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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

694

Participants

Timeline

Start Date

November 12, 2020

Primary Completion Date

August 27, 2029

Study Completion Date

August 27, 2029

Conditions
Prostatic Neoplasms
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.

Trial Locations (141)

3

Notre Dame De Secours, Byblos

100

Centre Hospitalier du Nord, Zghartā

1076

Péterfy Sándor utcai Kórház, Budapest

1090

Medizinische Universitaet Wien, Vienna

1106

Budapesti Bajcsy Zsilinszky Korhaz es Rendelointezet, Budapest

1122

Orszagos Onkologiai Intezet, Budapest

1125

Eszak Budai Szent Janos Centrumkorhaz, Budapest

1145

Budapesti Uzsoki Utcai Korhaz, Budapest

1204

Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Budapest

2109

Macquarie University Hospital, North Ryde

2200

Rigshospitalet, Copenhagen N

2220

Genesis Care Hurstville, Hurstville

2298

Calvary Mater Newcastle, Waratah

2610

ZAS Augustinus, Antwerp

2730

Gentofte Herlev Hospital, Herlev

3002

Epworth Healthcare, East Melbourne

3065

St Vincent's Hospital - Melbourne, Fitzroy

4020

Ordensklinikum Linz GmbH Elisabethinen, Linz

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4670

Bundaberg Hospital, Bundaberg

Hervey Bay Hospital, Bundaberg

5020

Universitaetsklinikum Salzburg Landeskrankenhaus, Salzburg

6014

GenesisCare Wembley, Wembley

6200

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara

8000

A.Z. Sint Jan, Bruges

8200

Aarhus University Hospital, Aarhus N

8500

Az Groeninge, Kortrijk

9000

UZ Gent, Ghent

Aalborg University Hospital, Aalborg

10967

Vivantes Klinikum Am Urban, Berlin

11009

Hospital Universitario Puerto Del Mar, Cadiz

11407

Hosp. de Jerez de La Frontera, Jerez de la Frontera

11883

Sodersjukhuset, Stockholm

13210

Associated Medical Professionals of Ny, Syracuse

15006

Fakultni nemocnice v Motole, Prague

15405

Hosp. Arquitecto Marcide, Ferrol

19004

MidLantic Urology, Bala-Cynwyd

20132

Ospedale San Raffaele, Milan

20520

Turku University Hospital, Turku

28041

Hosp. Univ. 12 de Octubre, Madrid

28046

Hosp. Univ. de La Paz, Madrid

29010

Hosp Virgen de La Victoria, Málaga

31008

Complejo Hosp. de Navarra, Navarra

Clinica Univ. de Navarra, Pamplona

33016

Urological Research Network, Hialeah

33521

Tampere University Hospital, Tampere

34000

Consultorio de Especialidad en Urologia Privado, Durango

34010

Koc University, School of Medicine, Koc University Hospital, Istanbul

34096

Istanbul University Cerrahpasa Medical Faculty, Istanbul

34147

Bakirkoy Training and Research Hospital, Istanbul

34722

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi, Istanbul

34890

Kartal Dr Lutfi Kirdar Egitim ve Arastirma Hastanesi, Istanbul

35340

Dokuz Eylul Universitesi Tip Fakultesi, Izmir

37530

Hospital MAC Leon, León

38126

Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer, Braunschweig

40138

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

41013

Hosp. Virgen Del Rocio, Seville

45212

The Urology Group, Cincinnati

46026

Hosp. Univ. I Politecni La Fe, Valencia

47130

First Urology, PSC, Jeffersonville

48084

Michigan Institute of Urology, Troy

48149

Universitaetsklinikum Muenster, Münster

50009

Hosp. Clinico Univ. Lozano Blesa, Zaragoza

50134

Azienda Ospedaliero Universitaria Careggi, Florence

53100

Oncologia Integral Satelite, Naucalpan

54187

Sakarya Üniversitesi Tıp Fakültesi Hastanesi, Sakarya

64623

Avix Investigacion Clinica S C, Monterrey

65130

Vaasa Central Hospital, Vaasa

68020

Centro de Investigacion Clinica de Oaxaca, Oaxaca City

72211

Arkansas Urology, Little Rock

72530

Oncocenter, Puebla City

76000

Cuidados Oncologicos, Querétaro

77027

Houston Metro Urology, Houston

78745

Urology Austin, Austin

80228

Colorado Clinical Research, Lakewood

81675

Klinikum rechts der Isar - der Technischen Universität München, München

85741

Arizona Urology Specialists, Tucson

90220

Oulu University Hospital, Oulu

94901

Uroexam s.r.o., Nitra

97477

Oregon Urology Institute, Springfield

99202

Spokane Urology, Spokane

105077

City Clinical Hospital #57, Moscow

119991

I.M. Sechenov First Moscow State Medical University, Moscow

125284

Hertzen Oncology Research Institute, Moscow

153040

Ivanovo Regional Oncology Dispensary, Ivanovo

191104

Leningrad Regional Oncology Dispensary, Saint Petersburg

197022

SPb SBIH 'City Clinical Oncological Dispensary', Saint Petersburg

620102

SHI Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg

625041

Multifunctional clinical medical center 'Medical city', Tyumen

30130-100

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

81520 060

Liga Paranaense de Combate ao Cancer, Curitiba

59075-740

Liga Norte Riograndense Contra O Cancer, Natal

90035-001

Associacao Hospitalar Moinhos de Vento, Porto Alegre

90050-170

Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre

22250-905

Oncoclinicas Rio de Janeiro S A, Rio de Janeiro

41253 190

Hospital Sao Rafael, Salvador

01308 901

Sociedade Beneficente de Senhoras Hospital Sirio Libanes, São Paulo

01421-000

Hospital Alemao Oswaldo Cruz, São Paulo

04014-002

Hospital Sao Camilo Unidade Vila Mariana, São Paulo

05652 900

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, São Paulo

305 99

Fakultni nemocnice Plzen, Urologicka klinika, Pilsen

120 00

Urocentrum Praha, Prague

Urologicka klinika 1 LF UK a VFN, Prague

00290

Helsinki University Hospital, Helsinki

01307

Universitatsklinikum Carl Gustav Carcus Dresden, Dresden

D-45147

Universitatsklinikum Essen, Essen

00133

Fondazione Policlinico Tor Vergata, Roma

00144

Istituto Nazionale Tumori Regina Elena, Roma

00189

Azienda Ospedaliera Sant Andrea, Roma

0000

King Hussein Cancer Center, Amman

11 00 2807

St Georges Hospital university medical centre, Beirut

1107 2020

American Universitty of Beirut Medical Center, Beirut

85 796

Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy, Bydgoszcz

82-300

NU-MED Grupa S.A Centrum Radioterapii i Onkologii, Elblag

80 952

Uniwersyteckie Centrum Kliniczne, Gdansk

81 519

Szpitale Pomorskie Sp z o o, Gdynia

25 734

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Kielce

75 581

Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie, Koszalin

93 513

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi, Lodz

26-600

Radomskie Centrum Onkologii, Radom

02 781

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warsaw

1099-023

Ipo Lisboa, Lisbon

1350-352

Hosp. Cuf Tejo, Lisbon

1400-038

Fund. Champalimaud, Lisbon

1449-005

Uls Lisboa Ocidental - Hosp. Sao Francisco Xavier, Lisbon

1500 650

Hosp. Da Luz Lisboa, Lisbon

1649 035

Uls Santa Maria - Hosp. Santa Maria, Lisbon

4099-001

Uls Santo Antonio - Hosp. Santo Antonio, Porto

4520-211

Uls de Entre Douro E Vouga - Hosp. Sao Sebastiao, Santa Maria da Feira

851 05

CUIMED - urologická ambulancia, Bratislava

04191

Východoslovenský Onkologický Ústav, Košice

036 59

Univerzitná nemocnica Martin, Martin

05801

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

08001

MILAB s.r.o., Prešov

911 01

Privátna urologická ambulancia, Trenčín

205 02

Urologiska Mottagningen, Malmo

112 19

Prostatacancercentrum, Stockholm

01250

Adana Baskent Yuregir Hospital, Adana

06230

Hacettepe University Medical Faculty, Ankara

06520

Memorial Ankara Hastanesi, Ankara

06590

Ankara University Medical Faculty, Ankara

All Listed Sponsors
lead

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

NCT04557059 - A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer | Biotech Hunter | Biotech Hunter