Prostate Cancer Clinical Trial

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Summary

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.

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Full Description

High-risk prostate cancer accounts for approximately 15 percent (%) of newly diagnosed prostate cancers. A systemic therapy that eradicates micrometastatic disease is needed to improve survival in high-risk participants undergoing RP with pLND. It is hypothesized that androgen blockade prior to and after RP with pLND may improve outcomes for participants at the highest risk for recurrence. This study is designed to evaluate if androgen blockade administered prior to and after RP with pLND will increase the rate of pathological complete response (pCR) and lead to better overall outcomes. ERLEADA (apalutamide, also known as JNJ-56021927 and ARN-509) is an orally available, non-steroidal small molecule, which acts as a potent and selective antagonist of the androgen receptor (AR), currently being developed for the treatment of prostate cancer. The study includes screening phase (approximately up to 35 days before randomization), treatment phase (the planned Treatment Phase will include a total of 12 treatment cycles of apalutamide or placebo; 6 cycles prior to RP with pLND (Cycle 1 through Cycle 6) and 6 cycles after RP with pLND (Cycle 7 through Cycle 12). Cycle 1 Day 1 will start within 3 days after randomization) and follow-up phase. The end of study (study completion) is defined as last participant assessment at study site with approximate study duration of 8 years. Participants will undergo efficacy, pharmacokinetics and biomarker evaluations. The safety will be monitored throughout the study. An open-label sub-study comparing apalutamide plus ADT before and after RP with pLND with standard of care treatment will be initiated at selected sites upon notification by the sponsor.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate
High-risk disease defined by a total Gleason Sum Score greater than equal to (>=) 4+3 (=Grade Groups [GG] 3 5) and >=1 of the following 4 criteria: a) Any combination of Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in >= 6 systematic cores (with >=1 core Gleason Score 8 [4+4 or 5+3] included); b) Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in >=3 systematic cores and Prostate-specific antigen (PSA) >=20 ng/mL (with >= 1 core Gleason Score 8 [4+4 or 5+3] included); c) Gleason Score >=9 (=GG 5) in at least 1 systematic or targeted core; d) At least 2 systematic or targeted cores with continuous Gleason Score >=8 (=GG 4), each with > 80 percent (%) involvement
Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Contraceptive use by male participants (and female partners of male participants enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
Able to receive androgen deprivation therapy (ADT) for at least 13 months

Exclusion Criteria:

Distant metastasis based on conventional imaging (clinical stage M1). 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. Participants are considered eligible only if the central radiological review confirms clinical stage M0
(a) Prior treatment with androgen receptor antagonists; (b) Treatment with gonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF) signature
History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
Use of any investigational agent less than or equals to (<=)4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
Major surgery <=4 weeks prior to randomization
Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

2500

Study ID:

NCT03767244

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 219 Locations for this study

