NCT04167969 · Memorial Sloan Kettering Cancer Center
The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
(64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer
Patients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots
DIAGNOSTIC_TEST
PET/MRI/fluorescence imaging
Imaging will be performed using the GE Signa PET/MRI.
OTHER
Blood and urine sampling
Staff will perform the IV blood draws and collect urine samples
PROCEDURE
laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection
Surgery will be performed within 24 h of the third PET/MRI scan.
DRUG
89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots
Patients (up to 6) will receive an intravenous (IV) injection of approximately 5-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer within 24-48 h before surgery. Patients will then undergo one preoperative PET/MR imaging
Primary outcome measures
Side effects
Time frame: 1 year
Will be described using CTCAE version 5 criteria.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Collaborators
Cornell University/Weill Cornell Medical Center, National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations