Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer

NCT02307552 | Terminated Results DMC

• 1 other identifier: 2013-9305
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Imaging; ultrasound; prostate; cancer; diagnostic tool; catheter; urethra; digital rectal exam

Outcome Measures

Primary Outcomes (1)

• Measure Novel Transurethral Ultrasound Signatures to Detect Prostate Cancer

  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

  one year

Study Arms (1)

All patients

EXPERIMENTAL

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

Interventions

UreScan DEVICE

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.

All patients

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Health

Orange, California, 92868, United States

Location

Related Publications (1)

• Holmes DR 3rd, Davis BJ, Bruce CJ, Robb RA. 3D visualization, analysis, and treatment of the prostate using trans-urethral ultrasound. Comput Med Imaging Graph. 2003 Sep-Oct;27(5):339-49. doi: 10.1016/s0895-6111(02)00102-7.

  PMID: 12821027 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Thomas Ahlering, MD
• Organization: UC Irvine

tahlerin@uci.edu

714 456-6068

Study Officials

• Thomas E Ahlering, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman and Professor

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: December 4, 2014
• Study Start: June 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 27, 2017
• Results First Posted: June 27, 2017

Record last verified: 2017-06

Locations

US (1)