ReIMAGINE: A prospective prostate cancer risk study in the mpMRI era.


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Teresa Marsden, Neil McCartan, Louise Brown, Manuel Rodriguez-Justo, Mieke Van Hemelrijck, Ton Coolen, Gerhardt Attard, Shonit Punwani, Caroline M Moore, Hashim U Ahmed, Mark Emberton

Abstract

Background

Existing prostate cancer (PCa) risk models are limited by the baseline error conferred from systematic TRUS sampling (missed cancers and under-grading). The adoption of an MRI-led PCa diagnostic pathway allows us to correct much of this error.  The ReIMAGINE Consortium has been created and configured to develop novel methods of risk-stratification that incorporate the full range of contemporary diagnostics (commercial and academic) against an MRI-led diagnostic pathway.  The risk-stratification will be calibrated against accurate histological status and three downstream events: clinical progression, metastatic progression and death.


 


Method

We have developed a multicentre, prospective, observational, longitudinal cohort study which will recruit 1000 treatment-naive men undergoing an mpMRI prostate due to an elevated PSA or abnormal clinical examination. Those with a suspicious MRI (score≥3), PSA≤20 and radiological stage of ≤T3b are eligible. Primary outcomes include the presence of ≥ Gleason 7 PCa at baseline and time to metastasis, clinical progression and death. ReIMAGINE is funded by The Medical Research Council, U.K. and Cancer Research U.K.

Baseline blood, urine, fresh prostate tissue samples (targeted and systematic), digital pathology and radiomic data will be biobanked ahead of transfer to consortium partners. Tissue and radiomic data will be subject to analysis for the discovery and validation of novel disease biomarkers.

Results

Under ethical approval (19/LO/1128), recruitment began at 2 U.K. centres in late 2019 (n=286). 5 patients have been withdrawn. Acceptance to the study has been high (65%) and so far, there are 14 commercial and 4 academic partners spanning imaging (radiomics, artificial intelligence and machine learning), fluidic and tissue-based biomarkers. A mean of 36ml (SD+/-10.6), 12ml (SD+/-3.1) and 3ml (SD+/-0.7) urine, plasma and serum has been donated for research, respectively. 275 patients have donated blood, urine and prostate tissue. The trial has been implemented successfully within a standard of care mpMRI diagnostic pathway and has been approved to continue recruitment during the COVID-19 pandemic. A third site will open in 2020.

Conclusion

The consortium will develop, or adjust, risk models for prostate cancer and provide a platform for the evaluation of novel diagnostics in an mp-MRI led diagnostic pathway. Recruitment is ongoing.

Impact statement