68Ga PSMA PET for Patients With Biochemical Recurrence of Prostate Cancer

This study evaluates PSMA-HBED-CC labelled with Gallium-68, abbreviated 68Ga PSMA. This is a
radiotracer that attaches to receptors in the membrane of prostate cancer cells. The 68Ga
PSMA is identified using a positron emission tomography (PET) scanner. It is believed that
68Ga PSMA will identify prostate cancer more precisely than normal imaging methods (MRI, CT,
or ultrasound). Imaging is key to successful treatment - disease must be identified to be
treated.

Men who have biochemical recurrence of prostate cancer are invited to test 68Ga PSMA.
Participants undergo the 68Ga PSMA PET scan before further treatment. Clinical information,
including any MRI, CT, or ultrasound imaging and biopsy/surgery information, will be used to
determine if the 68Ga PSMA PET imaging was better than the standard imaging. The study team
will collect this information for about 1 year after the PSMA scan.

Depending on findings, participants may be invited back for a second 68Ga PSMA scan. This is
done if the first scan showed positive lymph nodes or soft tissue metastases but a surgery or
biopsy result does not.

The results from these scans will be shared with the participant. Results will also be
entered into the participant's medical record and shared with the treating oncologists.

Inclusion Criteria:

- Pathologically proven prostate adenocarcinoma

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

- If post-radical prostatecomy, PSA > 0.2 ng/mL measured > 6 weeks post-operative and
confirmed persistent PSA > 0.2 ng/mL (AUA recommendation for biochemical recurrence)

- If post-radiation therapy, PSA that is ≥ 2 mg/mL rise above PSA nadir (ASTRO
recommendation for biochemical recurrence)

- Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under
an IND for initial efficacy investigations)

- No other malignancy within the past 2 years (skin basal cell or cutaneous superficial
squamous cell carcinoma or superficial bladder cancer are exempt from this criterion)

- Karnofsky performance status (KPS) ≥ 50 (ECOG/WHO of 0, 1, or 2)

- Ability to understand and willingness to provide informed consent

Exclusion Criteria:

- Cannot receive furosemide

- History of Stevens Johnson syndrome

- History or diagnosis of Paget's disease

- Malignancy other than current disease under study

- Allergy to sulfa or sulfa-containing medications

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements