Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer 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
HBED-CC PSMA in order to demonstrate its utility. The investigators plan to utilize this data
to obtain further approvals of the HBED-CC PSMA compound, so that this agent will become
available for clinical imaging in prostate cancer patients.

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 HBED-CC
PSMA to market. In the vacuum of availability, academic groups must take the lead in order to
collect the necessary data for future FDA approval.

This study focuses on three patients populations that are imaged. In the pre-prostatectomy
population, the primary objective is to determine the sensitivity and specificity for
detection on nodal metastasis. In the biochemical recurrence population, the primary
objective is to determine the sensitivity of recurrence location. In the castrate resistant
prostate cancer population the primary objective is to determine if PSMA PET detects more
metastatic lesions than conventional imaging.

Inclusion Criteria:

1. Known prostate cancer with a clinical concern for the presence of metastatic disease
as delineated below:

- Treatment naïve patients with one of the following risk factors: CAPRA (Cancer of
the Prostate Risk Assessment) score ≥ 5, PSA ≥ 15 ng/mL and/or Gleason score ≥
4+4.

- Patients with biochemical recurrence after prostatectomy or radiation therapy
with a PSA doubling time less than 12 months.

i. These patients may have received androgen deprivation therapy prior to
imaging.

- Patients with castrate resistant prostate cancer with progressive disease as
defined by PCWG2 criteria (27).

i. Patients with castrate resistant prostate cancer can be either on treatment or
off treatment

2. Age > 18.

3. Karnofsky performance status of > 50 (or ECOG/WHO equivalent).

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

Exclusion Criteria:

1. Patients exceeding the weight limitations of the scanner or are not able to enter the
bore of the PET scanner due to BMI.

2. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis,
etc.).

3. Inability to complete the needed investigational due to other reasons (severe
claustrophobia, radiation phobia, etc.).