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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
robotic radical prostatectomy
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer focused on measuring prostatectomy, surgery, prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Arm A

Arm B

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

Collect and analyze descriptive characteristics of patient population and summarize patient outcome data.

Secondary Outcome Measures

Correlate the patient characteristics to the surgical outcomes.
Determine the overall survival
Determine the rate of local recurrence in patients undergoing robotic prostatectomy and compare these metrics to historical controls.
disease- free survival

Full Information

First Posted
May 8, 2012
Last Updated
November 4, 2020
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01643954
Brief Title
Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at The James
Official Title
Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at Ohio State University/The James.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2008 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostatectomy, surgery, prostate cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
No Intervention
Arm Description
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 Title
Arm B
Arm Type
Other
Arm Description
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 Type
Procedure
Intervention Name(s)
robotic radical prostatectomy
Other Intervention Name(s)
laparoscopic surgery, The da Vinci system
Intervention Description
robotic assisted surgery
Primary Outcome Measure Information:
Title
Collect and analyze descriptive characteristics of patient population and summarize patient outcome data.
Time Frame
up to 20 years
Secondary Outcome Measure Information:
Title
Correlate the patient characteristics to the surgical outcomes.
Time Frame
up to 20 years
Title
Determine the overall survival
Time Frame
up to 20 years
Title
Determine the rate of local recurrence in patients undergoing robotic prostatectomy and compare these metrics to historical controls.
Time Frame
up to 20 years
Title
disease- free survival
Time Frame
up to 20 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Clinton, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
Jamesline

Learn more about this trial

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

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