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-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04497844 |
Recruitment Status :
Recruiting
First Posted : August 4, 2020
Last Update Posted : March 15, 2023
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Brief 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) provides superior efficacy in improving radiographic progression-free survival (rPFS).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Castrate Sensitive Prostate Cancer | Drug: Niraparib Drug: Abiraterone acetate (AA) Drug: Prednisone Drug: Placebo for Niraparib | Phase 3 |
Prostate cancer is a heterogenous disease and recent genomic analyses have highlighted specific germline and somatic mutations and alternative driver growth signaling pathways in patients with metastatic disease. Abiraterone acetate plus prednisone (AA-P) is an established standard of care for the treatment of participants with mCSPC and is included in widely accepted clinical treatment guidelines. Niraparib is an investigational agent in the castration-sensitive cancer population and has been approved for the treatment of ovarian cancer. The addition of niraparib to the AA-P backbone regimen may improve initial disease control and long-term outcomes compared with AA-P alone in a biomarker selected population. The study will consist of 4 phases; a Prescreening Phase for biomarker evaluation for eligibility only, a Screening Phase, a Treatment Phase, and a Follow-up Phase. Efficacy evaluations include the following: tumor measurements by computed tomography (CT), magnetic resonance imaging (MRI; abdomen, chest, and pelvis), Technetium-99m (99mTc) bone scans, serum prostate sensitive antigen (PSA) evaluations, and patient reported outcomes (PROs). Safety evaluations include incidence of adverse events and clinical laboratory parameters.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 692 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | September 23, 2020 |
Estimated Primary Completion Date : | November 15, 2024 |
Estimated Study Completion Date : | May 7, 2027 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Prostate cancer
Arm | Intervention/treatment |
---|---|
Experimental: Niraparib with Abiraterone Acetate plus Prednisone (AA-P)
Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily.
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Drug: Niraparib
Participants will receive Niraparib 200 mg once daily. Drug: Abiraterone acetate (AA) Participants will receive AA 1000 mg once daily. Drug: Prednisone Participants will receive prednisone 5 mg once daily. |
Experimental: AA plus Prednisone (AA-P)
Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily.
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Drug: Prednisone
Participants will receive prednisone 5 mg once daily. Drug: Placebo for Niraparib Participants will receive matching placebo for Niraparib once daily. |
Primary Outcome Measures :
- Radiographic Progression-free Survival (rPFS) [ Time Frame: Up to 47 months ]rPFS is defined as time from randomization date to date of radiographic progression or death, whichever occurs first. Radiographic progression will be evaluated by Prostate Cancer Working Group 3 (PCWG3) criteria.
Secondary Outcome Measures :
- Overall Survival (OS) [ Time Frame: Up to 78 months ]OS is defined as the time from date of randomization to date of death from any cause.
- Symptomatic Progression-free Survival [ Time Frame: Up to 47 months ]Symptomatic progression free survival is defined as time from the date of randomization to the onset of symptoms consistent with progression of metastatic prostate cancer.
- Time to Subsequent Therapy [ Time Frame: Up to 47 months ]Time to Subsequent Therapy is defined as the time from date of randomization to the date of initiation of subsequent therapy for prostate cancer.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 78 months ]An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. AE does not necessarily have a causal relationship with intervention.
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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)
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497844
Contacts
Contact: Study Contact | 844-434-4210 | Participate-In-This-Study@its.jnj.com |
Locations


United States, Alabama | |
Urology Centers Of Alabama | Recruiting |
Homewood, Alabama, United States, 35209 | |
United States, Arizona | |
Mayo Clinic Arizona | Recruiting |
Phoenix, Arizona, United States, 85054 | |
Urological Associates of Southern Arizona, P.C. | Recruiting |
Tucson, Arizona, United States, 85741 | |
United States, California | |
Greater Los Angeles VA Healthcare System | Recruiting |
Los Angeles, California, United States, 90073 | |
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center | Recruiting |
Orange, California, United States, 92868 | |
San Bernardino Urological Associates | Recruiting |
San Bernardino, California, United States, 92404 | |
UCSD Moores Cancer Center | Withdrawn |
San Diego, California, United States, 92093-0987 | |
VA Medical Center | Withdrawn |
San Francisco, California, United States, 94121 | |
University of San Francisco California | Recruiting |
