Prostate Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

°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

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT04167969

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Karim Touijer, MD
Contact
646-422-4486
Alberto Vargas, MD
Contact
646-888-5410

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT04167969

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.