Prostatic NeoplasmsPhase 3AMPLITUDENCT04497844
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-MutatedProstatic Neoplasms (mCSPC)
A Phase 3 study testing Niraparib+ Abiraterone acetate fixed dose combination (FDC), Abiraterone acetate (AA) and Prednisone in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 387 sites in 33 countries.
Trial summary
The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Niraparib+ Abiraterone acetate fixed dose combination (FDC), Abiraterone acetate (AA) and Prednisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 696 participants
- Where
- 387 sitesin 33 countries
- Study dates
- 23 Sep 2020to 1 Nov 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of prostate adenocarcinoma
- Must have appropriate deleterious homologous recombination repair (HRR) gene alteration
- Metastatic disease as documented by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (for soft tissue lesions) or 99mTc bone scan (for bone lesions). Participants with a single bone lesion on Technetium-99m (99mTc) bone scan with no other non-nodal metastatic disease must have confirmation of bone metastasis by CT or MRI. Participants with lymph node-only disease are not eligible
- Androgen deprivation therapy (either medical or surgical castration) must have been started >=14 days prior to randomization and participants be willing to continue androgen deprivation therapy (ADT) through the treatment phase
- Other allowed prior therapy for metastatic castration-sensitive prostate cancer (mCSPC): (a) maximum of 1 course of radiation and 1 surgical intervention for symptomatic control of prostate cancer (example, uncontrolled pain, impending spinal cord compression or obstructive symptoms). Participants with radiation or surgical interventions to all known sites of metastatic disease will be excluded from trial participation. Radiation must be completed prior to randomization (b) Up to a maximum of 6 months of ADT prior to randomization; (c) Up to a maximum of 45 days of abiraterone acetate + prednisone (AA-P) prior to randomization (d) Up to a maximum of 2 weeks of ketoconazole for prostate cancer prior to randomization
Who cannot join
- Prior treatment with a poly (adenosine diphosphate-ribose) polymerase inhibitor (PARP inhibitor)
- History of adrenal dysfunction
- Long-term use of systemically administered corticosteroids (greater than [>] 5 milligrams [mg] of prednisone or the equivalent) during the study is not allowed. Short-term use (<=4 weeks, including taper) and locally administered steroids (for example, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated
- History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)
Trial locations and contacts
387 sites in 33 countries.
387 sites in 33 countries
United States53 sites
New York Oncology Hematology
Albany, New York, 12206
Texas Oncology-Austin
Austin, Texas, 78731
Baltimore VA Medical Center
Baltimore, Maryland, 21201
Ralph H. Johnson Veterans Affairs Medical Center
Charleston, South Carolina, 29401
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80907
Maryland Oncology Hematology, PA
Columbia, Maryland, 21044
Advanced Urology Institute
Daytona Beach, Florida, 32114
Texas Oncology - Northeast
Denton, Texas, 76201
AdventHealth Medical Group Urology of Denver
Denver, Colorado, 80210
Durham VAMC
Durham, North Carolina, 27705
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida, 33308
Urology of Indiana
Greenwood, Indiana, 46143
Urology Centers Of Alabama
Homewood, Alabama, 35209
Houston Metro Urology
Houston, Texas, 77027
University of Florida Health Jacksonville
Jacksonville, Florida, 32209
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
First Urology
Jeffersonville, Indiana, 47130
Colorado Clinical Research
Lakewood, Colorado, 80228
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604
Greater Los Angeles VA Healthcare System
Los Angeles, California, 90073
Urology Associates
Nashville, Tennessee, 37209
Texas Oncology P A
New Braunfels, Texas, 78130
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Manhattan VAMC
New York, New York, 10010
Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Virginia Oncology Associates
Norfolk, Virginia, 23502
Eastern Connecticut Hematology & Oncology Assoc.
Norwich, Connecticut, 06360
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
GU Research Network
Omaha, Nebraska, 68130
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
Orange, California, 92868
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Arizona
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15232
VA Portland Health Care System
Portland, Oregon, 97239
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23298
Mosaic Life Care
Saint Joseph, Missouri, 64507
Oregon Oncology Specialists
Salem, Oregon, 97301
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
San Bernardino Urological Associates
San Bernardino, California, 92404
University of San Francisco California
San Francisco, California, 94158
VA Puget Sound Healthcare System
Seattle, Washington, 98108
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Prisma Health
Seneca, South Carolina, 29672
St. Louis VA Medical Center
St Louis, Missouri, 63109
Associated Medical Professionals
Syracuse, New York, 13210
MultiCare Health System
Tacoma, Washington, 98405
Montefiore Medical Center
The Bronx, New York, 10461
Chesapeake Urology Associates
Towson, Maryland, 21204
Michigan Institute of Urology
Troy, Michigan, 48084
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, 85741
Texas Oncology - Northeast 1
Tyler, Texas, 75702
Brazil31 sites
Fundacao Pio XII
Barretos, 14784-400
Cetus Oncologia
Belo Horizonte, 30110-022
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte, 30130-090
CIONC Centro Integrado de Oncologia de Curitiba
Curitiba, 80810 050
Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
Florianópolis, 88020 210
Pronutrir
Fortaleza, 60 810180
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
Goiânia, 74605-070
Fundacao Sao Francisco Xavier
Ipatinga, 35162 189
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
Joinville, 89201-260
Liga Norte Riograndense Contra O Cancer
Natal, 59075-740
UPCO Unidade de Pesquisa Clinica em Oncologia
Pelotas, 96020 080
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090
Hospital Ernesto Dornelles
Porto Alegre, 90160-093
MultiHemo Servicos Medicos S.A
Recife, CEP: 50070-460
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, 20230-130
Universidade do Estado do Rio de Janeiro - UERJ
Rio de Janeiro, 20551-030
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, 22250 905
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, 22775 001
Nucleo de Oncologia da Bahia
Salvador, 40170 110
Hospital Sao Rafael
Salvador, 41253 190
Fundacao do ABC Centro Universitario FMABC
Santo André, 09060 870
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, 01221 020
Irmandade Santa Casa de Misericordia de Sao Paulo
São Paulo, 01221-020
Instituto de Ensino e Pesquisa São Lucas
São Paulo, 01236-030
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246 000
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01323 900
Hospital Alemao Oswaldo Cruz
São Paulo, 01421-000
Núcleo de Pesquisa São Camilo
São Paulo, 04014-002
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
São Paulo, 04039-004
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
Sorocaba, 18030-005
Centro Oncológico do Triângulo
Uberlândia, 38408-150
China30 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021
Peking University First Hospital
Beijing, 100034
Beijing Friendship Hospital Capital Medical University
Beijing, 100050
Beijing Cancer Hospital
Beijing, 100142
Beijing University Third Hospital
Beijing, 100191
Beijing Hospital
Beijing, 100730
West China Hospital of Sichuan University
Chengdu, 610041
Sichuan Provincial Peoples Hospital
Chengdu, 610072
Western Theater General Hospital of the Chinese People's Liberation Army
Chengdu, 610083
Chongqing University Cancer Hospital
Chongqing, 400030
Southwest Hospital, The Third Military Medical University
Chongqing, 400038
Sun Yat Sen University Cancer Center
Guangzhou, 430030
Guangzhou First Municipal People's Hospital
Guangzhou, 510180
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, 510289
Zhejiang Provincial People's Hospital
Hangzhou, 310014
The First Affiliated Hospital of NanChang University
Nanchang, 330006
Jiangsu Province Cancer Hospital
Nanjing, 210000
Nanjing Drum Tower Hospital
Nanjing, 210008
The First Affiliated Hospital of Ningbo University
Ningbo, 315010
Fudan University Shanghai Cancer Center
Shanghai, 200032
Huashan Hospital Fudan University
Shanghai, 200040
Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
Shanghai, 200127
The Fifth People's Hospital of Shanghai, Fudan University
Shanghai, 200240
Huadong Hospital Affiliated to Fudan University
Shanghai, 200400
Shengjing Hospital Of China Medical University
Shenyang, 110004
Second Affiliated Hospital of Soochow University
Suzhou, 200233
The First Affliated Hospital of Soochow University
Suzhou, 215006
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, 430030
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061
France18 sites
Institut de Cancerologie de l Ouest ICO
Angers, 49933
Institut Sainte Catherine
Avignon, 84918
CHRU De Besancon
Besançon, 25030
Institut Bergonie
Bordeaux, 33000
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Georges Francois Leclerc
Dijon, 21000
Centre Oscar Lambret
Lille, 59000
Centre Leon Berard
Lyon, 69008
Hopital Prive Jean Mermoz
Lyon, 69008
Institut Regional du Cancer de Montpellier Val d'Aurelle
Montpellier, 34298
Polyclinique de Gentilly
Nancy, 54100
CHU De Poitiers
Poitiers, 86021
Centre Hopitalier Inter-Communal De Cornouaille
Quimper, 29000
HIA Begin
Saint-Mandé, 94163
Institut de Cancérologie de Loire
Saint-Priest-en-Jarez, 42271
Clinique Sainte Anne
Strasbourg, 67000
Hopital Foch
Suresnes, 32151
CHRU de Tours
Tours, 37044
Italy16 sites
Ospedale S. Donato - Asl 8 Arezzo
Arezzo, 52100
Divisione di Oncologia - Istituto per la ricerca e cura del cancro
Candiolo, 10060
Istituti Ospitalieri di Cremona, AO di Cremona
Cremona, 26100
Azienda Ospedaliera ''Vito Fazzi''
Lecce, 73100
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014
Ospedale San Raffaele
Milan, 20132
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
European Institute of Oncology
Milan, 20141
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, 80138
Aou San Luigi Gonzaga
Orbassano, 10043
Istituto Oncologico Veneto Iov Irccs Padova
Padova, 35128
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
ASL Napoli 2 Nord-SM delle Grazie Hospital
Pozzuoli, 80078
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013
Ospedale S. Chiara
Trento
Ospedale San Bortolo
Vicenza, 36100
Spain16 sites
Hosp Univ A Coruna
A Coruña, 15006
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025
Hosp Clinic de Barcelona
Barcelona, 08036
Hosp. Gral. Univ. de Castellon
Castellon, 12004
Institut Català D'Oncologia Girona
Girona, 17007
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407
Hosp. Univ. de La Princesa
Madrid, 28006
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
Hosp. Univ. 12 de Octubre
Madrid, 28041
Hosp. Univ. La Paz
Madrid, 28046
Hosp. Univ. Hm Monteprincipe
Madrid, 28660
Hosp Virgen de La Victoria
Málaga, 29010
Corporacio Sanitari Parc Tauli
Sabadell, 08208
Hosp. Univ. Marques de Valdecilla
Santander, 39008
Hosp. Virgen Del Rocio
Seville, 41013
Hosp. Clinico Univ. de Valencia
Valencia, 46010
Turkey (Türkiye)16 sites
Adana Baskent Yuregir Hospital
Adana, 01250
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, 06200
Memorial Ankara Hastanesi
Ankara, 06520
Gazi Hastanesi
Ankara, 06560
Ankara University Medical Faculty
Ankara, 06590
Ankara Bilkent Sehir Hastanesi
Ankara, 06800
Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi
Bursa, 16310
Trakya University Medical Faculty
Edirne, 22030
Istanbul University Istanbul Medical Faculty
Istanbul, 34000
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
Istanbul, 34098
Bakirkoy Training and Research Hospital
Istanbul, 34147
T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
Istanbul, 34722
Dokuz Eylul Universitesi Arastirma ve Uygulama Hastanesi
Izmir, 35340
Izmir Medical Point Hospital
Izmir, 35530
Sakarya Üniversitesi Tıp Fakültesi Hastanesi
Sakarya, 54050
Medical Park Samsun Hastanesi
Samsun, 55200
Ukraine16 sites
CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
Cherkasy, 18009
Municipal Non-profit enterprise 'Bukovinian clinical oncology center'
Chernivtsi, 58013
Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
Dnipro, 49005
Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
Dnipro, 49100
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
Dnipro, 49102
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, 76008
Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
Kamyanske, 51900
Municipal non-profit enterprise 'Regional Center of Oncology'
Khakhiv, 61070
Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
Kharkiv, 61037
Kherson Regional Oncological Dispensary
Kherson, 73035
State Nonprofit Enterprise National Cancer Institute
Kyiv, 03022
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
Kyiv, 03115
Kyiv Regional Oncological Dispensary
Kyiv, 04107
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
Lviv, 79010
Podilskiy Regional Center of Oncology
Vinnitsa, 21029
Municipal non-profit enterprise Zhytomyr Regional Oncology Dispensary of Zhytomyr Regional Council
Zhytomyr, 10002
Argentina15 sites
CIPREC
Buenos Aires, C1061AAS
Asociacion de Beneficencia Hospital Sirio Libanes
Buenos Aires, C1419AHN
Centro Oncológico Korben
Buenos Aires, C1426AGE
Hospital Militar Cosme Argerich
C.a.b.a., C1426BOR
CINME Centro de Investigaciones Metabolicas
Caba, C1056ABI
Centro de Urologia (CDU)
Ciudad Automoma Buenos Aires, C1120AAT
Hospital Italiano de Buenos Aires
Ciudad Autonoma de, C1199ABB
Clinica Adventista Belgrano
Ciudad de Buenos Aires, C1430EGF
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, 5000
Centro Urologico Profesor Bengio
Córdoba, X5000KPH
Instituto Médico de Río Cuarto
Córdoba, X5800
Hospital Privado de Cordoba
Córdoba, XX5016KEH
Hospital Privado de Comunidad
Mar del Plata, B7602CBM
Centro de Investigacion Pergamino SA
Pergamino, B2700CPM
ARS Médica
San Salvador de Jujuy, Y4600AFW
Russia15 sites
Altai Regional Oncology Dispensary
Barnaul, 656045
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
Chelyabinsk, 454087
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040
Moscow City Clinical Hospital # 62
Moscow, 125130
Hertzen Oncology Research Institute
Moscow, 125284
Privolzhsky District Medical Centre
Nizhny Novgorod, 603001
Clinical Oncology Dispensary
Omsk, 644013
LLC Novaya Clinica
Pyatigorsk, 357500
Pyatigorsk Interdistrict Oncology Dispensary
Pyatigorsk, 357502
Leningrad Regional Oncology Dispensary
Saint Petersburg, 191104
Private Medical Institution Euromedservice
Saint Petersburg, 196603
Republican Oncology Dispensary
Saransk, 430032
Tomsk Cancer Research Institute
Tomsk, 634050
Multifunctional clinical medical center 'Medical city'
Tyumen, 625041
Bashkir State Medical University
Ufa, 450083
South Korea14 sites
Pusan National University Hospital
Busan, 49241
Kyungpook National University Chilgok Hospital
Daegu, 41404
Keimyung University Dongsan Hospital
Daegu, 42601
Chungnam National University Hospital
Daejeon, 35015
Chonnam National University Hospital
Gwangju, 61469
National Cancer Center
Gyeonggi-do, 10408
Seoul National University Bundang Hospital
Seongnam-si, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591
Ajou University Hospital
Suwon, 16499
United Kingdom13 sites
Ysbyty Gwynedd
Bangor, LL57 2PW
Belfast City Hospital