San Francisco, California, United States, 94158 | |
United States, Colorado | |
Rocky Mountain Cancer Centers | Recruiting |
Colorado Springs, Colorado, United States, 80907 | |
The Urology Center of Colorado | Recruiting |
Denver, Colorado, United States, 80211 | |
Colorado Permanente Medical Group | Withdrawn |
Denver, Colorado, United States, 80230 | |
Colorado Clinical Research | Recruiting |
Lakewood, Colorado, United States, 80228 | |
United States, Connecticut | |
Eastern Connecticut Hematology & Oncology Assoc. | Recruiting |
Norwich, Connecticut, United States, 06360 | |
United States, Florida | |
Advanced Urology Institute | Completed |
Daytona Beach, Florida, United States, 32114 | |
University of Florida Health Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32209 | |
Cancer Specialists of North Florida | Recruiting |
Jacksonville, Florida, United States, 32256 | |
United States, Indiana | |
Urology of Indiana | Recruiting |
Greenwood, Indiana, United States, 46143 | |
First Urology | Completed |
Jeffersonville, Indiana, United States, 47130 | |
United States, Louisiana | |
Ochsner Clinic Foundation | Recruiting |
New Orleans, Louisiana, United States, 70121 | |
United States, Maryland | |
Baltimore VA Medical Center | Not yet recruiting |
Baltimore, Maryland, United States, 21201 | |
Maryland Oncology Hematology, PA | Recruiting |
Columbia, Maryland, United States, 21044 | |
Chesapeake Urology Associates | Recruiting |
Towson, Maryland, United States, 21204 | |
United States, Michigan | |
Michigan Institute of Urology | Recruiting |
Troy, Michigan, United States, 48084 | |
United States, Mississippi | |
University of Mississippi Medical Center | Withdrawn |
Jackson, Mississippi, United States, 39213 | |
United States, Missouri | |
Mosaic Life Care | Recruiting |
Saint Joseph, Missouri, United States, 64507 | |
St. Louis VA Medical Center | Recruiting |
Saint Louis, Missouri, United States, 63109 | |
United States, Nebraska | |
GU Research Network | Completed |
Omaha, Nebraska, United States, 68130 | |
United States, New York | |
New York Oncology Hematology | Recruiting |
Albany, New York, United States, 12206 | |
Montefiore Medical Center | Recruiting |
Bronx, New York, United States, 10461 | |
Kings County Hospital Center | Withdrawn |
Brooklyn, New York, United States, 11203 | |
Memorial Sloan Kettering Cancer Center | Not yet recruiting |
Brooklyn, New York, United States, 11203 | |
Memorial Sloan Kettering Cancer Center | Not yet recruiting |
Jamaica, New York, United States, 11432 | |
Queens Cancer Center of Queens Hospital Center | Withdrawn |
Jamaica, New York, United States, 11432 | |
Manhattan VAMC | Recruiting |
New York, New York, United States, 10010 | |
Mount Sinai | Recruiting |
New York, New York, United States, 10029 | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Associated Medical Professionals | Recruiting |
Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
Durham VAMC | Recruiting |
Durham, North Carolina, United States, 27705 | |
United States, Oklahoma | |
Stephenson Cancer Center | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Oregon | |
VA Portland Health Care System | Recruiting |
Portland, Oregon, United States, 97239 | |
Oregon Oncology Specialists | Recruiting |
Salem, Oregon, United States, 97301 | |
United States, Pennsylvania | |
Keystone Urology Specialists | Recruiting |
Lancaster, Pennsylvania, United States, 17604 | |
Philadelphia VA Medical Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Thomas Jefferson University | Withdrawn |
Philadelphia, Pennsylvania, United States, 19107 | |
University of Pittsburgh Medical Center (UPMC) | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, South Carolina | |
Ralph H. Johnson Veterans Affairs Medical Center | Recruiting |
Charleston, South Carolina, United States, 29401 | |
Prisma Health | Recruiting |
Seneca, South Carolina, United States, 29672 | |
United States, Tennessee | |
West Cancer Center | Withdrawn |
Germantown, Tennessee, United States, 38138 | |
Urology Associates | Recruiting |
Nashville, Tennessee, United States, 37209 | |
United States, Texas | |
Texas Oncology-Denton South | Recruiting |
Denton, Texas, United States, 76201 | |
Houston Metro Urology | Recruiting |
Houston, Texas, United States, 77027 | |
Houston Methodist Hospital | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Texas Oncology P.A. | Recruiting |
New Braunfels, Texas, United States, 78130 | |
Texas Oncology-Tyler | Recruiting |
Tyler, Texas, United States, 75702 | |
United States, Utah | |
University of Utah Huntsman Cancer Institute | Recruiting |
Salt Lake City, Utah, United States, 84112 | |
United States, Virginia | |
Virginia Oncology Associates | Recruiting |
Norfolk, Virginia, United States, 23502 | |
Virginia Commonwealth University - Massey Cancer Center | Recruiting |
Richmond, Virginia, United States, 23298 | |
Urology of Virginia, PLCC | Withdrawn |
Virginia Beach, Virginia, United States, 23462 | |
United States, Washington | |
VA Puget Sound Healthcare System | Recruiting |
Seattle, Washington, United States, 98108 | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109 | |
MultiCare Health System | Recruiting |
Tacoma, Washington, United States, 98405 | |
