Prostate Cancer Clinical Trial
Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Baltimore Maryland, 21287, United States
How clear is this clinincal trial information?