Prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10036909 Term: Prostate cancer metastatic
Conditions
Interventions
Product Code: ZD4054
Pharmaceutical Form: Tablet
Sponsors
Christie Hospital NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histological confirmation of prostate adenocarcinoma. 2. Documented evidence of bone metastasis on radionuclide bone scan, MRI or plain radiograph 3. Biochemical progression of prostate cancer, documented while the patient is surgically or medically castrate: -Biochemical progression is defined as at least 2 stepwise increases in PSA over a period of =1 month with at least 14 days between each measurement irrespective of assay or laboratory. -The final PSA value must be =1.2ng/mL in patients who have had a radical prostatectomy and =1.5ng/mL in all other patients 4. Surgically or medically castrated with serum testosterone =2.4nmol/L (70ng/dL) 5. ECOG performance status 0 – 2. 6. Life expectancy of 6 months or more. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment. 2. Prior targeted cancer therapies (such as gefitinib, bevacizumab) 3. Systemic radionuclide therapy within 12 weeks of starting study treatment. 4. Current therapy, within 4 weeks of study entry with potent inhibitors on CYP3A4 (ketoconazole, itraconazole, ritinavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem and verapamil), inhibitors of CYPs 2D6 and 2C9 (quinidine and fluconazole), and potent P450 inducers (phenytoin, rifampicin, caramazepine and phenobarbitone). 5. Definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonists. 6. Ineligibility for MRI scanning includes standard MRI criteria (for example, metal implants such as cochlear implants, cardiac pacemakers, heart valves, aneurysm clips and metal fragments in eyes) and patients known to be allergic to gadolinium-based MRI contrast agents 7. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall aim of this study is to acquire blood, urine and tissue samples and imaging in patients with advanced prostate cancer that has spread to bone, before and during treatment with ZD4054. The samples will be used for research studies designed to elucidate the mechanism of action of this compound and to endeavour to improve therapies in this disease setting.; Secondary Objective: The secondary research objectives are: 1. To improve knowledge of cancer biology 2. To investigate potential biomarkers (proteins and genes) for biological resistance and response to treatment 3. To find new assays (tests) to monitor response to treatment and expedite clinical development of new drugs that target specific molecules in cancer cells 4. To discover and evaluate biomarkers that can predict for increased risk of disease relapse or progression ;Primary end point(s): The primary outcome measures are changes in histopathological morphology, immunohistochemistry staining patterns, genomic and DNA methylation patterns and changes in proteomics, metabonomics and imaging biomarkers before and after treatment with ZD4054. | — |
Countries
United Kingdom
Outcome results
None listed