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ACTIVE NOT RECRUITING
NCT04557059
PHASE3

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer

Sponsor: Janssen Pharmaceutica N.V., Belgium

View on ClinicalTrials.gov

Summary

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

Official title: A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational Cohort

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

693

Start Date

2020-11-12

Completion Date

2029-08-27

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

RADIATION

Radiotherapy

Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.

DRUG

LHRHa

Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12 or as a 6-monthly depot preparation within 3 days after randomization.

DRUG

Apalutamide

Participants will receive therapeutic dose of apalutamide 240 mg once daily for 180 Days.

Locations (141)

Arizona Urology Specialists

Tucson, Arizona, United States

Arkansas Urology

Little Rock, Arkansas, United States

Colorado Clinical Research

Lakewood, Colorado, United States

Urological Research Network

Hialeah, Florida, United States

First Urology, PSC

Jeffersonville, Indiana, United States

Michigan Institute of Urology

Troy, Michigan, United States

Associated Medical Professionals of Ny

Syracuse, New York, United States

The Urology Group

Cincinnati, Ohio, United States

Oregon Urology Institute

Springfield, Oregon, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Urology Austin

Austin, Texas, United States

Houston Metro Urology

Houston, Texas, United States

Spokane Urology

Spokane, Washington, United States

Bundaberg Hospital

Bundaberg, Australia

Hervey Bay Hospital

Bundaberg, Australia

Epworth Healthcare

East Melbourne, Australia

St Vincent's Hospital - Melbourne

Fitzroy, Australia

Genesis Care Hurstville

Hurstville, Australia

Macquarie University Hospital

North Ryde, Australia

Calvary Mater Newcastle

Waratah, Australia

GenesisCare Wembley

Wembley, Australia

Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria

Universitaetsklinikum Salzburg Landeskrankenhaus

Salzburg, Austria

Medizinische Universitaet Wien

Vienna, Austria

ZAS Augustinus

Antwerp, Belgium

A.Z. Sint Jan

Bruges, Belgium

UZ Gent

Ghent, Belgium

Az Groeninge

Kortrijk, Belgium

Empresa Brasileira de Servicos Hospitalares - EBSERH - Hospital das Clinicas da UFMG

Belo Horizonte, Brazil

Liga Paranaense de Combate ao Cancer

Curitiba, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

Associacao Hospitalar Moinhos de Vento

Porto Alegre, Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, Brazil

Hospital Sao Rafael

Salvador, Brazil

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, Brazil

Hospital Sao Camilo Unidade Vila Mariana

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Fakultni nemocnice Plzen, Urologicka klinika

Pilsen, Czechia

Urocentrum Praha

Prague, Czechia

Urologicka klinika 1 LF UK a VFN

Prague, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus N, Denmark

Rigshospitalet

Copenhagen N, Denmark

Gentofte Herlev Hospital

Herlev, Denmark

Helsinki University Hospital

Helsinki, Finland

Oulu University Hospital

Oulu, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

Vaasa Central Hospital

Vaasa, Finland

Vivantes Klinikum Am Urban

Berlin, Germany

Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

Braunschweig, Germany

Universitatsklinikum Carl Gustav Carcus Dresden

Dresden, Germany

Universitatsklinikum Essen

Essen, Germany

Klinikum rechts der Isar - der Technischen Universität München

München, Germany

Universitaetsklinikum Muenster

Münster, Germany

Péterfy Sándor utcai Kórház

Budapest, Hungary

Budapesti Bajcsy Zsilinszky Korhaz es Rendelointezet

Budapest, Hungary

Orszagos Onkologiai Intezet

Budapest, Hungary

Eszak Budai Szent Janos Centrumkorhaz

Budapest, Hungary

Budapesti Uzsoki Utcai Korhaz

Budapest, Hungary

Jahn Ferenc Del-pesti Korhaz es Rendelointezet

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Radioterapia Oncologica, A.O.U. San'T Orsola

Bologna, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Ospedale San Raffaele

Milan, Italy

Fondazione Policlinico Tor Vergata

Roma, Italy

Istituto Nazionale Tumori Regina Elena

Roma, Italy

Azienda Ospedaliera Sant Andrea

Roma, Italy

King Hussein Cancer Center

Amman, Jordan

St Georges Hospital university medical centre

Beirut, Lebanon

American Universitty of Beirut Medical Center

Beirut, Lebanon

Notre Dame De Secours

Byblos, Lebanon

Centre Hospitalier du Nord

Zghartā, Lebanon

Consultorio de Especialidad en Urologia Privado

Durango, Mexico

Hospital MAC Leon

León, Mexico

Avix Investigacion Clinica S C

Monterrey, Mexico

Oncologia Integral Satelite

Naucalpan, Mexico

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, Mexico

Oncocenter

Puebla City, Mexico

Cuidados Oncologicos

Querétaro, Mexico

Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

Bydgoszcz, Poland

NU-MED Grupa S.A Centrum Radioterapii i Onkologii

Elblag, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Szpitale Pomorskie Sp z o o

Gdynia, Poland

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, Poland

Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie

Koszalin, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

Lodz, Poland

Radomskie Centrum Onkologii

Radom, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Ipo Lisboa

Lisbon, Portugal

Hosp. Cuf Tejo

Lisbon, Portugal

Fund. Champalimaud

Lisbon, Portugal

Uls Lisboa Ocidental - Hosp. Sao Francisco Xavier

Lisbon, Portugal

Hosp. Da Luz Lisboa

Lisbon, Portugal

Uls Santa Maria - Hosp. Santa Maria

Lisbon, Portugal

Uls Santo Antonio - Hosp. Santo Antonio

Porto, Portugal

Uls de Entre Douro E Vouga - Hosp. Sao Sebastiao

Santa Maria da Feira, Portugal

Ivanovo Regional Oncology Dispensary

Ivanovo, Russia

City Clinical Hospital #57

Moscow, Russia

I.M. Sechenov First Moscow State Medical University

Moscow, Russia

Hertzen Oncology Research Institute

Moscow, Russia

Leningrad Regional Oncology Dispensary

Saint Petersburg, Russia

SPb SBIH 'City Clinical Oncological Dispensary'

Saint Petersburg, Russia

Multifunctional clinical medical center 'Medical city'

Tyumen, Russia

SHI Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, Russia

CUIMED - urologická ambulancia

Bratislava, Slovakia

Východoslovenský Onkologický Ústav

Košice, Slovakia

Univerzitná nemocnica Martin

Martin, Slovakia

Uroexam s.r.o.

Nitra, Slovakia

Urologicka ambulancia e.cho Poprad, s.r.o

Poprad, Slovakia

MILAB s.r.o.

Prešov, Slovakia

Privátna urologická ambulancia

Trenčín, Slovakia

Hospital Universitario Puerto Del Mar

Cadiz, Spain

Hosp. Arquitecto Marcide

Ferrol, Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. de La Paz

Madrid, Spain

Hosp Virgen de La Victoria

Málaga, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp. de Navarra

Pamplona, Spain

Hosp. Virgen Del Rocio

Seville, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, Spain

Urologiska Mottagningen

Malmo, Sweden

Prostatacancercentrum

Stockholm, Sweden

Sodersjukhuset

Stockholm, Sweden

Adana Baskent Yuregir Hospital

Adana, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, Turkey (Türkiye)

Hacettepe Universitesi Hastanesi

Ankara, Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, Turkey (Türkiye)

Koc University, School of Medicine, Koc University Hospital

Istanbul, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Bakirkoy Training and Research Hospital

Istanbul, Turkey (Türkiye)

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, Turkey (Türkiye)

Kartal Dr Lutfi Kirdar Egitim ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye)

Dokuz Eylul Universitesi Arastirma ve Uygulama Hastanesi

Izmir, Turkey (Türkiye)

Sakarya Üniversitesi Tıp Fakültesi Hastanesi

Sakarya, Turkey (Türkiye)