Clinical Study 3: October 2017- 2019

The aim of this study is the development and validation of an accurate diagnostic gene signature for prostate cancer using urine.

Specifically, Caldera is comparing extracellular vesicle isolation strategies and also the selection of the best gene expression algorithm for detection of both indolent and aggressive disease.

Caldera has compared the results of the Caldera urine diagnostic test for over 300 donors with the current gold standard diagnostic methods for prostate cancer diagnosis.

This analysis enables the accuracy of the test in terms of the sensitivity and specificity to be determined. The results and the overall performance of the test are currently under external review.

Caldera continues to recruit men under suspicion of prostate cancer in both NZ and Australia. The Australian cohort have an advantage in that all men receive an mpMRI test in their clinical workup. The addition of the mpMRI data to the analysis may help to resolve discrepant results due to biopsy sampling errors.

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