The ReIMAGINE prostate cancer risk study protocol: 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 and urine for biomarker analyses

• Published in: PloS one 2022-02, Vol.17 (2), p.e0259672-e0259672
• Main Authors: Marsden, Teresa, McCartan, Neil, Brown, Louise, Rodriguez-Justo, Manuel, Syer, Tom, Brembilla, Giorgio, Van Hemelrijck, Mieke, Coolen, Ton, Attard, Gerhardt, Punwani, Shonit, Moore, Caroline M, Ahmed, Hashim U, Emberton, Mark
• Format: Article
• Language: English
• Subjects: Aged; Artificial Intelligence; Biological markers; Biomarkers; Biomarkers, Tumor - blood; Biomarkers, Tumor - urine; Biopsy; Blood; Cancer; Cohort analysis; Consortia; Diagnosis; Donation of organs, tissues, etc; Health risks; Humans; Image-Guided Biopsy; Learning algorithms; Machine learning; Magnetic resonance imaging; Male; Medical diagnosis; Medical imaging; Medical research; Metastases; Middle Aged; Multiparametric Magnetic Resonance Imaging; Neoplasm Grading; Oncology, Experimental; Prostate - diagnostic imaging; Prostate - pathology; Prostate cancer; Prostatic Neoplasms - blood; Prostatic Neoplasms - diagnosis; Prostatic Neoplasms - pathology; Prostatic Neoplasms - urine; Radiomics; Risk; Risk Factors; Study Protocol; Tissues; Ultrasonography, Interventional; Urine
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0259672

The ReIMAGINE Consortium was conceived to develop risk-stratification models that might incorporate the full range of novel prostate cancer (PCa) diagnostics (both commercial and academic). ReIMAGINE Risk is an ethics approved (19/LO/1128) multicentre, prospective, observational cohort study which will recruit 1000 treatment-naive men undergoing a multi-parametric MRI (mpMRI) due to an elevated PSA (≤20ng/ml) or abnormal prostate examination who subsequently had a suspicious mpMRI (score≥3, stage ≤T3bN0M0). Primary outcomes include the detection of ≥Gleason 7 PCa at baseline and time to clinical progression, metastasis and death. Baseline blood, urine, and biopsy cores for fresh prostate tissue samples (2 targeted and 1 non-targeted) will be biobanked for future analysis. High-resolution scanning of pathology whole-slide imaging and MRI-DICOM images will be collected. Consortium partners will be granted access to data and biobanks to develop and validate biomarkers using correlation to mpMRI, biopsy-based disease status and long-term clinical outcomes. Recruitment began in September 2019(n = 533). A first site opened in September 2019 (n = 296), a second in November 2019 (n = 210) and a third in December 2020 (n = 27). Acceptance to the study has been 65% and a mean of 36.5ml(SD+/-10.0), 12.9ml(SD+/-3.7) and 2.8ml(SD+/-0.7) urine, plasma and serum donated for research, respectively. There are currently 4 academic and 15 commercial partners spanning imaging (~9 radiomics, artificial intelligence/machine learning), fluidic (~3 blood-based and ~2urine-based) and tissue-based (~1) biomarkers. The consortium will develop, or adjust, risk models for PCa, and provide a platform for evaluating the role of novel diagnostics in the era of pre-biopsy MRI and targeted biopsy.