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| ID | Type | Description | Link |
|---|---|---|---|
| 7054IL/0024 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicalutamide | Drug | 150mg p.o. daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical progression | Throughout study period | |
| Tolerability in terms of adverse events and laboratory parameters | Throughout study period |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Throughout study period | |
| Time to treatment failure | Throughout study period | |
| Prostate-specific antigen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manfred P Wirth, Professor | Technische Universität Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Wooloongabba | Queensland | Australia | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22129214 | Derived | 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. |
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| Placebo |
| Drug |
|
| Initial study period up to 2005 amended protocol |
| East Melbourne |
| Victoria |
| Australia |
| Research Site | Graz | Austria |
| Research Site | Linz | Austria |
| Research Site | Mistelbach | Austria |
| Research Site | Oberwart | Austria |
| Research Site | Sankt Pölten | Austria |
| Research Site | Antwerp | Belgium |
| Research Site | Bruges | Belgium |
| Research Site | Brussels | Belgium |
| Research Site | Ghent | Belgium |
| Research Site | Kortrijk | Belgium |
| Research Site | Leuven | Belgium |
| Research Site | Mons | Belgium |
| Research Site | Ostend | Belgium |
| Research Site | Seraing | Belgium |
| Research Site | Brno | Czechia |
| Research Site | Hradec Králové | Czechia |
| Research Site | Olomouc | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Berlin | Germany |
| Research Site | Bonn | Germany |
| Research Site | Dresden | Germany |
| Research Site | Freiburg im Breisgau | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Jena | Germany |
| Research Site | Lübeck | Germany |
| Research Site | Lüdenscheid | Germany |
| Research Site | Mannheim | Germany |
| Research Site | München | Germany |
| Research Site | Regensburg | Germany |
| Research Site | Sigmaringen | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Miskolc | Hungary |
| Research Site | Nyíregyháza | Hungary |
| Research Site | Dublin | Ireland |
| Research Site | Haifa | Israel |
| Research Site | Petah Tikva | Israel |
| Research Site | Tel Aviv | Israel |
| Research Site | Tel Litwinsky | Israel |
| Research Site | Bari | BA | Italy |
| Research Site | Bergamo | BG | Italy |
| Research Site | Belluno | BL | Italy |
| Research Site | Bologna | BO | Italy |
| Research Site | Brescia | BS | Italy |
| Research Site | Como | CO | Italy |
| Research Site | Cesena | FO | Italy |
| Research Site | Anagni | FR | Italy |
| Research Site | Carpi | MO | Italy |
| Research Site | Fidenza | PR | Italy |
| Research Site | Roma | 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 | Italy |
| Research Site | Dolo | VE | Italy |
| Research Site | Portogruaro | VE | Italy |
| Research Site | México | Mexico |
| Research Site | Amsterdam | Netherlands |
| Research Site | Breda | Netherlands |
| Research Site | Capelle aan den 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 | Netherlands |
| Research Site | Warsaw | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Almada | Portugal |
| Research Site | Coimbra | Portugal |
| Research Site | Lisbon | Portugal |
| Research Site | Porto | Portugal |
| Research Site | Vila Nova de Gaia | Portugal |
| Research Site | Somerset West | Cape Town | South Africa |
| Research Site | Bloemfontein | South Africa | 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 | Granada | Andalusia | Spain |
| Research Site | Málaga | Andalusia | Spain |
| Research Site | Seville | Andalusia | Spain |
| Research Site | Bilbao | Basque Country | Spain |
| Research Site | Salamanca | Castille and León | Spain |
| Research Site | Guadalajara | Castille-La Mancha | Spain |
| Research Site | Badalona(barcelona) | Catalonia | Spain |
| Research Site | Barcelona | Catalonia | Spain |
| Research Site | Hospitalet de Llobregat(barcel | Catalonia | Spain |
| Research Site | A Coruña | Galicia | Spain |
| Research Site | Vigo(pontevedra) | Galicia | Spain |
| Research Site | Alcalá de Henares | Madrid | Spain |
| Research Site | Getafe | Madrid | Spain |
| Research Site | Madrid | Madrid | Spain |
| Research Site | Pamplona | Navarre | Spain |
| Research Site | Oviedo | Principality of Asturias | Spain |
| Research Site | San Juan(alicante) | Valencia | Spain |
| Research Site | Valencia | Valencia | Spain |
| Research Site | Reading | Berkshire | United Kingdom |
| Research Site | Colchester | Essex | United Kingdom |
| Research Site | Barnet | Hertfordshire | United Kingdom |
| Research Site | Tooting | London | United Kingdom |
| Research Site | Belfast | Northern Ireland | United Kingdom |
| Research Site | Taunton | Somerset | United Kingdom |
| Research Site | Gwent | South Wales | United Kingdom |
| Research Site | Eastbourne | Sussex | 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 | Edinburgh | United Kingdom |
| Research Site | Falkirk | 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 | Sheffield | United Kingdom |
| Research Site | Shrewsbury | United Kingdom |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C053541 | bicalutamide |
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