TheranosticTrials.org

Clinical Trial · NCT04167969

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

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.

Sponsor

Memorial Sloan Kettering Cancer Center

Phase

Phase 1

ClinicalTrials.gov

NCT04167969

Study contact

Hong Truong, MD, MS

truongh1@mskcc.org 646-422-4360

Drug / Compound

Isotope(s):
Target(s):

Eligibility

Inclusion

  • PSA level \> 20 ng/mL
  • Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
  • Tumor clinical stage T3a or higher
  • Patient is scheduled for standard of care salvage pelvic lymph node dissection (with or without robotic assistance)
  • Patient is scheduled for standard of care laparoscopic radical prostatectomy (with or without robotic assistance) Salvage PLND
  • Primary RP + PLND
  • 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
  • Gleason score 8-10, or
  • Patients meeting one of the following criteria:
  • Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion

Exclusion

  • 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
  • Unmanageable claustrophobia
  • Inability to lie in the scanner for 30 min
  • Prior pelvic radiotherapy (N/A for Salvage PLND )
  • Weight greater than the 400-lb weight limit of the PET scanner
  • Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND)
  • Contraindications to standard-of-care MR imaging (e.g., metal implants, claustrophobia)