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Use of Indocyanine Green in Robotic Prostate Surgeries

Primary Purpose

Prostate Cancer Adenocarcinoma, Erectile Dysfunction Following Radical Prostatectomy

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
using Indocyanine Green
Nerve-sparing robot-assisted laparoscopic radical prostatectomy
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer Adenocarcinoma focused on measuring erectile dysfunction and indocyanine green, radical prostatectomy and indocyanine green

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Patients with low-intermediate risk prostate cancer Exclusion Criteria: Patients high risk prostate cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group using Indocyanine Green

    The Indocyanine Green -unused group

    Arm Description

    Performing nerve-sparing robot-assisted laparoscopic radical prostatectomy by IV injecting of Indocyanine Green

    Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green

    Outcomes

    Primary Outcome Measures

    Evaluation of erectile function.
    Evaluation of erectile function after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green.Evaluation of surgical margin positivity after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green. Both groups will evaluate their erectile function by completing the preoperative International Index of Erectile Function Every groups of participants will fill the International Index of Erectile Function -5 again after surgery in 3. -6. -9. -12 months. The possible scores for the International Index of Erectile Function- 5 range from 0 to 30, and Erectile disfonction is classified into five categories based on the scores: severe (0-10), moderate (11-16), mild to moderate (17-21), mild (22-25), and no erectile disfonction (26-30).
    Evaluation of surgical margin positivity
    Postoperative surgical margin positivity will be compared in both groups according to the results of the postoperative pathology report. Surgical margin positivity in both groups will be evaluated as a percentage and it will be evaluated whether there is a significant difference between the two groups

    Secondary Outcome Measures

    Full Information

    First Posted
    May 31, 2023
    Last Updated
    July 21, 2023
    Sponsor
    Ankara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05960149
    Brief Title
    Use of Indocyanine Green in Robotic Prostate Surgeries
    Official Title
    Evaluation of the Effect of Intraoperative Indocyanine Green Use on Erectile Function and Surgical Margin Positivity in Patients Undergoing Nerve-Sparing Robot-Assisted Laparoscopic Radical Prostatectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 30, 2023 (Anticipated)
    Primary Completion Date
    December 3, 2025 (Anticipated)
    Study Completion Date
    March 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Imaging of the vascular nerve bundle using Indocyanine Green
    Detailed Description
    Comparison of erectile function and surgical margin positivity after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery performed by imaging the vascular nerve bundle using Indocyanine Green with the results after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery without Indocyanine Green

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer Adenocarcinoma, Erectile Dysfunction Following Radical Prostatectomy
    Keywords
    erectile dysfunction and indocyanine green, radical prostatectomy and indocyanine green

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group using Indocyanine Green
    Arm Type
    Experimental
    Arm Description
    Performing nerve-sparing robot-assisted laparoscopic radical prostatectomy by IV injecting of Indocyanine Green
    Arm Title
    The Indocyanine Green -unused group
    Arm Type
    Experimental
    Arm Description
    Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green
    Intervention Type
    Drug
    Intervention Name(s)
    using Indocyanine Green
    Other Intervention Name(s)
    IV Indocyanine Green injection
    Intervention Description
    Nerve-sparing robot-assisted laparoscopic radical prostatectomy using Indocyanine Green
    Intervention Type
    Procedure
    Intervention Name(s)
    Nerve-sparing robot-assisted laparoscopic radical prostatectomy
    Intervention Description
    Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green
    Primary Outcome Measure Information:
    Title
    Evaluation of erectile function.
    Description
    Evaluation of erectile function after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green.Evaluation of surgical margin positivity after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green. Both groups will evaluate their erectile function by completing the preoperative International Index of Erectile Function Every groups of participants will fill the International Index of Erectile Function -5 again after surgery in 3. -6. -9. -12 months. The possible scores for the International Index of Erectile Function- 5 range from 0 to 30, and Erectile disfonction is classified into five categories based on the scores: severe (0-10), moderate (11-16), mild to moderate (17-21), mild (22-25), and no erectile disfonction (26-30).
    Time Frame
    up to 12 months
    Title
    Evaluation of surgical margin positivity
    Description
    Postoperative surgical margin positivity will be compared in both groups according to the results of the postoperative pathology report. Surgical margin positivity in both groups will be evaluated as a percentage and it will be evaluated whether there is a significant difference between the two groups
    Time Frame
    Up to 12 months

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with low-intermediate risk prostate cancer Exclusion Criteria: Patients high risk prostate cancer
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Araz Musaev, Dr
    Phone
    +905364536276
    Email
    msyv.araz@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Araz Musaev
    Organizational Affiliation
    Ankara Universitry
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Use of Indocyanine Green in Robotic Prostate Surgeries

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