NCT01401972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2010

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

10 years

First QC Date

September 1, 2010

Last Update Submit

September 20, 2019

Conditions

Prostate Cancer

Keywords

prostatecancerultrasoundspectroscopy

Outcome Measures

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

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

    Up to year 2019

Secondary Outcomes (1)

  • sensitivity and specificity of ultrasound-based imaging of the prostate

    Up to year 2019

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Prostate Cancer

You may not qualify if:

  • Not having radical prostatectomy surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Prostate speciments are retained after radical prostatectomy surgery

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Gregory Czarnota, PhD, M.D.

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 1, 2010

First Posted

July 26, 2011

Study Start

September 1, 2008

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 23, 2019

Record last verified: 2019-09

Locations

CA(1)