NCT03943368

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

4.7 years

First QC Date

May 7, 2019

Last Update Submit

June 3, 2024

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Postoperative PSA

    PSA blood test measured at threshold of 0.1 at 3-6 and 18-24 months

    Up to 24 months

Secondary Outcomes (4)

  • Surgical Margin Status

    Immediately postoperatively

  • Androgen Deprivation or Radiation Therapy

    Up to 24 months postoperatively

  • Postoperative Erectile Function

    Up to 24 months postoperatively

  • Postoperative Urinary Function

    Up to 24 months postoperatively

Study Arms (2)

Experimental: Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

Subjects whose surgeon will only be viewing MR images in connection with the case.

Interventions

Ceevra RevealDEVICE

3D Digital models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source MR image.

Experimental: Intervention Arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UCLA Urology

Los Angeles, California, 90094, United States

Location

UC Irvine

Orange, California, 92868, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mount Sinai Health System

New York, New York, 10029, United States

Location

Swedish Urology Group

Seattle, Washington, 98104, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Related Publications (2)

  • Shirk JD, Reiter RE, Wallen EM, Pak RW, Ahlering T, Badani KK, Porter JR. Trifecta Outcomes After Use of 3-Dimensional Digital Models for Planning of Robotic Prostatectomy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2434143. doi: 10.1001/jamanetworkopen.2024.34143.

    PMID: 39283633DERIVED

  • 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.

    PMID: 35848770DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • James Porter, MD

    Swedish Medical Center

    PRINCIPAL INVESTIGATOR

  • Raymond Pak, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Thomas Ahlering, MD

    UC Irvine

    PRINCIPAL INVESTIGATOR

  • Robert Reiter, MD

    UCLA Urology

    PRINCIPAL INVESTIGATOR

  • Ketan Badani, MD

    Mount Sinai Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 9, 2019

Study Start

January 1, 2019

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(6)