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

Tracking Information
First Submitted Date ICMJE	October 1, 2009
First Posted Date ICMJE	October 2, 2009
Last Update Posted Date	February 28, 2012
Study Start Date ICMJE	June 2009
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 1, 2009)	Causality of each adverse events as assessed by NCI CTCAE v. 3.0; 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
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00989105 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 1, 2009)	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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Technetium Tc 99m Demobesin-4 for Imaging Procedures in Patients With Prostate Cancer
Official Title ICMJE	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
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 Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Prostate Cancer
Intervention ICMJE	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
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: February 27, 2012)	8
Original Estimated Enrollment ICMJE; (submitted: October 1, 2009)	45
Actual Study Completion Date	December 2011
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00989105
Other Study ID Numbers ICMJE	CDR0000650867; UKM-ICRF-CR0402-11; CRUK-CR0402-11; EUDRACT-2007-005324-32; EU-20981
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Cancer Research UK
Study Sponsor ICMJE	Cancer Research UK
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Norbert Avril, MD St. Bartholomew's Hospital
PRS Account	Cancer Research UK
Verification Date	February 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP