Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery

PRIMARY OBJECTIVES:

I. To assess the ability of Cu-64-TP3805 to detect prostate cancer (PC) within the prostate gland, as compared with whole mount step-sectioned surgical pathology of the prostate after radical prostatectomy.

OUTLINE:

Patients receive copper Cu 64 TP3805 intravenously (IV) and undergo PET/computed tomography (CT) at 30 minutes and 2 hours post-injection. Patients then undergo radical prostatectomy within 1 to 3 weeks after scans.

After completion of study, patients are followed up at 24 hours.

Inclusion criteria

• Ability to provide signed informed consent and willingness to comply with protocol requirements
• Biopsy confirmed presence of adenocarcinoma of the prostate gland
• Have intermediate or high-risk PC as defined by >= T2b disease, or Gleason score >= 7 or prostate-specific antigen (PSA) >= 10 ng/dL
• Scheduled to undergo radical prostatectomy with pelvic lymph node dissection (either open or robotic)
• Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection

Exclusion criteria

• Participating would significantly delay the scheduled standard of care therapy
• Administered a radioisotope within 10 physical half-lives prior to study drug injection
• Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study