Using nanoparticles to improve prostate cancer surgery
Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles
PHASE1 · Memorial Sloan Kettering Cancer Center · NCT04167969
This study is testing a new tracer to see if it can help doctors find prostate cancer cells better during surgery than the usual imaging methods.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT04167969 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of a novel tracer, 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot, to identify prostate cancer tumor cells before and during surgical procedures. By utilizing PET/MRI scans after the tracer injection, researchers aim to determine if this method provides more accurate localization of tumor deposits compared to standard imaging techniques. The study represents the first application of this tracer in human subjects undergoing prostate cancer surgery, focusing on its distribution and behavior in the body.
Who should consider this trial
Good fit: Ideal candidates include adult males aged 18 and older with advanced prostate cancer, indicated by specific clinical stages, Gleason scores, or elevated PSA levels.
Not a fit: Patients with contraindications to MRI or those not scheduled for prostate cancer surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical interventions for prostate cancer, potentially improving patient outcomes.
How similar studies have performed: While this specific approach is novel, similar studies using targeted imaging agents have shown promise in improving cancer detection and surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 1 other locations
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
- Weill Cornell Medicine — New York, New York, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Hong Truong, MD, MS — Memorial Sloan Kettering Cancer Center
- Study coordinator: Hong Truong, MD, MS
- Email: truongh1@mskcc.org
- Phone: 646-422-4360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Molecular Phenotyping, Ultrasmall Silica Nanoparticles, PET/MRI, 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer, -DFO-PSMAi-PEG-Cy5.5-C' dots, 19-333