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

Phase 1

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT00989105
• Lead Sponsor: Cancer Research UK

Brief 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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biodistribution of radioactivity of 99mTc DB4 by gamma-camera imaging
Pharmacokinetics of 99mTc DB4 in blood and urine and assessment of decline over 6 hours
Causality of each adverse events as assessed by NCI CTCAE v. 3.0

Secondary Outcome Measures

Name	Time	Method
Performance of 99mTc DB4 gamma-camera imaging compared with conventional imaging (CT scan and/or MRI)
Levels of expression in gastrin-releasing peptide in prostate tumor samples and lymph node specimens

Trial Locations

Locations (1)

Saint Bartholomew's Hospital; 🇬🇧 London, England, United Kingdom