Intra-operative Trans-rectal Ultrasound Guidance for Robot-assisted Radical Prostatectomy

Prostate Cancer Clinical Trial

— TRUS-RP  

Official title:

Intra-operative Trans-rectal Ultrasound Guidance for Robot-assisted Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001597
• Other study ID #: H11-02267
• Secondary ID: 385902-2010
• Status: Completed
• Phase: N/A
• First received: November 22, 2013
• Last updated: December 4, 2013
• Start date: March 2013
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

Radical prostatectomy, or the surgical extirpation of the prostate, is a standard treatment for prostate cancer. The state of the art radical prostatectomy involves a robotic laparoscopic surgery system (the da Vinci) which provides the surgeon with excellent 3D visualization of the surgical site and improved dexterity over standard laparoscopic instruments. While the long term prognosis of prostate cancer patients who undergo radical prostatectomy has improved significantly over the past two decades, there remain significant rates of disease recurrence and complications.

The investigators hypothesis is that advanced trans-rectal ultrasound (TRUS) imaging can be deployed and used easily during surgery, can be registered to the robot coordinate systems with high accuracy, and can be controlled from the surgeon's console, in order to improve the visualization of the prostate and peri-prostatic anatomy, and in order to produce a cancer probability map that can be used to make decisions on surgical margins.

The investigators objectives are

1. To demonstrate that TRUS imaging can be integrated with the da Vinci radical prostatectomy

2. To determine the ability of TRUS imaging to intra-operatively visualize the prostate and peri-prostatic tissue from the surgical console

This is an observational study; trans-rectal ultrasound will be used to visualize the prostate and periprostatic structures during surgery but the standard of care will not be affected by this ultrasound imaging.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All men who undergo robot-assisted radical prostatectomy are eligible.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Innovation Council, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact on completion time	We will report the total additional ultrasound set-up time for each of the patients.	1 year	No
Primary	Time required to register the trans-rectal ultrasound coordinates to the da Vinci coordinates	We will measure and report the time required to carry out the registration of the ultrasound transducer relative to the da Vinci coordinate system for each of the patients.	1 year	No
Secondary	Successful prostate visualization	For each patient in the cohort, we will report the total time of ultrasound use and the specific context in which it was used, e.g. identification of the bladder neck, identification of rectal wall, identification of the seminal vesicles, identification of the prostate apex.	1 year	No