A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC (LIBERTAS)
Last Updated August 15, 2024
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CR109327
OVERVIEW
-
Age
years -
Phase
phase 33 -
Sites
Sites -
Status
Recruiting
SUMMARY
The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level < 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.
CONDITIONS
- Metastatic Castrate-sensitive Prostate Cancer
ELIGIBILITY
Inclusion Criteria:
* Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
* Metastatic prostate cancer disease documented by conventional imaging (example, computed tomography [CT], magnetic resonance imagi
DETAILS
LOCATIONS
Locations in:
United States, Australia, Brazil, Canada, China, France, Germany, Mexico, Poland
| Country (9) | City or Province (90) | Status |
| United States | Homewood Urology Centers Of Alabama |
RECRUITING
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| United States | Tucson Arizona Urology Specialists |
RECRUITING
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| United States | Little Rock Arkansas Urology |
RECRUITING
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| United States | Santa Barbara Sansum Clinic Pharm |
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| United States | Lakewood Colorado Clinical Research |
RECRUITING
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| United States | Daytona Beach Advanced Urology Institute |
RECRUITING
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| United States | Chicago Ridge Associated Urological Specialists LLC |
RECRUITING
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| United States | Joliet Advanced Urology Associates |
RECRUITING
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| United States | Greenwood Urology of Indiana |
RECRUITING
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| United States | Jeffersonville First Urology, PSC |
RECRUITING
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| United States | Silver Spring Maryland Oncology Hematology P A |
RECRUITING
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| United States | Towson Chesapeake Urology Research Associates |
RECRUITING
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| United States | Troy Michigan Institute of Urology |
RECRUITING
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| United States | Basking Ridge MSKCC Basking Ridge |
RECRUITING
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| United States | Middletown MSKCC Monmouth |
RECRUITING
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| United States | Montvale MSKCC Bergen |
RECRUITING
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| United States | Commack MSKCC Commack |
RECRUITING
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| United States | Harrison MSKCC Westchester |
RECRUITING
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| United States | New York Columbia University Medical Center |
RECRUITING
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| United States | New York Memorial Sloan Kettering Cancer Center |
RECRUITING
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| United States | Syracuse Associated Medical Professionals |
RECRUITING
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| United States | Uniondale MSKCC Nassau Regional Cancer Center |
RECRUITING
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| United States | Cincinnati TriState Urologic Services PSC Inc. DBA The Urology Group |
RECRUITING
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| United States | Gahanna Central Ohio Urology Group |
RECRUITING
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| United States | Middleburg Heights Helios Clinical Research, LLC |
RECRUITING
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| United States | Tigard Northwest Cancer Specialists PC |
RECRUITING
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| United States | Bala-Cynwyd Centers for Advanced Urology LLC d b a MidLantic Urology |
RECRUITING
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| United States | Pittsburgh University of Pittsburgh Medical Center |
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| United States | Pittsburgh VA Pittsburgh |
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| United States | Germantown The Conrad Pearson Clinic |
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| United States | Nashville Urology Associates |
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| United States | Austin Texas Oncology P A |
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| United States | Dallas Parkland Health and Hospital System |
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| United States | Dallas UT Southwestern Medical Center |
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| United States | Houston Houston Metro Urology |
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| United States | San Antonio Texas Oncology San Antonio Northeast |
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| United States | Salt Lake City University of Utah Huntsman Cancer Institute |
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| United States | Norfolk Virginia Oncology Associates |
RECRUITING
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| United States | Roanoke Oncology and Hematology Associates of Southwest Virginia, Inc. |
RECRUITING
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| United States | Virginia Beach Urology Of Virginia, Pllc |
RECRUITING
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| Australia | Macquarie University Macquarie University Hospital |
RECRUITING
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| Australia | Melbourne Peter MacCallum Cancer Centre |
RECRUITING
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| Australia | South Brisbane Mater Misericordiae Hospital |
RECRUITING
