NCT00476645

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

August 5, 2014

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

3 years

First QC Date

May 18, 2007

Results QC Date

June 30, 2014

Last Update Submit

August 4, 2014

Conditions

Prostatic NeoplasmsProstate Cancer

Outcome Measures

Primary Outcomes (1)

  • PSA Reduction ≥ 50%

    Number of subjects with serum PSA reduction ≥ 50% at 3 months

    3 months

Secondary Outcomes (2)

  • PSA Doubling Time

    3 months

  • Stable Disease After One Year

    12 months

Study Arms (1)

Fulvestrant

EXPERIMENTAL
Drug: Fulvestrant

Interventions

FulvestrantDRUG

Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly

Also known as: Faslodex, ICI 182,780
Fulvestrant

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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).

    RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Associate Professor of Medicine (Oncology)
Organization
Stanford University Medical Center
sandysri@stanford.edu
650-725-2078

Study Officials

  • Dr. Sandy Srinivas

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

May 18, 2007

First Posted

May 22, 2007

Study Start

September 1, 2006

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

August 5, 2014

Results First Posted

August 5, 2014

Record last verified: 2014-08

Locations

US(1)