Using AI to improve prostate cancer diagnosis and management
Hybrid Intelligence for Trustable Diagnosis and Patient Management of Prostate Cancer (HIT-PIRADS)
This study is testing a new AI tool to see if it can help doctors better diagnose and manage prostate cancer while reducing unnecessary biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | Male |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06804785 on ClinicalTrials.gov |
What this trial studies
This project aims to develop a novel diagnostic and patient management strategy for prostate cancer called HIT-PIRADS, utilizing artificial intelligence to enhance the accuracy of prostate cancer detection. The approach focuses on increasing the positive predictive value for clinically significant prostate cancer while minimizing unnecessary biopsies and their associated risks. The AI system is designed to be interpretable and trustworthy for physicians, ultimately leading to a reproducible risk scoring system that can be implemented in community hospitals. The long-term vision is for HIT-PIRADS to be widely adopted, influencing treatment and prevention strategies for prostate cancer.
Who should consider this trial
Good fit: Ideal candidates include males aged 18 to 89 with elevated PSA levels or abnormal digital rectal exams who are biopsy naïve.
Not a fit: Patients currently undergoing prostate cancer treatment or those who have had recent prostate infections or invasive procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnoses of prostate cancer, reducing the need for invasive procedures.
How similar studies have performed: Other studies utilizing AI for cancer diagnosis have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Ismail Turkbey
- Email: ismail.turkbey@nih.gov
- Phone: 240.760.6112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.