TheranosticTrials.org

Clinical Trial · NCT03497377

Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer.

Overview

The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\]DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. Preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection. Investigators propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by ultra sensitive but less specific \[18F\]Sodium Fluoride (NaF)-PET/CT imaging for prostate cancer.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase

Phase 1

Contacts

Martin Pomper, MD,PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03497377

Drug / Compound

DCFPyL

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

NaF

Isotope(s):
Target(s):
  • Bone Metabolism
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
  • 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
  • Histological confirmation of prostate cancer
  • Rising PSA on two observations taken at least 1 week apart
  • Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
  • Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
  • 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

Exclusion

  • Unable to lie flat during or tolerate PET/CT (or PET/MRI imaging if available)
  • 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
  • Serum creatinine \> 3 times the upper limit of normal
  • Total bilirubin \> 3 times the upper limit of normal
  • Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
  • Liver Transaminases \> 5times the upper limit of normal