RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-02-17

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04167969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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)	* 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 * Weight greater than the 400-lb weight limit of the PET scanner * Unmanageable claustrophobia * Inability to lie in the scanner for 30 min

Inclusion Criteria

Exclusion Criteria

* 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)

* 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
* Weight greater than the 400-lb weight limit of the PET scanner
* Unmanageable claustrophobia
* Inability to lie in the scanner for 30 min

Contacts and Locations

Study Contact

Karim Touijer, MD

CONTACT

646-422-4486

touijerk@mskcc.org

Heiko Schoder, MD

CONTACT

212-639-8001

Principal Investigator

Karim Touijer, MD, MPH

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Weill Cornell Medicine

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Karim Touijer, MD, MPH, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-17

Study Completion Date2026-11

Study Record Updates

Study Start Date2021-02-17

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Prostate Cancer