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

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

Age range

18+ years

Sex

Male

Healthy volunteers

No

Interventions

• Drug
  (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, or (89Zr)-DFO-PSMAi-PEG-Cy5.5-C' dots

  Patients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, up to 48 hours before surgery.

• 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.

Locations (2)