Single-Port Versus Multi-Port Robotic Radical Prostatectomy

NCT04696263 | Withdrawn FDA Device

• 1 other identifier: CASE7820
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Neoplasm of Prostate

Outcome Measures

Primary Outcomes (1)

• Recovery of Urinary Continence Following Catheter Removal

  Continence will be defined as the absence of pads (even safety pads).

  Up to 12 months post-treatment

Secondary Outcomes (19)

• Operative time

  During operation, an average operative time is 192 minutes

• Estimated blood loss in milliliters

  During operation, an average operative time is 192 minutes

• Number of additional ports

  Within 24 hours of surgery

• Number of SP procedures converted to other procedure types

  Within 24 hours of surgery

• Intraoperative complication rate

  Within 24 hours of surgery

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

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

ACTIVE COMPARATOR

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

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

Interventions

Da Vinci ® Xi system - MP Robotic Radical Prostatectomy DEVICE

After pneumoperitoneum is established, four 8mm, one 12 mm, and one 5 mm trocars are placed for instrumentation. After the robot is docked, radical prostatectomy is performed with the SOC approach.

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

Da Vinci ® SP system - SP Robotic Radical Prostatectomy DEVICE

After induction of general anesthesia and supine participant positioning, a 3.5 cm infraumbilical incision will be made for single-port access into the space of Retzius. Radical prostatectomy is then performed with the SOC approach

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

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jihad Kaouk, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: September 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)