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

Prostate Cancer Clinical Trial

Official title:

Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at Ohio State University/The James.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01643954
• Other study ID #: OSU-08108
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 23, 2008
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1531
• Est. completion date: December 2025
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• robotic radical prostatectomy
robotic assisted surgery

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect and analyze descriptive characteristics of patient population and summarize patient outcome data.		up to 20 years
Secondary	Correlate the patient characteristics to the surgical outcomes.		up to 20 years
Secondary	Determine the overall survival		up to 20 years
Secondary	Determine the rate of local recurrence in patients undergoing robotic prostatectomy and compare these metrics to historical controls.		up to 20 years
Secondary	disease- free survival		up to 20 years

External Links

•   Jamesline