Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Robotic Laparoscopic Radical Prostatectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00292019
First received: February 14, 2006
Last updated: July 7, 2009
Last verified: July 2009
History of Changes
  Purpose
This is a pilot study to evaluate the role of RALRP in the management of localized prostate cancer.

Condition Intervention
Prostate Cancer
 Procedure: Laparoscopic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Robotic Laparoscopic Radical Prostatectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:
Estimated Enrollment: 20
Study Start Date: March 2004
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility
Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292019

Contacts
Contact: Wendy Shoff, RN 519-685-8500 ext 57350 wendy.shoff@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4G5
Contact: Joseph Chin, MD, fRCSC    519-685-8451      
Principal Investigator: Joseph Chin, MD, FRCSC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Joseph Chin, MD< FRCSC London Health Sciences Centre
  More Information

Responsible Party: Dr. J. Chin, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00292019     History of Changes
Other Study ID Numbers: R-04-030  10280 
Study First Received: February 14, 2006
Last Updated: July 7, 2009
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on September 29, 2016