Using Virtual Reality (VR) Models for Robotic Prostatectomy

A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic prostatectomy) and improved patient care.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Ceevra Reveal

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90094
      • UCLA Urology
    • Orange, California, United States, 92868
      • UC Irvine
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Health System
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Seattle, Washington, United States, 98104
      • Swedish Urology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is undergoing robotic prostatectomy being performed by participating surgeon
• Patient is willing to be randomized between intervention and control arms

Exclusion Criteria:

• Patients with prior pelvic radiation
• Patients with prior androgen deprivation therapy
• Patients with prior localized ablative therapy
• Patients with prior TURP or other surgical BPH treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Intervention Arm; Subjects whose surgeon will be viewing Digital 3D models in addition to the source MR image and biopsy results in connection with the case.	Device: Ceevra Reveal; 3D Digital models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source MR image.
No Intervention: Control Arm; Subjects whose surgeon will only be viewing MR images in connection with the case.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative PSA	PSA blood test measured at threshold of 0.1 at 3-6 and 18-24 months	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Margin Status	Defined as positive or negative surgical margin	Immediately postoperatively
Androgen Deprivation or Radiation Therapy	Any occurrence of salvage or adjuvant therapy post surgery	Up to 24 months postoperatively
Postoperative Erectile Function	Nerve sparing immediately postoperatively, SHIM score at 3-6 and 18-24 months	Up to 24 months postoperatively
Postoperative Urinary Function	Bladder neck sparing immediately postoperatively, pads per day at 3-6 and 18-24 months	Up to 24 months postoperatively

Collaborators and Investigators

• Sponsor: Ceevra, Inc.
• Investigators: Principal Investigator: Thomas Ahlering, MD, UC Irvine; Principal Investigator: Raymond Pak, MD, Mayo Clinic; Principal Investigator: Robert Reiter, MD, UCLA Urology; Principal Investigator: Ketan Badani, MD, Mount Sinai Health System; Principal Investigator: James Porter, MD, Swedish Medical Center

Publications and helpful links

General Publications

• Shirk JD, Reiter R, Wallen EM, Pak R, Ahlering T, Badani KK, Porter JR. Effect of 3-Dimensional, Virtual Reality Models for Surgical Planning of Robotic Prostatectomy on Trifecta Outcomes: A Randomized Clinical Trial. J Urol. 2022 Sep;208(3):618-625. doi: 10.1097/JU.0000000000002719. Epub 2022 Jul 18.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 20171006RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes