Fulvestrant in Hormone Refractory Prostate Cancer
18 Years
85 Years
Male
Prostatic Neoplasms, Prostate Cancer
Trial Information
Fulvestrant in Hormone Refractory Prostate Cancer
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.
Inclusion Criteria:
1. Must give signed written informed consent 2. Must be of age 18 yearsor older 3. Histologically confirmed adenocarcinoma of the prostate 4. Must be currently
receiving LHRH agonists and have castrate levels of testosterone or have had an
orchiectomy 5. Must have had rise in PSA despite anti-androgen withdrawal 6. Must exhibit
two consecutive rises in PSA after the last hormonal manipulation 7. Minimum PSA > 5mg/dL
8. KPS > 80% 9. Up to one prior chemotherapy treatments allowed 10.Life expectancy of
greater than 6 months
Exclusion Criteria:1. Concomitant hormonal therapy other than an LHRH 2. Noncompliance 3.
Platelets less than 100 x 10^9 /L 4. International normalization ratio (INR) greater than
1.6 5. Total bilirubin greater than 1.5 x ULRR 6. 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
7. History of:
1. bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor
deficiency) or
2. long-term anticoagulant therapy (other than antiplatelet therapy).
3. hypersensitivity to active or inactive excipients of fulvestrant (ie castor oil or
Mannitol)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
at 3months and monthly
Safety Issue:
Yes
Principal Investigator
Dr. Sandy Srinivas
Investigator Role:
Principal Investigator
Investigator Affiliation:
Stanford University
Authority:
United States: Institutional Review Board
Study ID:
PROS0010
NCT ID:
NCT00476645
Start Date:
September 2006
Completion Date:
December 2009
Related Keywords:
- Prostatic Neoplasms
- Prostate Cancer
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| Stanford University School of Medicine | Stanford, California 94305-5317 |
