Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to Progression (TTP)

Outcome Description:

Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.

Outcome Time Frame:

Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).

Safety Issue:

No

Principal Investigator

AstraZeneca Emerging Oncology Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D4320C00006

NCT ID:

NCT00090363

Start Date:

July 2004

Completion Date:

August 2011

Related Keywords:

• Prostate Cancer
• rising PSA
• bone metastases
• Clinical study
• pain-free or mildly symptomatic
• Neoplasm Metastasis
• Prostatic Neoplasms
• Bone Neoplasms
• Bone Marrow Diseases