Fulvestrant in Hormone Refractory Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer; Prostatic Neoplasms
• Interventions: Drug: Fulvestrant

• Registration Number: NCT00476645
• Lead Sponsor: Stanford University

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-05-18
• Study First Submitted QC: 2007-05-18
• Study First Posted: 2007-05-22
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Results First Submitted: 2014-06-30
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-04
• Last Update Submitted: 2014-08-04
• Results First Posted: 2014-08-05
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fulvestrant	Fulvestrant	-

Primary Outcome Measures

Name	Time	Method
PSA Reduction ≥ 50%	3 months	Number of subjects with serum PSA reduction ≥ 50% at 3 months

Secondary Outcome Measures

Name	Time	Method
Stable Disease After One Year	12 months	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.
PSA Doubling Time	3 months	Number of subjects with prolongation of PSA doubling time

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States