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

Launched by NORTHWESTERN UNIVERSITY · Jan 27, 2025

Keywords

ClinConnect Summary

The HIT-PIRADS trial is studying a new way to diagnose prostate cancer using artificial intelligence. The aim is to make the diagnosis process quicker and less invasive, potentially reducing the need for procedures like biopsies, which can be uncomfortable. This study is currently looking for male participants aged 18 to 89 who have certain signs that may indicate prostate cancer, such as an elevated PSA test result or an abnormal digital rectal exam.

To be eligible for the trial, participants must not have previously undergone a biopsy and should have a good overall health status. They also need to have a life expectancy of at least 10 years. However, those who have received recent prostate cancer treatments or certain medications, or who have had recent prostate infections or procedures, will not qualify. If you decide to participate, you can expect to be involved in a study that seeks to improve how prostate cancer is diagnosed, which could ultimately benefit many patients in the future.

Gender

MALE

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.