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NCT04167969RecruitingPhase 1

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

Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles

Source: ClinicalTrials.gov · Last updated 10 Jun 2026

Brief summary (registry, in English)

The purpose of this study is to see whether using the copper-64 (64Cu) or zirconium-89 (89Zr) radiolabeled PSMA-targeting C' dot tracer, termed 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, is a safe way to identify tumor cells before and during surgery for prostate cancer. The researchers want to determine whether pre-operative PET/MRI scans and intra-operative optical imaging performed in prostate cancer patients after the injection of one of these investigational tracers more accurately localizes cancerous deposits within the surgical bed as compared with conventional imaging scans alone. The researchers will study how the tracer travels through your body and where it is distributed. This study is the first time that the tracer will be used in patients undergoing surgery for prostate cancer.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
16 (estimated)
First submitted
18 Nov 2019
Start date
17 Feb 2021
Primary completion date
Nov 2027
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT04167969

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 16
  • From 17 Feb 2021 to the primary completion date, Nov 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 )

Lab values

  • 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

Other

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

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Weill Cornell Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesNot yet recruiting
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.