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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Sunnybrook Health Sciences Centre.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01401972
First received: September 1, 2010
Last updated: April 25, 2012
Last verified: April 2012

September 1, 2010
April 25, 2012
September 2008
September 2013   (final data collection date for primary outcome measure)
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 2012 (up to 4 years) ] [ Designated as safety issue: No ]
These parameters will be obtained before radical prostatectomy to correlate with pathological findings from the prostate specimen after surgery.
Same as current
Complete list of historical versions of study NCT01401972 on ClinicalTrials.gov Archive Site
sensitivity and specificity of ultrasound-based imaging of the prostate [ Time Frame: Up to year 2012 (up to 4 years) ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Conventional Ultrasound for Imaging of Prostate Cancer Extent and Response in Human Cancer Patients
Conventional and Contrast-Assisted Frequency Functional Ultrasound for Imaging of Prostate Cancer Extent and Response in Human Cancer Patients

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Prostate speciments are retained after radical prostatectomy surgery

Non-Probability Sample

The study will investigate a population of 30 men with prostate cancer undergoing radical prostatectomy surgery.

Prostate Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prostate Cancer

Exclusion Criteria:

  • Not having radical prostatectomy surgery
Male
Not Provided
No
Contact: Gregory Czarnota, PhD (416) 480-6100 ext 7073 gregory.czarnota@sunnybrook.ca
Canada
 
NCT01401972
Ultrasound Prostate Cancer
No
Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Not Provided
Principal Investigator: Gregory Czarnota, PhD, M.D. Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP