Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at The James
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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 : November 6, 2020
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Procedure: robotic radical prostatectomy | Not Applicable |
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 |

Arm | Intervention/treatment |
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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.
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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 .
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Procedure: robotic radical prostatectomy
robotic assisted surgery
Other Names:
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- Collect and analyze descriptive characteristics of patient population and summarize patient outcome data. [ Time Frame: up to 20 years ]
- 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 ]

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

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
United States, Ohio | |
Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Steven Clinton, MD | Ohio State University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
prostatectomy surgery prostate cancer |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |