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.

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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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1052

Study ID:

NCT02489318

Recruitment Status:

Active, not recruiting

Sponsor:

Aragon Pharmaceuticals, Inc.

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There is 1 Location for this study

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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

Florianópolis , , Brazil

Goiânia , , 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

Wuxi , , 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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1052

Study ID:

NCT02489318

Recruitment Status:

Active, not recruiting

Sponsor:


Aragon Pharmaceuticals, Inc.

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