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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

(64Cu)-labeled PSMA-targeting particle tracer, or 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots

PET/MRI

Blood and urine sampling

laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Molecular Phenotyping, Ultrasmall Silica Nanoparticles, PET/MRI, 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer, 19-333

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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
Weight greater than the 400-lb weight limit of the PET scanner
Unmanageable claustrophobia
Inability to lie in the scanner for 30 min

Sites / Locations

Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostate cancer patients

Arm Description

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

Outcomes

Primary Outcome Measures

Side effects

Will be described using CTCAE version 5 criteria.

Secondary Outcome Measures

Full Information

NCT ID

NCT04167969

First Posted

November 18, 2019

Last Updated

March 8, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Elucida Oncology, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04167969

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 17, 2021 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Elucida Oncology, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Molecular Phenotyping, Ultrasmall Silica Nanoparticles, PET/MRI, 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer, 19-333

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prostate cancer patients

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

(64Cu)-labeled PSMA-targeting particle tracer, or 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

PET/MRI

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Blood and urine sampling

Intervention Description

Staff will perform the IV blood draws and collect urine samples

Intervention Type

Procedure

Intervention Name(s)

laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection

Intervention Description

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

Primary Outcome Measure Information:

Title

Side effects

Description

Will be described using CTCAE version 5 criteria.

Time Frame

1 year

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Prostate cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karim Touijer, MD, MPH

Phone

646-422-4486

touijerk@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Alberto Vargas, MD

Phone

646-888-5410

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karim Touijer, MD, MPH

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karim Touijer, MD

Phone

646-422-4486

First Name & Middle Initial & Last Name & Degree

Alberto Vargas, MD

Phone

646-888-5410

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

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

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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