Actively Recruiting

Phase 1
Age: 18Years +
MALE
NCT04167969

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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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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