Single-Port Versus Multi-Port Robotic Radical Prostatectomy

Withdrawn before enrolling · Not applicable

Conditions studied: Malignant Neoplasm of Prostate

In brief

The purpose of this study is to compare two different techniques to perform the standard of care surgery to treat prostate cancer. This surgery is called robotic radical prostatectomy. There are two robotic surgical systems approved by the Food and Drug Administration (FDA) to perform this surgery. First system is called the Da Vinci ® Xi system. With this system, six small incisions are made during the surgery. Second system is called the Da Vinci ® SP system. With this system a single incision is made during the surgery. Same surgery is done with each surgical system. This study aims to understand whether a single incision surgery ends up with better recovery after surgery.

Key facts

Study ID

NCT04696263

Run by

Case Comprehensive Cancer Center

People needed

0

Starts

2022-09-01

Expected to finish

2025-03-01

Last updated by the study team

2025-03-10

Who can join

Age: 19 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have histologically or cytologically confirmed prostate cancer, stage T1a, T2a or T2b prostate cancer using MRI staging.
• Life expectancy greater than 10 years.
• Participants must have ability to understand and the willingness to sign a written informed consent document or have a surrogate with the ability to understand and the willingness to sign a written informed consent for radical prostatectomy.

You may not qualify if…

• Participants with any prior extensive pelvic surgery or pelvic fractures.
• Prior treatment for prostate cancer such as radiotherapy or focal therapy.
• Uncorrected coagulopathy.
• Active soft tissue or urinary infection.
• Poor surgical risk (defined as American Society of Anesthesiology score > 3)
• Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.)
• Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Where it is running

• Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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