A Phase III Trial to Test the Efficacy of ZD4054, an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.
- Conditions
- Prostate Cancer
- Registration Number
- JPRN-jRCT2080220534
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- Not specified
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method