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

NCT00989105 | Terminated Phase 1

• 5 other identifiers: CDR0000650867UKM-ICRF-CR0402-11CRUK-CR0402-11EUDRACT-2007-005324-32EU-20981
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• 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

Interventions

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

pharmacological study OTHER

computed tomography PROCEDURE

magnetic resonance imaging PROCEDURE

single photon emission computed tomography PROCEDURE

technetium Tc 99m demobesin-4 RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (1)

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Immunohistochemistry; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Norbert Avril, MD

  St. Bartholomew's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

GB (1)