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UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
University of Southern California
Los Angeles California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
University of California Los Angeles
Los Angeles California, 90095, United States
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
UC Davis Medical Center
Sacramento California, 95817, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
Colorado Clinical Research
Lakewood Colorado, 80228, United States
Yale Cancer Center
New Haven Connecticut, 06510, United States
Stamford Hospital
Stamford Connecticut, 06904, United States
Urology Specialists LLC
Hialeah Florida, 33002, United States
University of Florida
Jacksonville Florida, 32209, United States
Mayo Clinic - Division Of Hematology/oncology
Jacksonville Florida, 32224, United States
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
Miami Florida, 33176, United States
Florida Hospital
Orlando Florida, 32804, United States
Emory University - Winship Cancer Institute
Atlanta Georgia, 30322, United States
University of Chicago
Chicago Illinois, 60637, United States
DuPage Medical Group
Lisle Illinois, 60532, United States
Wichita Urology Group
Wichita Kansas, 67226, United States
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States
Ochsner LSU Health Shreveport - Regional Urology
Shreveport Louisiana, 71106, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Beth Isreal Deaconess Medical Center
Boston Massachusetts, 02215, United States
Michigan Institute of Urology, PC
Troy Michigan, 48084, United States
Saint Louis University
Saint Louis Missouri, 63110, United States
Washington University
Saint Louis Missouri, 63110, United States
Urology Cancer Center, PC
Omaha Nebraska, 68130, United States
New Hampshire Oncology Hematology, PA
Hooksett New Hampshire, 03106, United States
Garden State Urology
Morristown New Jersey, 07960, United States
Albany Medical College
Albany New York, 12208, United States
Great Lakes Physician PC d/b/a Western New York Urology Associates
Cheektowaga New York, 14225, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Weill Cornell Medical College
New York New York, 10065, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States
Duke University School of Medicine
Durham North Carolina, 27705, United States
Medication Management, LLC
Greensboro North Carolina, 27403, United States
Carolina Urology Partners, PLLC
Huntersville North Carolina, 28078, United States
Cleveland VA Medical Center
Cleveland Ohio, 44106, United States
University of Toledo
Toledo Ohio, 43614, United States
Oklahoma City VAMC
Oklahoma City Oklahoma, 73104, United States
Oklahoma University Health Science Center
Oklahoma City Oklahoma, 73104, United States
MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
Penn State Health
Hershey Pennsylvania, 17033, United States
Omega Medical Research
Warwick Rhode Island, 02886, United States
Medical University of South Carolina
Charleston South Carolina, 29403, United States
Ralph H. Johnson Veterans Affairs Medical Center
Charleston South Carolina, 29425, United States
Greenville Health
Greenville South Carolina, 29605, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
VA North Texas Health Care System
Dallas Texas, 75216, United States
Texas Oncology P.A.
Houston Texas, 77024, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Texas Oncology
Plano Texas, 75024, United States
Virginia Urology
Richmond Virginia, 23235, United States
Urology of Virginia, PLCC
Virginia Beach Virginia, 23462, United States
University of Washington School of Medicine
Seattle Washington, 98195, United States
CAMC Memorial Hospital, Charleston Area Medical Center Physicians
Charleston West Virginia, 25304, United States
Hospital Aleman
Caba , 1118, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de , C1199, Argentina
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Cordoba , 5000, Argentina
Centro Urologico Profesor Bengio
Cordoba , X5000, Argentina
Uroclinica
Mendoza , 5500, Argentina
Hospital Italiano de Rosario
Rosario , 2000, Argentina
Clinica Mayo de UMCB
San Miguel de Tucuman , 4000, Argentina
Epworth Eastern Hospital
Box Hill , 3128q, Australia
St. Vincent's Hospital Sydney
Darlinghurst , 2010, Australia
Austin Health
Heidelberg , 3084, Australia
Australian Urology Associates Pty Ltd
Malvern , 3144, Australia
Royal Melbourne Hospital
Parkville , 3050, Australia
Northern Cancer Institute
St Leonards , 2065, Australia
Australian Clinical Trials - SAN Clinic
Wahroonga , 2076, Australia
Westmead Hospital
Westmead , 2145, Australia
Princess Alexandra Hospital
Woolloongabba , 4102, Australia
Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará
Fortaleza , 60430, Brazil
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
Goiania , 74605, Brazil
Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
Ijui , 98700, Brazil
Liga Norte Riograndense Contra O Cancer
Natal , 59075, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre , 90020, Brazil
Universidade do Estado do Rio de Janeiro - UERJ
Rio de Janeiro , 20551, Brazil
Associacao Umane
Sao Paulo , 01232, Brazil
Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo
Sao Paulo , 01246, Brazil
Instituto Do Cancer Brasil
Três Lagoas , 79601, Brazil
Prostate Cancer Centre
Calgary Alberta, T2V 1, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Exdeo Clinical Research Inc
Abbotsford British Columbia, V2S 3, Canada
Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre
Vancouver British Columbia, V5Z 1, Canada
Nova Scotia Health Authority
Halifax Nova Scotia, B3H 2, Canada
McMaster Institute of Urology
Hamilton Ontario, L8N 4, Canada
London Health Sciences Center
London Ontario, N6A 5, Canada
Sunnybrook Health Sciences Center
Toronto Ontario, M4N 3, Canada
University Health Network (UHN) Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
CHUM - Centre hospitalier universitaire de Montreal
Montreal Quebec, H2X 0, Canada
CHU de Québec-Université Laval-Hôpital de l'Enfant-Jésus
Quebec , G1R 2, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králove , 500 0, Czechia
Krajská nemocnice Liberec
Liberec , 460 6, Czechia
Uromedical Center s.r.o.
Olomouc , 77200, Czechia
Fakultni nemocnice Plzen, Urologicka klinika
Plzen , 305 9, Czechia
Thomayerova nemocnice
Praha 4 , 140 5, Czechia
Vseobecna fakultni nemocnice v Praze
Praha , 120 0, Czechia
CHU d'Angers
Angers , 49933, France
CHRU Besançon -Hôpital Jean Minjoz
Besançon Cedex , 25030, France
Hôpital Pellegrin CHU Bordeaux
Bordeaux N/a , 33076, France
APHP - Hopital Henri Mondor
Créteil , 94010, France
Hopital Edouard Herriot - CHU Lyon
Lyon cedex 03 , 69437, France
CHU de Nantes hôtel-Dieu
Nantes , 44000, France
Institut Mutualiste Montsouris
Paris , 75014, France
Clinique de la Croix du Sud
Quint-Fonsegrives , 31130, France
Chu Rennes - Hopital Pontchaillou
Rennes Cedex , 35033, France
CHU de Toulouse - Hôpital Rangueil
Toulouse Cedex 9 , 31059, France
CHRU Tours Hôpital Bretonneau
Tours , 37000, France
Universitaetsklinikum der RWTH Aachen
Aachen , 52074, Germany
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
Braunschweig , 38126, Germany
Universitatsklinikum Essen
Essen , 45147, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main , 60590, Germany
Prostata zentrum Nordwest
Gronau , 48599, Germany
Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie
Hamburg , 20246, Germany
Urologikum Hamburg
Hamburg , 22399, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar , 66421, Germany
Universitaetsklinikum Koeln
Koeln , 50937, Germany
Universitätsklinikum Schleswig Holstein Campus Lübeck
Lubeck , 23538, Germany
Praxis Dr. med. Ralf Eckert
Lutherstadt Eisleben , 06295, Germany
Klinikum St. Elisabeth Straubing GmbH
Straubing , 94315, Germany
Kliniken Nordoberpfalz, Klinik für Urologie
Weiden/Opf , 92637, Germany
Praxisgemeinschaft f. Onkologie u. Urologie - Germany
Wilhelmshaven , 26389, Germany
Asaf Harofe Medical Center
Beer Yaakov , 60930, Israel
Rambam Health Care Campus
Haifa , 31096, Israel
Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)
Kfar Saba , 44281, Israel
Rabin Medical Center
Petach Tikva , 49100, Israel
The Chaim Sheba Medical Center
Ramat Gan , 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Policlinico Abano Terme
Abano Terme , 35031, Italy
Generale Regionale F. Miulli
Acquaviva delle Fonti , 70021, Italy
Ospedale di Bassano del Grappa
Bassano del Grappa , 36061, Italy
ASST Spedali Civili Brescia
Brescia , 25123, Italy
ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
Chieti , 66100, Italy
Azienda Ospedaliero Universitaria Careggi
Firenze , 50134, Italy
San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico
MIlano , 20127, Italy
Ospedale San Raffaele
Milano , 20132, Italy
Istituto Europeo di Oncologia
Milano , 20141, Italy
Clinica di Urologia Policlinico di Modena - Università di Modena e reggio Emilia
Modena , 41100, Italy
Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
Novara , 28100, Italy
Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano , 10043, Italy
Università Campus Bio-Medico di Roma
Roma , 00128, Italy
Istituto Nazionale Tumori Regina Elena
Roma , 00144, Italy
Azienda Ospedaliera Sant Andrea
Roma , 00189, Italy
Ospedale Molinette, AO Città della Salute e della Scienza di
Torino , 10126, Italy
UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento
Verona , 37126, Italy
Akita University Hospital
Akita , 010-8, Japan
Chiba University Hospital
Chiba , 260-8, Japan
Chiba Cancer Center
Chuo-ku, Chiba-City, , 260-8, Japan
Hakodate Goryokaku Hospital
Hakodate , 040-8, Japan
Hirosaki University Hospital
Hirosaki , 036-8, Japan
Kanazawa University Hospital
Kanazawa , 920-8, Japan
Kobe City Medical Center General Hospital
Kobe , 650-0, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya , 343-8, Japan
Kurume University Hospital
Kurume , 830-0, Japan
Kyoto University Hospital
Kyoto , 606-8, Japan
National Hospital Organizaiton Shikoku Cancer Center
Matsuyama , 791-0, Japan
Kitasato University Hospital
Minami-Ku, Sagamihara-Shi , 252-0, Japan
University of Miyazaki Hospital
Miyazaki , 889-1, Japan
Nagano Municipal Hospital
Nagano , 381-8, Japan
Kindai University Hospital
Osaka-Sayama-shi , 589-8, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Toho University Sakura Medical Center
Sakura , 285-8, Japan
Hokkaido University Hospital
Sapporo-shi , 060-8, Japan
Iwate Medical University Hospital
Shiwa-gun , 028-3, Japan
Juntendo University Hospital
Tokyo , 113-8, Japan
Nippon Medical School Hospital
Tokyo , 113-8, Japan
Yamaguchi University Hospital
Ube , 755-8, Japan
Yokohama City University Medical Center
Yokohama , 232-0, Japan
Chonnam National University Hospital
Gwangju , 61469, Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do , 13605, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
NKI-AVL, Amsterdam
Amsterdam , 1066 , Netherlands
Catharinaziekenhuis
Eindhoven , 5623 , Netherlands
St. Antonius Ziekenhuis (St. Antonius Hospital)
Nieuwegein , 3430E, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen , 6524 , Netherlands
Samodzielny Publiczny Wielospecjalistyczny Zakład Opieki Zdrowotnej MSWiA w Bydgoszczy
Bydgoszcz , 85-01, Poland
Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
Bydgoszcz , 85-09, Poland
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
Koszalin , 75-58, Poland
Pratia MCM Krakow
Krakow , 30-51, Poland
City Clinic Sp. z o.o.
Warszawa , 02-47, Poland
Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia
Wrocław , 53-41, Poland
Altai Regional Oncology Dispensary
Barnaul , 65604, Russian Federation
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
Chelyabinsk , 45408, Russian Federation
Moscow City Clinical Hospital # 62
Moscow , 12513, Russian Federation
Botkin City Clinical Hospital
Moscow , 12528, Russian Federation
Hertzen Oncology Research Institute
Moscow , 12528, Russian Federation
Clinical Oncology Dispensary
Omsk , 64401, Russian Federation
Medical-sanitary unit 'Neftyanik'
Tyumen , 62500, Russian Federation
Vologda Regional Oncological Dispensary
Vologda , 16001, Russian Federation
Hosp. Univ. A Coruña
A Coruña , 15006, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 8035, Spain
Hosp. Puerta Del Mar
Cadiz , 11009, Spain
Hosp. Gral. Univ. de Castellon
Castellón , 12004, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera , 11407, Spain
Hosp. Univ. Ramon Y Cajal
Madrid , 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Univ. La Paz
Madrid , 28046, Spain
Fund. Hosp. de Manacor
Manacor , 07500, Spain
Hosp. Virgen de La Victoria
Málaga , 29010, Spain
Hosp. Univ. Marques de Valdecilla
Santander , 39008, Spain
Hosp. Virgen Del Rocio
Sevilla , 41013, Spain
Inst. Valenciano de Oncologia
Valencia , 46009, Spain
Hosp. Clinico Univ. de Valencia
Valencia , 46010, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 807, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
Tungs' Taichung MetroHarbor Hospital
Taichung , 435, Taiwan
Chi Mei Medical Center - Yong Kang
Tainan , 710, Taiwan
National Taiwan University Hospital.
Taipei , 10002, Taiwan
Southmead Hospital
Bristol , BS10 , United Kingdom
University Hospital of Wales
Cardiff , CF14 , United Kingdom
Ninewells Hospital
Dundee , DD2 1, United Kingdom
The Royal Marsden NHS Trust
London , SW3 6, United Kingdom
University College London
London , WC1E , United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
Preston , PR2 9, United Kingdom
Southampton General Hospital
Southampton , SO16 , United Kingdom
Royal Marsden Hospital
Sutton , SM2 5, United Kingdom
MidYorkshire NHS Trust
Wakefield , WF1 4, United Kingdom
New Cross Hospital
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

2500

Study ID:

NCT03767244

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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