biopsy results or surgery pathology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ART-Pro-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSI MRI | Diagnostic Test | In ART-Pro-1, patients receive standard of care mpMRI, with addition of the RSI sequence, and subsets of the patients' images are read separately by two expert radiologists at the center, one of whom is the standard of care radiologist (Reader 1). Three research reports are generated using: bpMRI only (Reader 1), mpMRI (Reader 1), and bpMRI + RSIrs (Reader 2). The clinical report is submitted by Reader 1. Patients' future prostate cancer management will be recorded and used to evaluate the performance of the MRI techniques being tested. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients diagnosed with a grade group ≥2 prostate cancer on biopsy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients undergoing a biopsy that reveals no cancer or only grade group 1 prostate cancer | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients referred for a multiparametric prostate MRI at any of the five participating sites, with a clinical suspicion of prostate cancer and that meet all the inclusion/exclusion criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tyler Seibert, MD, PhD | Contact | 858-246-2180 | tseibert@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tyler Seibert, MD, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | San Diego | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39811103 | Derived | Baxter MT, Conlin CC, Bagrodia A, Barrett T, Bartsch H, Brau A, Cooperberg M, Dale AM, Guidon A, Hahn ME, Harisinghani MG, Javier-DesLoges JF, Kamran SC, Kane CJ, Kuperman JM, Margolis DJA, Murphy PM, Nakrour N, Ohliger MA, Rakow-Penner R, Shabaik A, Simko JP, Tempany CM, Wehrli N, Woolen SA, Zou J, Seibert TM. 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. Eur Urol Open Sci. 2024 Dec 20;71:132-143. doi: 10.1016/j.euros.2024.12.003. eCollection 2025 Jan. |
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| OTHER |
| Cambridge University Hospitals NHS Foundation Trust | OTHER |
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| University of California, San Francisco | Not yet recruiting | San Francisco | California | 94143 | United States |
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| Massachusetts General Hospital | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
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| Weill Cornell Medical College | Not yet recruiting | New York | New York | 10065 | United States |
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| Cambridge University Hospitals NHS Foundation Trust | Not yet recruiting | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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