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MRI-Based Machine Learning Approach Versus Radiologist MRI Reading for the Detection of Prostate Cancer, The PRIMER Trial

PRIMER (Prostate MRI With Machine LEarning vs. Radiologist) A Novel MRI-Based Machine Learning Approach vs Radiologist MRI Reading for Targeted Prostate Biopsy: A Non-Inferiority, Within-Person Randomized Controlled Trial for Prostate Cancer Detection

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
20 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Biopsies, Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This clinical trial studies how well a magnetic resonance imaging (MRI)-based machine learning approach (i.e., artificial intelligence \[AI\]) works as compared to radiologist MRI readings in detecting prostate cancer."
  • "One of the current methods used to help diagnose possible prostate cancer is performing a prostate MRI."
  • "An MRI uses a magnetic field to take pictures of the body."
  • "The MRI images are examined by a radiologist."
  • "If a suspicious area is seen in the MRI, the radiologist assigns it a PIRADS score."
  • "The AI system has been developed also to be able to analyze prostate MRI images and detect suspicious areas in the prostate that may be cancer."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares artificial intelligence (AI) with doctors who read MRI scans to find prostate cancer. MRI uses magnets to take pictures inside the body. The study is for people having a prostate biopsy (a tissue sample test) or surgery to remove the prostate.

This clinical trial studies how well a magnetic resonance imaging (MRI)-based machine learning approach (i.e., artificial intelligence \[AI\]) works as compared to radiologist MRI readings in detecting prostate cancer. One of the current methods used to help diagnose possible prostate cancer is performing a prostate MRI. An MRI uses a magnetic field to take pictures of the body. The MRI images are examined by a radiologist. If a suspicious area is seen in the MRI, the radiologist assigns it a PIRADS score. This stands for Prostate Imaging Reporting and Data System. The PIRADS score is used to report how likely it is that a suspicious area in the prostate is cancer. The AI system has been developed also to be able to analyze prostate MRI images and detect suspicious areas in the prostate that may be cancer. The AI system's ability to diagnose aggressive prostate cancer may be similar to detection performed by experienced radiologists using the standard PIRADS system of analyzing prostate MRI.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Biopsy group: Having a prostate biopsy through the skin between the scrotum and anus, guided by combined MRI and ultrasound images, as part of usual care.
  • Surgery group: Having the whole prostate removed as the main treatment for prostate cancer, as part of usual care.
  • Both groups: Have a 3T multiparametric MRI—a strong-magnet scan with several types of images, including images with contrast dye—within 365 days before the biopsy or surgery.
  • Both groups: Agree to join the study.

Who can't join

  • Both groups: Under age 20.
  • Both groups: Have had surgery for an enlarged prostate that was not caused by cancer.
  • Both groups: MRI was not read using PI-RADS, a scoring system for signs of prostate cancer, or has major image flaws.
  • Biopsy group: Have had prostate cancer or a prior prostate biopsy.
  • Biopsy group: Having a saturation biopsy, which takes many tissue samples from the prostate.
  • Surgery group: Getting hormone treatment before prostate removal.
  • Surgery group: Do not have an MRI from before treatment.
  • Surgery group: Already included in the biopsy group.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

CA