Recruiting
Phase 1

Nanoparticles

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04167969

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

(64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer

PET/MRI/fluorescence imaging

Blood and urine sampling

laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection

89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots

Study Details

Brief summary:

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

Prostate Cancer

Study ID

NCT04167969

Start date

Feb 17, 2021

Status verified date

Jun, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Prostate cancer patients

Patients will receive an intravenous (IV) injection of approximately 6-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer up to 48 h before surgery. Patients will then undergo serial preoperative PET/MR imaging (see below) to help characterize the safety, biodistribution/pharmacokinetics, and dosimetry of this agent. To assess total radioactivity in whole blood/plasma and urine samples, as well as radioactive metabolites, blood and urine samples will be collected at approximately 30 min post-injection as well as before each imaging session.

Interventions

(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

PET/MRI/fluorescence imaging

Imaging will be performed using the GE Signa PET/MRI.

Blood and urine sampling

Staff will perform the IV blood draws and collect urine samples

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.

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 measure

  • Side effects [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Hong Truong, MD, MS

646-422-4360truongh1@mskcc.org

Heiko Schoder, MD

212-639-8001

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Hong Truong, MD, MS

646-422-4360

Heiko Schoder, MD

212-639-8001

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • Molecular Phenotyping
  • Ultrasmall Silica Nanoparticles
  • PET/MRI
  • 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer
  • (89Zr)-DFO-PSMAi-PEG-Cy5.5-C' dots
  • 19-333

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-10.