Fulvestrant in Hormone Refractory Prostate Cancer

Not Recruiting

Trial ID: NCT00476645


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).

Official Title

Fulvestrant in Hormone-refractory Prostate Cancer

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - 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)


drug: Fulvestrant

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Denise Haas

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