Clinical trial NCT04167969: 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
Overall status: RECRUITING
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Molecular Phenotyping
Ultrasmall Silica Nanoparticles
PET/MRI
64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer
19-333
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Elucida Oncology
name: National Cancer Institute (NCI)
First posted: 2019-11-19
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Side effects
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Karim Touijer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: