Clinical Trial TitlePhase 3, double blind trial, using investigational product in asymptomatic subjects with Gleason sum equal to or lesser than 7, metastatic androgen independent prostatic adenocarcinoma
Clinical Trial Protocol Description:
An investigational product will be used for the treatment of asymptomatic, metastatic, androgen independent prostate adenocarcinoma. The objective of the trial is to assess the safety and the effectiveness of the investigational product in delaying the progression of prostate cancer and delaying onset of disease-related pain.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a histologically documented adenocarcinoma of the prostate with Gleason score of 7 or lower.
- Have metastatic disease as evidenced by soft tissue and/or bony metastases on imaging studies.
- Have current or historical evidence of disease progression concomitant with surgical or medical castration.
- Have a serum PSA greater than 5ng/dl.
- Are a man over the age of 18.
- Have a life expectancy of at least six months.
This is a partial list of eligibility criteria.