A Cancer Research UK Phase I Trial of 99mTc Demobesin-4 (a Diagnostic Radiopharmaceutical) Given Once Via Bolus Intravenous Injection for Imaging of Prostate Cancer
- To assess the safety of technetium Tc 99m (^99mTc) demobesin-4 (DB4) in patients with
- To assess the biodistribution of ^99mTc DB4 in these patients.
- To assess the pharmacokinetics of ^99mTc DB4 in these patients.
- To assess the performance of ^99mTc DB4 in detecting metastatic spread of prostate
cancer in these patients.
- To compare uptake of ^99mTc DB4 with levels of expression in gastrin-releasing peptide
receptor in prostate tumor samples and lymph node specimens.
OUTLINE: Patients are stratified according to diagnosis (cancer confined to prostate vs
locally advanced disease vs metastatic disease).
Patients receive technetium Tc 99m (^99mTc) demobesin-4 (DB4) IV bolus over 1 minute and
undergo imaging by single photon emission computer tomography, CT scan, and/or MRI up to 3
hours after infusion. Some patients undergo radical prostatectomy or surgical pelvic lymph
Blood and urine samples are collected at 5, 10, 20, 30, and 45 minutes at baseline and at 1,
2, 3, 4, and 6 hours after ^99mTc DB4 IV infusion for pharmacokinetic studies. Tumor tissue
samples obtained during radical prostatectomy and surgical lymph node biopsies are analyzed
for gastrin-releasing peptide receptor by IHC.
After completion of study intervention, patients are followed for up to 28 days.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Masking: Open Label, Primary Purpose: Diagnostic
Causality of each adverse events as assessed by NCI CTCAE v. 3.0
Norbert Avril, MD
St. Bartholomew's Hospital
United Kingdom: Medicines and Healthcare Products Regulatory Agency