Evaluation of the MiCheck MIA test performance in differentiating aggressive from non-aggressive prostate cancer: the MiCheck-01 prospective trial

Background: A diagnostic test which can better inform both clinicians and patients regarding a decision to proceed with a prostate biopsy, while still utilizing traditional parameters of Prostate Specific Antigen (PSA) kinetics and/or the digital rectal examination (DRE) is still an unmet need. The MiChecktextregistered test is designed as a triage test to assist clinicians in the decision to proceed to prostate biopsy. The MiChecktextregisteredtest is a simple blood test that measures the levels of the Glypican-1 protein and related signalling molecules. The MiChecktextregistered-01 prospective trial builds on a previous pilot trial that examined the ability of the MiChecktextregistered test to distinguish between normal subjects, patients with benign disease or Gleason 7 and above prostate cancer. The MiChecktextregistered test showed sensitivity of 60% and specificity of 96% in distinguishing between subjects with Gleason ≥7 and normal or BPH patients. In a separate study, the MiChecktextregistered test could differentiate aggressive (GS ≥3+4) from non-aggressive (GS 3+3) prostate cancer with a sensitivity of 85% and specificity of 90%. Methods: The trial consists of two arms: Arm 1 (normal patients, n = 50) and Arm 2 (prostate biopsy patients, n = 300).

Inclusion criteria: Arm 1: Age ≥50, Low PSA (performed at most 12 months prior, defined as PSA textless 1.5 ng/mL between ages 50 and 60 and PSA textless 3 ng/mL above age 60). Arm2: Age ≥40, all subjects who are referred for or have undergone either a de novo or a repeat prostate biopsy for high PSA (defined as PSA ≥ 1 ng/ml between ages 40 and 49, PSA ≥2 ng/mL between ages 50 and 60 and PSA ≥ 3 ng/mL for age 60 and above age 60). 
Key exclusion criteria: prior history of cancer, patients taking ADT, DRE or other prostate manipulation within 72 hrs, subjects taking 5 ARIs. Results: The trial has recruited 30 Arm 2 patients to date. Interim analyses will be performed following accrual of 100 and 200 Arm 2 patients. Full accrual is expected by mid Q4 2017. Conclusions: Interim analysis data will be presented showing test performance. COI and Funding: The trial is funded by Minomic International Ltd. Neal Shore is a member of Minomic's Clinical Advisory Panel.