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.

Inclusion criteria

• all racial and ethnic groups,
• males 21 years of age or older,
• able to withstand body positioning for the entire length of examination,
• presence of DRE detected abnormality,
• scheduled for TRUS-biopsy or surgical removal or prostate,
• able to comprehend, sign, and date the written informed consent form (ICF)

Exclusion criteria

• previous pelvic surgery,
• significant hip and / vertebral arthritis,
• rectal Crohn's disease,
• locally disseminated cancer of pelvic structure,
• anal fissure, anal fistula, infected anal fistula,
• anal cancer,
• rectal cancer,
• 1st, 2nd or 3rd degree hemorrhoids,
• pelvic irradiation,
• dehydrated impacted stool,
• no vulnerable patients such as students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity will be included in the study