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

NCT06804785 | Recruiting

• 2 other identifiers: STU002186925U01CA268808-02
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Elevated PSA; Elevated Prostate-Specific Antigen; Abnormal digital rectal exam; Prostate Cancer; Prostate; AI; Artificial Intelligence; Oncology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

National Institutes of Health

Bethesda, Maryland, 20892, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Ismail Turkbey

CONTACT

240.760.6112; ismail.turkbey@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: February 3, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)