Belfast, BT9 7AB
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 5BE
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
Guy's Hospital
Great Maze Pond, SE1 9RT
Prince Of Wales Hospital
Grimsby, DN33 2BA
Marie Curie Research Wing - Mount Vernon Hospital
Hillingdon, HA6 2RN
Raigmore Hospital
Inverness, IV2 3UJ
University College London Hospitals NHSFT
London, NW1 2PG
Churchill Hospital
Oxford, OX3 7LE
Royal Preston Hospital
Preston, PR2 9HT
Royal Marsden Hospital
Sutton, SM2 5PT
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Truro, TR1 3LJ
Australia11 sites
Sunshine Coast University Hospital
Birtinya, 4575
St Vincent s Hospital Sydney
Darlinghurst, 2010
Cancer Care Services Clinical Research Unit
Herston, 4029
Royal Hobart Hospital
Hobart, 7000
Icon Cancer Centre Kurralta Park
Kurralta Park, 5037
Liverpool Hospital
Liverpool, 2170
Peter MacCallum Cancer Centre
Melbourne, 3000
Fiona Stanley Hospital
Murdoch, 6150
Macquarie University Hospital
North Ryde, 2109
ICON Cancer Care
South Brisbane, 4101
St John of God Subiaco Hospital
Subiaco, 6008
Canada11 sites
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
McMaster Institute of Urology
Hamilton, Ontario, L8N 4A6
British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)
Kelowna, British Columbia, V1Y 5L3
Kingston Health Sciences Centre, Kingston General Health Research Institute
Kingston, Ontario, K7L2V7
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9
McGill University - Jewish General Hospital
Montreal, Quebec, H3T 1E2
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, M5G2M9
British Columbia Cancer Agency BCCA Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
British Columbia Cancer Agency Vancouver Island Centre
Victoria, British Columbia, V8R 6V5
Poland11 sites
IN VIVO Sp. z o.o
Bydgoszcz, 85 048
Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
Bydgoszcz, 85 094
Centrum Onkologii im Prof F Lukaszczyka
Bydgoszcz, 85 796
Szpitale Pomorskie Sp z o o
Gdynia, 81 519
Przychodnia Lekarska KOMED Roman Karaszewski
Konin, 62-500
Klinika MedTrials
Krakow, 30 539
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, 93-509
Medisport
Lublin, 20-223
Urologica Praktyka Lekarska Adam Marcheluk
Siedlce, 08-110
Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
Warsaw, 04 073
Specjalistyczna przychodnia lekarska POLIMED
Wroclaw, 53-329
Belarus8 sites
Bobruisk Interregional Oncology Dispensary
Babruysk, 213825
Brest Regional Oncology Dispensary
Brest, 224027
Grodno University Hospital
Grodno, 230017
Gomel Regional Clinical Oncology Dispensary
Homyel, 246012
N N Alexandrov National Cancer Centre of Belarus
Lesnoy, 223040
Minsk city Clinical Oncological Dispensary
Minsk, 220013
Mogilev Regional Oncology Dispensary
Mogilev, 212018
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, 210603
Belgium8 sites
ZNA Middelheim
Antwerp, 2020
ZAS Augustinus
Antwerp, 2610
Grand Hopital De Charleroi Site Les Viviers
Charleroi, 6060
Jolimont
Haine-St-Paul, 7100
CHC MontLegia
Liège, 4000
CHU UCL Namur - Site Sainte Elisabeth
Namur, 5000
Clinique St Pierre
Ottignies, 1340
Algemeen Ziekenhuis Delta
Roeselare, 8800
Germany8 sites
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
Braunschweig, 38126
Universitaetsklinikum Koelnt
Cologne, 50937
Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I
Dresden, 01307
Urologicum Duisburg
Duisburg, 47169
Medizinische Hochschule Hannover
Hanover, 30625
Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
München, 81675
Universitaetsklinikum Muenster
Münster, 48149
Studienpraxis Urologie Drs. Feyerabend
Nürtingen, 72622
Mexico8 sites
Consultorio de Especialidad en Urologia Privado
Durango, 34000
Consultorio Privado
León, 37000
Centro de Investigacion Clínica Gramel S.C.1
Mexico City, 3720
Avix Investigacion Clinica S C
Monterrey, 64710
i Can Oncology Center
