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.
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.
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 micromoles/Liter [mcmol/L]), (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
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There is 1 Location for this study
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
Daytona Beach Florida, , United States
Fort Myers Florida, , United States
Hialeah Florida, , United States
Lakewood Ranch Florida, , United States
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
Scarborough Maine, , United States
Baltimore Maryland, , United States
Boston Massachusetts, , United States
Saint Louis Missouri, , United States
Morristown New Jersey, , United States
Albany New York, , United States
Bronx New York, , United States
Brooklyn New York, , United States
New York New York, , United States
Poughkeepsie New York, , United States
Rochester New York, , United States
Syracuse New York, , United States
Cary North Carolina, , United States
Raleigh North Carolina, , United States
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
Campinas , , Brazil
Curitiba , , Brazil
Florianopolis , , Brazil
Goiania , , Brazil
Ijui , , Brazil
Natal , , Brazil
Porto Alegre , , Brazil
Ribeirao Preto , , Brazil
Rio de Janeiro , , Brazil
Salvador , , Brazil
Santo André , , Brazil
Sao Jose do Rio Preto , , Brazil
Sao Paulo , , Brazil
Sorocaba , , Brazil
São Paulo , , Brazil
Calgary Alberta, , Canada
Surrey British Columbia, , Canada
Vancouver British Columbia, , Canada
Victoria British Columbia, , Canada
London Ontario, , Canada
Ottawa Ontario, , Canada
Toronto Ontario, , Canada
Gatineau Quebec, , Canada
Laval Quebec, , Canada
Montreal Quebec, , Canada
Montréal Quebec, , Canada
Sherbrooke Quebec, , Canada
Quebec , , Canada
Beijing , , China
ChengDu , , China
ChongQing , , China
GuangZhou , , China
Hangzhou , , China
Nanchang , , China
NanJing , , China
Ningbo , , China
ShangHai , , 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
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
Évry-Courcouronnes , , 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
Jerusalem , , Israel
Kfar Saba , , Israel
Petach-Tikva , , Israel
Ramat-Gan , , Israel
Tel-Aviv , , Israel
Daegu , , Korea, Republic of
Gyeonggi-do , , Korea, Republic of
Jeollanam-do , , Korea, Republic of
Seoul , , Korea, Republic of
Georgetown , , Malaysia
Kuala Lumpur , , Malaysia
Kuching , , Malaysia
Putrajaya , , Malaysia
Culiacan , , Mexico
Guadalajara , , Mexico
Leon , , Mexico
Mexico , , Mexico
Morelia , , Mexico
Zapopan , , Mexico
Alkmaar , , Netherlands
Amsterdam , , Netherlands
Den Haag , , Netherlands
Nijmegen , , Netherlands
Rotterdam , , Netherlands
Bialystok , , Poland
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
Khakhiv , , Ukraine
Kyiv , , Ukraine
Lviv , , Ukraine
Aberdeen , , United Kingdom
Birmingham , , United Kingdom
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
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