Argentina | |
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês | Recruiting |
Buenos Aires, Argentina, C1419AHN | |
Hospital Militar Cosme Argerich | Recruiting |
C.a.b.a., Argentina, C1426BOR | |
Hospital Aleman | Withdrawn |
Caba, Argentina, 1118 | |
CIPREC Arenales | Recruiting |
Caba, Argentina, C1061AAS | |
Centro de Urologia (CDU) | Recruiting |
Ciudad Automoma Buenos Aires, Argentina, C1120AAT | |
CINME - Centro de Investigaciones Metabolicas | Recruiting |
Ciudad Autonoma de Buenos Aires, Argentina, C1027AAP | |
Hospital Italiano de Buenos Aires | Completed |
Ciudad Autonoma de, Argentina, C1199ABB | |
Centro Oncológico Korben | Recruiting |
Ciudad Autónoma de Buenos Aires, Argentina, C1426AGE | |
Clínica Adventista Belgrano | Recruiting |
Ciudad De Buenos Aires, Argentina, C1430EGF | |
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Recruiting |
Cordoba, Argentina, 5000 | |
Centro Urologico Profesor Bengio | Recruiting |
Cordoba, Argentina, X5000KPH | |
Instituto Médico de Río Cuarto | Recruiting |
Cordoba, Argentina, X5800 | |
Hospital Privado de Cordoba | Recruiting |
Cordoba, Argentina, XX5016KEH | |
Hospital Privado de Comunidad | Recruiting |
Mar Del Plata, Argentina, B7602CBM | |
Centro de Investigacion Pergamino SA | Recruiting |
Pergamino, Argentina, B2700CPM | |
ARS Médica | Recruiting |
San Salvador De Jujuy, Argentina, Y4600AFW | |
Australia | |
Sunshine Coast University Hospital | Recruiting |
Birtinya, Australia, 4575 | |
St. Vincent's Hospital Sydney | Recruiting |
Darlinghurst, Australia, 2010 | |
Royal Brisbane and Women's Hospital | Recruiting |
Herston, Australia, 4029 | |
Royal Hobart Hospital | Recruiting |
Hobart, Australia, 7000 | |
Ashford Cancer Centre | Recruiting |
Kurralta Park, Australia, 5037 | |
Liverpool Hospital | Recruiting |
Liverpool, Australia, 2170 | |
Peter MacCallum Cancer Centre | Recruiting |
Melbourne, Australia, 3000 | |
Fiona Stanley Hospital | Recruiting |
Murdoch, Australia, 6150 | |
Macquarie University Hospital | Recruiting |
North Ryde, Australia, 2109 | |
ICON Cancer Care | Recruiting |
South Brisbane, Australia, 4101 | |
St John of God Subiaco Hospital | Recruiting |
Subiaco, Australia, 6008 | |
Belarus | |
Bobruisk Interregional Oncological Dispensary | Suspended |
Bobruisk, Belarus, 213825 | |
Brest Regional Oncology Dispensary | Suspended |
Brest, Belarus, 224027 | |
Gomel Regional Clinical Oncology Dispensary | Suspended |
Gomel, Belarus, 246012 | |
Grodno University Hospital | Suspended |
Grodno, Belarus, 230017 | |
State Institution N.N. Alexandrov Republican Scientific and | Suspended |
Lesnoy, Belarus, 223040 | |
Minsk city Clinical Oncological Dispensary | Suspended |
Minsk, Belarus, 220013 | |
Mogilev Regional Hospital | Suspended |
Mogilev, Belarus, 212018 | |
Vitebsk Regional Clinical Hospital | Suspended |
Vitebsk, Belarus, 210603 | |
Belgium | |
ZNA Middelheim | Recruiting |
Antwerp, Belgium, 2020 | |
Grand Hôpital de Charleroi, site Notre Dame | Recruiting |
Charleroi, Belgium, 6000 | |
Jolimont | Recruiting |
Haine-St-Paul, Belgium, 7100 | |
CHC MontLegia | Recruiting |
Liege, Belgium, 4000 | |
CHU UCL Namur - Site Sainte Elisabeth | Recruiting |
Namur, Belgium, 5000 | |
Clinique St Pierre | Recruiting |
Ottignies, Belgium, 1340 | |
Algemeen Ziekenhuis Delta | Recruiting |
Roeselare, Belgium, 8800 | |
GZA Ziekenhuizen | Recruiting |
Wilrijk, Belgium, 2610 | |
Brazil | |
Fundacao Pio XII | Recruiting |
Barretos, Brazil, 14784-400 | |
Cetus Oncologia | Recruiting |
Belo Horizonte, Brazil, 30110-022 | |
PERSONAL - Oncologia de Precisão e Personalizada | Recruiting |
Belo Horizonte, Brazil, 30130-090 | |
CIONC - Centro Integrado de Oncologia de Curitiba | Recruiting |
Curitiba, Brazil, 80810-050 | |
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN | Recruiting |
Florianopolis, Brazil, 88034-000 | |
Pronutrir | Recruiting |
Fortaleza, Brazil, 60 810180 | |
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge | Recruiting |
Goiania, Brazil, 74605-070 | |
Associacao Hospital de Caridade Ijui | Withdrawn |
Ijui, Brazil, 98700-000 | |
Fundação São Francisco Xavier | Recruiting |
Ipatinga, Brazil, 35162 189 | |
Instituto Joinvilense de Hematologia e Oncologia Ltda - Centro de Hematologia e Oncologia | Recruiting |
Joinville, Brazil, 89201-260 | |
Liga Norte Riograndense Contra O Cancer | Recruiting |
Natal, Brazil, 59075-740 | |
UPCO Unidade de Pesquisa Clinica em Oncologia | Recruiting |
Pelotas, Brazil, 96020 080 | |
Irmandade Santa Casa de Misericordia de Porto Alegre | Recruiting |
Porto Alegre, Brazil, 90020-090 | |
Hospital Ernesto Dornelles | Recruiting |
Porto Alegre, Brazil, 90160-093 | |
MultiHemo Servicos Medicos S.A | Recruiting |
Recife, Brazil, CEP: 50070-460 | |
Ministerio da Saude - Instituto Nacional do Cancer | Recruiting |
Rio de Janeiro, Brazil, 20230-130 | |
Universidade do Estado do Rio de Janeiro - UERJ | Recruiting |
Rio de Janeiro, Brazil, 20551-030 | |
Oncoclínicas Rio de Janeiro S.A. | Recruiting |
Rio de Janeiro, Brazil, 22250-905 | |
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) | Recruiting |
Rio de Janeiro, Brazil, 22775-001 | |
Núcleo de Oncologia da Bahia | Recruiting |
Salvador, Brazil, 40170-110 | |
Hospital Sao Rafael | Recruiting |
Salvador, Brazil, 41253-190 | |
Fundacao do ABC - Centro Universitario FMABC | Recruiting |
Santo Andre, Brazil, 09060-870 | |
Irmandade Santa Casa de Misericordia de Sao Paulo | Recruiting |
Sao Paulo, Brazil, 01221-020 | |
Associacao Umane | Withdrawn |
Sao Paulo, Brazil, 01232-910 | |
Instituto de Ensino e Pesquisa São Lucas | Recruiting |
Sao Paulo, Brazil, 01236-030 | |
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo | Recruiting |
Sao Paulo, Brazil, 01246-000 | |
Hospital Alemão Oswaldo Cruz | Recruiting |
Sao Paulo, Brazil, 01421-000 | |
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE | Recruiting |
Sao Paulo, Brazil, 04039-004 | |
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado | Recruiting |
Sorocaba, Brazil, 18030-005 | |
Instituto do Cancer Arnaldo Vieira de Carvalho | Recruiting |
São Paulo, Brazil, 01221-020 | |
Real e Benemérita Associação Portuguesa de Beneficência | Recruiting |
São Paulo, Brazil, 01323-900 | |
Núcleo de Pesquisa São Camilo | Recruiting |
São Paulo, Brazil, 04014-002 | |
Centro Oncológico do Triângulo | Recruiting |
Uberlândia, Brazil, 38408-150 | |
Bulgaria | |
MHAT Deva Maria | Recruiting |
Burgas, Bulgaria, 8001 | |
UMHAT 'Dr. Georgi Stranski', EAD | Withdrawn |
Pleven, Bulgaria, 5800 | |
UMHAT 'Dr. Georgi Stranski', EAD | Completed |
Pleven, Bulgaria, 5800 | |
Complex Oncology Center - Plovdiv EOOD | Withdrawn |
Plovdiv, Bulgaria, 4004 | |
District Oncology Dispensary with In-Patient Stationary - Plovdiv | Recruiting |
Plovdiv, Bulgaria, 4004 | |
Multifunctional Hospital for Active Treatment for Women Health Nadezhda | Recruiting |
Sofia, Bulgaria, 1330 | |
Specialized Hospital for Active Treatment in Oncology | Completed |
Sofia, Bulgaria, 1756 | |
UMHAT Sofia Med | Recruiting |
Sofia, Bulgaria, 1797 | |
Comprehensive Cancer Center | Completed |
Vratsa, Bulgaria, 3001 | |
Canada, Alberta | |
Prostate Cancer Centre | Recruiting |
Calgary, Alberta, Canada, T2V 1P9 | |
Cross Cancer Institute | Recruiting |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, British Columbia | |
British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI) | Recruiting |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
British Columbia Cancer Agency (BCCA) - Vancouver Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
British Columbia Cancer Agency - Vancouver Island Centre | Recruiting |
Victoria, British Columbia, Canada, V8R 6V5 | |
Canada, Ontario | |
McMaster Institute of Urology | Recruiting |
Hamilton, Ontario, Canada, L8N 4A6 | |
Kingston Health Sciences Centre, Kingston General Health Research Institute | Recruiting |
Kingston, Ontario, Canada, K7L2V7 | |
Sunnybrook Health Sciences Center | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
University Health Network (UHN) Princess Margaret Cancer Centre | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
Centre Hospitalier de l'Universite de Montreal | Recruiting |
Montreal, Quebec, Canada, H2X 0A9 | |
McGill University - Jewish General Hospital | Recruiting |
Montreal, Quebec, Canada, H3T 1E2 | |
China | |
Cancer Hospital Chinese Academy of Medical Sciences | Recruiting |
Beijing, China, 100021 | |
Peking University First Hospital | Recruiting |
Beijing, China, 100034 | |
Beijing Friendship Hospital, Capital Medical University | Recruiting |
Beijing, China, 100050 | |
Beijing Cancer Hospital | Recruiting |
Beijing, China, 100142 | |
Beijing University Third Hospital | Recruiting |
Beijing, China, 100191 | |
Beijing Hospital | Recruiting |
Beijing, China, 100730 | |
Hunan Cancer hospital | Withdrawn |
Changsha, China, 410013 | |
West China Hospital of Sichuan University | Recruiting |
Chengdu, China, 610041 | |
Sichuan Provincial People's Hospital | Recruiting |
Chengdu, China, 610072 | |
Western Theater General Hospital of the Chinese People's Liberation Army | Recruiting |
Chengdu, China, 610083 | |
Chongqing University Cancer Hospital | Recruiting |
Chongqing, China, 400030 | |
Southwest Hospital, The Third Military Medical University | Recruiting |
Chongqing, China, 400038 | |
PLA Army Characteristic Medical Center | Not yet recruiting |
Chongqing, China, 400042 | |
Sun Yat-Sen University Cancer Center | Recruiting |
GuangZhou, China, 430030 | |
Guangzhou First Municipal People's Hospital | Recruiting |
Guangzhou, China, 510180 | |
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Recruiting |
Guangzhou, China, 510289 | |
Zhejiang Provincial People's Hospital | Recruiting |
Hangzhou, China, 310014 | |
The First Affiliated Hospital of NanChang University | Recruiting |
Nanchang, China, 330006 | |
Jiangsu Province Cancer Hospital | Recruiting |
Nanjing, China, 210000 | |
Nanjing Drum Tower Hospital | Recruiting |
Nanjing, China, 210008 | |
Ningbo First Hospital | Recruiting |
Ningbo, China, 315010 | |
Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University | Withdrawn |
Shanghai, China, 200025 | |
Fudan University Shanghai Cancer Center | Recruiting |
Shanghai, China, 200032 | |
Zhongshan Hospital,Fudan University | Not yet recruiting |
Shanghai, China, 200032 | |
Huashan Hospital Fudan University | Recruiting |
Shanghai, China, 200040 | |
Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University | Recruiting |
Shanghai, China, 200127 | |
The Fifth People's Hospital of Shanghai, Fudan University | Recruiting |
Shanghai, China, 200240 | |
Huadong Hospital Affiliated to Fudan University | Recruiting |
Shanghai, China, 200400 | |
Shengjing Hospital of China Medical University | Recruiting |
Shenyang, China, 110004 | |
Second Affiliated Hospital of Soochow University | Recruiting |
SuZhou, China, 200233 | |
The First Affliated Hospital of Soochow University | Recruiting |
Suzhou, China, 215006 | |
The First Affiliated Hospital of Wenzhou Medical University | Recruiting |
Wenzhou, China, 325000 | |
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology | Recruiting |
Wuhan, China, 430030 | |
The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting |
Xi'an, China, 710061 | |
Yantai Yuhuangding Hospital | Withdrawn |
Yantai, China, 264000 | |
Czechia | |
Fakultni nemocnice u sv. Anny v Brne | Recruiting |
Brno, Czechia, 656 91 | |
FN Hradec Kralove, Urologicka klinika | Recruiting |
Hradec Kralove, Czechia, 500 05 | |
Krajská nemocnice Liberec | Recruiting |
Liberec, Czechia, 460 63 | |
Uromedical Center s.r.o. | Recruiting |
Olomouc, Czechia, 77900 | |
Urologicka klinika 1.LF UK a VFN | Recruiting |
Praha 2, Czechia, 128 00 | |
Thomayerova nemocnice | Withdrawn |
Praha 4, Czechia, 140 59 | |
Denmark | |
Aalborg University Hospital | Recruiting |
Aalborg, Denmark, 9000 | |
Copenhagen University Hospital | Recruiting |
Copenhagen, Denmark, 2100 | |
Herlev Hospital | Completed |
Herlev, Denmark, DK-2730 | |
Næstved Hospital | Recruiting |
Naestved, Denmark, 4700 | |
Odense Universitetshospital | Recruiting |
Odense, Denmark, DK-5000 | |
Vejle Hospital | Recruiting |
Vejle, Denmark, DK-7100 | |
France | |
Institut de Cancérologie de l'Ouest (ICO) | Recruiting |
Angers Cedex 9, France, 49933 | |
Institut Sainte Catherine | Recruiting |
Avignon Cedex 9, France, 84918 | |
CHRU De Besancon | Recruiting |
Besancon, France, 25030 | |
Institut Bergonié | Recruiting |
Bordeaux, France, 33000 | |
Centre Jean Perrin | Recruiting |
Clermont Ferrand, France, 63011 | |
Centre Georges François Leclerc | Recruiting |
Dijon, France, 21000 | |
Centre Oscar Lambret | Recruiting |
Lille, France, 59020 | |
Centre Leon Bérard | Recruiting |
Lyon, France, 69008 | |
Hopital Prive Jean Mermoz | Recruiting |
Lyon, France, 69008 | |
Hopital de la Timone | Withdrawn |
Marseille, France, 130005 | |
Hôpital Privé Clairval | Withdrawn |
Marseilli, France, 13009 | |
Institut Regional du Cancer de Montpellier Val d'Aurelle | Recruiting |
Montpellier, France, 34298 | |
Polyclinique de Gentilly | Recruiting |
Nancy, France, 54100 | |
CHU De Poitiers | Recruiting |
Poitiers Cedex, France, 86021 | |
Centre Hopitalier Inter-Communal De Cornouaille | Recruiting |
Quimper, France, 29000 | |
Polyclinique de Courlancy | Withdrawn |
Reims, France, 51100 | |
Centre de radiothérapie et d'Oncologie médicale de l'Essonne | Withdrawn |
Ris Orangis, France, 91130 | |
HIA Begin | Recruiting |
Saint Mande, France, 94163 | |
Institut de Cancérologie de Loire | Recruiting |
Saint-Priest-en-Jarez, France, 42271 | |
Clinique Sainte Anne | Recruiting |
Strasbourg, France, 67000 | |
Hopital Foch | Recruiting |
Suresnes, France, 32151 | |
CHRU de Tours | Recruiting |
Tours, France, 37044 | |
Germany | |
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer | Recruiting |
Braunschweig, Germany, 38126 | |
Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I | Recruiting |
Dresden, Germany, 01307 | |
Urologicum Duisburg | Recruiting |
Duisburg, Germany, 47169 | |
Urologikum Hamburg | Withdrawn |
Hamburg, Germany, 22399 | |
Medizinische Hochschule Hannover | Completed |
Hannover, Germany, 30625 | |
Universitaetsklinikum Koeln | Recruiting |
Koeln, Germany, 50937 | |
Urologie Neandertal Praxis Mettmann | Withdrawn |
Mettmann, Germany, 40822 | |
Universitaetsklinikum Muenster | Recruiting |
Muenster, Germany, 48149 | |
Klinikum rechts der Isar - III. Med. Klinik und Poliklinik | Recruiting |
München, Germany, 81675 | |
Studienpraxis Urologie Drs. Feyerabend | Recruiting |
Nuertingen, Germany, 72622 | |
Hungary | |
Magyar Honvedseg Egeszsegugyi Kozpont | Withdrawn |
Budapest, Hungary, 1062 | |
Semmelweis Egyetem, Urológia Klinika | Withdrawn |
Budapest, Hungary, 1082 | |
Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály | Withdrawn |
Budapest, Hungary, 1122 | |
Jahn Ferenc Del-pesti Korhaz es Rendelointezet | Recruiting |
Budapest, Hungary, 1204 | |
Uzsoki Utcai Korhaz | Withdrawn |
Budapest, Hungary, H-1145 | |
Debreceni Egyetem | Recruiting |
Debrecen, Hungary, 4032 | |
Petz Aladar Megyei Oktato Korhaz | Recruiting |
Gyor, Hungary, 9024 | |
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Completed |
Gyula, Hungary, 5700 | |
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz | Recruiting |
Miskolc, Hungary, 3526 | |
Szegedi Tudomanyegyetem | Recruiting |
Szeged, Hungary, 6720 | |
Szent Borbala Hospital Tatabanya | Recruiting |
Tatabanya, Hungary, 2800 | |
Zala Megyei Szent Rafael Korhaz | Withdrawn |
Zalaegerszeg, Hungary, 8900 | |
Israel | |
Haemek Medical Center - Afula | Recruiting |
Afula, Israel, 1834111 | |
Soroka Hospital | Recruiting |
Beer-Sheva, Israel, 85101 | |
