Clinical trial NCT06579417: ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer
Official title: Advanced Restriction Imaging and Reconstruction Technology for Prostate MRI (ART-Pro)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Prostate cancer
Multiparametric MRI
Biparametric MRI
Restriction Spectrum Imaging
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: GE Healthcare
name: University of California, San Francisco
name: Massachusetts General Hospital
name: Weill Medical College of Cornell University
name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2024-08-30
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients diagnosed with a grade group ≥2 prostate cancer on biopsy
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients undergoing a biopsy that reveals no cancer or only grade group 1 prostate cancer
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: University of California, San Diego
name: Tyler Seibert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: