Robotic Laparoscopic Radical Prostatectomy

NCT00292019 | Completed

• 2 other identifiers: R-04-03010280
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Study Arms (1)

Robotic prostatectomy

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

Procedure: Laparoscopic

Interventions

Laparoscopic PROCEDURE

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

Robotic prostatectomy

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate cancer patients eligible for a radical prostatectomy

You may qualify if:

• 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

You may not qualify if:

• 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. -

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Joseph Chin, MD< FRCSC

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 15, 2006
• Study Start: March 4, 2004
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CA (1)