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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

Phase 1
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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



- 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.


- To assess the performance of ^99mTc DB4 in detecting metastatic spread of prostate
cancer in these patients.


- 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.

Inclusion Criteria


- 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


- 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


- 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

- No other concurrent investigational drugs

- Concurrent anticancer therapy allowed

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Causality of each adverse events as assessed by NCI CTCAE v. 3.0

Safety Issue:


Principal Investigator

Norbert Avril, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Bartholomew's Hospital


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

June 2009

Completion Date:

December 2011

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms