Robotic Laparoscopic Radical Prostatectomy

NCT ID: NCT00292019

Last Updated: 2017-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-04

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Robotic prostatectomy

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

Laparoscopic

Intervention Type PROCEDURE

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

Interventions

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Laparoscopic

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

Intervention Type PROCEDURE

Eligibility Criteria

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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. -


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Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Chin, MD< FRCSC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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10280

Identifier Type: -

Identifier Source: secondary_id

R-04-030

Identifier Type: -

Identifier Source: org_study_id

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