Impact of Intraoperative ICG on Functional Outc in RARP

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06446648
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ICG — DRUG
    Administer an IV ICG injection intraoperatively, using the optimal dosage and timing defined in the second phase of the study. Utilize the newly developed 3D vascular map for visualization of the arteries before and after prostate resection.

Study Details

This is a pilot, 3 phases open-label feasibility study with the 3rd phase consisting of randomized 2-arm intervention trial, to assess the systematic use of indocyanine green (ICG) in subjects with prostate adenocarcinoma during robot-assisted radical prostatectomy and its impact on sexual function outcomes at 12 months postoperatively.

Key Dates

Start date
Jul 12, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: SOC group
    Robot-Assisted Radical Prostatectomy will be performed as a standard procedure.
  • Experimental: ICG group
    Robot-Assisted Radical Prostatectomy using ICG

Primary Outcome Measure

Continence Rate at 3 month Post-surgery [ Time Frame: 3 months ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center University of California, IrvineOrangeCalifornia92868
David Lee, MD
[email protected]
877-827-8839

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By research site
Chao Family Comprehensive Cancer Center University of California, Irvine· Orange, CA

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