Phase 3, double blind trial, using investigational product in asymptomatic subjects with Gleason sum equal to or lesser than 7, metastatic androgen independent prostatic adenocarcinoma
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.
You may be eligible for this study if:
- You have a histologically documented adenocarcinoma of the prostate with Gleason score of 7 or lower
- You have metastatic disease as evidenced by soft tissue and/or bony metastases on imaging studies
- You have current or historical evidence of disease progression concomitant with surgical or medical castration
- You have a serum PSA greater than 5ng/dl
- You are a man over the age of 18
- You have a life expectancy of at least six months
This is a partial list of eligibility criteria.