Trial Title:
ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer
NCT ID:
NCT06579417
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate cancer
Multiparametric MRI
Biparametric MRI
Restriction Spectrum Imaging
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
RSI MRI
Description:
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.
Arm group label:
ART-Pro-1
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Probability Sample
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California San Diego
Address:
City:
San Diego
Zip:
92037
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tyler M Seibert, MD, PhD
Phone:
858-246-2180
Email:
tseibert@health.ucsd.edu
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sean A Woolen, MD
Phone:
415-353-2573
Email:
sean.woolen@ucsf.edu
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Mukesh G Harisinghani, MD
Phone:
617-726-2000
Email:
mharisinghani@mgh.harvard.edu
Facility:
Name:
Weill Cornell Medical College
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Daniel JA Margolis, MD
Phone:
212-746-5454
Email:
djm9016@med.cornell.edu
Facility:
Name:
Cambridge University Hospitals NHS Foundation Trust
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Tristan Barrett, MD
Phone:
44 + 01223 805000
Email:
tristan.barrett@nhs.net
Start date:
December 15, 2023
Completion date:
July 2029
Lead sponsor:
Agency:
University of California, San Diego
Agency class:
Other
Collaborator:
Agency:
GE Healthcare
Agency class:
Industry
Collaborator:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
Weill Medical College of Cornell University
Agency class:
Other
Collaborator:
Agency:
Cambridge University Hospitals NHS Foundation Trust
Agency class:
Other
Source:
University of California, San Diego
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06579417
