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Observational Study for Prostate Cancer Diagnosis Using AI

This study, called HIT-PIRADS, is developing a new way to diagnose prostate cancer using artificial intelligence (AI). The goal is to create a more accurate diagnosis method that can help reduce delays and potentially avoid invasive procedures like biopsies. Researchers will be looking at how many participants are found to have clinically significant prostate cancer (csPCa) between 2016 and 2026. You might be able to join if you are a man between 18 and 89 years old, have elevated PSA (prostate-specific antigen, a blood test marker) or an abnormal digital rectal exam, and have not had a prostate biopsy before. This study is observational, meaning researchers will be watching and collecting information rather than testing a specific treatment.

Study design
This is an observational study with a planned enrollment of 800 men. It is not testing a specific treatment or intervention.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06804785

Hybrid Intelligence for Trustable Diagnosis and Patient Management of Prostate Cancer (HIT-PIRADS)

Withdrawn
Not specifiedAges 18–89Observational
Northwestern University
Updated 2026-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with detection of clinically significant prostate cancer (csPCa)
Measured over 01/01/2016-12/31/2026

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 the patient's lab report.
Patients must be biopsy naïve, confirmed with patient or medical record.
Patients must be male, ≥18 and ≤ 89 years of age.
Patient must have a life expectancy ≥10 years, determined by PI.
Patients must exhibit an ECOG performance status of 0-2, as noted in their medical record.

Exclusion

Patients who are on a 5-α-reductase inhibitor within 12 months of enrollment, as confirmed by medical record.
Patients who have had a prostate infection within 1 month of enrollment, as confirmed by medical record.
Patients who are receiving or who received prostate cancer treatment (e.g., androgen deprivation therapy, surgery, radiation therapy or adjuvant/neoadjuvant therapy with investigational drugs) per their medical record.
Patients who've had an invasive urological procedure within 1 month of enrollment, as confirmed by their medical record and patient reporting.
Patients with no access to the rectum for a transrectal ultrasound, as determined by the Urologist.
Patients with a contraindication to magnetic resonance imaging (MRI).
Vulnerable populations: Prisoners or adult men \>89 years old.

What this trial measures

  • Number of Participants with detection of clinically significant prostate cancer (csPCa)01/01/2016-12/31/2026

    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.