Prostate Cancer Clinical Trial

An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

Summary

The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival.

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Full Description

This is a randomized, double-blind, placebo-controlled, multicenter study of apalutamide plus GnRH agonist compared with GnRH agonist among participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT). The study will include a Screening Phase, Treatment Phase, a Posttreatment Phase, and a Long-term Follow-up Phase. Participants will either receive either apalutamide (experimental) or bicalutamide 50 milligram (mg) capsule plus placebo as control group. Safety will be monitored throughout the study.

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Eligibility Criteria

Inclusion Criteria:

Age >= 18 years
Indicated and planned to receive primary radiation therapy for prostate cancer
Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score >=8 and >=cT2c, 2) Gleason score >=7, PSA >=20 nanogram per milliliters (ng/mL), and >=cT2c
Charlson index (CCI) <=3
An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1
Adequate organ function: (1) aspartate aminotransferase (AST), alanine aminotransferase (ALT), within normal limits (WNL), (2) serum creatinine less than (<) 1.5 milligram/deciliter (mg/dL) (<133 micromolesLiter [mcmolL]), (3) platelets greater than or equal to (>=)140,000/microLiter (mcL), independent of transfusion and/or growth factors within 3 months prior to randomization, (4) Hemoglobin >= 12.0 gram/deciliter (g/dL) (7.4 millimloes [mmol], independent of transfusion and/or growth factors within 3 months prior to randomization
Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
Signed, written, informed consent
Be able to swallow whole study drug tablets

Exclusion Criteria: -

Presence of distant metastasis, (clinical stage M1). Isolated pelvic nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Patients are considered eligible only if the central radiological review confirms clinical stage M0.
Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen or both for >3 months prior to randomization
Bilateral orchiectomy
History of pelvic radiation
Prior systemic (example [e.g.], chemotherapy) or local (e.g. radical prostatectomy, cryotherapy) treatment for prostate cancer
History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness <= 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents (including cyproterone acetate) for prostate cancer
Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy (e.g., sipuleucel-T) for prostate cancer
Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study
Use of 5-alpha reductase inhibitors (e.g., dutasteride, finasteride) <=4 weeks prior to randomization
Use of any investigational agent <=4 weeks prior to randomization
Current chronic use of opioid analgesics for >=3 weeks for oral or >7 days for non-oral formulations
Major surgery <=4 weeks prior to randomization
Current or prior treatment with anti-epileptic medications for the treatment of seizures
Gastrointestinal conditions affecting absorption
Known or suspected contraindications or hypersensitivity to apalutamide, bicalutamide or GnRH agonists or any of the components of the formulations
Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1503

Study ID:

NCT02531516

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

Chandler Arizona, , United States

Scottsdale Arizona, , United States

Tucson Arizona, , United States

Bakersfield California, , United States

Los Angeles California, , United States

Orange California, , United States

San Bernardino California, , United States

San Diego California, , United States

San Francisco California, , United States

Aurora Colorado, , United States

Denver Colorado, , United States

Middlebury Connecticut, , United States

Bradenton Florida, , United States

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Fort Myers Florida, , United States

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Naples Florida, , United States

Plantation Florida, , United States

Meridian Idaho, , United States

Evergreen Park Illinois, , United States

Harvey Illinois, , United States

Jeffersonville Indiana, , United States

Wichita Kansas, , United States

Ashland Kentucky, , United States

New Orleans Louisiana, , United States

Shreveport Louisiana, , United States

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Boston Massachusetts, , United States

Saint Louis Missouri, , United States

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New York New York, , United States

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Portland Oregon, , United States

Springfield Oregon, , United States

Bala-Cynwyd Pennsylvania, , United States

Bryn Mawr Pennsylvania, , United States

Lancaster Pennsylvania, , United States

Philadelphia Pennsylvania, , United States

East Greenwich Rhode Island, , United States

Charleston South Carolina, , United States

Myrtle Beach South Carolina, , United States

Nashville Tennessee, , United States

Dallas Texas, , United States

Houston Texas, , United States

San Antonio Texas, , United States

Fairfax Virginia, , United States

Virginia Beach Virginia, , United States

Burien Washington, , United States

Spokane Washington, , United States

Morgantown West Virginia, , United States

C.a.b.a. , , Argentina

Caba , , Argentina

Ciudad Autonoma de Buenos Aires , , Argentina

Ciudad Autónoma de Buenos Aires , , Argentina

Pergamino , , Argentina

Rosario , , Argentina

San Salvador De Jujuy , , Argentina

Aalst , , Belgium

Bonheiden , , Belgium

Brussel , , Belgium

Haine-St-Paul , , Belgium

Leuven , , Belgium

Liège , , Belgium

Namur , , Belgium

Roeselare , , Belgium

Sint-Niklaas , , Belgium

Turnhout , , Belgium

Wilrijk , , Belgium

Barretos , , Brazil

Belo Horizonte , , Brazil

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Natal , , Brazil

Porto Alegre , , Brazil

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Rio de Janeiro , , Brazil

Salvador , , Brazil

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São Paulo , , Brazil

Calgary Alberta, , Canada

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London Ontario, , Canada

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Quebec , , Canada

Beijing , , China

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Hangzhou , , China

Nanchang , , China

NanJing , , China

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Wuhan , , China

Xi'An , , China

Hradec Králove , , Czechia

Liberec , , Czechia

Nový Jicin , , Czechia

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Opava , , Czechia

Pardubice , , Czechia

Praha 10 , , Czechia

Praha 2 , , Czechia

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Praha 8 , , Czechia

Zlin , , Czechia

Amiens , , France

Angers Cedex 02 , , France

Avignon Cedex 9 , , France

Bayonne , , France

Besancon , , France

Bordeaux , , France

Brest , , France

Dijon , , France

Hyères , , France

La Tronche , , France

Le Mans , , France

Lille , , France

Marseille cedex 05 , , France

Marseilli , , France

Montpellier , , France

Neuilly-sur-Seine , , France

Paris , , France

Ris Orangis , , France

Saint Herblain , , France

Saint-Brieuc , , France

Saint-Mandé , , France

Saint-Priest-en-Jarez , , France

Strasbourg , , France

Toulouse , , France

Tours , , France

Vandoeuvre-les-Nancy , , France

Villejuif Cedex , , France

Braunschweig , , Germany

Chemnitz , , Germany

Dessau , , Germany

Frankfurt , , Germany

Gronau , , Germany

Jena , , Germany

Münster , , Germany

Nürtingen , , Germany

Ulm , , Germany

Weiden , , Germany

Beer Yaakov , , Israel

Beer-Sheva , , Israel

Haifa , , Israel

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Petach-Tikva , , Israel

Ramat-Gan , , Israel

Tel-Aviv , , Israel

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Seoul , , Korea, Republic of

Georgetown , , Malaysia

Kuala Lumpur , , Malaysia

Kuching , , Malaysia

Putrajaya , , Malaysia

Culiacan , , Mexico

Guadalajara , , Mexico

Leon , , Mexico

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Morelia , , Mexico

Zapopan , , Mexico

Alkmaar , , Netherlands

Amsterdam , , Netherlands

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Nijmegen , , Netherlands

Rotterdam , , Netherlands

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Bydgoszcz , , Poland

Gdynia , , Poland

Gliwice , , Poland

Kielce , , Poland

Lodz , , Poland

Olsztyn , , Poland

Poznan , , Poland

Walbrzych , , Poland

Bucuresti , , Romania

Cluj-Napoca , , Romania

Floresti , , Romania

Iasi , , Romania

Otopeni , , Romania

Ploiesti , , Romania

Sibiu , , Romania

Targu Mures , , Romania

Timisoara , , 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

Saint-Petersburg , , Russian Federation

Saransk , , Russian Federation

St Petersburg , , Russian Federation

Tambov , , Russian Federation

Tyumen , , Russian Federation

Ufa , , Russian Federation

Vologda , , Russian Federation

Barakaldo , , Spain

Barcelona , , Spain

Castellon , , Spain

Hospitalet de Llobregat , , Spain

Las Palmas de Gran Canaria , , Spain

Madrid , , Spain

Málaga , , Spain

Reus , , Spain

Santiago de Compostela , , Spain

Sevilla , , Spain

Stockholm , , Sweden

Umeå , , Sweden

Örebro , , Sweden

Kaohsiung , , Taiwan

Taichung , , Taiwan

Tainan , , Taiwan

Taipei City , , Taiwan

Taipei , , Taiwan

Taoyuan , , Taiwan

Adana , , Turkey

Ankara , , Turkey

Edirne , , Turkey

Istanbul , , Turkey

Izmir , , Turkey

Kayseri , , Turkey

Kocaeli , , Turkey

Dnipro , , Ukraine

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Kyiv , , Ukraine

Lviv , , Ukraine

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Bristol , , United Kingdom

Derby , , United Kingdom

Glasgow , , United Kingdom

Oxford , , United Kingdom

Plymouth , , United Kingdom

Preston , , United Kingdom

Sheffield , , United Kingdom

Sutton , , United Kingdom

Wolverhampton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1503

Study ID:

NCT02531516

Recruitment Status:

Active, not recruiting

Sponsor:


Aragon Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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