TheranosticTrials.org

Clinical Trial · NCT03062254

Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy

Overview

Broadly, the objective of this study is to evaluate the fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT in bone metastases from prostate cancer following treatment with radium-223 as a surrogate marker for tumor cell killing.

Sponsor

Unknown Organization

Phase

Phase 2

ClinicalTrials.gov

NCT03062254

Drug / Compound

dichloride

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

Eligibility

Inclusion

  • Hemoglobin greater than or equal to 100 g/L with no blood transfusions or EPO in preceding 3 weeks
  • Recently failed (within 3 months) or failing novel androgen receptor pathway inhibitors (abiraterone + prednisone or enzalutamide) with intention of continuing the drug for at least 7 months OR minimum 14 day washout period from either agent prior to study enrollment
  • Life expectancy of greater than 6 months
  • Resident of Canada
  • Male sex
  • Platelets greater than or equal to 100 x109/L
  • Planned change in systemic anti-neoplastic therapy during the approximately 7 month trial
  • Unable to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 30 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug.
  • Serum testosterone less than or equal to 50 ng/dl
  • ECOG performance status 0 - 2, inclusive
  • Patient has good IV access
  • Neutrophils greater than or equal to 1.5 x109/L
  • Patients who are claustrophobic
  • Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
  • Inclusion Criteria
  • Progressive (symptoms, conventional imaging, PSA, bone scan, FCH PET/CT or other) castration-resistant prostate cancer in the judgment of the treating physician without change in systemic anti-neoplastic therapy since documented progression
  • Six or greater bone metastases robustly-avid on recent (4 weeks) MDP or NaF scintigraphy
  • Patients who exceed the safe weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (70 cm diameter)

Exclusion

  • No unmanageable fecal incontinence
  • Not received docetaxel for castration-resistant disease
  • No known visceral metastases or adenopathy greater than 3 cm short axis on conventional imaging
  • No prior hemi-body radiotherapy
  • No impending or established spinal cord compression