Single-Port Versus Multi-Port Robotic Radical Prostatectomy

Case Comprehensive Cancer Center (Case CCC)

Status: Withdrawn

Conditions: Malignant Neoplasm of Prostate

Treatments: Device: Da Vinci ® SP system - SP Robotic Radical Prostatectomy; Device: Da Vinci ® Xi system - MP Robotic Radical Prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04696263

CASE7820

Details and patient eligibility

About

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.

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP system)

Active Comparator group

Description:

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:

Device: Da Vinci ® SP system - SP Robotic Radical Prostatectomy

Extraperitoneal MultiPort (MP) Robotic Radical Prostatectomy (Da Vinci ® Xi system)

Active Comparator group

Description:

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:

Device: Da Vinci ® Xi system - MP Robotic Radical Prostatectomy