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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate cancer patients<br>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<br>* 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.<br>Diagnostic Test: PET/MRI<br>* Imaging will be performed using the GE Signa PET/MRI.<br>Other: Blood and urine sampling<br>* Staff will perform the IV blood draws and collect urine samples<br>Procedure: laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection<br>* Surgery will be performed within 24 h of the third PET/MRI scan.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Molecular Phenotyping, Ultrasmall Silica Nanoparticles, PET/MRI, 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer, 19-333