Fulvestrant in Hormone Refractory Prostate Cancer

Stanford University

Status and phase: Completed; Phase 2

Conditions: Prostatic Neoplasms; Prostate Cancer

Treatments: Drug: Fulvestrant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00476645

IRB-01890

PROS0010 (Other Identifier)

96025 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Fulvestrant

Experimental group

Treatment:

Drug: Fulvestrant