Rambam Medical Center | Recruiting |
Haifa, Israel, 31096 | |
Hadassah Hospital | Recruiting |
Jerusalem, Israel, 91200 | |
Rabin Medical Center, Beilinson Hospital | Recruiting |
Petach Tikvah, Israel, 49100 | |
Sheba Medical Center Tel Hashomer | Recruiting |
Ramat Gan, Israel, 52621 | |
Tel-Aviv Sourasky Medical Center | Recruiting |
Tel-Aviv, Israel, 64239 | |
Yitzhak Shamir Medical Center | Withdrawn |
Tzrifin, Israel, 70300 | |
Italy | |
Ospedale S. Donato - Asl 8 Arezzo | Recruiting |
Arezzo, Italy, 52100 | |
Divisione di Oncologia - Istituto per la ricerca e cura del cancro | Recruiting |
Candiolo, Italy, 10060 | |
Istituti Ospitalieri di Cremona, AO di Cremona | Recruiting |
Cremona, Italy, 26100 | |
Azienda Ospedaliera ''Vito Fazzi'' | Recruiting |
Lecce, Italy, 73100 | |
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Recruiting |
Meldola, Italy, 47014 | |
Ospedale San Raffaele | Recruiting |
Milano, Italy, 20132 | |
Fondazione IRCCS Istituto Nazionale dei Tumori | Recruiting |
Milano, Italy, 20133 | |
European Institute of Oncology | Recruiting |
Milano, Italy, 20141 | |
Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS | Recruiting |
Napoli, Italy, 80138 | |
Aou San Luigi Gonzaga | Recruiting |
Orbassano, Italy, 10043 | |
Istituto Oncologico Veneto Iov Irccs Padova | Recruiting |
Padova, Italy, 35128 | |
Azienda Ospedaliero Universitaria Pisana | Recruiting |
Pisa, Italy, 56126 | |
ASL Napoli 2 Nord-SM delle Grazie Hospital | Recruiting |
Pozzuoli, Italy, 80078 | |
Casa Sollievo della Sofferenza, IRCCS | Recruiting |
San Giovanni Rotondo, Italy, 71013 | |
Ospedale S. Chiara | Recruiting |
Trento, Italy | |
Ospedale San Bortolo | Recruiting |
Vicenza, Italy | |
Korea, Republic of | |
Pusan National University Hospital | Recruiting |
Busan, Korea, Republic of, 49241 | |
Kyungpook National University Chilgok Hospital | Recruiting |
Daegu, Korea, Republic of, 41404 | |
Keimyung University Dongsan Hospital | Recruiting |
Daegu, Korea, Republic of, 42601 | |
Chungnam National University Hospital | Recruiting |
Daejeon, Korea, Republic of, 35015 | |
Chonnam National University Hospital | Recruiting |
Gwangju, Korea, Republic of, 61469 | |
National Cancer Center | Recruiting |
Gyeonggi-do, Korea, Republic of, 10408 | |
Seoul National University Bundang Hospital | Recruiting |
Gyeonggi-do, Korea, Republic of, 13620 | |
Ajou University Hospital | Recruiting |
Gyeonggi-do, Korea, Republic of, 16499 | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 03080 | |
Severance Hospital, Yonsei University Health System | Recruiting |
Seoul, Korea, Republic of, 03722 | |
Asan Medical Center | Recruiting |
Seoul, Korea, Republic of, 05505 | |
Gangnam Severance Hospital, Yonsei University Health System | Recruiting |
Seoul, Korea, Republic of, 06273 | |
Samsung Medical Center | Recruiting |
Seoul, Korea, Republic of, 06351 | |
The Catholic University of Korea, Seoul St. Mary's Hospital | Recruiting |
Seoul, Korea, Republic of, 06591 | |
Malaysia | |
Hospital Pulau Pinang | Recruiting |
George Town, Malaysia, 10990 | |
Hospital Sultan Ismail | Recruiting |
Johor Bahru, Malaysia, 81100 | |
Hospital Kuala Lumpur | Recruiting |
Kuala Lumpur, Malaysia, 50586 | |
University Malaya Medical Centre | Recruiting |
Kuala Lumpur, Malaysia, 59100 | |
Sarawak General Hospital | Recruiting |
Kuching, Malaysia, 93586 | |
Institut Kanser Negara - Clinical Research Center | Recruiting |
Putrajaya, Malaysia, 62250 | |
Mexico | |
Centro de Investigación Clínica Gramel S.C. | Recruiting |
Ciudad de Mexico, Mexico, 3720 | |
Consultorio de Especialidad en Urologia Privado | Recruiting |
Durango, Mexico, 34000 | |
Consultorio Privado | Recruiting |
Leon, Mexico, 37000 | |
Avix Investigacion Clinica, S.C. | Recruiting |
Monterrey, Mexico, 64710 | |
i Can Oncology Center | Recruiting |
Monterrey, Mexico, 64710 | |
Oncologia Integral Satelite | Recruiting |
Naucalpan, Mexico, 53100 | |
Consultorio de Oncología Médica | Recruiting |
Oaxaca, Mexico, 68020 | |
Consultorio Privado | Recruiting |
Zapopan, Mexico, 45040 | |
Netherlands | |
Reinier de Graaf Gasthuis | Recruiting |
Delft, Netherlands, 2625 AD | |
Tergooiziekenhuizen | Recruiting |
Hilversum, Netherlands, 1213XZ | |
UMC Radboud | Withdrawn |
Nijmegen, Netherlands, 6525AG | |
Canisius-Wilhelminaziekenhuis | Recruiting |
Nijmegen, Netherlands, 6532 SZ | |
Elisabeth-TweeSteden Ziekenhuis | Recruiting |
Tilburg, Netherlands, 5022 GC | |
New Zealand | |
Auckland City Hospital | Recruiting |
Auckland, New Zealand, 1023 | |
Canterbury Urology Research Trust | Recruiting |
Christchurch, New Zealand, 8013 | |
Dunedin Hospital | Recruiting |
Dunedin Central, New Zealand, 9016 | |
Tauranga Hospital | Recruiting |
Tauranga, New Zealand, 3112 | |
Poland | |
IN VIVO Sp. z o.o | Recruiting |
Bydgoszcz, Poland, 85-048 | |
Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza | Completed |
Bydgoszcz, Poland, 85-094 | |
Centrum Onkologii im. Prof. F. Lukaszczyka | Recruiting |
Bydgoszcz, Poland, 85-796 | |
Szpitale Pomorskie Sp. z o.o. | Recruiting |
Gdynia, Poland, 81-519 | |
Przychodnia Lekarska KOMED Roman Karaszewski | Recruiting |
Konin, Poland, 62-500 | |
Klinika MedTrials | Recruiting |
Krakow, Poland, 30-539 | |
