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

Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles

The purpose of this study is to see whether using the 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer is a safe way to identify tumor cells before and during surgery for prostate cancer. The researchers want to find out whether PET/MRI scans done after the injection of this investigational tracer are more accurate than the usual imaging scans used to locate deposits of prostate tumor cells. The researchers will study how the tracer travels through your body and where it is distributed. This study is the first time that this tracer will be used in people who are undergoing surgery for prostate cancer.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: (64Cu)-labeled PSMA-targeting particle tracer, or 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots; Diagnostic test: PET/MRI; Other: Blood and urine sampling; Procedure: laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Karim Touijer, MD, MPH; Phone Number: 646-422-4486; Email: touijerk@mskcc.org
• Study Contact Backup: Name: Alberto Vargas, MD; Phone Number: 646-888-5410

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Alberto Vargas, MD; Phone Number: 646-888-5410
      • Contact: Karim Touijer, MD; Phone Number: 646-422-4486

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prostate cancer patients; Patients will receive an intravenous (IV) injection of approximately 5 mCi (+/- 10%) of PSMAtargeting C' dot tracer up to 48 hours before surgery. Patients will then undergo serial preoperative PET/MR imaging 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

Drug: (64Cu)-labeled PSMA-targeting particle tracer, or 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots; Patients will be injected with approximately 5 mCi (+/- 10%) of a copper-64 (64Cu)-labeled PSMA-targeting particle tracer, or 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots, up to 48 hours before surgery.; Diagnostic test: PET/MRI; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Will be described using CTCAE version 5 criteria.	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI); Elucida Oncology
• Investigators: Principal Investigator: Karim Touijer, MD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PET/MRI; Molecular Phenotyping; Ultrasmall Silica Nanoparticles; 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer; 19-333
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 19-333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No