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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Ismail Turkbey; Phone Number: 240.760.6112; Email: ismail.turkbey@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health
      • Contact: Ismail Turkbey; Phone Number: 240-760-6112; Email: mailto:ismail.turkbey@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients at an increased risk of having prostate cancer. An increased risk for prostate cancer means the patient may have had either a blood test which indicated they have an elevated prostate-specific antigen (PSA) (a protein produced by both cancerous and noncancerous tissue in the prostate), or an abnormal exam of the patient's rectum, anus or prostate gland.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with detection of clinically significant prostate cancer (csPCa)	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.	01/01/2016-12/31/2026

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Prostate Cancer; Oncology; Artificial Intelligence; Prostate; AI; Elevated PSA; Elevated Prostate-Specific Antigen; Abnormal digital rectal exam
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: STU00218692; 5U01CA268808-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No