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

Recruiting now · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04167969

Run by

Memorial Sloan Kettering Cancer Center

People needed

16

Starts

2021-02-17

Expected to finish

2027-11-01

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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