Clinical trial NCT00673205: (Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer
Official title: A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Metastatic Prostate Cancer
Keywords: androgen antagonists
prostate neoplasms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 3588
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: The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of non-metastatic cancer of the prostate gland
* Patient to be 18 years and above

Exclusion Criteria:

* Previous systemic therapy for prostate cancer
* Previous history of another form of cancer (not prostate) within 5 years of study start.

Primary outcomes:
measure: Time to clinical progression
timeFrame: Throughout study period
measure: Tolerability in terms of adverse events and laboratory parameters
timeFrame: Throughout study period
Secondary outcomes:
measure: Survival
timeFrame: Throughout study period
measure: Time to treatment failure
timeFrame: Throughout study period
measure: Prostate-specific antigen
timeFrame: Initial study period up to 2005 amended protocol
Other outcomes:
Locations:
city: Wooloongabba
country: Australia
facility: Research Site
state: Queensland
city: East Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Graz
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Mistelbach
country: Austria
facility: Research Site
city: Oberwart
country: Austria
facility: Research Site
city: St. Polten
country: Austria
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Mons
country: Belgium
facility: Research Site
city: Oostende
country: Belgium
facility: Research Site
city: Seraing
country: Belgium
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Praha 4
country: Czech Republic
facility: Research Site
city: Praha 5
country: Czech Republic
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Lubeck
country: Germany
facility: Research Site
city: Ludenscheid
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Sigmaringen
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Dublin 4
country: Ireland
facility: Research Site
city: Dublin 7
country: Ireland
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Petach Tikva
country: Israel
facility: Research Site
city: Tel-aviv
country: Israel
facility: Research Site
city: Tel-hashomer
country: Israel
facility: Research Site
city: Bari
country: Italy
facility: Research Site
state: BA
city: Bergamo
country: Italy
facility: Research Site
state: BG
city: Belluno
country: Italy
facility: Research Site
state: BL
city: Bologna
country: Italy
facility: Research Site
state: BO
city: Brescia
country: Italy
facility: Research Site
state: BS
city: Como
country: Italy
facility: Research Site
state: CO
city: Cesena
country: Italy
facility: Research Site
state: FO
city: Anagni
country: Italy
facility: Research Site
state: FR
city: Carpi
country: Italy
facility: Research Site
state: MO
city: Fidenza
country: Italy
facility: Research Site
state: PR
city: Siena
country: Italy
facility: Research Site
state: SI
city: Torino
country: Italy
facility: Research Site
state: TO
city: Treviso
country: Italy
facility: Research Site
state: TV
city: Udine
country: Italy
facility: Research Site
state: UD
city: Varese
country: Italy
facility: Research Site
state: VA
city: Dolo
country: Italy
facility: Research Site
state: VE
city: Portogruaro
country: Italy
facility: Research Site
state: VE
city: Roma
country: Italy
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Capelle A/d Ijssel
country: Netherlands
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Enschede
country: Netherlands
facility: Research Site
city: Gouda
country: Netherlands
facility: Research Site
city: Heerlen
country: Netherlands
facility: Research Site
city: Maastricht
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Roosendaal
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Spijkenisse
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Almada
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Vila Nova de Gaia
country: Portugal
facility: Research Site
city: Somerset West
country: South Africa
facility: Research Site
state: Cape Town
city: Bloemfontein
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: George
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Pietermarizberg
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Granada
country: Spain
facility: Research Site
state: Andalucia
city: Malaga
country: Spain
facility: Research Site
state: Andalucia
city: Sevilla
country: Spain
facility: Research Site
state: Andalucia
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Guadalajara
country: Spain
facility: Research Site
state: Castilla La Mancha
city: Salamanca
country: Spain
facility: Research Site
state: Castilla Leon
city: Badalona(barcelona)
country: Spain
facility: Research Site
state: Cataluna
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Hospitalet de Llobregat(barcel
country: Spain
facility: Research Site
state: Cataluna
city: Alcala de Henares
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: Getafe
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: Madrid
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: San Juan(alicante)
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: A Coruna
country: Spain
facility: Research Site
state: Galicia
city: Vigo(pontevedra)
country: Spain
facility: Research Site
state: Galicia
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Bilbao
country: Spain
facility: Research Site
state: Pais Vasco
city: Reading
country: United Kingdom
facility: Research Site
state: Berkshire
city: Colchester
country: United Kingdom
facility: Research Site
state: Essex
city: Barnet
country: United Kingdom
facility: Research Site
state: Hertfordshire
city: Tooting
country: United Kingdom
facility: Research Site
state: London
city: Belfast
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Taunton
country: United Kingdom
facility: Research Site
state: Somerset
city: Gwent
country: United Kingdom
facility: Research Site
state: South Wales
city: Eastbourne
country: United Kingdom
facility: Research Site
state: Sussex
city: Birmingham
country: United Kingdom
facility: Research Site
state: West Midlands
city: Bolton
country: United Kingdom
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Cleveland
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Falkirk
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Kent
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Shrewsbury
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Technical University of Dresden, Germany
name: Manfred P Wirth, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iversen P, McLeod DG, See WA, Morris T, Armstrong J, Wirth MP; Casodex Early Prostate Cancer Trialists' Group. Antiandrogen monotherapy in patients with localized or locally advanced prostate cancer: final results from the bicalutamide Early Prostate Cancer programme at a median follow-up of 9.7 years. BJU Int. 2010 Apr;105(8):1074-81. doi: 10.1111/j.1464-410X.2010.09319.x.