Clinical Trial · NCT02420977

Evaluation of PSMA-based PET as an Imaging Biomarker in Prostate Cancer

Overview

This research is being done to see if an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer before surgery.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase

Early Phase 1

Contacts

Curtiland Deville, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02420977

Drug / Compound

DCFPyL

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • At least 10 days after most recent prostate biopsy
  • Newly diagnosed prostate cancer pathologically proven by prostate biopsy
  • Key inclusion criteria (the entire list of inclusion and exclusion criteria will appear later in section 4 of the protocol)
  • Patients considered as candidates for and medically fit to undergo radiation and ADT
  • Prostate biopsy histology grade ≥ Gleason 8-10

Exclusion

  • Hemorrhagic cystitis or active prostatitis
  • Prior pelvic external beam radiation therapy or brachytherapy
  • Chemotherapy for prostate cancer
  • Investigational therapy for prostate cancer
  • Hormone deprivation therapy