An observational study in Prostate Cancer, sponsored by Northwestern University. Withdrawn at 1 site in United States. Open to male participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Northwestern University · Observational
The purpose of this study is to develop a new way to diagnose prostate cancer through the use of artificial intelligence. The goal is for this new method to reduce delays in diagnoses and to avoid invasive procedures such as biopsies.
The overall goal of this project is to create a diagnosis and patient management strategy (called HIT-PIRADS) for prostate cancer (PCa) that will significantly increase positive predictive value (PPV) for clinically significant PCa detection while minimizing unnecessary prostate biopsies and related morbidities. Due to its interpretable nature and bias correction paradigm, the AI system will generate predictions that physicians can trust. One of the immediate outcomes of the system will be a reproducible risk scoring system that can be used in community hospitals and locales without MRI-subspeciality genitourinary trained radiologists to improve the accuracy of prostate imaging nationwide. In the long term, the investigators expect HIT-PIRADS to be widely adopted in clinics and trigger other treatment and prevention strategies to be developed based on HIT-PIRADS.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
Browse Prostatic Neoplasms studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients at an increased risk of having prostate cancer. An increased risk for prostate cancer means the patient may have had either a blood test which indicated they have an elevated prostate-specific antigen (PSA) (a protein produced by both cancerous and noncancerous tissue in the prostate), or an abnormal exam of the patient's rectum, anus or prostate gland.
Exclusion Criteria:
Biopsy naïve participants with elevated PSA (4.0-10.0 ng/ml) or abnormal digital rectal exam with PSA of 2.00-10.00 ng/ml as indicated in their lab report.
Number of Participants with detection of clinically significant prostate cancer (csPCa)
csPCa is defined as PCa with a Gleason Grade Group of 2 through 5 found on prostate biopsy. Detection of csPCa will be compared for HITPIRADS vs. PIRADS v2.1 with a focus on suspicious lesions.
Time frame: 01/01/2016-12/31/2026
Plan to share: Yes
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This study is withdrawn, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Northwestern University