(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer

Non-Metastatic Prostate Cancer Clinical Trial

— Capri  

Official title:

A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673205
• Other study ID #: D6876C00024
• Secondary ID: 7054IL/0024
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2008
• Last updated: December 9, 2010
• Start date: September 1995
• Est. completion date: August 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyAustralia: National Health and Medical Research CouncilAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Ministry of Social Affairs, Public Health and the EnvironmentBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Direction Générale de la SantéFrance: French Data Protection AuthorityFrance: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesGermany: Federal Ministry of Food, Agriculture and Consumer ProtectionUnited Kingdom: Department of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceHungary: National Institute of PharmacyIreland: Ministry of HealthIsrael: The Israel National Institute for Health Policy Research and Health Services ResearchIsrael: Israeli Health Ministry Pharmaceutical AdministrationIsrael: Ministry of HealthItaly: Ministry of HealthItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyMexico: Federal Commission for Protection Against Health RisksMexico: Ministry of HealthMexico: National Council of Science and TechnologyMexico: National Institute of Public Health, Health SecretariatNetherlands: Dutch Health Care InspectorateNetherlands: Medicines Evaluation Board (MEB)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ministry of HealthPoland: Ministry of Science and Higher EducationPortugal: National Pharmacy and Medicines InstituteSouth Africa: Department of HealthSouth Africa: Medicines Control CouncilSpain: Ministry of HealthSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3588
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Non-Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Bicalutamide
150mg p.o. daily
• Placebo

Locations

Country	Name	City	State
Australia	Research Site	East Melbourne	Victoria
Australia	Research Site	Wooloongabba	Queensland
Austria	Research Site	Graz
Austria	Research Site	Linz
Austria	Research Site	Mistelbach
Austria	Research Site	Oberwart
Austria	Research Site	St. Polten
Belgium	Research Site	Antwerpen
Belgium	Research Site	Brugge
Belgium	Research Site	Brussels
Belgium	Research Site	Gent
Belgium	Research Site	Kortrijk
Belgium	Research Site	Leuven
Belgium	Research Site	Mons
Belgium	Research Site	Oostende
Belgium	Research Site	Seraing
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Praha 4
Czech Republic	Research Site	Praha 5
Germany	Research Site	Berlin
Germany	Research Site	Bonn
Germany	Research Site	Dresden
Germany	Research Site	Freiburg
Germany	Research Site	Heidelberg
Germany	Research Site	Jena
Germany	Research Site	Lubeck
Germany	Research Site	Ludenscheid
Germany	Research Site	Mannheim
Germany	Research Site	Munchen
Germany	Research Site	Regensburg
Germany	Research Site	Sigmaringen
Hungary	Research Site	Budapest
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyiregyhaza
Ireland	Research Site	Dublin 4
Ireland	Research Site	Dublin 7
Israel	Research Site	Haifa
Israel	Research Site	Petach Tikva
Israel	Research Site	Tel-aviv
Israel	Research Site	Tel-hashomer
Italy	Research Site	Anagni	FR
Italy	Research Site	Bari	BA
Italy	Research Site	Belluno	BL
Italy	Research Site	Bergamo	BG
Italy	Research Site	Bologna	BO
Italy	Research Site	Brescia	BS
Italy	Research Site	Carpi	MO
Italy	Research Site	Cesena	FO
Italy	Research Site	Como	CO
Italy	Research Site	Dolo	VE
Italy	Research Site	Fidenza	PR
Italy	Research Site	Portogruaro	VE
Italy	Research Site	Roma
Italy	Research Site	Siena	SI
Italy	Research Site	Torino	TO
Italy	Research Site	Treviso	TV
Italy	Research Site	Udine	UD
Italy	Research Site	Varese	VA
Mexico	Research Site	Mexico
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Breda
Netherlands	Research Site	Capelle A/d Ijssel
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Enschede
Netherlands	Research Site	Gouda
Netherlands	Research Site	Heerlen
Netherlands	Research Site	Maastricht
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Roosendaal
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Spijkenisse
Netherlands	Research Site	Utrecht
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Portugal	Research Site	Almada
Portugal	Research Site	Coimbra
Portugal	Research Site	Lisboa
Portugal	Research Site	Porto
Portugal	Research Site	Vila Nova de Gaia
South Africa	Research Site	Bloemfontein
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	George
South Africa	Research Site	Johannesburg
South Africa	Research Site	Pietermarizberg
South Africa	Research Site	Pretoria
South Africa	Research Site	Somerset West	Cape Town
Spain	Research Site	A Coruna	Galicia
Spain	Research Site	Alcala de Henares	Comunidad de Madrid
Spain	Research Site	Badalona(barcelona)	Cataluna
Spain	Research Site	Barcelona	Cataluna
Spain	Research Site	Bilbao	Pais Vasco
Spain	Research Site	Getafe	Comunidad de Madrid
Spain	Research Site	Granada	Andalucia
Spain	Research Site	Guadalajara	Castilla La Mancha
Spain	Research Site	Hospitalet de Llobregat(barcel	Cataluna
Spain	Research Site	Madrid	Comunidad de Madrid
Spain	Research Site	Malaga	Andalucia
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Pamplona	Navarra
Spain	Research Site	Salamanca	Castilla Leon
Spain	Research Site	San Juan(alicante)	Comunidad Valenciana
Spain	Research Site	Sevilla	Andalucia
Spain	Research Site	Valencia	Comunidad Valenciana
Spain	Research Site	Vigo(pontevedra)	Galicia
United Kingdom	Research Site	Barnet	Hertfordshire
United Kingdom	Research Site	Belfast	Northern Ireland
United Kingdom	Research Site	Birmingham	West Midlands
United Kingdom	Research Site	Bolton
United Kingdom	Research Site	Bristol
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Cleveland
United Kingdom	Research Site	Colchester	Essex
United Kingdom	Research Site	Eastbourne	Sussex
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Falkirk
United Kingdom	Research Site	Gwent	South Wales
United Kingdom	Research Site	Hull
United Kingdom	Research Site	Kent
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Plymouth
United Kingdom	Research Site	Reading	Berkshire
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Shrewsbury
United Kingdom	Research Site	Taunton	Somerset
United Kingdom	Research Site	Tooting	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Czech Republic,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Mexico,  Netherlands,  Poland,  Portugal,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical progression		Throughout study period	No
Primary	Tolerability in terms of adverse events and laboratory parameters		Throughout study period	Yes
Secondary	Survival		Throughout study period	No
Secondary	Time to treatment failure		Throughout study period	No
Secondary	Prostate-specific antigen		Initial study period up to 2005 amended protocol	No