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OpenTrials
Completed

NCT Number: NCT00292019

Robotic Laparoscopic Radical Prostatectomy

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

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Key information

Age range

40 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Laparoscopic

Procedure

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2004
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2006
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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