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Clinical Trial · NCT03471650
Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer
Overview
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.
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase
Phase 2
Contacts
Mohamad Allaf, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT03471650Drug / Compound
DCFPyL
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- PSMA
Ligand Class: Small Molecules
Eligibility
Inclusion
- PSA of 2-10 ng/mL
- Elect to undergo TRUS-guided prostate biopsy as part of routine clinical care
- Clinical stage T1c-T2a on digital rectal exam
Exclusion
- History of prior prostate biopsy
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