Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer

Stopped early · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02307552

Run by

University of California, Irvine

People needed

1

Starts

2013-06-01

Expected to finish

2014-05-01

Last updated by the study team

2017-07-27

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of California, Irvine Health — Orange, California, United States

Full record on ClinicalTrials.gov

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