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

STATUS

Recruiting
End date

Nov 7, 2023
participants needed

10
sponsor

Memorial Sloan Kettering Cancer Center

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Updated on 19 February 2022

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prostatectomy

tumor cells

prostate specific antigen

prostate tumor

surgery for prostate cancer

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.

Details

Condition	Prostate Cancer
Treatment	PET/MRI, Blood and urine sampling, (64Cu)-labeled PSMA-targeting particle tracer, or 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots, laparoscopic radical prostatectomy and bilateral pelvic LN dissection, laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection
Clinical Study Identifier	NCT04167969
Sponsor	Memorial Sloan Kettering Cancer Center
Last Modified on	19 February 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age 18 years
	Primary RP + PLND
	Tumor clinical stage T3a or higher
	Patients meeting one of the following criteria
	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)
	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
	Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND)
	months, unstable angina, cardiac arrhythmias other than chronic atrial
	fibrillation and chronic active or persistent hepatitis, or New York Heart
	Prior pelvic radiotherapy (N/A for Salvage PLND )
	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

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