Robotic Laparoscopic Radical Prostatectomy

Prostate Cancer Clinical Trial

Official title:

Robotic Laparoscopic Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292019
• Other study ID #: R-04-030
• Secondary ID: 10280
• Status: Completed
• Phase: N/A
• First received: February 14, 2006
• Last updated: August 25, 2017
• Start date: March 4, 2004
• Est. completion date: June 30, 2016

Study information

• Verified date: August 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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:

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Procedure:
• Laparoscopic
Patients with prostate cancer who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robots.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada,