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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
History of Changes
  Purpose

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.


Condition Intervention Phase
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
 Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cancer Research UK:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989105

Locations
United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Cancer Research UK
Investigators
Principal Investigator: Norbert Avril, MD St. Bartholomew's Hospital
  More Information

No publications provided

Responsible Party: Cancer Research UK
ClinicalTrials.gov Identifier: NCT00989105     History of Changes
Other Study ID Numbers: CDR0000650867, UKM-ICRF-CR0402-11, CRUK-CR0402-11, EUDRACT-2007-005324-32, EU-20981
Study First Received: October 1, 2009
Last Updated: February 27, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Cancer Research UK:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
 stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013