patients with HRPC and bone metastases will be enrolled in the study
Conditions
Interventions
Trade Name: Glivec
Product Name: imatinib
Product Code: STI-571
Pharmaceutical Form: Chewable tablet
Trade Name: ciprofloxacin
Product Name: ciprofloxacin
Product Code: ciprofloxacin
Pharmaceutical
Sponsors
department of clinical pharmacology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Age: >18 years old • Laboratory analysis: adequate organ functions is required and defined as platelet count >100,000/mm3, absolute neutrophil count >1,500/mm3, serum bilirubin 40 mL/min, or serum creatinine less than 1.5x the upper limit of normal, hemoglobin >10. No presence of any clinically relevant abnormal value, which the investigator considers may affect the validity of the study • Physical examination: no co-morbidities in terms of symptomatic congestive heart failure, unstable angina or recent myocardial infarction, and oxygen-dependent lung disease, no clinically relevant abnormal findings which could interfere with the objectives of the present study • serum testosterone level (60g/day) abuse • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects and signature of informed consent prior to inclusion in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Age: 1.5 mg/dL, AST and ALT >2x the upper limit of normal, serum creatinine clearance 50 ng/dL) • Any medication during two weeks before the start of the study, which the investigator considers may affect the validity of the study • Chemotherapy or radiation therapy within the last 30 days and systemic radioisotope therapy within the last 90 days • Participation in the evaluation of any drug within two weeks before the start of the study or participation in studies with radiotracer injection within 1 year before the start of the study • History of drug or alcohol abuse • Inability to comprehend the full nature and purpose of the study or unwillingness to sign the informed consent • Life expectancy > 3 months • Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for >5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary aim: To measure [18F]ciprofloxacin pharmacokinetics in bone metastases of HRPC patients before and after imatinib mesylate therapy with PET. ;Secondary Objective: Secondary aim: To assess the test-retest variability of the [18F]ciprofloxacin/PET procedure. ;Primary end point(s): • Total [18F]ciprofloxacin concentrations in HRPC bone metastases measured from 0 to 2 hours after radiotracer injection and expressed as the area under the time-activity curve (AUCPET) in the region of interest defined in the PET image. • Test-retest variability for [18F]ciprofloxacin given as percent difference of AUCPET between measurement 1 and 1additional. • Difference in AUCPET before and after treatment with imatinib mesylate: ? AUCtumor= AUCPET before treatment - AUCPET after treatment. | — |
Countries
Austria
Outcome results
None listed