Trial Information

Prostate Mechanical Imager (PMI) Clinical Bridging Study

The clinical application of a Prostate Mechanical Imaging (PMI) technique for prostate
assessment is examined in this study. PMI technology is based on the visualization of
internal structures and dimensions of the prostate by measuring mechanical stress patterns
on the gland surface with pressure sensor arrays. Temporal and spatial changes in the
stress pattern provide information on the hardness of the prostate. Projected patient sample
size for the study is 40 men over the age of 21. Patients will be selected for the study if
both of the following criteria are met: (1) abnormal DRE findings; and (2) patients who are
scheduled for a TRUS-guided prostate biopsy and/ or radical prostatectomy due to an abnormal
DRE, and/or increased PSA, and/or other clinical indications.

The study is designed to assess the imaging capability of the PMI in three clinical sites,
performed by four physicians. Each clinical investigator will perform PMI examination on 10
respective patients with DRE detected abnormality. Pathology data will be collected from
TRUS-guided biopsy or radical prostatectomy and will be used as reference data in case there
is a discrepancy between the DRE findings and PMI images. Study Hypothesis: Proportion of
patients with PMI reconstructed image is anticipated to be consistent with the 84% imaging
capability demonstrated in the previous clinical study conducted with the prior version of
the PMI device.