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi | Recruiting |
Lodz, Poland, 93-509 | |
Medisport | Recruiting |
Lublin, Poland, 20-223 | |
Urologica Praktyka Lekarska Adam Marcheluk | Completed |
Siedlce, Poland, 08-110 | |
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. | Recruiting |
Warszawa, Poland, 04-073 | |
Specjalistyczna przychodnia lekarska POLIMED | Recruiting |
Wroclaw, Poland, 53-329 | |
Portugal | |
Hosp. Garcia de Orta | Recruiting |
Almada, Portugal, 2805-607 | |
Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A. | Recruiting |
Coimbra, Portugal, 3000075 | |
Fundação Champalimaud | Recruiting |
Lisboa, Portugal, 1400-038 | |
Chln - Hosp. Santa Maria | Recruiting |
Lisboa, Portugal, 1649-035 | |
Puerto Rico | |
Puerto Rico Medical Research Center | Recruiting |
Hato Rey, Puerto Rico, 00917 | |
Russian Federation | |
Altai Regional Oncology Dispensary | Completed |
Barnaul, Russian Federation, 656045 | |
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine | Completed |
Chelyabinsk, Russian Federation, 454087 | |
Ivanovo Regional Oncology Dispensary | Suspended |
Ivanovo, Russian Federation, 153040 | |
GUZ Kursk Regional Oncology Dispensary | Withdrawn |
Kursk, Russian Federation, 305524 | |
Russian Scientific Center of Roentgenoradiology | Withdrawn |
Moscow, Russian Federation, 117997 | |
Moscow City Clinical Hospital # 62 | Suspended |
Moscow, Russian Federation, 125130 | |
Hertzen Oncology Research Institute | Suspended |
Moscow, Russian Federation, 125284 | |
Privolzhsky District Medical Centre | Completed |
Nizhny Novgorod, Russian Federation, 603001 | |
Clinical Oncology Dispensary | Suspended |
Omsk, Russian Federation, 644013 | |
LLC Novaya Clinica | Completed |
Pyatigorsk, Russian Federation, 357500 | |
Pyatigorsk Regional Oncology Dispensary | Suspended |
Pyatigorsk, Russian Federation, 357502 | |
Private Medical Institution Euromedservice | Suspended |
Saint Petersburg, Russian Federation, 196603 | |
Leningrad Regional Oncology Dispensary | Suspended |
Saint-Petersburg, Russian Federation, 191104 | |
Russian Scientific Center of Radiology and Surgical Technologies | Withdrawn |
Sankt-Peterburg, Russian Federation, 197758 | |
Republican Oncology Dispensary | Completed |
Saransk, Russian Federation, 430032 | |
Oncologic Dispensary No.2 | Withdrawn |
Sochi, Russian Federation, 354057 | |
Tomsk Cancer Research Institute | Completed |
Tomsk, Russian Federation, 634050 | |
Multifunctional clinical medical center 'Medical city' | Suspended |
Tyumen, Russian Federation, 625041 | |
Bashkir State Medical University | Completed |
Ufa, Russian Federation, 450083 | |
South Africa | |
CancerCare Rondebosch | Completed |
Cape Town, South Africa, 7700 | |
Steve Biko Academic Hospital | Recruiting |
Pretoria, South Africa, 0001 | |
East Rand Urology Research Unit | Recruiting |
Vosloorus, South Africa, 1475 | |
Spain | |
Hosp. Univ. A Coruña | Recruiting |
A Coruña, Spain, 15006 | |
Hosp. de la Santa Creu i Sant Pau | Recruiting |
Barcelona, Spain, 08025 | |
Hosp. Clinic I Provincial de Barcelona | Recruiting |
Barcelona, Spain, 08036 | |
Hosp. Gral. Univ. De Castellon | Recruiting |
Castellon, Spain, 12004 | |
Institut Català D'Oncologia Girona | Recruiting |
Girona, Spain, 17007 | |
Hosp. Univ. de Jaen | Withdrawn |
Jaén, Spain, 23007 | |
Hosp. de Jerez de La Frontera | Recruiting |
Jerez de la Frontera, Spain, 11407 | |
Hosp. Univ. Arnau de Vilanova de Lleida | Withdrawn |
Lleida, Spain, 25198 | |
Hosp. Univ. de La Princesa | Recruiting |
Madrid, Spain, 28006 | |
Hosp. Univ. Ramon Y Cajal | Recruiting |
Madrid, Spain, 28034 | |
Hosp. Univ. 12 De Octubre | Recruiting |
Madrid, Spain, 28041 | |
Hosp. Univ. La Paz | Recruiting |
Madrid, Spain, 28046 | |
Hosp. Univ. Hm Monteprincipe | Recruiting |
Madrid, Spain, 28660 | |
Hosp. Virgen de La Victoria | Recruiting |
Málaga, Spain, 29010 | |
Hosp. Univ. Infanta Cristina | Withdrawn |
Parla, Madrid, Spain, 28981 | |
Corporacio Sanitari Parc Tauli | Recruiting |
Sabadell, Spain, 08208 | |
Hosp. Univ. Marques De Valdecilla | Recruiting |
Santander, Spain, 39008 | |
Hosp. Virgen Del Rocio | Recruiting |
Sevilla, Spain, 41013 | |
Hosp. Clinico Univ. De Valencia | Recruiting |
Valencia, Spain, 46010 | |
Sweden | |
Salgrenska University hospital | Recruiting |
Göteborg, Sweden, 413 45 | |
Urologiska Mottagningen | Recruiting |
Malmö, Sweden, 205 02 | |
Södersjukhuset | Recruiting |
Stockholm, Sweden, 11883 | |
Karolinska Universitetssjukhuset Solna | Recruiting |
Stockholm, Sweden, 17164 | |
Akademiska Sjukhuset | Withdrawn |
Uppsala, Sweden, 751 85 | |
Taiwan | |
Kaohsiung Chang Gung Memorial Hospital | Recruiting |
Kaohsiung City, Taiwan, 83301 | |
Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting |
Kaohsiung, Taiwan, 807 | |
China Medical University Hospital | Recruiting |
Taichung, Taiwan, 40447 | |
Taichung Veterans General Hospital | Completed |
Taichung, Taiwan, 40705 | |
Tungs' Taichung MetroHarbor Hospital | Recruiting |
Taichung, Taiwan, 435 | |
National Taiwan University Hospital. | Recruiting |
Taipei, Taiwan, 10002 | |
Taipei Veterans General Hospital | Recruiting |
Taipei, Taiwan, 11217 | |
Chang-Gung Memorial Hospital, LinKou Branch | Recruiting |
Taoyuan, Taiwan, 333 | |
Thailand | |
