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Glowing nanoparticles could help surgeons see hidden prostate cancer

NCT ID NCT04167969

Diagnosis Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests whether a special nanoparticle tracer can help surgeons see prostate cancer cells during surgery. Sixteen men with high-risk prostate cancer will receive an injection of the tracer, then undergo PET/MRI scans and surgery. The goal is to see if the tracer safely highlights cancer deposits better than standard imaging, allowing for more precise removal.

What this could mean

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

Active substance
ultrasmall silica nanoparticles (C' dots) labeled with copper-64 or zirconium-89
What this could lead to
If successful, this could lead to a way for surgeons to see hidden prostate cancer cells during surgery, potentially improving removal accuracy.
What could go wrong
This is a very early (Phase 1) trial with only 16 people, so it is mainly checking safety and feasibility. The tracer may not work as hoped, and side effects are unknown.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 16 people

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

Started

Feb 2021

Expected to finish

Nov 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: Primary RP + PLND * Age ≥18 years * Patients meeting one of the following criteria: * Tumor clinical stage T3a or higher * Gleason score 8-10, or * PSA level \> 20 ng/mL * Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion * Patient is scheduled for standard of care laparoscopic radical prostatectomy (with or without robotic assistance) Salvage PLND * Age ≥18 years * Patients with presence of suspicious lymph node on CT or MRI (of a pelvic node =\> 10mm in short axis or a node with abnormal morphology such as roundness irregularity or loss of fatty hilum, or PSMA-avid on PSMA PET imaging * Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion * Patient is scheduled for standard of care salvage pelvic lymph node dissection (with or without robotic assistance) Exclusion Criteria: * Contraindications to standard-of-care MR imaging (e.g., metal implants, claustrophobia) * Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND) * Prior pelvic radiotherapy (N/A for Salvage PLND ) * Medical illness unrelated to the tumor that, in the opinion of the attending physician and principal investigator, will preclude administration of the tracer °This includes patients with uncontrolled infection, chronic renal insufficiency (EGFR \< 60 mL/min/1.73m2), myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease * Weight greater than the 400-lb weight limit of the PET scanner * Unmanageable claustrophobia * Inability to lie in the scanner for 30 min

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

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

Prostate cancer

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

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Weill Cornell Medicine

    NOT_YET_RECRUITING

    New York, New York, 10065, United States

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