Single-Port Versus Multi-Port Robotic Radical Prostatectomy
Key facts
- Who runs it
- Case Comprehensive Cancer Center
- Where
- Cleveland, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- 1 Sept 2022
- Ended
- Mar 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Da Vinci ® Xi system - MP Robotic Radical Prostatectomy
- Da Vinci ® SP system - SP Robotic Radical Prostatectomy
- Record updated
- 10 March 2025
- Why it stopped
- Study closure based on study population not found and not enough study staff
Who can take part
- Age
- 19 years and older
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Participants with any prior extensive pelvic surgery or pelvic fractures
- Prior treatment for prostate cancer such as radiotherapy or focal therapy
- Poor surgical risk (defined as American Society of Anesthesiology score > 3)
- Active soft tissue or urinary infection
- 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
- Uncorrected coagulopathy
Where in United States
- Case Comprehensive Cancer CenterCleveland, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP system)Existing treatment, for comparison
All participants will undergo SOC robotic radical prostatectomy. The procedure for this arm uses the Da Vinci ® SP system. Access point consists of one 3.5 cm single infraumbilical incision for the SP-RARP
Treatment: Da Vinci ® SP system - SP Robotic Radical Prostatectomy
- Extraperitoneal MultiPort (MP) Robotic Radical Prostatectomy (Da Vinci ® Xi system)Existing treatment, for comparison
All participants will undergo SOC robotic radical prostatectomy. The procedure for this arm uses the Da Vinci ® Xi system, where four 8mm trocars will be used along with a 12 mm assistant trocar (a surgical instrument) to create six small incisions during the surgery
Treatment: Da Vinci ® Xi system - MP Robotic Radical Prostatectomy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Single-Center Randomized Study Of Single-Port Versus Multi-Port Robotic Radical Prostatectomy
- Record updated
- 10 March 2025