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Conventional Ultrasound for Imaging of Prostate Cancer Extent and Response in Human Cancer Patients

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ClinicalTrials.gov Identifier: NCT01401972
Recruitment Status : Recruiting
First Posted : July 26, 2011
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
In this observational study the investigators will undertake imaging studies on men with prostate cancer. The primary hypothesis is that ultrasound spectroscopy could be used to determine the extent of disease inside and outside of the prostate gland in patients with prostate cancer. It is hoped that the changes in ultrasound backscatter parameters obtained before radical prostatectomy could be used to correlate with pathological findings from the prostate specimen after surgery.

Condition or disease
Prostate Cancer

Detailed Description:

This project is an early validation study in human subjects that will use ultrasound imaging and spectroscopy to predict the tumour extent before treatment so that this may allow the most appropriate treatment intervention to be individualised to patients. For examples, patients with evidence of extra-prostatic tissue involvement may be best served with definitive radiation therapy rather than radical prostatectomy as surgery alone in this situation, is not optimum. Furthermore, these ultrasound parameters may be used to monitor cell death occurring at various time points during patients' radiation treatment for prostate cancer.

The research is exploratory since upon data analysis it will examine the use of different ultrasound parameters as potential markers of pre-treatment tumour extent and cell death, and correlate these with tumour shrinkage and complete pathological response. Sensitivity and specificity values for the various ultrasound parameters will be calculated for the different time points used and receiver-operator curves will be generated. From this data the investigators will potentially estimate the best time-points at which to make a prediction about patient response and the best ultrasound-spectroscopy variables to use for this purpose.

Study Design

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Conventional and Contrast-Assisted Frequency Functional Ultrasound for Imaging of Prostate Cancer Extent and Response in Human Cancer Patients
Study Start Date : September 2008
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. ultrasound backscatter parameters such as aggregate mid-band fit, spectroscopic slope and intercept and the number of vessels with detectable blood flow and their sizes [ Time Frame: Up to year 2019 ]
    These parameters will be obtained before radical prostatectomy to correlate with pathological findings from the prostate specimen after surgery.

Secondary Outcome Measures :
  1. sensitivity and specificity of ultrasound-based imaging of the prostate [ Time Frame: Up to year 2019 ]
    the changes in the ultrasound backscatter parameters obtained from the ultrasonic spectroscopy during patient's radiation treatment would be used to monitor tumor response and to correlate with pathological findings in patients with prostate cancer.

Biospecimen Retention:   Samples With DNA
Prostate speciments are retained after radical prostatectomy surgery

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will investigate a population of 30 men with prostate cancer undergoing radical prostatectomy surgery.

Inclusion Criteria:

  • Prostate Cancer

Exclusion Criteria:

  • Not having radical prostatectomy surgery
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01401972

Contact: Gregory J. Czarnota (416) 480-6100 ext 7073 gregory.czarnota@sunnybrook.ca
Contact: William T. Tran (416) 480-6100 ext 1099 william.tran@sunnybrook.ca

Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Gregory Czarnota, PhD, M.D.    (416) 480-6100 ext 7073    gregory.czarnota@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Principal Investigator: Gregory Czarnota, PhD, M.D. Sunnybrook Health Sciences Centre
More Information

Responsible Party: Dr. Gregory Czarnota, Dr., Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01401972     History of Changes
Other Study ID Numbers: Ultrasound Prostate Cancer
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases