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