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

NCT ID: NCT00989105

Last Updated: 2012-02-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-12-31

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.

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

pharmacological study

Intervention Type: OTHER

computed tomography

Intervention Type: PROCEDURE

magnetic resonance imaging

Intervention Type: PROCEDURE

single photon emission computed tomography

Intervention Type: PROCEDURE

technetium Tc 99m demobesin-4

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research UK

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norbert Avril, MD

Role: PRINCIPAL_INVESTIGATOR

St. Bartholomew's Hospital

Locations

Saint Bartholomew's Hospital

London, England, United Kingdom

Countries

United Kingdom

Other Identifiers

UKM-ICRF-CR0402-11

Identifier Type: -

Identifier Source: secondary_id

CRUK-CR0402-11

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2007-005324-32

Identifier Type: -

Identifier Source: secondary_id

EU-20981

Identifier Type: -

Identifier Source: secondary_id

CDR0000650867

Identifier Type: -

Identifier Source: org_study_id