Intraoperative Imaging with Indocyanine Green for the Improvement of Functional Outcomes in Patients with Prostate Cancer

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This phase II trial studies whether using indocyanine green (ICG) for imaging taken during surgery (intraoperative) improves functional outcomes in patients with prostate cancer. A treatment option for prostate cancer that is caught early is a type of surgery called robot-assisted radical prostatectomy (RARP). The surgery uses a robot to help remove the entire prostate gland to get rid of the cancer. There are side effects that can happen after surgery, and these can include problems with sexual function. These problems can affect a person's quality of life in the long term. Intraoperative imaging can be used during RARP to help the surgeon visualize the anatomy near the prostate and guide the surgical procedure. ICG is a special dye that can help visualize blood vessels better which may improve the images captured during intraoperative imaging and help the surgeon avoid certain areas or blood vessels during the RARP. Using ICG for intraoperative imaging may improve functional outcomes in patients with prostate cancer.

Inclusion Criteria

Subjects must be ≥ 18 years old, male, and sexually active
Histologically/pathologically confirmed localized prostate adenocarcinoma
Most recent preoperative Sexual Health Inventory for Men (SHIM) score ≥ 16
Subjects who are candidates for good nerve sparing preoperatively determined by the investigator by assessing imaging findings
Ability to read, write and understand and willingness to sign a written informed consent form
Subjects must pass medical clearance from primary care provider and cardiologist, if applicable
Subject must be determined to be medical fit for RARP by the investigator

Exclusion Criteria

No locally advanced or metastatic prostate adenocarcinoma
Preoperative diagnosis of erectile dysfunction with use of invasive interventions such as intrapenile injections and intrapenile prosthesis implants. Oral interventions are acceptable and are not exclusionary
Received neoadjuvant treatment for high-risk prostate cancer or received prior focal treatment of the prostate or prior definitive radiotherapy
History of allergic reactions or hypersensitivity attributed to iodide compounds, ICG, or any component of ICG
Subjects who are preoperatively not foreseen as ideal candidates for nerve sparing interventions by the investigator
Subjects who are unable to comply with study and follow-up procedures as judged by the investigator
Subjects who are illiterate
Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes
Any other disease, metabolic disorder, or abnormal finding upon physical examination or laboratory examination that makes the subject unsuitable for receiving the intervention, affects the interpretation of study outcomes, or poses risks to subject safety, as determined by the investigator

PRIMARY OBJECTIVE:

I. Assessment of systematic use of ICG during robotic prostatectomy and its impact on postoperative sexual function outcomes at 12 months postoperatively.

SECONDARY OBJECTIVES:

I. To create a three-dimensional (3D) map of the surgical arterial vasculature of the prostate by utilizing 3D Slicer Image Computing Platform.

II. Define the optimal amount of the ICG dosage and timing of the ICG injection for robotic prostatectomy.

III. Assessment of the predictive ability of the ICG for functional outcomes.

OUTLINE:

PHASE I: Patients undergo regularly scheduled robot-assisted radical prostatectomy and recording of details regarding the location and size of the arteries encountered during nerve preserving procedure on study.

PHASE II: Patients undergo regularly scheduled robot-assisted radical prostatectomy and receive ICG intravenously (IV) before arteries are separated from the prostate. Patients then undergo fluorescence imaging before prostate resection and recording of details regarding the location and size of the arteries as well as the relation of timing dosage, amount of dosage, and ability to visualize the arteries on study.

PHASE III: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo regularly scheduled robot-assisted radical prostatectomy and receive standard of care treatment on study.

ARM II: Patients undergo regularly scheduled robot-assisted radical prostatectomy and receive ICG IV during surgery. Patients undergo fluorescence imaging before and after prostate resection on study.

After completion of study intervention, patients are followed up at 6 weeks, every 3 months for the first year after surgery, and then every 6 months for the second year after surgery.

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Intraoperative Imaging with Indocyanine Green for the Improvement of Functional Outcomes in Patients with Prostate Cancer

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Intraoperative Imaging with Indocyanine Green for the Improvement of Functional Outcomes in Patients with Prostate Cancer

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