OncoMatch/Clinical Trials/NCT04167969
The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer
Is NCT04167969 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, or (89Zr)-DFO-PSMAi-PEG-Cy5.5-C' dots for prostate cancer.
Treatment: (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, or (89Zr)-DFO-PSMAi-PEG-Cy5.5-C' dots — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage T3A OR HIGHER (TNM)
Tumor clinical stage T3a or higher; Gleason score 8-10; PSA level > 20 ng/mL
Prior therapy
Cannot have received: androgen-deprivation therapy
Exception: N/A for Salvage PLND
Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND)
Cannot have received: pelvic radiotherapy
Exception: N/A for Salvage PLND
Prior pelvic radiotherapy (N/A for Salvage PLND)
Lab requirements
Kidney function
chronic renal insufficiency (EGFR < 60 mL/min/1.73m2) excluded
Cardiac function
myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation, New York Heart Association Classification III or IV heart disease excluded
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Center · New York, New York
- Weill Cornell Medicine · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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