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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04167969
• Other study ID #: 19-333
• Status: Recruiting
• Phase: Phase 1
• Start date: February 17, 2021
• Est. completion date: November 2026

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Karim Touijer, MD, MPH
• Phone: 646-422-4486
• Email: touijerk[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Elucida Oncology, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effects	Will be described using CTCAE version 5 criteria.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center