Fulvestrant in Hormone Refractory Prostate Cancer
Trial ID or NCT#
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).
Fulvestrant in Hormone-refractory Prostate Cancer
- - Must give signed written informed consent - Must be of age 18 years or older - Histologically confirmed adenocarcinoma of the prostate - Must be currently receiving LHRH agonists and have castrate levels of testosterone or have had an orchiectomy - Must have had rise in PSA despite anti-androgen withdrawal - Must exhibit two consecutive rises in PSA after the last hormonal manipulation - Minimum PSA > 5mg/dL - KPS > 80% - Up to one prior chemotherapy treatments allowed - Life expectancy of greater than 6 months
- - Concomitant hormonal therapy other than an LHRH - Noncompliance - Platelets less than 100 x 10e9 /L - International normalization ratio (INR) greater than 1.6 - Total bilirubin greater than 1.5 x ULRR - ALT or AST greater than 2.5 x ULRR if no demonstrable liver metastases or greater than 5.0 x ULRR in presence of liver metastases - History of bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) - History of long-term anticoagulant therapy (other than antiplatelet therapy) - History of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or Mannitol)
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