AI for Prostate Cancer

Overseen By Andrei Purysko, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Low quality MRI, PI-QUAL 1

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether artificial intelligence (AI) can identify prostate cancer on MRI scans more effectively than a radiologist working alone. It employs a specialized AI tool, the AI Rad Companion (AIRC) Prostate MRI application, to detect and assess potential cancerous areas in the prostate. The trial compares results from three approaches: a radiologist alone, a radiologist assisted by AI, and AI alone. Men who plan to undergo a prostate biopsy after an MRI, have a PSA level between 3-10 ng/mL, and have not been treated for or diagnosed with prostate cancer are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to cutting-edge research that could enhance prostate cancer detection for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the AI Rad Companion (AIRC) Prostate MRI application is safe for detecting prostate cancer lesions?

Research shows that the AI Rad Companion Prostate MRI application helps doctors better understand prostate MRI images. This software builds on earlier tools and already assists doctors in reading medical images.

The FDA has approved similar applications before, indicating that these tools are considered safe for use in medical settings. This AI tool focuses on analyzing images, so it poses no known physical risks to patients. Instead, it may help doctors identify cancerous areas more accurately, leading to better diagnosis and treatment planning. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AI Rad Companion (AIRC) Prostate MRI application because it uses advanced AI technology to enhance the accuracy of prostate cancer detection. Unlike traditional prostate MRI scans that rely heavily on a radiologist's expertise, AIRC offers an AI-aided analysis, which can help reduce human error and increase diagnostic precision. This technology has the potential to streamline the biopsy process by providing clearer insights, leading to more targeted and efficient interventions.

What evidence suggests that the AI Rad Companion is effective for detecting prostate cancer?

Studies have shown that using AI in prostate MRI can simplify the detection of cancerous areas. In this trial, participants will undergo AI-aided MRI and prostate biopsy using the AI Rad Companion (AIRC) Prostate MRI application. AI often surpasses doctors alone in identifying prostate cancer. The AI Rad Companion assists doctors by marking prostate images to guide biopsies, aiding in the identification of suspicious spots. Research also shows that AI can enhance doctors' agreement on MRI image interpretations. This increased accuracy and consensus suggest that AI could be a valuable tool in detecting prostate cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Andrei Purysko, MD

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for individuals undergoing an MRI before a prostate biopsy due to suspected prostate cancer. Participants will be involved in testing whether AI can improve lesion detection on MRIs compared to standard radiologist evaluations.

Inclusion Criteria

Prostate-specific antigen (PSA) between 3-10 ng/mL

I am between 55 and 80 years old.

I am scheduled for a prostate biopsy after an MRI.

Exclusion Criteria

Pre-biopsy MRI is of low quality

PI-QUAL score of 1 using PI-QUAL version 2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

MRI and Biopsy

Participants undergo MRI and systematic biopsy, with AI-aided interpretation of MRI images

Up to 30 days

1 visit (in-person)

Data Analysis

MRI images and clinical data are analyzed to aid in the development of AI methods for image quality assessment

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after MRI and biopsy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AI Rad Companion (AIRC) Prostate MRI application

Trial Overview The study tests the 'AI Rad Companion Prostate MRI' application, which assigns PI-RADS scores to lesions for cancer likelihood. It compares the effectiveness of AI alone, a radiologist aided by AI, and a radiologist without AI in interpreting MRI images.

How Is the Trial Designed?

Group I: AI-aided MRI & Prostate Biopsy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Siemens Medical Solutions

Industry Sponsor

Trials

26

Recruited

6,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10236970/

Future of prostate imaging: Artificial intelligence in ... Precise mapping of the prostate has become possible through AI and this has greatly improved the accuracy of biopsy. AI has also allowed for ...

2. siemens-healthineers.com siemens-healthineers.com/en-th/digital-health-solutions/digital-solutions-overview/clinical-decision-support/ai-rad-companion/prostate-mr

AI-Rad Companion Prostate MR Your aide for biopsy support The application supports in annotating images of the prostate gland for targeted MR/US-fusion biopsies and seamless information transfer to the urologist.

3. mmrjournal.biomedcentral.com mmrjournal.biomedcentral.com/articles/10.1186/s40779-023-00464-w

What benefit can be obtained from magnetic resonance ... First, AI methods achieved a better overall performance than that of clinical assessments of radiologists for the diagnosis of PCa. In ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1076633222005001

Improving Prostate Cancer Detection With MRI: A Multi- ... Our results show that the addition of a boosted parallel random forest model-based CAD generated MRI image series improves inter-reader agreement for PI-RADS ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K193283.pdf

K193283.pdf - accessdata.fda.gov AI-Rad Companion Prostate MR aims to assist the radiologist in the preparation of MR prostate images for targeted biopsies of the prostate gland ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232899.pdf

K232899.pdf - accessdata.fda.gov Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy ...

7. siemens-healthineers.com siemens-healthineers.com/en-us/digital-health-solutions/ai-rad-companion

AI-Rad Companion AI-Rad Companion supports the physicians reading workflow and may increase your diagnostic precision when interpreting medical images.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9339427/

Artificial intelligence for prostate MRI: open datasets, available ... A total of 3,369 multi-vendor prostate MRI cases are available in open datasets, acquired from 2003 to 2021 in Europe or USA at 3 T (n = 3,018; ...