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

Case Comprehensive Cancer Center, Cleveland, OH
Prostate CancerDa Vinci ® SP system - SP Robotic Radical Prostatectomy - Device
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is comparing two different ways to do a surgery that is already the standard of care for treating prostate cancer. The study is looking to see if one method of surgery, which uses a single incision, results in a better recovery than the method that uses six small incisions.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 19 Secondary · Reporting Duration: Up to 1 year

During operation, an average operative time is 192 minutes
Estimated blood loss in milliliters
Operative time
Hour 16
Hospital stay in hours
Time to liquid oral intake
Time to solid oral intake
Month 1
Units of parenteral morphine equivalents (mg)
Up to 1 year
Body image questionnaire scores
International Index of Erectile Function (IIEF-5) scale scores
Number of pads used daily
Participant and Observer Scar Assessment Scale scores
Time to baseline
Time to return-to-work
Month 12
Recovery of Urinary Continence Following Catheter Removal
Hour 24
Intraoperative complication rate
Intraoperative peritoneum breach rate
Number of SP procedures converted to other procedure types
Number of additional ports
Number of participants requiring Intraoperative Trendelenburg position
Within 30 days
Number of postoperative complications
Day 7
Visual analog pain scale scores

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP sys...
1 of 2
Extraperitoneal MultiPort (MP) Robotic Radical Prostatectomy (Da Vinci ® Xi syst...
1 of 2

Active Control

66 Total Participants · 2 Treatment Groups

Primary Treatment: Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP system) · No Placebo Group · N/A

Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP system)
Device
ActiveComparator Group · 1 Intervention: Da Vinci ® SP system - SP Robotic Radical Prostatectomy · Intervention Types: Device
Extraperitoneal MultiPort (MP) Robotic Radical Prostatectomy (Da Vinci ® Xi system)
Device
ActiveComparator Group · 1 Intervention: Da Vinci ® Xi system - MP Robotic Radical Prostatectomy · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
433 Previous Clinical Trials
30,512 Total Patients Enrolled
29 Trials studying Prostate Cancer
2,647 Patients Enrolled for Prostate Cancer
Jihad Kaouk, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center
2 Previous Clinical Trials
295 Total Patients Enrolled
1 Trials studying Prostate Cancer
276 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Could you provide a figure of the individuals participating in this research project?

"Affirmative. According to information posted on clinicaltrials.gov, this medical study is presently recruiting participants; the listing was first published on September 1st 2022 and most recently updated November 8th 2022. Sixty-six patients are needed from one primary site for participation in the trial." - Anonymous Online Contributor

Unverified Answer

Are there still openings available for people to join this research effort?

"Affirmative. Evidenced from the data on clinicaltrials.gov, this medical trial is presently in search of 66 individuals to enrol at a single site. The first post was made on September 1st 2022 and it was last updated November 8th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.