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Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02307552
Recruitment Status : Terminated (The probe could not be anchored in place and would rotate about its axis, thus comparison was difficult.)
First Posted : December 4, 2014
Results First Posted : June 27, 2017
Last Update Posted : July 27, 2017
Information provided by (Responsible Party):
Thomas E. Ahlering, University of California, Irvine

Brief Summary:

This study is being performed to verify the ability to use minimally invasive transurethral ultrasonic imaging technology for the purpose of identifying prostate cancer. Transurethral ultrasonic prostate imaging, may in the future, be used for detection and monitoring these disease processes to minimize the need for obtaining surgical biopsy specimens. The hypothesis is that tissue-density variations, as revealed in diagnostic ultrasonic imaging, results in unique image signatures for identification of prostate cancer. This imaging procedure provides a multifaceted view of the entire in-situ gland.

The current use of Prostate Specific Antigen (PSA) for determining the likelihood of presence of cancer in the prostate gland requires interpretation and has a good but limited to predict prostate cancer on biopsy, with significant false prediction rates. More importantly as a blood test, the PSA test lacks the ability to pinpoint the location of the cancer within the prostate gland. Preliminary study findings have suggested that "Transurethral Ultrasonic Scanning" (TUUS) presents the desired improved diagnostic sensitivity for detection of cancer within the imaged prostate gland, and has the intrinsic capability to provide high resolution images of the transverse and future three-dimensional views of the entire gland better than currently used Transurethral Ultrasound (TRUS). Two important goals of the practicality of this minimally invasive technology will be assessed by this study. 1. The ability of TUUS to directly detect prostate cancer locations in the prostate. 2. The use of TUUS to successfully guide the prostate needle biopsy to cancer loci with a high rate accuracy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: UreScan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer
Study Start Date : June 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: All patients
All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.
Device: UreScan
The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection.

Primary Outcome Measures :
  1. Measure Novel Transurethral Ultrasound Signatures to Detect Prostate Cancer [ Time Frame: one year ]
    The primary objective of this Institutional Review Board -controlled study is to determine if Trans urethral ultrasound can be used to identify prostate cancer, thus avoiding prostate needle biopsies for diagnosis

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men undergoing a standard of care radical prostatectomy for prostate cancer.
  • Aged > 40 years old.
  • Men who have a serious prostate obstruction, are excluded due to the difficulty of catheter insertion.

Exclusion Criteria:

  • Women are excluded as they do not have a prostate gland.
  • Minors are excluded as prostate cancer is generally found only in men aged > 40 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02307552

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United States, California
University of California, Irvine Health
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
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Principal Investigator: Thomas E Ahlering, MD University of California, Irvine

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Responsible Party: Thomas E. Ahlering, Vice Chairman and Professor, University of California, Irvine Identifier: NCT02307552    
Other Study ID Numbers: 2013-9305
First Posted: December 4, 2014    Key Record Dates
Results First Posted: June 27, 2017
Last Update Posted: July 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Thomas E. Ahlering, University of California, Irvine:
diagnostic tool
digital rectal exam
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases