Fulvestrant in Hormone Refractory Prostate Cancer

• Efficacy, defined as the first evidence of a total serum PSA decline of >50% from baseline maintained for at least 28 days and confirmed with two consecutive measurements taken two weeks apart [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]
  

• Time to progression, defined as the time from first administration of study drug to the first observation of disease progression [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]
  
• Disease progression, defined as an increase of >25% over the baseline PSA on two consecutive measurements two weeks apart, need for palliative therapy, or a decline in at least 20% in KPS [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]
  
• Time to sustained biochemical response, defined as the time from first administration of drug to first evidence of sustained response [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]
  
• Duration of sustained response, defined as time from PSA decrease of >50% from baseline to the first evidence of disease progression [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]
  

Drug: Fulvestrant
im Dose is Day 1 250mg, day 14 250mg, thereafter qmonth 250 mg
Other Name: ICI 182,780

The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA). In vitro studies have shown that fulvestrant downregulates androgen receptor (AR) in LNCaP cancer cell lines to a significant extent, thereby inhibiting growth of tumor cells. In addition, it is important to emphasize that fulvestrant has also been found to decrease growth of AR-negative prostate cancer cells. These observations provide the rational for using fulvestrant for the treatment of AIPC and HRPC.