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

• Status: Active, not recruiting
• Trial end date: 2023-03-07
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Progenics Pharmaceuticals, Inc.

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