Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients

Imaging and staging of prostate cancer is critical for surgical and treatment planning.
Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled
PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to
obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become
available for clinical imaging in prostate cancer patients. In the pre-prostatectomy
population, the primary objective is to determine the sensitivity and specificity for
detection on nodal metastasis.

This compound has been shown to be superior to choline based PET agents for the staging of
prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented
and therefore no company or private entity will make the investment required to bring
Ga-68-PSMA-11 to market. In the vacuum of availability, academic groups must take the lead in
order to collect the necessary data for future FDA approval.

Inclusion Criteria:

- Biopsy proven prostate adenocarcinoma.

- Planned prostatectomy with lymph node dissection.

- Intermediate to high-risk disease (as determined by elevated PSA [PSA>10], T-stage
[T2b or greater], Gleason score [Gleason score > 6] or other risk factors).

- Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA
PET.

- Karnofsky performance status of greater than 50 (or ECOG/WHO equivalent).

- Age > 18.

- Ability to understand a written informed consent document, and the willingness to sign
it.

Exclusion Criteria:

- Patients not capable of getting PET study due to weight, claustrophobia, or inability
to lay still for the duration of the exam.

- Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy.

- Including focal ablation techniques (HiFu).

- Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and
surgery.