64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer

64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer: A Prospective, Non-randomized, Single Arm, Single Center, Open-label Phase 1/2 Study

This research project is testing a new compound which may potentially detect specific cancer lesions in men with prostate cancer.

This is a prospective, non-randomized, single arm, single center, open-label study of 64Cu-SAR-bisPSMA PET in patients with known or suspected prostate cancer (PC).

Patients will be screened during a 28-day period and assessed against the inclusion and exclusion criteria. During screening the investigator will determine the patient's disease status (for patients with suspected prostate cancer) or stage of disease (for patients with known prostate cancer) and management plan based on the available standard of care test results (including available imaging, histopathology, biochemical markers, clinical and symptoms history, etc.). Eligible patients will receive a single administration of 64Cu-SAR-bisPSMA and complete a PET scan at an early time (1-4 hours) and a late time (24-72 hours).

The patient's status will only be assessed in patients with suspected disease at study entry and will be characterized as suspected or known prostate cancer during the follow up.

Staging will only be assessed in patients with known prostate cancer at study entry and will be characterized according to the TNM system and as Localized, Regional or Distant (nodes/visceral/bone).

Inclusion Criteria:

1. Signed an informed consent.
2. >18 years of age.
3. Known diagnosis of prostate adenocarcinoma confirmed by histopathology OR patients with suspicion of prostate cancer based on elevated PSA but negative standard of care imaging and/or negative biopsy.
4. The Eastern Cooperative Oncology (ECOG) performance status 0-2.
5. Adequate recovery from acute toxic effects of any prior therapy.
6. Adequate renal function (eGFR of 30 ml/min/1.73m2 or higher)

Exclusion Criteria:

1. Participants must not receive other investigational agents within 28 days prior to 64Cu-SAR-bisPSMA administration.
2. Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to 64Cu-SAR-bisPSMA administration.
3. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
4. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.