Status:
RECRUITING
ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
GE Healthcare
University of California, San Francisco
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
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 cli...
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 evalu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06579417
Start Date
December 15 2023
End Date
July 1 2029
Last Update
November 6 2024
Active Locations (5)
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1
University of California San Diego
San Diego, California, United States, 92037
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Weill Cornell Medical College
New York, New York, United States, 10065