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| ID | Type | Description | Link |
|---|---|---|---|
| 7054IL/0023 |
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The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicalutamide | Drug | 150mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical progression | Throughout study period | |
| Overall patient survival | Throughout study period |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment failure | Throughout study period | |
| Serum prostate-specific antigen | Initial study period up to 2006 amended protocol | |
| Tolerability in terms of adverse events and laboratory parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William See | Medical College of Wisconsin | Principal Investigator |
| David G. McLeod | Walter Reed Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| 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 |
once daily |
|
| Throughout study period |
| Mobile |
| Alabama |
| United States |
| Research Site | Scottsdale | Arizona | United States |
| Research Site | Tucson | Arizona | United States |
| Research Site | Berkeley | California | United States |
| Research Site | Laguna Woods | California | United States |
| Research Site | Newport Beach | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | San Francisco | California | United States |
| Research Site | Santa Monica | California | United States |
| Research Site | Thousand Oaks | California | United States |
| Research Site | Torrance | California | United States |
| Research Site | Van Nuys | California | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Middlebury | Connecticut | United States |
| Research Site | New Haven | Connecticut | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Aventura | Florida | United States |
| Research Site | Bay Pines | Florida | United States |
| Research Site | Boca Raton | Florida | United States |
| Research Site | Daytona Beach | Florida | United States |
| Research Site | Fort Myers | Florida | United States |
| Research Site | Gainesville | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Ocala | Florida | United States |
| Research Site | Saint Augustine | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Fort Wayne | Indiana | United States |
| Research Site | Greenwood | Indiana | United States |
| Research Site | Iowa City | Iowa | United States |
| Research Site | Kansas City | Kansas | United States |
| Research Site | Louisville | Kentucky | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Greenbelt | Maryland | United States |
| Research Site | Rockville | Maryland | United States |
| Research Site | Burlington | Massachusetts | United States |
| Research Site | Newtown | Massachusetts | United States |
| Research Site | Ann Arbor | Michigan | United States |
| Research Site | Detroit | Michigan | United States |
| Research Site | Rochester | Minnesota | United States |
| Research Site | Hattiesburg | Mississippi | United States |
| Research Site | Jackson | Mississippi | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Omaha | Nebraska | United States |
| Research Site | Lebanon | New Hampshire | United States |
| Research Site | Albany | New York | United States |
| Research Site | Manhasset | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Syracuse | New York | United States |
| Research Site | The Bronx | New York | United States |
| Research Site | Asheville | North Carolina | United States |
| Research Site | Durham | North Carolina | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Lancaster | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Cordova | Tennessee | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | Danville | Virginia | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Virginia Beach | Virginia | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | Madison | Wisconsin | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| Research Site | Cheyenne | Wyoming | United States |
| Research Site | Calgary | Alberta | Canada |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Victoria | British Columbia | Canada |
| Research Site | Winnipeg | Manitoba | Canada |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | Kingston | Ontario | Canada |
| Research Site | London | Ontario | Canada |
| Research Site | North York | Ontario | Canada |
| Research Site | Oakville | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Québec | Canada |
| 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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