TheranosticTrials.org

Clinical Trial · NCT03585114

Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers

Overview

Primary Objective: * To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria. Secondary Objectives: * To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans correlate with overall survival (OS) * To determine whether baseline SUVmax correlate with rPFS * To compare number of lesions detected with standard imaging at baseline and at the time of progression

Sponsor

Jilin University

Phase

Phase 2

Contacts

Matthew C. Dallos, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03585114

Drug / Compound

DCFPyL

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

Eligibility

Inclusion

  • Wiling to comply with clinical trial instructions and requirements
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
  • Eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel, cabazitaxel) for their disease
  • Histologically confirmed diagnosis of prostate cancer
  • Metastatic castrate resistant prostate cancer as defined by Prostate Cancer Working Group 3

Exclusion

  • History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
  • Radiation or chemotherapy within 2 weeks prior to trial enrollment
  • Administration of another radioisotope within five physical half-lives of trial enrollment
  • Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \>5 times the upper limit of normal
  • Serum creatinine \> 3 times the upper limit of normal
  • Presence of prostate brachytherapy implants
  • Serum total bilirubin \> 3 times the upper limit of normal
  • Inadequate venous access