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OpenTrials
Completed

NCT Number: NCT01401972

Conventional 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.

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Key information

Sex eligibility

Male

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prostate Cancer

Exclusion criteria

  • Not having radical prostatectomy surgery

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

Conventional and Contrast-Assisted Frequency Functional Ultrasound for Imaging of Prostate Cancer Extent and Response in Human Cancer Patients

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2011
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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