Glow-in-the-dark dye may help surgeons spot hidden prostate cancer cells

NCT ID NCT07725523

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This trial tests whether a fluorescent dye called zopocianine can make prostate cancer cells glow under near-infrared light during surgery. Men with prostate cancer scheduled for prostatectomy receive a single dose of the dye before surgery. The goal is to see if the dye helps surgeons detect and remove cancerous tissue that might otherwise be missed.

What this could mean

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

Active substance
a fluorescent dye called zopocianine (OTL78) that targets prostate cancer cells and glows under near-infrared light during surgery
What this could lead to
If successful, this approach could help surgeons remove prostate cancer more completely during prostatectomy, potentially reducing the chance of leaving cancerous tissue behind.
What could go wrong
This is an early-phase trial with only 36 participants, so results may not apply broadly. The dye may not reliably distinguish all cancerous tissue, and there is a risk of false positives or false negatives.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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. Provision of signed and dated informed consent and HIPAA form 2. Male participants 18 years of age and older 3. Known primary prostate cancer and any one of the following: 1. Grade group 3-5; 2. Suspected extra-prostatic extension (EPE) or seminal vesicle invasion (SVI); 3. Suspected lymph node metastasis (clinical stage cN1) by magnetic resonance imaging or by Prostate Specific Membrane Antigen positron emission tomography 4. Planned to undergo a standard of care robotic prostatectomy and lymph node dissection 5. Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments 6. Agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including through final study visit (6 weeks) after the dose of study drug. Sperm donation is prohibited during the study and for 3 months after the dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent. 7. Patient scheduled to have or has had a PSMA-PET Scan for surgical treatment planning within 12 months of surgery. Exclusion Criteria: 1. The surgeon plans to perform an extraperitoneal approach 2. History of anaphylactic reactions to products containing indocyanine green 3. History of allergy to any of the components of ZOPOCIANINE: 1. 2-\[3-(1,3-dicarboxypropyl)ureido\] pentanedioic acid (DUPA) 2. Polyethylene glycol-dipeptide linker 3. Chlorodye 4. Impaired renal or hepatic function: 1. Renal: creatinine clearance (eGFR) \< 50 mL/min 2. Hepatic: total bilirubin \> 2 × upper limit of normal or ALT/AST \> 3 × upper limit of normal. 5. Patients with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening calculated via the Bazett formula. 6. Significant acute or chronic medical, neurologic, or illness in the participant that, in the judgment of the Principal Investigator, could compromise participant safety, limit the ability to complete the study, and/or compromise the objectives of the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Indiana University Health North Hospital

    Carmel, Indiana, 46032, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

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