TheranosticTrials.org

Clinical Trial · NCT02151760

Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer

Overview

This study is being done to determine the safety, biodistribution, and radiation dosimetry of 18F-DCFPyL, and to detect prostate cancer by visual analysis.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase

Phase 1

Contacts

Steve Y Cho, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02151760

Drug / Compound

DCFPyL

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

Eligibility

Inclusion

  • Histological confirmation of prostate cancer
  • 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.
  • Platelet count \> 50,000/mm3
  • Patients may be enrolled into this protocol only if all of the following inclusion criteria are met:
  • Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.
  • PSA ≥ 1.0 ng/mL
  • Neutrophil count \> 1,000/mm3
  • Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, 18F-Sodium Fluoride PET, or 18F-FDG PET

Exclusion

  • Patients will be excluded from enrollment if any of the following apply:
  • Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 30 days prior to study radiotracer administration
  • Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants)
  • Total bilirubin \> 3 times the upper limit of normal
  • Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest).
  • Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma.
  • Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
  • Administered a radioisotope within 5 physical half-lives prior to study enrollment
  • Karnovsky performance status of \< 60
  • Serum creatinine \> 3 times the upper limit of normal
  • Liver Transaminases \> 5times the upper limit of normal