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

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.

Eligibility

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.

Conditions2

Locations1 site

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