Actively Recruiting
The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-27
16
Participants Needed
2
Research Sites
297 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
C
Cornell University/Weill Cornell Medical Center
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 years or older
- Tumor clinical stage T3a or higher, or Gleason score 8-10, or PSA level greater than 20 ng/mL
- Patients deemed fit for surgery based on preoperative evaluation
- Scheduled for standard laparoscopic radical prostatectomy (with or without robotic assistance)
- Presence of suspicious lymph node on CT or MRI or PSMA-avid on PSMA PET imaging for salvage pelvic lymph node dissection
- Scheduled for standard salvage pelvic lymph node dissection (with or without robotic assistance)
You will not qualify if you...
- Contraindications to standard MR imaging, such as metal implants or claustrophobia
- Prior androgen-deprivation therapy for prostate cancer (except for salvage pelvic lymph node dissection patients)
- Prior pelvic radiotherapy (except for salvage pelvic lymph node dissection patients)
- Medical illness unrelated to tumor that prevents tracer administration, including uncontrolled infection, chronic renal insufficiency, recent myocardial infarction, unstable angina, certain cardiac arrhythmias, active hepatitis, or severe heart disease
- Weight over 400 pounds, exceeding PET scanner limit
- Unmanageable claustrophobia
- Inability to lie still in the scanner for 30 minutes
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
2
Weill Cornell Medicine
New York, New York, United States, 10065
Not Yet Recruiting
Research Team
H
Hong Truong, MD, MS
CONTACT
H
Heiko Schoder, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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