Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in 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.

The 68Ga PSMA will be tested in men who have biochemical recurrence of prostate cancer after
surgery or radiation treatment. 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:

- Ability to understand and willingness to provide informed consent.

- Pathologically proven prostate adenocarcinoma.

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

- If post-radical prostatectomy, a PSA level of > 0.2 ng/mL measured more than 6 weeks
post-operatively with a second confirmatory persistent PSA > 0.2 ng/mL.

- If post-radiation therapy, a PSA level that is equal to, or greater than, a 2 mg/mL
rise above the lowest PSA value ('nadir').

- A PSA level result within the last 2 months meeting criteria above.

- 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 greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within
the last 3 months.

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.