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
  Purpose

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
Prostate Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

Prostate speciments are retained after radical prostatectomy surgery


Estimated Enrollment: 10
Study Start Date: September 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders 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.

Criteria

Inclusion Criteria:

  • Prostate Cancer

Exclusion Criteria:

  • Not having radical prostatectomy surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401972

Contacts
Contact: Gregory Czarnota, PhD (416) 480-6100 ext 7073 gregory.czarnota@sunnybrook.ca

Locations
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
Investigators
Principal Investigator: Gregory Czarnota, PhD, M.D. Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Gregory Czarnota, Dr., Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01401972     History of Changes
Other Study ID Numbers: Ultrasound Prostate Cancer
Study First Received: September 1, 2010
Last Updated: April 25, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
prostate
cancer
ultrasound
spectroscopy

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

ClinicalTrials.gov processed this record on October 21, 2014