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Fulvestrant in Hormone Refractory Prostate Cancer

This study has been completed.
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University Identifier:
First received: May 18, 2007
Last updated: August 4, 2014
Last verified: August 2014
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).

Condition Intervention Phase
Prostatic Neoplasms
Prostate Cancer
Drug: Fulvestrant
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fulvestrant in Hormone-refractory Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • PSA Reduction ≥ 50% [ Time Frame: 3 months ]
    Number of subjects with serum PSA reduction ≥ 50% at 3 months

Secondary Outcome Measures:
  • PSA Doubling Time [ Time Frame: 3 months ]
    Number of subjects with prolongation of PSA doubling time

  • Stable Disease After One Year [ Time Frame: 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.

Enrollment: 10
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fulvestrant Drug: Fulvestrant
Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly
Other Names:
  • Faslodex
  • ICI 182,780

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00476645

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Dr. Sandy Srinivas Stanford University
  More Information

Srinivas S, Harshman LC, Feldman D. "Effect of fulvestrant on PSA doubling time in patients with castration-resistant prostate cancer (CRPC)." JCO. Annual Meeting, ASCO 2010. 20 May 2010;28(15-suppl)(abs e15112).

Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University Identifier: NCT00476645     History of Changes
Other Study ID Numbers: IRB-01890
96025 ( Other Identifier: Stanford University alternate IRB Number )
PROS0010 ( Other Identifier: OnCore )
Study First Received: May 18, 2007
Results First Received: June 30, 2014
Last Updated: August 4, 2014

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Estrogens processed this record on May 23, 2017