Malignant Neoplasm of ProstateNCT04696263
Single-Port Versus Multi-Port Robotic Radical Prostatectomy
A study testing Da Vinci ® Xi system - MP Robotic Radical Prostatectomy and Da Vinci ® SP system - SP Robotic Radical Prostatectomy in people with Malignant Neoplasm of Prostate, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Malignant Neoplasm of Prostate
- What is being tested?
- Da Vinci ® Xi system - MP Robotic Radical Prostatectomy and Da Vinci ® SP system - SP Robotic Radical Prostatectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Prospective Single-Center Randomized Study Of Single-Port Versus Multi-Port Robotic Radical Prostatectomy
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
- Being tested
- Da Vinci ® Xi system - MP Robotic Radical Prostatectomy, Da Vinci ® SP system - SP Robotic Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Da Vinci ® Xi system - MP Robotic Radical ProstatectomyDevice
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.
Da Vinci ® SP system - SP Robotic Radical ProstatectomyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Da Vinci ® Xi system - MP Robotic Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of Urinary Continence Following Catheter Removal
Continence will be defined as the absence of pads (even safety pads).
Measured: Up to 12 months post-treatment
Secondary outcomes (19)
Operative time
Time elapsed from skin incision to placement of the final skin suture
Measured: During operation, an average operative time is 192 minutes
Estimated blood loss in milliliters
Estimated blood loss, measured in volume (mL)
Measured: During operation, an average operative time is 192 minutes
Number of additional ports
Number of additional ports needed in surgery
Measured: Within 24 hours of surgery
Number of SP procedures converted to other procedure types
For SP procedures, conversion to MP robotic surgery or standard laparoscopic surgery, or open surgery will be recorded
Measured: Within 24 hours of surgery
Intraoperative complication rate
Intraoperative complication rate compared between the two systems
Measured: Within 24 hours of surgery
Number of participants requiring Intraoperative Trendelenburg position
Intraoperative Trendelenburg position requirement for the participant will be recorded. Position involves placing the head low and feet elevated, increasing blood return to the heart, cardiac output and vital organ perfusion
Measured: Within 24 hours of surgery
Intraoperative peritoneum breach rate
Intraoperative peritoneum breach rate as defined by intraoperative pneumoperitoneum after insufflation of extraperitoneal space
Measured: Within 24 hours of surgery
Visual analog pain scale scores
Pain intensity will be evaluated with a visual analog pain scale, a validated instrument scored from 0 to 10, 10 being the worst
Measured: Within 7 days of surgery
Units of parenteral morphine equivalents (mg)
Analgesic requirements will be obtained from medical charts and reported as units of parenteral morphine equivalents (mg)
Measured: Up to 1 month post-procedure
Time to liquid oral intake
Time to liquid oral intake
Measured: Post-surgery, an average of 16 hours
Time to solid oral intake
Time to solid oral intake
Measured: Post-surgery, an average of 16 hours
Number of postoperative complications
Postoperative complications recorded according to the Clavien- Dindo classification
Measured: Within 30 days
Body image questionnaire scores
Body image perception, measured using the body image questionnaire, which consists of two sub-scales: the body image scale, which assesses attitudes to bodily appearance and consists of five questions (score 5-20) where higher scores mean worse outcomes, and the cosmetic scale which assesses the degree of satisfaction with the appearance of the scar and consists of three questions (score 3-24), where higher scores mean worse outcomes.
Measured: Up to 1 year
Participant and Observer Scar Assessment Scale scores
Scar evaluation by using a validated assessment tool, the Participant and Observer Scar Assessment Scale.17 It consists of two scales: the observer scale and the participant scale (Figs. 1 and 2). Both scales contain six items that are scored numerically. Each of the six items on both scales has a 10-step score, with 10 indicating the worst imaginable scar or sensation. The total score of both scales consists of adding the scores of each of the six items (range, 6 to 60). The lowest score, 6, reflects normal skin, whereas the highest score, 60, reflects the worst imaginable scar.
