ClinicalTrials.gov
ClinicalTrials.gov Menu

Robotic Laparoscopic Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00292019
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a pilot study to evaluate the role of RALRP in the management of localized prostate cancer.

Condition or disease Intervention/treatment
Prostate Cancer Procedure: Laparoscopic

Detailed Description:
To establish a robotic-assisted laparoscopic radical prostatectomy programme at the University of Western Ontario/London Health Sciences Centre and to critically evaluate the role of this programme in the management of localized prostate cancer in surgical candidates Details of surgical procedure, operative outcome, patient outcome including quality of life will be collected.

Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Robotic Laparoscopic Radical Prostatectomy
Actual Study Start Date : March 4, 2004
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Robotic prostatectomy
Patients who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robotics.
 Procedure: Laparoscopic
Patients with prostate cancer who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robots.


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prostate cancer patients eligible for a radical prostatectomy
Criteria

Inclusion Criteria:

  1. Informed Consent
  2. Locally confined, stage T1a, T2a or T2b prostate cancer
  3. Aged 40-65 and judged by the study doctor to be a suitable candidate for a radical prostatectomy.
  4. Serum prostate specific antigen equal to or less than 10mg/ml
  5. Histologically confirmed adenocarcinoma of the prostate
  6. Gleason score equal to or less than 7
  7. Life expectancy of greater than 10 years.
  8. Prostate size on TRUS measurement less than 40 grams

Exclusion Criteria:

  1. Patients who have undergone prior hormone therapy.
  2. Patients with a previous transurethral resectioning of the prostate (TURP)
  3. History of other cancers other than basal cell carcinoma.
  4. Patients with any prior abdominal surgery.
  5. Any condition, or history of illness or surgery than, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (eg significant cardiovascular conditions)
  6. Patients with a large median lobe of the prostate. -

Exclusion Criteria:

Contacts and Locations
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292019


Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Joseph Chin, MD< FRCSC London Health Sciences Centre
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00292019     History of Changes
Other Study ID Numbers: R-04-030
10280
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017