F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer

PRIMARY OBJECTIVES:

I. To evaluate fluorine F 18 DCFPyL (18F-DCFPyL) PET/CT for detection of recurrent prostate
cancer after initial therapy in patients with elevated prostate-specific antigen (PSA).

OUTLINE:

Participants receive fluorine F 18 DCFPyL intravenously (IV). After 60-120 minutes,
participants undergo whole body PET/CT. Immediately after the first scan, participants may
undergo a second PET/CT without receiving fluorine F 18 DCFPyL.

After completion of study, participants are followed up at 24-72 hours.

Inclusion Criteria:

- Biopsy proven prostate adenocarcinoma

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

- Post radical prostatectomy (RP) - American Urological Association (AUA)
recommendation

- PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical
prostatectomy

- Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA
measurements greater than 0.2 ng/mL)

- Post-radiation therapy - American Society for Radiation Oncology (ASTRO) -
Phoenix consensus definition

- A rise of PSA measurement of 2 or more ng/mL over the nadir

- Able to provide written consent

- Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group [ECOG] /
World Health Organization [WHO] equivalent)

Exclusion Criteria:

- Unable to provide informed consent

- Inability to lie still for the entire imaging time

- Inability to complete the needed investigational and standard-of-care imaging
examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

- Any additional medical condition, serious intercurrent illness, or other extenuating
circumstance that, in the opinion of the Investigator, may significantly interfere
with study compliance