Imaging Tracer Agent (PSMA-Targeting C’ Dots) for the Detection of Prostate Cancer

Inclusion Criteria

• COHORT 1: Age >= 18
• COHORT 1: Patients meeting one of the following criteria: * Tumor clinical stage T3a or higher * Gleason score 8-10, or * Prostate-specific antigen (PSA) level > 20 ng/mL
• COHORT 1: Patients deemed fit for surgery on the basis of preoperative evaluation at the physician’s discretion
• COHORT 1: Patient is scheduled for standard of care laparoscopic radical proctectomy (with or without robotic assistance)
• COHORT 2: Age >= 18 years
• COHORT 2: Patients with presence of suspicious lymph node on computed tomography (CT) or MRI (pelvic node => 10mm in short axis or a node with abnormal morphology such as roundness irregularity or loss of fatty hilum, or prostate-specific membrane antigen (PSMA)-avid on PSMA positron emission tomography (PET) imaging
• COHORT 2: Patients deemed fit for surgery on the basis of preoperative evaluation at the physician’s discretion
• COHORT 2: Patient is scheduled for standard of care salvage pelvic lymph node dissection (with or without robotic assistance)

Exclusion Criteria

• Contraindications to standard-of-care MR imaging (e.g., metal implants, claustrophobia)
• Prior androgen-deprivation therapy for prostate cancer (not applicable [N/A] for cohort 2)
• Prior pelvic radiotherapy (N/A for cohort 2)
• Medical illness unrelated to the tumor that, in the opinion of the attending physician and principal investigator, will preclude administration of the tracer * This includes patients with uncontrolled infection, chronic renal insufficiency (epidermal growth factor receptor [EGFR] < 60 mL/min/1.73 m^2), 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
• Weight greater than the 400-pound (lb) weight limit of the PET scanner
• Unmanageable claustrophobia
• Inability to lie in the scanner for 30 min