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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

February 14, 2006
July 7, 2009
March 2004
June 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00292019 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Robotic Laparoscopic Radical Prostatectomy
Robotic Laparoscopic Radical Prostatectomy

This is a pilot study to evaluate the role of RALRP in the management of localized prostate cancer.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Prostate cancer patients eligible for a radical prostatectomy
Prostate Cancer
Procedure: Laparoscopic
Patients with prostate cancer who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robots.
Robotic prostatectomy
Patients who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robotics.
Intervention: Procedure: Laparoscopic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2011
June 2011   (final data collection date for primary outcome measure)

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:

-
Male
40 Years to 65 Years
No
Contact: Wendy Shoff, RN 519-685-8500 ext 57350 wendy.shoff@lhsc.on.ca
Canada
 
NCT00292019
R-04-030, 10280
No
Dr. J. Chin, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Joseph Chin, MD< FRCSC London Health Sciences Centre
Lawson Health Research Institute
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP