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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04167969

Collaborator

Elucida Oncology (Industry), National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

32.4

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	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	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 17, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Side effects [1 year]
Will be described using CTCAE version 5 criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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