ProUroCare Medical Inc

Early Human Clinical Experience

Initial human clinical testing of ProUroScan demonstrated a direct comparison to TRUS, a test that utilizes a rectal probe using sound wave echoes to create an image of the prostate gland in order to visually inspect for abnormal conditions. During February 2000, the device was put through a series of trials in clinical settings, conducted at the Veterans Administration Medical Center in Minneapolis, Minnesota, and the Grand Strand Urology Clinic in Myrtle Beach, South Carolina, which included testing of human participants. During these trials, traditional DRE, TRUS scans, and the ProUroScan system tests were performed on each of the eight patients studied. Following these tests, radical prostatectomies (i.e., prostate removals) were performed on the subjects and the histopathologies (i.e., disease manifestations) of the excised prostates were compared to the earlier findings.

Results of the trials compared ProUroScan to traditional DRE and to TRUS. The initial results indicated that the ProUroScan directly correlated to the physician-conducted DRE results and also demonstrated a significant correlation to each patient’s historical and current prostate disease status. The ProUroScan also identified areas of hardness that traditional DREs did not detect. In one instance, the ProUroScan detected an abnormality that was undetected by TRUS. In another instance, TRUS detected two abnormalities and ProUroScan only identified one abnormality.

The analysis of the results of the initial clinical trials demonstrated that the ProUroScan was fully functional, exhibiting no hardware malfunctions during the model and patient examinations. The ProUroScan was able to detect and process patient data from locations within the prostate not detected during a normal DRE examination. The physicians conducting the trial using the ProUroScan determined the system to be both accurate and useful in detecting potential prostate disease based upon the size of the prostate and presence of nodules in areas of the prostate that were missed or not available to a physician during a normal DRE examination. Additional trials have not been performed since those in 2000.

Although the results of these studies were very positive, they have not been confirmed by independent studies. Additional studies will be conducted to gather more information and to meet the requirements of an FDA application.



Prostate Disease Resources

Detection Alternatives

    • Digital Rectal Examination (DRE)

      • Accuracy of Prostate Weight Estimation by Digital Rectal Examination Versus Transrectal Ultrasonography , Journal of Urology. 173(1):63-65, January 2005 Loeb, Stacy; Han, Misop; Roehl, Kimberly A.; Antenor, Jo Ann V.; Catalona, William J.
      • Digital Rectal Examination , Campbell’s Urology, Eighth Edition. pp. 3063, H. Ballentine Carter, MD and Alan W. Partin, MD, PhD.
      • The Benefit and Cost of Prostate Cancer Early Detection. The Investigators of the American Cancer Society – National Prostate Cancer Detection Project , Cancer J. Clinical, 43: 134, 1993. Littrup, P.J., Goodman, A.C., and Mettlin, C.J.
      • Digital Rectal Examination for Detecting Prostate Cancer at Prostate-Specific Antigen Levels of 4 ng/mL or Less , Journal of Urology, March 1999, Vol. 161, pages 835 – 839, Gustavo F. Carvalhal, Deborah S. Smith, Douglas E. Mager, Christian Ramos and William J. Catalona
      • Progress Toward Identifying Aggressive Prostate Cancer, The New England Journal of Medicine, July 8, 2004, pp. 180 -181.
    • Prostate-Specific Antigen (PSA) Testing

