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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Cancer Research UK
ClinicalTrials.gov Identifier:
NCT00989105
First received: October 1, 2009
Last updated: February 27, 2012
Last verified: February 2012

October 1, 2009
February 27, 2012
June 2009
December 2011   (final data collection date for primary outcome measure)
  • Causality of each adverse events as assessed by NCI CTCAE v. 3.0 [ Designated as safety issue: Yes ]
  • Biodistribution of radioactivity of 99mTc DB4 by gamma-camera imaging [ Designated as safety issue: No ]
  • Pharmacokinetics of 99mTc DB4 in blood and urine and assessment of decline over 6 hours [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00989105 on ClinicalTrials.gov Archive Site
  • Performance of 99mTc DB4 gamma-camera imaging compared with conventional imaging (CT scan and/or MRI) [ Designated as safety issue: No ]
  • Levels of expression in gastrin-releasing peptide in prostate tumor samples and lymph node specimens [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
December 2011
December 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer meeting 1 of the following criteria:

    • Disease confined to the prostate that is to be treated with radical prostatectomy after imaging
    • Locally advanced disease that is to be treated with radiotherapy

      • Patients must agree to undergo surgical pelvic lymph node staging to assist with determination of radiation fields
    • Metastatic disease at initial diagnosis or recurrent or progressive disease

      • Patients receive standard of care

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Neutrophils ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Serum creatinine ≤ 1.5 times ULN
  • Must be registered with the Cancer Research UK Drug Development Office
  • Capable of cooperating with imaging procedure and follow-up
  • Fertile patients must use effective contraception during and for 6 months after completion of study therapy
  • Not at high medical risk because of non-malignant systemic disease, including active uncontrolled infection
  • No history of recent significant cardiac arrhythmia
  • No prior NYHA class III-IV cardiac disease or concurrent congestive heart failure
  • No other condition that, in the Investigator's opinion, would not make the patient a good candidate for the clinical trial

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No chemotherapy or radiotherapy prior to or within 2 weeks of study therapy
  • No prior major thoracic and/or abdominal surgery from which the patient has not yet recovered
  • No other concurrent investigational drugs
  • Concurrent anticancer therapy allowed
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00989105
CDR0000650867, UKM-ICRF-CR0402-11, CRUK-CR0402-11, EUDRACT-2007-005324-32, EU-20981
Not Provided
Cancer Research UK
Cancer Research UK
Not Provided
Principal Investigator: Norbert Avril, MD St. Bartholomew's Hospital
Cancer Research UK
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP