Fulvestrant in Hormone Refractory Prostate Cancer

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).

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms; Prostate Cancer
• Intervention / Treatment: Drug: Fulvestrant

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: AstraZeneca

Publications and helpful links

General Publications

• 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).

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 18, 2007
• First Submitted That Met QC Criteria: May 18, 2007
• First Posted (Estimate): May 22, 2007

Study Record Updates

• Last Update Posted (Estimate): August 5, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant
• Other Study ID Numbers: IRB-01890; 96025 (Other Identifier: Stanford University alternate IRB Number); PROS0010 (Other Identifier: OnCore)