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

Description

The purpose of this study is to see whether using the 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer is a safe way to identify tumor cells before and during surgery for prostate cancer. The researchers want to find out whether PET/MRI scans done after the injection of this investigational tracer are more accurate than the usual imaging scans used to locate deposits of prostate tumor cells. The researchers will study how the tracer travels through your body and where it is distributed. This study is the first time that this tracer will be used in people who are undergoing surgery for prostate cancer.

Conditions

Prostate Cancer

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Study Overview

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Study Details

Study overview

The purpose of this study is to see whether using the 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer is a safe way to identify tumor cells before and during surgery for prostate cancer. The researchers want to find out whether PET/MRI scans done after the injection of this investigational tracer are more accurate than the usual imaging scans used to locate deposits of prostate tumor cells. The researchers will study how the tracer travels through your body and where it is distributed. This study is the first time that this tracer will be used in people who are undergoing surgery for prostate cancer.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Karim Touijer, MD, MPH, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2026-11