Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

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 biochemical recurrence
population, the primary objective is to determine the sensitivity and positive predictive
value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor
location confirmed by histopathology/biopsy.

Inclusion Criteria:

- Histopathological proven prostate adenocarcinoma.

- Rising PSA after definitive therapy with prostatectomy or radiation therapy (external
beam or brachytherapy).

- Post radical prostatectomy (RP) - AUA recommendation

- PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,

- Confirmatory persistent PSA greater than 0.2 ng/mL

- Post-radiation therapy -ASTRO-Phoenix consensus definition

- Nadir + greater than or equal to 2 ng/mL rise in PSA

- 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:

- Investigational therapy for prostate cancer.

- Unable to lie flat, still or tolerate a PET scan.

- Prior history of any other malignancy within the last 2 years, other than skin basal
cell or cutaneous superficial squamous cell carcinoma that has not metastasized and
superficial bladder cancer.

- Contraindication to furosemide administration including prior allergy or adverse
reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed
if Furosemide is omitted as part of the PET imaging protocol if a second-generation
scatter correction is available for the used PET device).