MRI-based machine learning versus radiologist reads to detect prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective interventional study enrolls men undergoing transperineal MRI/TRUS fusion prostate biopsy (Group 1) and men undergoing radical prostatectomy or prostatectomy after biopsy (Group 2). In the biopsy cohort, patients are randomized to arms in which targeted biopsies are obtained sequentially based on standard PIRADS reads, a Green Learning (GL) AI prediction, and a Deep Learning (DL) AI prediction, alongside standard-of-care systematic cores. The primary objective is to show non-inferiority of GL AI-targeted biopsy versus PIRADS, with secondary goals including DL AI detection rates, patient-level diagnostic performance comparisons, biopsy core characteristics, predictors of clinically significant cancer, and spatial correlation with prostatectomy specimens. All participants require a 3T multiparametric prostate MRI performed within the study windows and are enrolled at the USC/Norris Comprehensive Cancer Center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* PROSTATE BIOPSY COHORT: Patients undergoing transperineal MRI/TRUS fusion prostate biopsy (PBx) as per standard of care
* PROSTATE BIOPSY COHORT: Patients who underwent or are undergoing 3T multiparametric MRI (T2W, diffusion weighted imaging \[DWI\], apparent diffusion coefficient \[ADC\], and dynamic contrast-enhanced \[DCE\]) within 365 days prior to biopsy
* PROSTATE BIOPSY COHORT: Patients who consented to the study
* RADICAL PROSTATECTOMY COHORT: Patients undergoing radical prostatectomy for primary treatment of prostate cancer as per standard of care
* RADICAL PROSTATECTOMY COHORT: Patients who underwent or are undergoing 3T multiparametric MRI (T2W, DWI, ADC, and DCE) within 365 days prior to radical prostatectomy
* RADICAL PROSTATECTOMY COHORT: Patients who consented to the study

Exclusion Criteria:

* PROSTATE BIOPSY COHORT: Patients with a history of prostate cancer
* PROSTATE BIOPSY COHORT: Patients with a history of surgical treatment on benign prostate hyperplasia
* PROSTATE BIOPSY COHORT: Patients undergoing saturation prostate biopsy
* PROSTATE BIOPSY COHORT: Patients under 20 years old
* PROSTATE BIOPSY COHORT: Patients with previous PBx history
* PROSTATE BIOPSY COHORT: MRI which was not interpreted by PIRADS
* PROSTATE BIOPSY COHORT: MRI with significant artifact
* RADICAL PROSTATECTOMY COHORT: Patients who are undergoing neo-adjuvant hormonal therapy in conjunction with radical prostatectomy
* RADICAL PROSTATECTOMY COHORT: Patients with a history of surgical treatment on benign prostate hyperplasia
* RADICAL PROSTATECTOMY COHORT: Patients under 20 years old
* RADICAL PROSTATECTOMY COHORT: Patients without pre-treatment MRI
* RADICAL PROSTATECTOMY COHORT: MRI which was not interpreted by PIRADS
* RADICAL PROSTATECTOMY COHORT: MRI with significant artifact
* RADICAL PROSTATECTOMY COHORT: Patients who are included in the Biopsy cohort

Where it's running

• USC / Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Andre Luis Abreu, MD — University of Southern California
• Study coordinator: Ileana Aldana
• Email: Ileana.aldana@med.usc.edu
• Phone: 323-865-0702

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.