The present study is a phase II, open label, single-center, non-randomized, single-dose
study.
Twenty subjects in total will be enrolled at Weill Cornell Medical College (WCMC)/ NYPH.
The primary objective is to evaluate the ability of 89Zr-Df-IAB2M to detect localized,
clinically significant (defined as: ≥ 0.5 cm3 with Gleason pattern ≥ 4) prostate cancer
(PCa).
After the screening period (up to 28 days), each subject will be scheduled to receive 10 mg
infusion of IAB2M conjugated with 2.5 mCi 89Zr-Df.
2 - 4 days post-infusion, subjects will undergo a 89Zr-Df-IAB2M PET/CT scan. Images read by a
Nuc Med MD reporting: location, SUV and, if possible, size of all areas with abnormal uptake.
(they will also undergo a pelvic MRI if they have not obtained an MR image during the
screening period or on day of infusion)
Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours
after the injection) will also be performed prior to radical prostatectomy depending on
subject's availability and compliance.
Patient will undergo radical prostatectomy after completion of above imaging procedures.