Monterrey, 64710
Oncologia Integral Satelite
Naucalpan, 53100
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, 68020
Consultorio Privado 1
Zapopan, 45040
Taiwan8 sites
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung, 40705
Tungs' Taichung MetroHarbor Hospital
Taichung, 435
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan, 333
Bulgaria7 sites
MHAT Deva Maria
Burgas, 8001
UMHAT Dr Georgi Stranski EAD 1
Pleven, 5800
Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004
Multifunctional Hospital for Active Treatment for Women Health Nadezhda
Sofia, 1330
Specialized Hospital for Active Treatment in Oncology
Sofia, 1756
UMHAT Sofia Med
Sofia, 1797
Comprehensive Cancer Center
Vratsa, 3001
Hungary7 sites
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, 1204
Debreceni Egyetem
Debrecen, 4032
Petz Aladar Megyei Oktato Korhaz
Győr, 9024
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700
Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
Szegedi Tudomanyegyetem
Szeged, 6720
Szent Borbala Hospital Tatabanya
Tatabánya, 2800
Israel7 sites
Haemek Medical Center - Afula
Afula, 1834111
Soroka Hospital
Beersheba, 85101
Rambam Medical Center
Haifa, 31096
Hadassah Hospital
Jerusalem, 91200
Rabin Medical Center, Beilinson Hospital
Petach Tikvah, 49100
Sheba Medical Center Tel Hashomer
Ramat Gan, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Denmark6 sites
Aalborg University Hospital
Aalborg, 9000
Copenhagen University Hospital
Copenhagen, 2100
Herlev Hospital
Herlev, DK-2730
Næstved Hospital
Næstved, 4700
Odense Universitetshospital
Odense, DK-5000
Vejle Hospital
Vejle, DK-7100
Malaysia6 sites
Hospital Pulau Pinang
George Town, 10990
Hospital Sultan Ismail
Johor Bahru, 81100
Hospital Kuala Lumpur
Kuala Lumpur, 50586
University Malaya Medical Centre
Kuala Lumpur, 59100
Sarawak General Hospital
Kuching, 93586
Institut Kanser Negara Clinical Research Center
Putrajaya, 62250
Czechia5 sites
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91
FN Hradec Kralove, Urologicka klinika
Hradec Králové, 500 05
Krajská nemocnice Liberec
Liberec, 460 63
Uromedical Center s.r.o.
Olomouc, 77900
Urologicka klinika 1 LF UK a VFN
Prague, 128 00
Netherlands4 sites
Reinier de Graaf Gasthuis
Delft, 2625 AD
Tergooiziekenhuizen
Hilversum, 1213XZ
Canisius-Wilhelminaziekenhuis
Nijmegen, 6532 SZ
Elisabeth-TweeSteden Ziekenhuis
Tilburg, 5022 GC
New Zealand4 sites
Auckland City Hospital
Auckland, 1023
Canterbury Urology Research Trust
Christchurch, 8013
Dunedin Hospital
Dunedin Central, 9016
Tauranga Hospital
Tauranga, 3112
Portugal4 sites
Uls Almada Seixal - Hosp. Garcia de Orta
Almada, 2805-607
Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A.
Coimbra, 3000075
Fund. Champalimaud
Lisbon, 1400-038
Uls Santa Maria - Hosp. Santa Maria
Lisbon, 1649 035
Sweden4 sites
Salgrenska University hospital
Gothenburg, 413 45
Urologiska Mottagningen
Malmö, 205 02
Sodersjukhuset
Stockholm, 11883
Karolinska Universitetssjukhuset Solna
Stockholm, 17164
South Africa3 sites
CancerCare Rondebosch
Cape Town, 7700
Steve Biko Academic Hospital
Pretoria, 0001
East Rand Urology Research Unit
Vosloorus, 1475
Thailand3 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Ramathibodi Hospital
Bangkok, 10400
Siriraj Hospital
Bangkok, 10700
About this study
Official title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).
- Conditions
- Prostatic Neoplasms
- Being tested
- Niraparib+ Abiraterone acetate fixed dose combination (FDC), Abiraterone acetate (AA), Prednisone, Placebo FDC, Placebo AA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niraparib+ Abiraterone acetate fixed dose combination (FDC)Combination product
Participants will receive a FDC of Niraparib 200 mg + AA 1000 mg once daily.
Abiraterone acetate (AA)Drug
Participants will receive AA 1000 mg once daily.
