Fulvestrant in Hormone Refractory Prostate Cancer
Completed · Phase 2
Conditions studied: Prostatic Neoplasms, Prostate Cancer
In brief
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).
Key facts
- Study ID
- NCT00476645
- Run by
- Stanford University
- People needed
- 10
- Starts
- 2006-09-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2014-08-05
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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