TheranosticTrials.org

Clinical Trial · NCT01815515

Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer

Overview

This research is being done to see if an investigational radioactive drug called 18F-DCFBC can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase

Phase 1/2

Contacts

Zsolt Szabo, M.D (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01815515

Drug / Compound

DCFBC

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

Eligibility

Inclusion

  • Histological confirmation of prostate cancer
  • Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
  • Rising PSA on two observations taken at least 1 week apart
  • Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
  • Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
  • Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, \[18F\]Sodium Fluoride PET, and/or \[18F\]FDG PET
  • Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits

Exclusion

  • Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)
  • Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
  • Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
  • Liver Transaminases \> 5times the upper limit of normal
  • Total bilirubin \> 3 times the upper limit of normal
  • Serum creatinine \> 3 times the upper limit of normal
  • Unable to lie flat during or tolerate PET/CT