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

NCT ID: NCT06804785

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2028-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Institutes of Health

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ismail Turkbey

Role: CONTACT

ismail.turkbey@nih.gov

240.760.6112

Facility Contacts

Ismail Turkbey

Role: primary

mailto:ismail.turkbey@nih.gov

240-760-6112

Other Identifiers

5U01CA268808-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00218692

Identifier Type: -

Identifier Source: org_study_id