(UroToday.com) The 2023 European Association of Urology (EAU) annual congress held in Milan, Italy between March 10th and 13th, 2023 was host to a prostate cancer biopsy indication session evaluating the additive value of positron emission tomography (PET), micro-ultrasound, and/or markers in this setting. Professor Hashim Ahmed presented the study design for the ReIMAGINE prostate cancer risk study, a prospective cohort study in men with a suspicion of prostate cancer who are referred onto an MRI-based diagnostic pathway with donation of tissue, blood, urine and imaging for biomarker analyses.
Professor Ahmed began by highlighting that the goal of the ReIMAGINE study is to “correct 40 years of risk-stratification errors in early prostate cancer” by relying on a combination of clinical data, digitalized imaging and pathologic data, incorporation of artificial intelligence, and, importantly, biobanking of blood, urine, and prostate tissue samples.
This study will enroll men at high suspicion for prostate cancer based on elevated PSA results. Patients will subsequently undergo an MRI and have blood and urine collected. Patients will have systematic and MRI-targeted biopsy cores taken, as well as random non-targeted cores for further sampling purposes. All men will have to consent to the digitalization of their histopathologic biopsy tissue specimens.
The key objectives of this study are:
- Create the first deeply phenotyped cohort comprising MRI-derived prostate cancer endotypes from incident cases presenting in NHS centers that have high quality MRI and targeted biopsy in place
- To recruit an inception cohort of 1000 men with an MRI lesions
- Generate baseline clinical and demographic data, detailed histology, and imaging
The study eligibility criteria are summarized below:
As is the case with many studies conducted over the last few years, recruitment was affected by the COVID-19 pandemic, although the authors were able to recruit well over 1000 patients.
The study flow chart is as below. The median patient age was 67 years, PSA 6.3 ng/ml, 19% had a positive family history, and 11% were of black ethnicity.
As demonstrated in the slide below, collated/contoured MRI images have been collected for 1,029 patients, high-resolution histology slides have been digitized for 6,859 tissue specimens, and urine, blood, and serum samples have been banked for these patients.
What’s next for ReIMAGINE:
- Development of an AI-based (using both commercial and academic platforms) algorithm with subsequent validation for MRI lesion detection/classification
- Data and sample sharing with global consortium partners
- Deep phenotyping of measurable mpMRI disease
- First multi-omic insights into characteristics defining clinically significant prostate cancer
- Redefining risk stratification in the mpMRI diagnostic era
- “ReIMAGINE LIFE”: planned life-long follow up of the risk cohort via data linkage
Written by: Rashid K. Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 European Association of Urology (EAU) 38th annual congress held in Milan, Italy between March 10-13, 2023