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

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ClinicalTrials.gov Identifier: NCT01643954
Recruitment Status : Active, not recruiting
First Posted : July 18, 2012
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center

Study Description
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Brief Summary:
This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: robotic radical prostatectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at Ohio State University/The James.
Actual Study Start Date : September 23, 2008
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2035

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Steven Clinton, MD Ohio State University
More Information
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Additional Information:

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Responsible Party: Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01643954    
Other Study ID Numbers: OSU-08108
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Steven Clinton, Ohio State University Comprehensive Cancer Center:
prostatectomy
surgery
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases