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

Northwestern University

Status: Enrolling

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06804785

STU00218692

5U01CA268808-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full 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.

Enrollment: 800 estimated patients

Sex: Male

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

800 participants in 1 patient group

Cohort 1

Description:

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.