Robotic Laparoscopic Radical Prostatectomy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT00292019

First received: February 14, 2006

Last updated: August 25, 2017

Last verified: August 2017

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:

Genetics Home Reference related topics: prostate cancer

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:


Enrollment:	20
Actual Study Start Date:	March 4, 2004
Study Completion Date:	June 30, 2016
Primary Completion Date:	June 30, 2016 (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

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

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


Responsible Party:	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:	August 25, 2017

ClinicalTrials.gov processed this record on September 21, 2017

To Top