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Robotic Laparoscopic Radical Prostatectomy
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Lawson Health Research Institute.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Lawson Health Research Institute
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
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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:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
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) |
| 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:
- Informed Consent
- Locally confined, stage T1a, T2a or T2b prostate cancer
- Aged 40-65 and judged by the study doctor to be a suitable candidate for a radical prostatectomy.
- Serum prostate specific antigen equal to or less than 10mg/ml
- Histologically confirmed adenocarcinoma of the prostate
- Gleason score equal to or less than 7
- Life expectancy of greater than 10 years.
- Prostate size on TRUS measurement less than 40 grams
Exclusion Criteria:
- Patients who have undergone prior hormone therapy.
- Patients with a previous transurethral resectioning of the prostate (TURP)
- History of other cancers other than basal cell carcinoma.
- Patients with any prior abdominal surgery.
- 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)
- Patients with a large median lobe of the prostate. -
Exclusion Criteria:
Contacts and Locations
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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
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 |
ClinicalTrials.gov processed this record on July 27, 2017