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Using Nanoparticles to Guide Prostate Cancer Surgery

This study is looking at whether special nanoparticles, called 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, can help surgeons find prostate cancer cells more accurately during surgery. These nanoparticles are injected into your body and then used with imaging scans (PET/MRI and fluorescence imaging) to highlight cancer. Researchers want to see if this method is safe and better at locating cancer than standard imaging alone. They will also track how the nanoparticles move through your body. You may be eligible if you are an adult man with prostate cancer that is T3a or higher, has a Gleason score of 8-10, or a PSA level over 20 ng/mL, and are scheduled for a radical prostatectomy. The main goal is to monitor for any side effects for one year.

Study design
This interventional study plans to enroll 16 adult men with prostate cancer. It is not specified if it is randomized or blinded.
What's involved
You would receive an injection of the study drug, undergo PET/MRI imaging, have blood and urine samples taken, and then have surgery within 24-48 hours of your last scan.
Compensation
Not stated in the trial record.
Follow-up
Your side effects will be monitored for one year after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04167969

The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Memorial Sloan Kettering Cancer Center
~16 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:(64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracerPET/MRI/fluorescence imagingBlood and urine samplinglaparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Side effects
Measured over 1 year

Conditions

Prostate Cancer

Explore related trials

Prostate CarcinomaFOLH1 Gene

Where it's being run

2 sites across 1 states
New York2

Study leadership

  • Hong Truong, MD, MS · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Hong Truong, MD, MS
[email protected]
646-422-4360
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)
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

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
Weight greater than the 400-lb weight limit of the PET scanner
Unmanageable claustrophobia
Inability to lie in the scanner for 30 min

What this trial measures

  • Side effects1 year

    Will be described using CTCAE version 5 criteria.