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

  • End date
    Nov 7, 2023
  • participants needed
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 19 February 2022
tumor cells
prostate specific antigen
prostate tumor
surgery for prostate cancer


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.

Condition Prostate Cancer
Treatment PET/MRI, Blood and urine sampling, (64Cu)-labeled PSMA-targeting particle tracer, or 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots, laparoscopic radical prostatectomy and bilateral pelvic LN dissection, laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection
Clinical Study IdentifierNCT04167969
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on19 February 2022


Yes No Not Sure

Inclusion Criteria

Age 18 years
Primary RP + PLND
Tumor clinical stage T3a or higher
Patients meeting one of the following criteria
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)
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
Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND)
months, unstable angina, cardiac arrhythmias other than chronic atrial
fibrillation and chronic active or persistent hepatitis, or New York Heart
Prior pelvic radiotherapy (N/A for Salvage PLND )
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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