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

NCT ID: NCT04167969

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-17
• Study Completion Date: 2026-11-30

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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 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

Group Type: EXPERIMENTAL

(64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, or (89Zr)-DFO-PSMAi-PEG-Cy5.5-C' dots

Intervention Type: DRUG

Patients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, up to 48 hours before surgery.

PET/MRI/fluorescence imaging

Intervention Type: DIAGNOSTIC_TEST

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

Blood and urine sampling

Intervention Type: OTHER

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

Intervention Type: PROCEDURE

Surgery will be performed within 24 h of the third PET/MRI scan.

Interventions

(64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, or (89Zr)-DFO-PSMAi-PEG-Cy5.5-C' dots

Patients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, up to 48 hours before surgery.

Intervention Type: DRUG

PET/MRI/fluorescence imaging

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

Intervention Type: DIAGNOSTIC_TEST

Blood and urine sampling

Staff will perform the IV blood draws and collect urine samples

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cornell University/Weill Cornell Medical Center

UNKNOWN

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karim Touijer, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status: RECRUITING

Weill Cornell Medicine

New York, New York, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Karim Touijer, MD

Role: CONTACT

touijerk@mskcc.org

646-422-4486

Heiko Schoder, MD

Role: CONTACT

212-639-8001

Facility Contacts

Karim Touijer, MD

Role: primary

646-422-4486

Heiko Schoder, MD

Role: backup

212-639-8001

Michelle Bradbury, MD,PhD

Role: primary

msb2006@med.cornell.edu

917-294-4585

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

19-333

Identifier Type: -

Identifier Source: org_study_id