Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment robotic radical prostatectomy
Sponsor Ohio State University Comprehensive Cancer Center
Start date September 2008
End date December 2016
Trial size 4000 participants
Trial identifier NCT01643954, OSU-08108

Summary

This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Arm
(No Intervention)
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)
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 radical prostatectomy laparoscopic surgery
robotic assisted surgery

Primary Outcomes

Measure
Collect and analyze descriptive characteristics of patient population and summarize patient outcome data.
time frame: up to 20 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at Ohio State University/The James.
Principal investigator Steven Clinton, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.