68Ga PSMA in Preprostatectomy Patients

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 are scheduled to undergo a prostatectomy are invited to test 68Ga PSMA. Participants
undergo the 68Ga PSMA PET scan before the prostatectomy. Information from the prostatectomy,
including any MRI, CT, or ultrasound imaging, will be used to determine if the 68Ga PSMA PET
imaging was better than the standard imaging.

Depending on the prostatectomy 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 the surgery/biopsy results do 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:

- Biopsy-proven prostate adenocarcinoma

- Intermediate to high-risk disease, defined as one of the following factors: PSA > 10,
T2b or greater, or a Gleason score of 7 or greater

- A PSA level resulted within the past 2 months

- Planned prostatectomy with lymph node dissection

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

- Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation
therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques
(e.g., HiFu)

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

- Ability to understand and the willingness to provide informed consent.

Exclusion Criteria:

- Cannot receive furosemide

- Allergy to sulfa or sulfa-containing medications

- History of Stevens-Johnson syndrome

- Known Paget's disease

- 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