      • The Prostate-Specific Antigen (PSA) Test: Questions and Answers , National Cancer Institute, Bethesda, MD, 2004.
      • Practice Guidelines, American Family Physician, August 15, 2000.
      • Clinical Use of Prostate-Specific Antigen , Campbell’s Urology, Eighth Edition. pp. 3058 – 3060, H. Ballentine Carter, MD and Alan W. Partin, MD, PhD.
      • Use of Prostate-Specific Antigen (PSA) in Screening for and Monitoring Prostate Cancer, Oncology, February 2000.
      • Prostate-Specific Antigen (PSA) Best Practice Policy , Oncology Vol 14, No 2 pp. 267-286 (February 2000)
      • Prevalence of Prostate Cancer among Men with a Prostate-Specific Antigen Level ≤4.0 ng per Milliliter ; New England Journal of Medicine, May 27, 2004 350 (22) pages 2292 – 2294, Ian M. Thompson, MD, Donna K. Pauler, PhD, Phyllis J. Goodman, MS, Catherine M. Tangen, DrPH, M. Scott Lucia, MD, Howard L. Parnes, MDLori M. Minasian, MD, Leslie G. Ford, MD, Scott M. Lippman, MD, E. David Crawford, MD, John J. Crowley, PhD and Charles A. Coltman, Jr. MD
      • Prostate Cancers in Men with Low PSA Levels – Must We Find Them? , New England Journal of Medicine, May 27, 2004 350 (22) pages 2239 – 2246,
      • The Incidence of Prostate Cancer in a Screening Population With a Serum Prostate-Specific Antigen Between 2.5 and 4.0 ng/mL; Relation to Biopsy Strategy , Journal of Urology, March 2001 165(3) pages 757 – 760, Babaian, Richard J.; Johnston, Dennis A.; Naccarato, William; Ayala, Alberto; Bhadkamkar, Vijaya A.; Fritsche, Herbert A. Jr.
      • Report from Large NCI study Suggests PSA Testing Could be Done at Longer Intervals for Men Who Choose to Test , National Cancer Institute, Bethesda, MD, May 2002.
    • Transrectal Ultrasound (TRUS)

      • Transrectal Ultrasound – Directed Prostate Biopsy , Campbell’s Urology, Eighth Edition. pp. 3063, H. Ballentine Carter, MD and Alan W. Partin, MD, PhD.
    • Combined testing (DRE and PSA)

      • Diagnostic Modalities , Campbell’s Urology, Eighth Edition. pp. 3056, H. Ballentine Carter, MD and Alan W. Partin, MD, PhD.
    • ProUroScan (Mechanical Imaging System)

      • Correlation of Mechanical Imaging and Histopathology of Radical Prostatectomy Specimens: A Pilot Study for Detecting Prostate Cancer, Journal of Urology, September 1998. Peter Neimczyk, Kenneth B. Cummings, Armen P. Sarvazyan, Edita Bancila, W. Steven Ward and Robert E. Weiss
      • Mechanical Imaging: A New Technology for Medical Diagnostics, International Journal of Medical Infomatics, Volume 49 (1998), 195-216. Arman Sarvazyan.
    • Informed choice guidelines for patients

      • A Randomized Controlled Trial of Shared Decision Making for Prostate Cancer Screening , Archives of Family Medicine, Volume 8, July/August 1999, pp. 333 – 340. Robert J. Volk, PhD, Alvah R. Cass, MD, Stephen J. Spann, M

Prostate Cancer

    • Incidence

      • National Cancer Institute
      • Significance (Incidence and Mortality, Risk Factors)
  • Cancer Surveillance Series: Interpreting Trends in Prostate Cancer – Part I: Evidence of the Effects of Screening in Recent Prostate Cancer Incidence, Mortality and Survival Rates , Journal of the National Cancer Institute, Vol. 91, No. 12 1017 – 1024, June 16, 1999.
    • Effects of screening

      • Screening for Prostate Cancer: Recommendation and Rationale , Annals of Internal Medicine, December 3, 2002, Volume 137, Number 11, Pages 915 – 916.

