NCT00989105

Technetium Tc 99m Demobesin-4 for Imaging Procedures in Patients With Prostate Cancer

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Diagnostic procedures, such as technetium Tc 99m demobesin-4 followed by single-photon emission computer tomography, CT scan, and MRI, may help find prostate cancer and learn the extent of disease. PURPOSE: This phase I trial is studying the side effects of technetium Tc 99m demobesin-4 and to see how well it works for imaging procedures in patients with prostate cancer.

Detailed description

OBJECTIVES: Primary * To assess the safety of technetium Tc 99m (\^99mTc) demobesin-4 (DB4) in patients with prostate cancer. * To assess the biodistribution of \^99mTc DB4 in these patients. * To assess the pharmacokinetics of \^99mTc DB4 in these patients. Secondary * To assess the performance of \^99mTc DB4 in detecting metastatic spread of prostate cancer in these patients. Tertiary * 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 node biopsies. 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	immunohistochemistry staining method
OTHER	laboratory biomarker analysis
OTHER	pharmacological study
PROCEDURE	computed tomography
PROCEDURE	magnetic resonance imaging
PROCEDURE	single photon emission computed tomography
RADIATION	technetium Tc 99m demobesin-4

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-10-02
• Last updated: 2012-02-28

Locations

1 site across 1 country: United Kingdom