Actively Recruiting

Age: 18Years - 89Years
MALE
NCT06804785

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

Led by Northwestern University · Updated on 2025-05-31

800

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 89Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 to 89 years
  • Elevated PSA level between 4.0 and 10.0 ng/ml or abnormal digital rectal exam with PSA between 2.00 and 10.00 ng/ml
  • Biopsy-nafve patients confirmed by patient or medical record
  • Life expectancy of 10 years or more as determined by the principal investigator
  • ECOG performance status of 0 to 2 as noted in medical records
Not Eligible

You will not qualify if you...

  • Use of 5--reductase inhibitors within 12 months before enrollment
  • Prostate infection within 1 month before enrollment
  • Receiving or previously received prostate cancer treatment such as androgen deprivation therapy, surgery, radiation, or investigational drugs
  • Underwent invasive urological procedures within 1 month before enrollment
  • No access to the rectum for transrectal ultrasound
  • Contraindication to magnetic resonance imaging (MRI)
  • Prisoners or men older than 89 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Institutes of Health

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

I

Ismail Turkbey

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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