Prostate Mechanical Imager (PMI) Clinical Bridging Study

• Prostate Mechanical Imager provides reconstructed image of prostate [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
  

• Prostate Mechanical Imager recorded images of prostate are consistent with the abnormal digital rectal examination findings [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
  

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.