Nanoparticles for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have certain medical conditions like uncontrolled infections or heart issues, you may not be eligible to participate.
Is the treatment with 64Cu-labeled PSMA-targeting nanoparticles safe for humans?
The studies on 64Cu-labeled PSMA-targeting nanoparticles, used for imaging prostate cancer, show that they are generally safe in preclinical models, with high stability and specific targeting of cancer cells. However, they do show high uptake in the kidneys and liver, which may require monitoring in human trials.12345
How does the nanoparticle treatment for prostate cancer differ from other treatments?
The nanoparticle treatment for prostate cancer is unique because it uses prostate-specific membrane antigen (PSMA) targeting to enhance tumor accumulation and improve imaging and therapeutic efficacy. This approach involves multivalent nanocarriers that penetrate deep into tumor tissues, offering higher tumor retention and lower healthy tissue retention compared to traditional treatments.12467
What data supports the effectiveness of the drug 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots for prostate cancer?
Research shows that targeting prostate-specific membrane antigen (PSMA) with nanoparticles can improve tumor retention and penetration, leading to better imaging and treatment outcomes. Similar PSMA-targeting agents have demonstrated high tumor uptake and prolonged retention, suggesting potential effectiveness for prostate cancer.26789
Who Is on the Research Team?
Karim Touijer, MD, MPH
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Men over 18 with prostate cancer who are fit for surgery and scheduled for a specific type of operation to remove the prostate or salvage lymph node dissection. They must have certain tumor characteristics like size, shape, or PSA levels. Excluded are those with prior pelvic radiotherapy (except for some cases), weight over 400 lbs, severe claustrophobia, metal implants incompatible with MRI, recent heart issues, kidney problems or uncontrolled infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgery Imaging
Participants receive an intravenous injection of the PSMA-targeting C' dot tracer and undergo serial preoperative PET/MR imaging
Surgery
Participants undergo surgery for prostate cancer with guidance from imaging results
Follow-up
Participants are monitored for safety and effectiveness after treatment, including side effects described using CTCAE version 5 criteria
What Are the Treatments Tested in This Trial?
Interventions
- (64Cu)-labeled PSMA-targeting particle tracer, or 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Cornell University/Weill Cornell Medical Center
Collaborator
National Cancer Institute (NCI)
Collaborator
Elucida Oncology
Industry Sponsor