Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System

Launched by HOSPICES CIVILS DE LYON · Jan 26, 2021

Keywords

ClinConnect Summary

The CHANGE study is a clinical trial aimed at improving the detection of significant prostate cancers using advanced MRI technology combined with artificial intelligence (AI). The researchers want to see if this AI system can better identify cancers that are more likely to require treatment when compared to traditional methods. The study involves men over 18 years old who are suspected of having prostate cancer and are scheduled for a multiparametric MRI before their first biopsy or after previous negative biopsies. Key eligibility criteria include having a PSA level of 30 ng/ml or lower and not having had a prostate biopsy in the past 12 months.

Participants in this study can expect to undergo a multiparametric MRI of the prostate followed by both targeted and systematic biopsies. This will help validate the AI system's effectiveness across different imaging equipment and locations. The study is currently recruiting participants, and it’s important to note that individuals with certain medical histories, such as previous prostate cancer treatments or specific health conditions, may not be eligible. Overall, this trial hopes to enhance the accuracy of prostate cancer detection and improve patient outcomes.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Men over 18 years of age
• • Patient with clinical suspicion of prostate cancer referred for a multiparametric MRI of the prostate before a first series of biopsies or before new biopsies after one or more series of negative biopsies
• • PSA ≤ 30 ng / ml
• • Clinical stage ≤ T2c
• • Affiliation or beneficiary of a social security scheme
• Exclusion Criteria:
• • Men over 80 years of age
• • PSA\> 30 ng / ml
• • Stage T3 or T4 on digital rectal examination
• • Previous prostate biopsy performed within 12 months
• • History of prostate cancer diagnosed by biopsy or endourethral resection.
• • History of pelvic radiotherapy regardless of the cause.
• • History of total or focal treatment for prostate cancer.
• • History of hormone therapy
• • MRI performed more than 3 months before biopsy
• • Prostate MRI performed on a machine other than the center's machines accredited for the study.
• • Presence of a hip prosthesis
• • Contraindication to performing an MRI
• • Contraindication to performing prostate biopsy
• • Patient subject to a legal protection measure or deprived of liberty
• • Subject participating or having participated in interventional medical research with an exclusion period still in progress
• • Misunderstanding of the French language