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| Brazil | Barretos Fundacao Pio XII |
RECRUITING
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| Brazil | Belo Horizonte Hospital das Clínicas - Universidade Federal de Minas Gerais |
RECRUITING
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| Brazil | Rio de Janeiro Ministerio da Saude Instituto Nacional do Cancer |
RECRUITING
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| Brazil | Salvador Instituto D Or de Pesquisa e Ensino |
RECRUITING
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| Brazil | São Paulo Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo |
RECRUITING
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| Canada | Calgary Southern Alberta Institute of Urology / Prostate Cancer Centre |
RECRUITING
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| Canada | Halifax Nova Scotia Health Authority |
RECRUITING
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| Canada | Toronto Sunnybrook Health Sciences Center |
RECRUITING
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| Canada | Toronto Princess Margaret Hospital |
RECRUITING
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| Canada | Quebec CHU de Quebec Universite Laval Hopital de l Enfant Jesus |
RECRUITING
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| China | Changchun The First Hospital of Jilin University |
RECRUITING
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| China | Chengdu West China School of Medicine/West China Hospital, Sichuan University |
RECRUITING
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| China | Guangzhou Nanfang Hospital of Southern Medical Hospital |
RECRUITING
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| China | Jinan Shandong Provincial Hospital |
RECRUITING
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| China | Ningbo Ningbo First Hospital |
RECRUITING
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| China | Shenyang Shengjing Hospital Of China Medical University |
RECRUITING
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| China | Wuhan TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology |
RECRUITING
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| China | XI An The First Affiliated Hospital of Xian Jiaotong University |
RECRUITING
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| France | Bordeaux Institut Bergonie |
RECRUITING
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| France | Lyon Centre Leon Berard |
RECRUITING
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| France | Paris Hopital Cochin |
RECRUITING
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| France | Rennes Chu Rennes Hopital Pontchaillou |
RECRUITING
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| France | Villejuif Cedex Gustave Roussy |
RECRUITING
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| Germany | Aachen Universitaetsklinikum der RWTH Aachen |
RECRUITING
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| Germany | Augsburg Klinikum Augsburg |
RECRUITING
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| Germany | Dresden Universitaetsklinikum Carl Gustav Carus TU Dresden |
RECRUITING
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| Germany | Koeln Universitaetsklinikum Koelnt |
RECRUITING
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| Germany | Lubeck Universitatsklinikum Schleswig Holstein Campus Lubeck |
RECRUITING
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| Germany | Muenchen Klinikum rechts der Isar - der Technischen Universität München |
RECRUITING
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| Germany | Nuertingen Studienpraxis Urologie Nurtingen |
RECRUITING
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| Germany | Würzburg Universitatsklinikum Wurzburg |
RECRUITING
|
| Mexico | Chihuahua SCIENTIA Investigacion Clinica SC |
RECRUITING
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| Mexico | Durango Consultorio de Especialidad en Urologia Privado |
RECRUITING
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| Mexico | Merida Medical Care & Research SA de CV |
RECRUITING
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| Mexico | Queretaro Cuidados Oncologicos |
RECRUITING
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| Poland | Bydgoszcz Centrum Onkologii im. Prof. F. Lukaszczyka |
RECRUITING
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| Poland | Koszalin Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie |
RECRUITING
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| Poland | Warszawa Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy |
RECRUITING
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| Poland | Warszawa Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. |
RECRUITING
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| Poland | Wroclaw Specjalistyczna przychodnia lekarska POLIMED |
RECRUITING
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| United States | Dallas Texas Oncology P A |
RECRUITING
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| United States | Houston Texas Oncology P A |
RECRUITING
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| United States | Wichita Falls Texas Oncology P A |
RECRUITING
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| Brazil | Natal Liga Norte Riograndense Contra O Cancer |
RECRUITING
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| Brazil | Santo André CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia |
RECRUITING
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| China | Beijing Peking University First Hospital |
COMPLETED
|
| China | Guangzhou The First Affiliated Hospital Sun Yat sen University |
COMPLETED
|
Geo Locations
33.47177, -86.80082
32.22174, -110.92648
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-5.795, -35.20944
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39.9075, 116.39723
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