Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT00672282 - Casodex vs Placebo in Non-Metastatic Early Prostate Cancer Phase 3
Recruiting NCT06202248 - A Study to Assess Alpha DaRT224 for the Treatment of Men With Non-metastatic Locally Recurrent Prostate Cancer N/A
Recruiting NCT01317043 - A Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy Phase 2
Completed NCT06204302 - An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States
Completed NCT00239291 - Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer Phase 1/Phase 2
Recruiting NCT04049747 - Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer N/A
Active, not recruiting NCT05617885 - Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer Phase 1/Phase 2
Completed NCT00657904 - Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer Phase 3