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Fulvestrant in Hormone Refractory Prostate Cancer


Phase 2
18 Years
85 Years
Not Enrolling
Male
Prostatic Neoplasms, Prostate Cancer

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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 years
or 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