TheranosticTrials.org

Clinical Trial · NCT03852654

18F-DCFPyL PET-CT Scan and Prostate Cancer

Overview

Primary Objective: The primary objective of this study is to assess the efficacy of 18F-DCFPyL PET-CT for initial staging of prostate cancer in Veterans compared to conventional imaging (99mTc-MDP bone scan and Diagnostic CT or MRI). The primary clinical endpoint of our study is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging. Secondary Objectives: Frequency of the change in primary treatment plan after initial staging.

Sponsor

VA Greater Los Angeles Healthcare System

Phase

Phase 2/3

Contacts

Jafari Lida, M.D. (CONTACT)

lida.jafari@va.gov

310 268 3583

Nicholas G Nickols, M.D., Ph.D. (CONTACT)

nicholas.nickols@va.gov

310 268 3390

ClinicalTrials.gov

NCT03852654

Drug / Compound

DCFPyL

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

Eligibility

Inclusion

  • PSA greater than 10, or Gleason ≥4+3, or clinical stage greater than or equal toT2c.
  • Histologically confirmed adenocarcinoma of the prostate.
  • Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
  • Willing to comply with the procedural requirements of this protocol.
  • Plan to undergo (or have already undergone) routine care initial systemic staging with conventional imaging for prostate cancer.
  • No prior local therapy for prostate cancer (i.e., prostatectomy, radiotherapy, etc.).

Exclusion

  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
  • Primary small cell carcinoma of the prostate.
  • Weighs greater than 350 lbs., or unable to fit within the imaging gantry.
  • The subject has a condition or situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study.
  • Participation in this study significantly delay the scheduled standard of care therapy.
  • The subject undergone prior local therapy for prostate cancer (i.e. prostatectomy, radiotherapy, etc.).
  • Currently receiving androgen deprivation therapy (ADT) or anti-androgen? Previous use of ADT is allowed IF the subject has been off ADT or anti-androgen for 3 months or more.