RecruitingPhase 1NCT04167969

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

Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

16 participants

Start Date

Feb 17, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether tiny nanoparticles can help surgeons find and remove the right lymph nodes during prostate cancer surgery. The nanoparticles light up on imaging, making it easier to see which nodes may contain cancer. **You may be eligible if...** - You are 18 or older - You have high-risk prostate cancer (stage T3a or above, Gleason score 8–10, or PSA over 20) - You are scheduled for a radical prostatectomy (surgical removal of the prostate) - OR you have had prior prostate cancer treatment and now have suspicious lymph nodes on imaging (CT, MRI, or PSMA PET scan) and are scheduled for salvage lymph node removal surgery **You may NOT be eligible if...** - You have a metal implant or severe claustrophobia that prevents MRI scanning - You have previously had androgen deprivation therapy or pelvic radiation (for the primary surgery group) - You have serious health problems like kidney insufficiency, recent heart attack, or severe heart disease - You weigh over 400 lbs (due to PET scanner limits) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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_TESTPET/MRI/fluorescence imaging

Imaging will be performed using the GE Signa PET/MRI.

OTHERBlood and urine sampling

Staff will perform the IV blood draws and collect urine samples

PROCEDURElaparoscopic 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.

DRUG89Zr-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


Locations(2)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

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NCT04167969


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