Robotic Laparoscopic Radical Prostatectomy

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Laparoscopic

• Registration Number: NCT00292019
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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

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 Timeline

• Study Start: 2004-03-04
• Study First Submitted: 2006-02-14
• Study First Submitted QC: 2006-02-14
• Study First Posted: 2006-02-15
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

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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:

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotic prostatectomy	Laparoscopic	Patients who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robotics.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada