Status:
TERMINATED
Technetium Tc 99m Demobesin-4 for Imaging Procedures in Patients With Prostate Cancer
Lead Sponsor:
Cancer Research UK
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 ...
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00989105
Start Date
June 1 2009
End Date
December 1 2011
Last Update
February 28 2012
Active Locations (1)
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1
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE