Clinical trial NCT00090363: ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: rising PSA
bone metastases
Clinical study
pain-free or mildly symptomatic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2004-08-30
Enrollment: 447
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Surgically or medically castrated
* Bone metastasis
* Rising PSA

Exclusion Criteria:

* Opiate use
* Prior chemotherapy

Primary outcomes:
measure: Time to Progression (TTP)
timeFrame: 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 outcomes:
measure: Time to Death
timeFrame: 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).
measure: Change in Total Prostate Specific Antigen (PSA) Over Time
timeFrame: Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
measure: Objective Response Rate (ORR)
timeFrame: 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).
measure: Change in Number of Bone Metastases Over Time
timeFrame: Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Gainsville
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Simpsonville
country: United States
facility: Research Site
state: South Carolina
city: Wolloongabba
country: Australia
facility: Research Site
state: Queensland
city: Ashford
country: Australia
facility: Research Site
state: South Australia
city: Wodonga
country: Australia
facility: Research Site
state: Victoria
city: Nedlands
country: Australia
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Vancouver
country: Canada
facility: Research site
state: British Columbia
city: London
country: Canada
facility: Research site
state: Ontario
city: Toronto
country: Canada
facility: Research site
state: Ontario
city: Montreal
country: Canada
facility: Research site
state: Quebec
city: Quebec
country: Canada
facility: Research site
city: Arhus
country: Denmark
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Joensuu
country: Finland
facility: Research Site
city: OYS
country: Finland
facility: Research Site
city: Seinäjoki
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pontoise
country: France
facility: Research site
city: Toulouse
country: France
facility: Research Site
city: Jakarta
country: Indonesia
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Heerlen
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Fredrikstad
country: Norway
facility: Research Site
city: Moelv
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Tonsberg
country: Norway
facility: Research Site
city: Tromso
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Geneve
country: Switzerland
facility: Research Site
city: Locarno
country: Switzerland
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Maidstone
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: York
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Emerging Oncology Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: James ND, Caty A, Borre M, Zonnenberg BA, Beuzeboc P, Morris T, Phung D, Dawson NA. Safety and efficacy of the specific endothelin-A receptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: a double-blind, placebo-controlled, randomised, phase 2 trial. Eur Urol. 2009 May;55(5):1112-23. doi: 10.1016/j.eururo.2008.11.002. Epub 2008 Nov 29.