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

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.
 
ClinicalTrials.gov Identifier: NCT01643954
Recruitment Status : Active, not recruiting
First Posted : July 18, 2012
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE May 8, 2012
First Posted Date  ICMJE July 18, 2012
Last Update Posted Date March 13, 2019
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
Collect and analyze descriptive characteristics of patient population and summarize patient outcome data. [ Time Frame: up to 20 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at The James
Official Title  ICMJE Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at Ohio State University/The James.
Brief Summary This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Procedure: robotic radical prostatectomy
robotic assisted surgery
Other Names:
  • laparoscopic surgery
  • The da Vinci system
Study Arms  ICMJE
  • 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 .
    Intervention: Procedure: robotic radical prostatectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2012)
4000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2035
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01643954
Other Study ID Numbers  ICMJE OSU-08108
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven Clinton, Ohio State University Comprehensive Cancer Center
Study Sponsor  ICMJE Ohio State University Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven Clinton, MD Ohio State University
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP