Prostate Cancer Clinical Trial
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
Summary
The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.
Full Description
This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, multinational, multicenter study of apalutamide in participants with mHSPC. The study consists of 4 Phases: Screening Phase (up to 28 days before randomization), Treatment Phase (28 day treatment cycles until disease progression or the occurrence of unacceptable treatment related toxicity), an End of Treatment Phase (until 30 days after the last dose of study drug), and then a Survival Follow up Phase. In the event of a positive study result and notification of unblinding at either of the interim analyses or at the final analysis, participants in the treatment Phase will have the opportunity to enroll in an Open-label Extension Phase, which will allow participants to receive active drug (apalutamide) for approximately 3 years. Participants who are receiving apalutamide in the Open-label Extension Phase may continue receiving apalutamide in the Long-term Extension (LTE) Phase if they will continue to derive benefit from treatment (based on investigator assessment). Participants' safety will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of prostate adenocarcinoma as confirmed by the investigator
Metastatic disease documented by greater than or equal to (>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel <=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization
Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (<=) 6 months of ADT prior to randomization
Allowed prior treatments for localized prostate cancer (all treatments must have been completed >= 1 year prior to randomization) a) <= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies
Exclusion Criteria:
Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
Known brain metastases
Lymph nodes as only sites of metastases
Visceral (ie, liver or lung) metastases as only sites of metastases
Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
Prior treatment with other next generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
History of seizures or medications known to lower seizure threshold
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There is 1 Location for this study
Homewood Alabama, , United States
Tucson Arizona, , United States
San Bernardino California, , United States
San Diego California, , United States
Denver Colorado, , United States
Norwalk Connecticut, , United States
Fort Myers Florida, , United States
Chicago Illinois, , United States
Fort Wayne Indiana, , United States
Jeffersonville Indiana, , United States
New Orleans Louisiana, , United States
Baltimore Maryland, , United States
Rockville Maryland, , United States
Lansing Michigan, , United States
Troy Michigan, , United States
Omaha Nebraska, , United States
Las Vegas Nevada, , United States
Bronx New York, , United States
Brooklyn New York, , United States
Poughkeepsie New York, , United States
Syracuse New York, , United States
Raleigh North Carolina, , United States
Salisbury North Carolina, , United States
Cleveland Ohio, , United States
Middleburg Heights Ohio, , United States
Springfield Oregon, , United States
Bala-Cynwyd Pennsylvania, , United States
Bryn Mawr Pennsylvania, , United States
Lancaster Pennsylvania, , United States
Charleston South Carolina, , United States
Nashville Tennessee, , United States
Dallas Texas, , United States
Houston Texas, , United States
San Antonio Texas, , United States
Salt Lake City Utah, , United States
Richmond Virginia, , United States
Virginia Beach Virginia, , United States
Burien Washington, , United States
Spokane Washington, , United States
Milwaukee Wisconsin, , United States
Berazategui , , Argentina
C.a.b.a. , , Argentina
Capital Federal , , Argentina
Ciudad Automoma Buenos Aires , , Argentina
Ciudad Autonoma de Buenos Aires , , Argentina
Ciudad De Buenos Aires , , Argentina
Cordoba , , Argentina
La Plata , , Argentina
Pergamino , , Argentina
Rosario , , Argentina
San Miguel de Tucuman , , Argentina