King Chulalongkorn Memorial Hospital | Recruiting |
Bangkok, Thailand, 10330 | |
Ramathibodi Hospital | Recruiting |
Bangkok, Thailand, 10400 | |
Siriraj Hospital | Recruiting |
Bangkok, Thailand, 10700 | |
Turkey | |
Adana Baskent Yuregir Hospital | Recruiting |
Adana, Turkey, 01250 | |
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital | Recruiting |
Ankara, Turkey, 06200 | |
Memorial Ankara Hastanesi | Recruiting |
Ankara, Turkey, 06520 | |
Gazi University Hospital | Recruiting |
Ankara, Turkey, 06560 | |
Ankara University Medical Faculty | Recruiting |
Ankara, Turkey, 06590 | |
Ankara Bilkent City Hospital | Recruiting |
Ankara, Turkey, 06800 | |
Akdeniz University Medical Faculty | Withdrawn |
Antalya, Turkey, 07070 | |
Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi | Recruiting |
Bursa, Turkey, 16310 | |
Trakya University Medical Faculty | Recruiting |
Edirne, Turkey, 22030 | |
Istanbul University Istanbul Medical Faculty | Recruiting |
Istanbul, Turkey, 34000 | |
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd | Recruiting |
Istanbul, Turkey, 34098 | |
Bakirkoy Training and Research Hospital | Recruiting |
Istanbul, Turkey, 34147 | |
T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi | Recruiting |
Istanbul, Turkey, 34722 | |
Dokuz Eylul University Medical Faculty | Recruiting |
Izmir, Turkey, 35340 | |
Izmir Medical Point Hospital | Recruiting |
Izmir, Turkey, 35530 | |
Manisa Celal Bayar University | Withdrawn |
Manisa, Turkey, 45030 | |
Sakarya University Training and Research Hospital | Recruiting |
Sakarya, Turkey, 54100 | |
Medical Park Samsun Hastanesi | Recruiting |
Samsun, Turkey, 55200 | |
Ukraine | |
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' | Suspended |
Cherkasy, Ukraine, 18009 | |
Municipal Non-profit enterprise 'Bukovinian clinical oncology center' | Suspended |
Chernivtsi, Ukraine, 58013 | |
Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc | Suspended |
Dnipro, Ukraine, 49005 | |
Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council | Suspended |
Dnipro, Ukraine, 49100 | |
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4 | Completed |
Dnipro, Ukraine, 49102 | |
Ivano-Frankivsk Regional Clinical Hospital | Suspended |
Ivano-Frankivsk, Ukraine, 76008 | |
Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council | Completed |
Kamianske, Ukraine, 51900 | |
Municipal non-profit enterprise 'Regional Center of Oncology' | Suspended |
Khakhiv, Ukraine, 61070 | |
Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval | Suspended |
Kharkiv, Ukraine, 61037 | |
Kherson Regional Oncological Dispensary | Terminated |
Kherson, Ukraine, 73035 | |
State Institution National Cancer Institute | Suspended |
Kyiv, Ukraine, 03022 | |
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center | Suspended |
Kyiv, Ukraine, 03115 | |
Kyiv Regional Oncological Dispensary | Suspended |
Kyiv, Ukraine, 04107 | |
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital' | Completed |
Lviv, Ukraine, 79010 | |
Podilskiy Regional Center of Oncology | Suspended |
Vinnitsa, Ukraine, 21029 | |
Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council | Suspended |
Zhytomyr, Ukraine, 10002 | |
United Kingdom | |
Ysbyty Gwynedd | Recruiting |
Bangor, United Kingdom, LL57 2PW | |
Belfast City Hospital | Recruiting |
Belfast, United Kingdom, BT9 7AB | |
Brighton and Sussex University Hospitals NHS Trust | Recruiting |
Brighton, United Kingdom, BN2 5BE | |
Bristol Haematology and Oncology Centre | Recruiting |
Bristol, United Kingdom, BS2 8ED | |
Guy's Hospital | Recruiting |
Great Maze Pond, United Kingdom, SE1 9RT | |
Prince Of Wales Hospital | Recruiting |
Grimsby, United Kingdom, DN33 2BA | |
Marie Curie Research Wing - Mount Vernon Hospital | Recruiting |
Hillingdon, United Kingdom, HA6 2RN | |
Raigmore Hospital | Recruiting |
Inverness, United Kingdom, IV2 3UJ | |
University College London Hospitals NHSFT | Recruiting |
London, United Kingdom, NW1 2PG | |
Churchill Hospital | Recruiting |
Oxford, United Kingdom, OX3 7LE | |
Royal Preston Hospital | Recruiting |
Preston, United Kingdom, PR2 9HT | |
Royal Stoke University Hospital | Withdrawn |
Stoke-on-Trent, United Kingdom, ST4 6QG | |
Royal Marsden Hospital | Recruiting |
Sutton, United Kingdom, SM2 5PT | |
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital | Recruiting |
Truro, United Kingdom, TR1 3LJ |
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT04497844 |
Other Study ID Numbers: |
CR108852 2020-002209-25 ( EudraCT Number ) 67652000PCR3002 ( Other Identifier: Janssen Research & Development, LLC ) |
First Posted: | August 4, 2020 Key Record Dates |
Last Update Posted: | March 15, 2023 |
Last Verified: | March 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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 |
URL: | https://www.janssen.com/clinical-trials/transparency |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Prostatic Neoplasms Hypersensitivity Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Immune System Diseases Prednisone Abiraterone Acetate Niraparib Anti-Inflammatory Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hormone Antagonists Cytochrome P-450 Enzyme Inhibitors Poly(ADP-ribose) Polymerase Inhibitors |