Impact of Intraoperative ICG on Functional Outc in RARP

Recruiting Early Phase 1 Interventional Study
Prostate Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
University of California, Irvine · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 1\. Subjects must be ≥18 years old and male. * 2\. Histologically/pathologically confirmed localized prostate adenocarcinoma. * 3\. Most recent preoperative Sexual Health Inventory for Men (SHIM) score ≥10. * 4\. Subjects who are candidates for good nerve sparing preoperativel…
Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-8839

ucstudy@uci.edu

CONTACT

University of California Irvine Medical

CONTACT