Prostate Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : ZD4054
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material :
Sponsors
AstraZeneca
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Ages Eligible for Study: 18 Years and older (Japan: 20 Years and older) Genders Eligible for Study: Male Accepts Healthy Volunteers: No Inclusion Criteria: -Patients who answer TRUE to the following criteria may be eligible to participate in this trial. 1. Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases) 2. Increasing Prostate Specific Antigen (PSA) over a one month period 3. No pain, or mild pain from prostate cancer 4. Currently receiving treatment with surgical or medical castration Exclusion Criteria: -Patients who answer TRUE to the following may NOT eligible to participate in this trial. 1. Currently using opiates based pain killers 2. Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone) 3. Suffering from heart failure or had a myocardial infarction within last 6 months 4. A history of epilepsy or seizures
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety/Efficacy Primary Outcome Measures: -Overall survival [ Time Frame: study visits and assessments every 4 weeks for first 12 weeks then every 12 weeks ] [ Designated as safety issue: No ] Secondary Outcome Measures: -Progression free survival [ Time Frame: study visits and assessments every 4 weeks for first 12 weeks then every 12 weeks ] [ Designated as safety issue: No ] -Tolerability and safety profile of ZD4054 [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ] -Time to use of opiates [ Time Frame: Assessed every 12 weeks after progression ] [ Designated as safety issue: No ] -Incidence of skeletal related events [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ] -Bone metastases formation [ Time Frame: Assessed every 12 weeks after progression ] [ Designated as safety issue: No ] -Health Related Quality of Life [ Time Frame: Assessed every visit ] [ Designated as safety issue: No ] -Time to prostate-specific antigen (PSA) progression [ Time Frame: Assessed every 12 weeks after progression ] [ Designated as safety issue: No ] -Time to pain progression [ Time Frame: Assessed every 12 weeks after progression ] [ Designated as safety issue: No ] -Time to initiation of chemotherapy [ Time Frame: Assessed every 12 weeks after progression ] [ Designated as safety issue: No ] -Pharmacokinetic characteristics of ZD4054 [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ] | — |
Outcome results
None listed