A Phase II Study to Evaluate the Performance of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer in Men with an Elevated PSA
Johns Hopkins Kimmel Cancer Center in Baltimore
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.
To be eligible for the study, patients must have PSA of 2-10 ng/mL, must elect to undergo TRUS-guided prostate biopsy as part of routine clinical care. Patients can’t have prior prostate biopsy in the last 5 years. No prior diagnosis of prostate cancer. No palpable nodule in both lobes of the prostate or evidence of extraprostatic disease. No history of prior surgery for benign prostatic hyperplasia. No history of finasteride or dutasteride use in the last 6 months.
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.
03/05/2019 05:03 AM