Prostate Mechanical Imager (PMI) Clinical Bridging Study (PMI)

The purpose of this study is to evaluate an imaging capability Prostate Mechanical Imager (PMI), a PC-based device utilizing a transrectal probe with pressure sensor arrays and motion tracking system, aimed at providing composite elasticity images of the prostate.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms; Prostatic Hyperplasia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota/VA Medical Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Robert Wood Johnson Medical Center
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Urology Associates of Lancaster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

All adult male patients between over the age of 21 presenting to the participating clinical sites for urologic examination with the DRE detected prostate abnormality and 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 will be considered for inclusion. All ethnic and racial groups will be included.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prostate Mechanical Imager provides reconstructed image of prostate	1 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
Prostate Mechanical Imager recorded images of prostate are consistent with the abnormal digital rectal examination findings	1 Year

Collaborators and Investigators

• Sponsor: Artann Laboratories
• Collaborators: National Cancer Institute (NCI); Mayo Clinic; University of Minnesota; Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Armen Sarvazyan, Ph.D., D.Sc., Artann Laboratories

Publications and helpful links

General Publications

• Weiss RE, Egorov V, Ayrapetyan S, Sarvazyan N, Sarvazyan A. Prostate mechanical imaging: a new method for prostate assessment. Urology. 2008 Mar;71(3):425-9. doi: 10.1016/j.urology.2007.11.021.

Helpful Links

• Artann Laboratories
• ProUroCare Medical

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: January 14, 2009
• First Submitted That Met QC Criteria: January 14, 2009
• First Posted (Estimate): January 15, 2009

Study Record Updates

• Last Update Posted (Estimate): March 31, 2014
• Last Update Submitted That Met QC Criteria: March 28, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: PMI-03; 5R44CA082620 (U.S. NIH Grant/Contract)