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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Northwestern University
Study ID
NCT06804785
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Aug 31, 2025
Status verified
May 2025
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: Cohort 1
    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.

Primary Outcome Measure

Number of Participants with detection of clinically significant prostate cancer (csPCa) [ Time Frame: 01/01/2016-12/31/2026 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of HealthBethesdaMaryland20892
Ismail Turkbey
240-760-6112

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