Fulvestrant in Hormone Refractory Prostate Cancer
Trial ID or NCT#
NCT00476645
Status
NOT RECRUITING
Purpose
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
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)
Investigator(s)
Sandy Srinivas
Medical oncologist,
Urologic specialist,
Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology
Contact us to find out if this trial is right for you.
Contact
Denise Haas
6507361252
View on ClinicalTrials.gov
