- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01643954
Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at The James
December 24, 2025 updated by: Steven Clinton, Ohio State University Comprehensive Cancer Center
Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at Ohio State University/The James.
This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
1531
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
|
|
Other: 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 .
|
robotic assisted surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Collect and analyze descriptive characteristics of patient population and summarize patient outcome data.
Time Frame: up to 20 years
|
up to 20 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlate the patient characteristics to the surgical outcomes.
Time Frame: up to 20 years
|
up to 20 years
|
|
Determine the overall survival
Time Frame: up to 20 years
|
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
|
up to 20 years
|
|
disease- free survival
Time Frame: up to 20 years
|
up to 20 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steven Clinton, MD, Ohio State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 23, 2008
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Study Registration Dates
First Submitted
May 8, 2012
First Submitted That Met QC Criteria
July 17, 2012
First Posted (Estimated)
July 18, 2012
Study Record Updates
Last Update Posted (Estimated)
December 31, 2025
Last Update Submitted That Met QC Criteria
December 24, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Minimally Invasive Surgical Procedures
- Diagnostic Techniques, Surgical
- Endoscopy
- Laparoscopy
Other Study ID Numbers
- OSU-08108
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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