Measured: Up to 1 year
Number of pads used daily
Urinary continence, assessing the number of pads used daily. Continence will be defined as the absence of pads (even safety pads)
Measured: Up to 1 year
International Index of Erectile Function (IIEF-5) scale scores
Erectile Function assessed by the IIEF-5 scale, consisting of 5 questions, with scores ranging from 5-25. 25 being great and 5 being the worst
Measured: Up to 1 year
Time to return-to-work
Time to return-to-work, reported in days
Measured: Up to 1 year
Time to baseline
Time to baseline defined as the amount of time between surgery and when the patient becomes pain free and does not need painkillers
Measured: Up to 1 year
Hospital stay in hours
Hospital stay, counted in hours from the time of transfer to the post anesthesia care unit (PACU) to discharge
Measured: Post-surgery, an average of 16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Sep 2022
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Why it stopped: Study closure based on study population not found and not enough study staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jihad Kaouk, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696263
- Sponsor's protocol ID
- CASE7820
- Status last verified
- Mar 2025
- First submitted
- 4 Jan 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This trial will not study a drug, device, biological/vaccine, radiation, genetic, combination product or diagnostic test
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-Center Randomized Study Of Single-Port Versus Multi-Port Robotic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT04696263
- Acronym / sponsor ID
- CASE7820
- Conditions
- Malignant Neoplasm of Prostate
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closure based on study population not found and not enough study staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP system) | Active comparator | Device: Da Vinci ® SP system - SP Robotic Radical ProstatectomyAll 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 |
| Extraperitoneal MultiPort (MP) Robotic Radical Prostatectomy (Da Vinci ® Xi system) | Active comparator | Device: Da Vinci ® Xi system - MP Robotic Radical ProstatectomyAll 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Da Vinci ® Xi system - MP Robotic Radical ProstatectomyAfter 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. | Device | Extraperitoneal MultiPort (MP) Robotic Radical Prostatectomy (Da Vinci ® Xi system) |
| Da Vinci ® SP system - SP Robotic Radical ProstatectomyAfter 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 | Device | Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP system) |
Primary outcome
Recovery of Urinary Continence Following Catheter Removal
Time frame: Up to 12 months post-treatment
Continence will be defined as the absence of pads (even safety pads).
19 secondary outcomes
Operative time
Time frame: During operation, an average operative time is 192 minutes
Estimated blood loss in milliliters
Time frame: During operation, an average operative time is 192 minutes
Number of additional ports
Time frame: Within 24 hours of surgery
Number of SP procedures converted to other procedure types
Time frame: Within 24 hours of surgery
Intraoperative complication rate
Time frame: Within 24 hours of surgery
Number of participants requiring Intraoperative Trendelenburg position
Time frame: Within 24 hours of surgery
Intraoperative peritoneum breach rate
Time frame: Within 24 hours of surgery
Visual analog pain scale scores
Time frame: Within 7 days of surgery
Units of parenteral morphine equivalents (mg)
Time frame: Up to 1 month post-procedure
Time to liquid oral intake
Time frame: Post-surgery, an average of 16 hours
Time to solid oral intake
Time frame: Post-surgery, an average of 16 hours
Number of postoperative complications
Time frame: Within 30 days
Body image questionnaire scores
Time frame: Up to 1 year
Participant and Observer Scar Assessment Scale scores
Time frame: Up to 1 year
Number of pads used daily
Time frame: Up to 1 year
International Index of Erectile Function (IIEF-5) scale scores
Time frame: Up to 1 year
Time to return-to-work
Time frame: Up to 1 year
Time to baseline
Time frame: Up to 1 year
Hospital stay in hours
Time frame: Post-surgery, an average of 16 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No. This trial will not study a drug, device, biological/vaccine, radiation, genetic, combination product or diagnostic test
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihad Kaouk, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Da Vinci ® Xi system - MP Robotic Radical Prostatectomy and Da Vinci ® SP system - SP Robotic Radical Prostatectomy in people with Malignant Neoplasm of Prostate, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of Urinary Continence Following Catheter Removal (time frame: Up to 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.