Source
Division of Urology, Department of Surgery, Robert Wood Johnson Medical School/University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey, USA.
Abstract
OBJECTIVES:
To evaluate the ability of prostate mechanical imaging (PMI) technology to provide an objective and reproducible image and to assess the prostate nodularity.
METHODS:
We evaluated the PMI device developed by Artann Laboratories in a pilot clinical study. For the 168 patients (ages 44 to 94) who presented to an urologist for prostate evaluation, PMI-produced images and assessment of prostate size, shape, consistency/hardness, mobility, and nodularity were compared with digital rectal examination (DRE) findings. The PMI and DRE results were further tested for correlation against a transrectal ultrasound of the prostate (TRUS) guided biopsy for a subgroup of 21 patients with an elevated prostate-specific antigen level.
RESULTS:
In 84% of the cases, the PMI device was able to reconstruct three-dimensional (3D) and 2D cross-sectional images of the prostate. The PMI System and DRE pretests were able to determine malignant nodules in 10 and 6 patients, respectively, of the 13 patients with biopsy-confirmed malignant inclusions. The PMI System findings were consistent with all 8 biopsy negative cases, whereas the DRE had 1 abnormal reading for this group. The correlation between PMI and DRE detection of palpable nodularity was 81%, as indicated by the area under the receiver operating characteristic curve. Estimates of the prostate size provided by PMI and DRE were statistically significantly correlated.
CONCLUSIONS:
The PMI has the potential to enable a physician to obtain, examine, and store a 3D image of the prostate based on mechanical and geometrical characteristics of the gland and its internal structures.