San Salvador de Jujuy , , Argentina
Albury , , Australia
Elizabeth Vale , , Australia
Kogarah , , Australia
Port Macquarie , , Australia
South Brisbane , , Australia
St Leonards , , Australia
Barretos , , Brazil
Florianopolis , , Brazil
Goiania , , Brazil
Ijui , , Brazil
Natal , , Brazil
Ribeirao Preto , , Brazil
Rio de Janeiro , , Brazil
Salvador , , Brazil
Santo André , , Brazil
Sao Paulo , , Brazil
Sorocaba , , Brazil
São Paulo , , Brazil
Calgary Alberta, , Canada
Vancouver British Columbia, , Canada
Hamilton Ontario, , Canada
Kingston Ontario, , Canada
Toronto Ontario, , Canada
Quebec , , Canada
Beijing , , China
ChengDu , , China
ChongQing , , China
Fuzhou , , China
Guangzhou , , China
Hangzhou , , China
NanJing , , China
ShangHai , , China
Suzhou , , China
WuHan , , China
Xi'An , , China
Hradec Králove , , Czechia
Liberec , , Czechia
Nový Jicin , , Czechia
Olomouc , , Czechia
Opava , , Czechia
Pardubice , , Czechia
Praha 10 , , Czechia
Praha 2 , , Czechia
Praha 4 , , Czechia
Praha 5 , , Czechia
Praha 8 , , Czechia
Zlin , , Czechia
Clermont Ferrand , , France
Montpellier , , France
Nancy , , France
Paris , , France
Pierre Bénite , , France
Strasbourg , , France
Suresnes , , France
Bonn , , Germany
Braunschweig , , Germany
Hamburg , , Germany
Hannover , , Germany
Leipzig , , Germany
Lubeck , , Germany
Lutherstadt Eisleben , , Germany
Nürtingen , , Germany
Sindelfingen , , Germany
Straubing , , Germany
Budapest , , Hungary
Győr , , Hungary
Pécs , , Hungary
Sopron , , Hungary
Beer Sheva , , Israel
Haifa , , Israel
Holon , , Israel
Kfar Saba , , Israel
Petach Tikva , , Israel
Ramat Gan , , Israel
Zrifin , , Israel
Chuo-ku, Chiba-City, , , Japan
Hakata-Ku , , Japan
Koshigaya , , Japan
Matsuyama , , Japan
Minami-Ku, Sagamihara-Shi , , Japan
Miyazaki , , Japan
Nagano-shi , , Japan
Nagasaki-shi , , Japan
Osaka-Sayama-shi , , Japan
Osaka , , Japan
Sakura , , Japan
Sapporo , , Japan
Yokohama , , Japan
Yufu , , Japan
Daegu , , Korea, Republic of
Daejeon , , Korea, Republic of
Goyang-Si , , Korea, Republic of
Jeollanam-do , , Korea, Republic of
Seongnam-si , , Korea, Republic of
Seoul , , Korea, Republic of
Ciudad de México , , Mexico
Durango , , Mexico
Guadalajara , , Mexico
Leon , , Mexico
Mexico City , , Mexico
Mexico , , Mexico
Morelia , , Mexico
Zapopan , , Mexico
Bialystok , , Poland
Bydgoszcz , , Poland
Krakow , , Poland
Kutno , , Poland
Lodz , , Poland
Lublin , , Poland
Siedlce , , Poland
Sochaczew , , Poland
Warszawa , , Poland
Wroclaw , , Poland
Bucharest , , Romania
Cluj Napoca , , Romania
Craiova , , Romania
Targu Mures , , Romania
Barnaul , , Russian Federation
Ivanovo , , Russian Federation
Moscow , , Russian Federation
Nizhny Novgorod , , Russian Federation
Obninsk , , Russian Federation
Omsk , , Russian Federation
Pyatigorsk , , Russian Federation
Rostov-on-Don , , Russian Federation
Ryazan , , Russian Federation
Saint-Petersburg , , Russian Federation
Saransk , , Russian Federation
Sochi , , Russian Federation
St Petersburg , , Russian Federation
Tambov , , Russian Federation
Tomsk , , Russian Federation
Tyumen , , Russian Federation
Ufa , , Russian Federation
Vologda , , Russian Federation
Barcelona , , Spain
Cordoba , , Spain
Jerez de la Frontera , , Spain
Madrid , , Spain
Pamplona , , Spain
Göteborg , , Sweden
Malmö , , Sweden
Stockholm , , Sweden
Umeå , , Sweden
Uppsala , , Sweden
Växjö , , Sweden
Örebro , , Sweden
Ankara , , Turkey
Edirne , , Turkey
Istanbul , , Turkey
Izmir , , Turkey
Mersin , , Turkey
Cherkasy , , Ukraine
Dnipo , , Ukraine
Dnipro , , Ukraine
Ivano-Frankivsk , , Ukraine
Khakhiv , , Ukraine
Kharkiv , , Ukraine
Khmelnytsky , , Ukraine
Kyiv , , Ukraine
Lviv , , Ukraine
Odesa , , Ukraine
Poltava , , Ukraine
Uzhgorod , , Ukraine
Vinnitsa , , Ukraine
Zaporizhzhya , , Ukraine
Carlisle , , United Kingdom
Dundee , , United Kingdom
Glasgow , , United Kingdom
London , , United Kingdom
Newcastle Upon Tyne , , United Kingdom
Oxford , , United Kingdom
Plymouth , , United Kingdom
Scunthorpe , , United Kingdom
Stockton on Tees , , United Kingdom
Wolverhampton , , United Kingdom
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