Fulvestrant in Hormone Refractory Prostate Cancer

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Fulvestrant in Hormone-refractory Prostate Cancer

Conditions
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Prostatic Neoplasms, Prostate Cancer

Intervention / Treatment
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* Drug: Fulvestrant


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fulvestrant<br> | Drug: Fulvestrant<br>* Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly<br>* Other names: ICI 182,780;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA Reduction ≥ 50% | Number of subjects with serum PSA reduction ≥ 50% at 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA Doubling Time | Number of subjects with prolongation of PSA doubling time | 3 months | 
| Stable Disease After One Year | Stable disease was defined as continuing treatment without disease progression, with disease progression defined as 3 consecutive rises in serum PSA or objective progression by RECIST criteria. | 12 months |