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Glow-in-the-Dark dye could help surgeons spot hidden prostate cancer

NCT ID NCT05946603

Diagnosis Sponsor: Intuitive Surgical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a fluorescent dye called IS-002 that makes prostate cancer cells glow under special lights during robotic surgery. Fifty-nine men with prostate cancer received the dye before surgery, and surgeons used a special camera to see the glowing areas. The goal was to see if this helps remove all cancer and reduce leftover cancer cells at the surgical edges.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IS-002 (a fluorescent dye)
What this could lead to
If successful, this could help surgeons remove prostate cancer more completely during robotic surgery, potentially lowering the chance of leftover cancer cells.
What could go wrong
This is a small, early feasibility study (59 people) and the dye may not reliably highlight all cancer tissue. It is not a treatment itself, only a visual aid.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

59 people

The number who actually took part.

Started

Jun 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria 1. Subjects aged 18 to 75. 2. Subject has a confirmed adenocarcinoma of the prostate as defined by (histo-) pathology. 3. Subject has CAPRA ≥6; or ≥T3 disease on imaging (TRUS and/or MRI); or a Gleason sum score ≥8; or regional lymphadenopathy suspicious for nodal metastases on imaging. 4. Subject is scheduled to undergo robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using a da Vinci® X/Xi Surgical System equipped with Firefly® Fluorescence Imaging. 5. Subject is willing and able to provide written informed consent. 6. Subject can comply with the study procedures and study visits and understands an informed consent document. Exclusion criteria 1. Subject has known bone metastasis. 2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 3. Subject has a known history of acute or chronic liver or kidney disease. • Renal function at screening: i. Creatinine clearance: \<50 mL/min as determined using the Cockcroft-Gault formula ii. Albumin: \<LLN • Hepatic function at screening: i. AST and/or ALT: \>2.5x ULN ii. Total Bilirubin (serum): \>1.5x ULN 4. Subject has received neo-adjuvant therapy, radiation therapy, focal ablation therapy, hormonal therapy, or androgen deprivation therapy within the last 4 months. 5. Subject is currently receiving an investigational therapeutic agent; or has participated in a study of an investigational therapeutic agent within the past 6 months prior to the day of IS-002 infusion; or is involved in a significant risk investigational device study within the past 6 months prior to the day of IS-002 infusion. 6. Subject has any other condition or personal circumstance that, in the judgment of the site Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • MSKCC

    New York, New York, 10065, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • UCSF

    San Francisco, California, 94158, United States

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