ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)

Study Overview
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Brief Summary
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This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).

Official Title
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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)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: ZD4054 15 mg
* Drug: Placebo
* Drug: ZD4054 10 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgically or medically castrated Bone metastasis Rising PSA Exclusion Criteria: Opiate use Prior chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Matching placebo oral tablet once daily, with best supportive care | Drug: Placebo<br> <br> |
| Experimental: ZD4054 10 mg<br>ZD4054 10 mg oral tablet once daily, with best supportive care | Drug: ZD4054 10 mg<br>* 10mg oral tablet once daily<br>* Other names: (Zibotentan);|
| Experimental: ZD4054 15 mg<br>ZD4054 15 mg oral tablet once daily, with best supportive care | Drug: ZD4054 15 mg<br>* 15 mg oral tablet once daily<br>* Other names: Zibotentan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression (TTP) | 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. | 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Death | Median time (in days) from randomisation until death using the Kaplan-Meier method. | Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008). | 
| Change in Total Prostate Specific Antigen (PSA) Over Time | Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks. | Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006). | 
| Objective Response Rate (ORR) | Using the Response Evaluation Criteria in Solid Tumours (RECIST), an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR), which is subsequently confirmed as per RECIST. Objective Response Rate (ORR) is defined as the percentage of patients with OR. | For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006). | 
| Change in Number of Bone Metastases Over Time | Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation. | Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rising PSA, bone metastases, Clinical study, pain-free or mildly symptomatic