Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer

This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of
PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a
screening population. 150 biopsy-naïve patients with an elevated PSA (2-10 ng/mL) will be
enrolled in this study.

Within 28 days of informed consent, patients will undergo an 18F-DCFPyL PET/CT. All scans
will be read by a single experienced radiologist who will identify regions of interest (ROI)
with discrete radiotracer uptake. The maximum SUV value (SUVmax) of each ROI will be
recorded. For patients without a detectable ROI, the mean SUV (SUVmean) of a 1-2 cm volume of
the prostate will instead be recorded.

One to 28 days following PET/CT imaging, a systematic 12 to 14 core TRUS-guided prostate
biopsy will be performed. Immediately following completion of systematic TRUS biopsies,
fusion-targeted biopsies of all PET and/or MRI visible lesions will be performed, taking an
additional 2 to 3 cores from each radiographic ROI. All biopsy cores will be assessed for
Gleason score and percent cancer involvement.

Inclusion Criteria:

- ≥18 years of age

- PSA of 2-10 ng/mL

- Clinical stage T1c-T2a on digital rectal exam

- Elect to undergo TRUS-guided prostate biopsy as part of routine clinical care

- Willingness to sign informed consent and comply with all protocol requirements

Exclusion Criteria:

- History of prior prostate biopsy

- Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT

- Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT

- Administered oral contrast medium ≤120 hours prior to the date of study PET/CT

- Any medical condition or other circumstances that in the opinion of the investigators
compromise obtaining reliable data or achieving the study objectives