PrednisoneDrug
Participants will receive prednisone 5 mg once daily.
Placebo FDCDrug
Participants will receive matching placebo for Niraparib +AA FDC once daily.
Placebo AADrug
Participants will receive matching placebo for AA once daily.
| Study group | Role | What they receive |
|---|---|---|
| Niraparib with Abiraterone Acetate plus Prednisone (AAP) | Experimental | Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg) + abiraterone acetate (AA) 1000 mg fixed dose combination (FDC) along with placebo for AA and prednisone 5 mg once daily. Receives: Combination Product: Niraparib+ Abiraterone acetate fixed dose combination (FDC); Drug: Prednisone; Drug: Placebo AA |
| Placebo for Niraparib + AA FDC plus AA and prednisone (AAP) | Active comparator | Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib+AA FDC along with AA 1000 mg and prednisone 5 mg once daily. Receives: Drug: Abiraterone acetate (AA); Drug: Prednisone; Drug: Placebo FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors (RECIST) 1.1; (2) progression of bone lesions observed by bone scan per prostate cancer working group 3 (PCWG3) criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with >=2 new lesions indicated progression; A confirmatory scan not showing >=2 new lesions means no progression. If Week 8 scan shows <2 new bone lesions compared to baseline, first scan with >=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan >=6 weeks later.
Measured: From date of randomization (Day -3 to Day 1) up to approximately 49 months
HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per PCWG3 criteria: bone progression was confirmed by subsequent scan >= 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with >=2 new lesions indicated progression; A confirmatory scan not showing >=2 new lesions means no progression. If Week 8 scan shows <2 new bone lesions compared to baseline, first scan with >=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan >=6 weeks later.
Measured: From date of randomization (Day -3 to Day 1) up to approximately 49 months
All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per PCWG3 criteria: bone progression was confirmed by subsequent scan >= 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with >=2 new lesions indicated progression; A confirmatory scan not showing >=2 new lesions means no progression. If Week 8 scan shows <2 new bone lesions compared to baseline, first scan with >=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan >=6 weeks later.
Measured: From date of randomization (Day -3 to Day 1) up to approximately 49 months
Secondary outcomes (7)
BRCA Subgroup: Time to Symptomatic Progression
Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture [symptomatic and/or pathologic], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.
Measured: From date of randomization (Day -3 to Day 1) up to approximately 49 months
HRR Effector Subgroup: Time to Symptomatic Progression
Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture [symptomatic and/or pathologic], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.
Measured: From date of randomization (Day -3 to Day 1) up to approximately 49 months
All HRR: Time to Symptomatic Progression
Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture [symptomatic and/or pathologic], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.
Measured: From date of randomization (Day -3 to Day 1) up to approximately 49 months
Overall Survival (OS)
Measured: From date of randomization (Day -3 to Day 1) up to 83 months
Time to Subsequent Therapy
Measured: From date of randomization (Day -3 to Day 1) up to 83 months
Number of Participants With Treatment-emergent Serious Adverse Events
Measured: From Cycle 1 Day 1 up to 83 months
Number of Participants With Treatment-emergent Adverse Events by Severity
Measured: From Cycle 1 Day 1 up to 83 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start23 Sep 2020
- Primary completion7 Jan 2025
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 696 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497844
- Sponsor's protocol ID
- CR108852
- Other IDs
- 67652000PCR3002, 2020-002209-25, 2023-506365-64-00, 2023
- Acronym
- AMPLITUDE
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2020
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Publications
Attard G, Agarwal N, Graff JN, Sandhu S, Efstathiou E, Ozguroglu M, Pereira de Santana Gomes AJ, Vianna K, Luo H, Gotto GT, Cheng HH, Kim W, Varela CR, Schaeffer D, Kramer K, Li S, Baron B, Shen F, Mundle SD, McCarthy SA, Olmos D, Chi KN, Rathkopf DE. Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nat Med. 2025 Dec;31(12):4109-4118. doi: 10.1038/s41591-025-03961-8. Epub 2025 Oct 7.
PubMed 41057655