Organizations Focused on Prostate Cancer and Screening

  • American Urological Association (AUA)
  • The Management of Localized Prostate Cancer – A Patient’s Guide 1995
  • Prostate Cancer Awareness for Men (A doctor’s guide for patients developed by the American Urological Society. Based upon the PSA Best Practice Policy) 2000
  • Report on The Management of Clinically Localized Prostate Cancer – Clinical Practice Guidelines 1995
  • Centers for Medicare & Medicaid Services (CMS)
  • Secretary of Health and Human Services article
  • American Medical Association (AMA) – JAMA
  • Featured AMA Council on Scientific Affairs (CSA) Report: Screening and Early Detection of Prostate Cancer, June 2000
  • Are Guidelines Following Guidelines? The Methodological Quality of Clinical Practice Guidelines in the Peer-Reviewed Medical Literature, JAMA, Vol. 281 No. 20, May 26, 1999 pp. 1900 – 1905
  • American College of Physicians (ACP) – Annals of Internal Medicine
  • Clinical Guideline, Part 1: Early Detection of Prostate Cancer: Prior Probability and Effectiveness of Tests, March 1, 1997, Volume 126, Issue 5, Pages 394 – 406.
  • Clinical Guideline, Part III: Screening for Prostate Cancer, March 15, 1997, Volume 126, Issue 6, Pages 480-484.
  • American Cancer Society (ACS)
  • Prostate Cancer – Treatment Guidelines for Patients, Version IV/July 2004
  • Cancer Statistics 2005 – A Presentation From the American Cancer Society 2005
  • How is Prostate Cancer Found? www.cancer.org
  • American Foundation for Urological Disease, Inc. (AFUD)
  • Prostate Disease www.afud.org
  • Prostate Specific Antigen www.afud.org
  • Prostate Cancer www.afud.org
  • National Cancer Institute (NCI)
  • Evidence of Benefit (DRE, PSA, TRUS)
  • Summary of Evidence
  • The Prostate-Specific Antigen (PSA) Test: Questions and Answers , National Cancer Institute, Bethesda, MD, 2004.
  • Report from Large NCI study Suggests PSA Testing Could be Done at Longer Intervals for Men Who Choose to Test , National Cancer Institute, Bethesda, MD, May 2002.
  • Prostate, Lung, Colorectal & Ovarian Cancer Screening Trial (PLCO)
  • American Academy of Family Physicians (AAFP)
  • Diagnosis and Treatment of Prostate Cancer, American Family Physician, April 1, 1998, John Naitoh, MD, Rebecca L Zeiner, MD, Jean B. Dekernion, MD
  • Recommendations for Periodic Health Examinations, Prostate Cancer www.aafp.org
  • Prostate Cancer: What You Need to Know www.familydoctor.org
  • American Society for Therapeutic Radiology and Oncology (ASTRO)
  • American College of Surgeons (ACS)
  • The National Survey of Prostate Cancer in the United States by the American College of Surgeons , Journal of Urology 1982; 127: Pages 928 – 934. Murphy GP, Matarajan N, Pontes JE, et al
  • Trends in Patterns of Care for Prostate Cancer , 1974 -1983: Results of Surveys by the American College of Surgeons. Journal of Urology 1986; 136: Pages 416 – 421. Schmidt JD, Mettlin C, Matarajan N, Murphy GP, et al
  • U.S. Preventive Services Task Force (USPSTF)
  • Screening for Prostate Cancer: Recommendations and Rationale , Annals of Internal Medicine, December 3, 2002, Volume 137, Number 11, Pages 915 -916.
  • Disease Prevention Guidelines from the U.S. Preventive Services Task Force , Annals of Internal Medicine, January 15, 2002, Volume 136: Number 2, Pages 155 -156.
  • Prostate Cancer Foundation (PCF)
  • National Institutes of Health (NIH)
  • World Health Organization (WHO)

Popular Periodicals

  • Taking on Prostate Cancer , Fortune. May 13, 1996. Andy Grove (Intel’s CEO)
  • Prostate Priorities , Time. October 4, 2004. Dr. Sanjay Gupta

International Articles

  • United Kingdom
      • Screening for Prostate Cancer in the UK , British Medical Journal, October 6, 2001; 323: Pages 763 – 764.
    • Australia :

      • Prostate Cancer Screening, Summary of the review prepared by the Australian Health Technology Advisory Committee. http://www7.health.gov.au/pubs/ahtac/prostate.htm