What is the mechanism of action of this treatment?

Prostate Adenocarcinoma is commonly treated with androgen deprivation therapy (ADT), which reduces androgen levels to inhibit tumor growth, and radiation therapy, which uses high-energy rays to kill cancer cells. Surgical options, such as prostatectomy, involve the removal of the prostate gland. The Illuminare-1 trial explores the use of a fluorescent dye to visualize nerves during surgery, aiming to improve surgical precision and reduce nerve damage. This is crucial for patients as it can enhance surgical outcomes, minimize side effects, and improve quality of life by preserving nerve function.

What side effects are associated with this type of intervention?

Common treatments for Prostate Adenocarcinoma include surgical interventions, hormone therapy, and chemotherapy. Surgical treatments, such as prostatectomy, can lead to side effects like urinary incontinence and erectile dysfunction. Hormone therapy, including drugs like abiraterone, can cause side effects such as hypertension, hypokalemia, and increased risk of cardiovascular events. Chemotherapy, often involving drugs like docetaxel, can result in side effects such as fatigue, nausea, hair loss, and increased risk of infections. The use of fluorescent dyes like Illuminare-1 in surgery aims to improve nerve visualization and potentially reduce nerve damage, but the specific side effects of such dyes are still under investigation.

What prior FDA approvals exist?

FDA-approved treatments for prostate adenocarcinoma include a range of therapies such as androgen receptor signaling inhibitors (e.g., enzalutamide, abiraterone), taxane-based chemotherapies (e.g., docetaxel, cabazitaxel), and radioligand therapies (e.g., lutetium Lu 177 vipivotide tetraxetan). While these treatments focus on systemic management of the disease, the use of Illuminare-1 represents a novel approach aimed at improving surgical outcomes through enhanced intraoperative nerve visualization. This technique is unique and not directly comparable to existing FDA-approved treatments, which primarily target cancer cells rather than surgical precision.

What other types of research exist?

Promising novel alternatives to Illuminare-1 for intraoperative nerve visualization in prostate adenocarcinoma patients include aggregation-induced emission luminogens (AIEgens), cyanine-based polymer dots (Pdots), and gold nanocluster-loaded hybrid albumin nanoparticles. These agents have demonstrated strong fluorescence and potential for precise surgical guidance in various animal models and could be considered for clinical applications in 2024.

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Fluorescent Nerve Imaging with Illuminare-1 for Prostate Cancer

Phase 1

Recruiting

Led By Timothy Donahue, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for minimally invasive radical prostatectomy with pelvic lymph node dissection

18 years or older and capable of signing their own consent form

Must not have

Patients with significant renal dysfunction (<60 mL/min as assessed by the Cockcroft Gault calculation for creatinine clearance)

Known central nervous or peripheral nervous system disease or insult (including neurodegenerative diseases), current use of neurotoxic medications, or use of cytotoxic chemotherapy with known neurotoxicity within 1 month

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 45 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Illuminare-1, a substance that makes nerves glow, in prostate cancer surgeries. It aims to find a safe dose that helps surgeons see and avoid damaging nerves. The study will compare surgeries with and without this glowing guidance.

Who is the study for?

This trial is for adults over 18 who can consent and are scheduled for a specific prostate cancer surgery. It's not for those with prior pelvic procedures, recent investigational drugs use, significant kidney or liver issues, exposure to phototoxic drugs without proper washout period, or nervous system diseases.

What is being tested?

The study tests Illuminare-1's safety and optimal dose during prostate cancer surgery. Researchers will see if surgeries guided by Illuminare-1 are better than standard ones and will also examine how the body processes this drug.

What are the potential side effects?

Since this is the first test of Illuminare-1 in humans, potential side effects include reactions at different doses that could range from mild to severe; specifics will be determined as the trial progresses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a specific prostate surgery with lymph node removal.

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I am over 18 and can sign a consent form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced, with a creatinine clearance rate below 60 mL/min.

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I do not have a nervous system condition, nor am I taking medications that could harm my nerves.

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My liver is not working well (tests show it's functioning poorly).

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I have had surgery or radiation therapy in my pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 45 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 45 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 45 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

determine the safety of Illuminare-1

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Illuminare-1Experimental Treatment2 Interventions

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate Adenocarcinoma is commonly treated with androgen deprivation therapy (ADT), which reduces androgen levels to inhibit tumor growth, and radiation therapy, which uses high-energy rays to kill cancer cells. Surgical options, such as prostatectomy, involve the removal of the prostate gland. The Illuminare-1 trial explores the use of a fluorescent dye to visualize nerves during surgery, aiming to improve surgical precision and reduce nerve damage. This is crucial for patients as it can enhance surgical outcomes, minimize side effects, and improve quality of life by preserving nerve function.

Do neuroendocrine cells in human prostate cancer express androgen receptor?Quantification of expression of netrins, slits and their receptors in human prostate tumors.