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A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.


Inclusion Criteria:



Patients who answer TRUE to the following criteria may be eligible to participate in this
trial.

1. Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has
spread to the bone (bone metastases)

2. Increasing Prostate Specific Antigen (PSA) over a one month period

3. No pain, or mild pain from prostate cancer

4. Currently receiving treatment with surgical or medical castration

Exclusion Criteria:

Patients who answer TRUE to the following may NOT eligible to participate in this trial.

1. Currently using opiates based pain killers)

2. Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)

3. Suffering from heart failure or had a myocardial infarction within last 6 months

4. A history of epilepsy or seizures

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

Median time (in months) from randomisation until death using the Kaplan-Meier method

Outcome Time Frame:

From date of randomization until date of death, assessed up to 32 months

Safety Issue:

No

Principal Investigator

Martin Gleave, MD, FRCSC, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Prostate Centre at Vancouver General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

D4320C00014

NCT ID:

NCT00554229

Start Date:

November 2007

Completion Date:

August 2011

Related Keywords:

  • Prostate Cancer
  • Hormone Resistant Prostate Cancer
  • Endothelin A Receptor Antagonist
  • Endothelin A
  • Endothelin A antagonist
  • Neoplasm Metastasis
  • Prostatic Neoplasms

Name

Location
Research Site Mesa, Arizona  
Research Site Anaheim, California  
Research Site Danbury, Connecticut  
Research Site Washington, District of Columbia  
Research Site Boca Raton, Florida  
Research Site Ames, Iowa  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Chattanooga, Tennessee  
Research Site Ivins, Utah  
Research Site Bennington, Vermont  
Research Site Abington, Virginia  
Research Site Auburn, Washington  
Research Site Clarksburg, West Virginia  
Research Site Appleton, Wisconsin