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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Nov 18, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help surgeons find prostate cancer cells more accurately during surgery. Researchers are testing a special tracer called 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot, which is injected into the body before surgery. The goal is to see if scans using this tracer can show cancer cells better than the usual imaging tests. This is the first time this tracer is being used in people, and the study will look at how it moves through the body and where it goes.

To participate in this trial, you need to be a man aged 18 or older who is scheduled for surgery to remove prostate tissue. You might qualify if your cancer is at a certain stage or if your PSA level is high. The trial is currently looking for participants, and if you join, you can expect to receive the tracer before your surgery and undergo a special scan to see how well it works. It's important to note that people with certain medical conditions or those who have had certain treatments may not be eligible for this study.

Gender

MALE

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