Clinical trial · Observational
ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer
Advanced Restriction Imaging and Reconstruction Technology for Prostate MRI (ART-Pro)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RSI MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ART-Pro-1
- interventionNames
- Diagnostic Test: RSI MRI
Primary outcomes (1)
- measure
- Proportion of patients diagnosed with a grade group ≥2 prostate cancer on biopsy
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- Proportion of patients undergoing a biopsy that reveals no cancer or only grade group 1 prostate cancer
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Referred for mpMRI of the prostate for suspicion of prostate cancer * MRI is conducted using the standardized ART-Pro acquisition protocol Exclusion Criteria: * Currently incarcerated * Previous diagnosis of prostate cancer * Active non-prostate tumor(s) in structures of the body near the prostate * Previous prostate surgery * History of hip implant * Metal implants or implanted devices in the body or other criteria that are deemed to require deviation from the usual acquisition protocol or scanning procedures
References
Publications (1)
- DERIVEDBaxter 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. PMID 39811103