The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, PET/MRI/fluorescence imaging, Blood and urine sampling, laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles
Overview
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.
Interventions
- Drug (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer
Patients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots - Diagnostic test PET/MRI/fluorescence imaging
Imaging will be performed using the GE Signa PET/MRI. - Other Blood and urine sampling
Staff will perform the IV blood draws and collect urine samples - Procedure laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection
Surgery will be performed within 24 h of the third PET/MRI scan. - Drug 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots
Patients (up to 6) will receive an intravenous (IV) injection of approximately 5-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer within 24-48 h before surgery. Patients will then undergo one preoperative PET/MR imaging
Primary outcome measures
- Side effects [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 2 centers
- Memorial Sloan Kettering Cancer Center — New York
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT04167969 · 19-333