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Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at The James

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643954
First Posted: July 18, 2012
Last Update Posted: December 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center
  Purpose
This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.

Condition Intervention
Prostate Cancer Procedure: robotic radical prostatectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at Ohio State University/The James.

Resource links provided by NLM:


Further study details as provided by Steven Clinton, Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Collect and analyze descriptive characteristics of patient population and summarize patient outcome data. [ Time Frame: up to 20 years ]

Secondary Outcome Measures:
  • Correlate the patient characteristics to the surgical outcomes. [ Time Frame: up to 20 years ]
  • Determine the overall survival [ Time Frame: up to 20 years ]
  • Determine the rate of local recurrence in patients undergoing robotic prostatectomy and compare these metrics to historical controls. [ Time Frame: up to 20 years ]
  • disease- free survival [ Time Frame: up to 20 years ]

Estimated Enrollment: 4000
Study Start Date: September 2008
Estimated Study Completion Date: December 2035
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm A
Patients with prostate cancer who have undergone robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.
Arm B
Patients with prostate cancer that will undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center .
Procedure: robotic radical prostatectomy
robotic assisted surgery
Other Names:
  • laparoscopic surgery
  • The da Vinci system

Detailed Description:
This retrospective / prospective study will allow us to collect and analyze the presurgical, peri-operative, and outcome data of patients who undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center, beginning February 2008 onwards.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

ARM A:

Inclusion Criteria:

  • Patients with prostate cancer who have undergone robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.
  • Ability to understand and willingness to sign the written informed consent document.
  • 18 years and older

ARM B:

Inclusion Criteria:

  • Patients with prostate cancer that will undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.
  • Ability to understand and willingness to sign the written informed consent document.
  • 18 years and older
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643954


Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Steven Clinton, MD Ohio State University
  More Information

Additional Information:
Responsible Party: Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01643954     History of Changes
Other Study ID Numbers: OSU-08108
First Submitted: May 8, 2012
First Posted: July 18, 2012
Last Update Posted: December 23, 2013
Last Verified: December 2013

Keywords provided by Steven Clinton, Ohio State University Comprehensive Cancer Center:
prostatectomy
surgery
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases