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


N/A
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.


Inclusion Criteria:



- Prostate Cancer

Exclusion Criteria:

- Not having radical prostatectomy surgery

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

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

Outcome Description:

These parameters will be obtained before radical prostatectomy to correlate with pathological findings from the prostate specimen after surgery.

Outcome Time Frame:

Up to year 2012 (up to 4 years)

Safety Issue:

No

Principal Investigator

Gregory Czarnota, PhD, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre

Authority:

Canada: Ethics Review Committee

Study ID:

Ultrasound Prostate Cancer

NCT ID:

NCT01401972

Start Date:

September 2008

Completion Date:

September 2013

Related Keywords:

  • Prostate Cancer
  • prostate
  • cancer
  • ultrasound
  • spectroscopy
  • Prostatic Neoplasms

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