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Trial record 1 of 1 for:    NCT03767244
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A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy (PROTEUS)

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. Identifier: NCT03767244
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : July 23, 2021
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Apalutamide Drug: Androgen Deprivation Therapy (ADT) Drug: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : April 22, 2024
Estimated Study Completion Date : February 11, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Apalutamide

Arm Intervention/treatment
Experimental: Apalutamide + ADT
Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment.
Drug: Apalutamide
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
Other Name: JNJ-56021927

Drug: Androgen Deprivation Therapy (ADT)
Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter [ng/dL]).

Experimental: Placebo + ADT
Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment.
Drug: Androgen Deprivation Therapy (ADT)
Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter [ng/dL]).

Drug: Placebo
Participants will receive matching placebo oral tablets daily.

Primary Outcome Measures :
  1. Percentage of Participants with Pathologic complete response (pCR) [ Time Frame: Approximately 4 years ]
    pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter.

  2. Metastasis-Free Survival (MFS) [ Time Frame: Up to 7 years and 5 months ]
    MFS is defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis on conventional imaging [that is, computed tomography (CT)/magnetic resonance imaging (MRI) and bone scan]) evaluated by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.

Secondary Outcome Measures :
  1. Prostate Specific Antigen (PSA)-Free Survival [ Time Frame: Approximately 4 years ]
    PSA-free survival with testosterone recovery defined as the time from randomization to the first detectable serum PSA level with recovered testosterone levels after undetectable PSA post-radical prostatectomy with pelvic lymph node dissection or death, whichever occurs first.

  2. Progression-Free Survival (PFS) [ Time Frame: Approximately 8 years ]
    PFS is defined as the time from randomization to first documentation of BICR confirmed radiographic progressive disease or death due to any cause (whichever occurs first) plus 1 day. Progressive disease will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. As per RECIST v1.1. Unequivocal local-regional progression/recurrence or the distant metastasis observed on CT or MRI scans or identified by biopsy will be considered progression. Local-regional progression/recurrence is defined as local tumor recurrence in the prostate bed or occurrence of at least one new regional lymph node.

  3. Number of Participants with Adverse Events [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  4. Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
    Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing.

  5. Number of Participants with Vital Signs Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
    Number of participants with vital signs (including body temperature, heart rate, respiratory rate, and blood pressure) abnormalities will be reported.

  6. Number of Participants with Physical Examinations Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
    Number of participants with physical examinations (including general appearance of the subject, height, weight, and examination of the skin, ears, nose, throat, lungs, heart, abdomen, extremities, musculoskeletal system, lymphatic system, and nervous system) abnormalities will be reported.

  7. Number of Participants with Treatment Compliance Rate [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
    Number of participants who are complaint with study treatment will be assessed.

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Participants are considered eligible only if the central radiological review confirms clinical stage M0
  • (a) Prior treatment with androgen receptor antagonists; (b) Treatment with gonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF) signature
  • History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
  • Use of any investigational agent less than or equals to (<=)4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
  • Major surgery <=4 weeks prior to randomization
  • Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary

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 identifier (NCT number): NCT03767244

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Contact: Study Contact 844-434-4210

Hide Hide 225 study locations
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United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center Terminated
Los Angeles, California, United States, 90048
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
United States, Colorado
The Urology Center of Colorado Recruiting
Denver, Colorado, United States, 80211
Foothills Urology - Golden Off Recruiting
Golden, Colorado, United States, 80401-5027
United States, Connecticut
Yale Cancer Center Withdrawn
New Haven, Connecticut, United States, 06510
Stamford Hospital Recruiting
Stamford, Connecticut, United States, 06904
United States, Florida
Urology Specialists LLC Recruiting
Hialeah, Florida, United States, 33002
University of Florida Withdrawn
Jacksonville, Florida, United States, 32209
Mayo Clinic - Division Of Hematology/oncology Recruiting
Jacksonville, Florida, United States, 32224
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group Recruiting
Miami, Florida, United States, 33176
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
United States, Georgia
Emory University - Winship Cancer Institute Completed
Atlanta, Georgia, United States, 30322-1013
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
DuPage Medical Group Withdrawn
Lisle, Illinois, United States, 60532
United States, Kansas
Wichita Urology Group Withdrawn
Wichita, Kansas, United States, 67226
United States, Louisiana
Tulane University School of Medicine Withdrawn
New Orleans, Louisiana, United States, 70112
Regional Urology Recruiting
Shreveport, Louisiana, United States, 71106
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Beth Isreal Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Michigan Institute of Urology, PC Recruiting
Troy, Michigan, United States, 48084
United States, Missouri
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63110
Washington University Withdrawn
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Urology Cancer Center, PC Recruiting
Omaha, Nebraska, United States, 68130
United States, New Hampshire
New Hampshire Oncology Hematology, PA Withdrawn
Hooksett, New Hampshire, United States, 03106
United States, New Jersey
Garden State Urology Withdrawn
Morristown, New Jersey, United States, 07960
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Great Lakes Physician PC d/b/a Western New York Urology Associates Recruiting
Cheektowaga, New York, United States, 14225
Icahn School of Medicine at Mount Sinai Withdrawn
New York, New York, United States, 10029
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Duke University School of Medicine Recruiting
Durham, North Carolina, United States, 27705
Alliance Urology Specialists Recruiting
Greensboro, North Carolina, United States, 27403
Carolina Urology Partners, PLLC Completed
Huntersville, North Carolina, United States, 28078
United States, Ohio
Cleveland VA Medical Center Completed
Cleveland, Ohio, United States, 44106
University of Toledo Withdrawn
Toledo, Ohio, United States, 43614
United States, Oklahoma
Oklahoma City VAMC Recruiting
Oklahoma City, Oklahoma, United States, 73104
Oklahoma University Health Science Center Withdrawn
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
MidLantic Urology Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
Penn State Health Withdrawn
Hershey, Pennsylvania, United States, 17033
United States, Rhode Island
Omega Medical Research Recruiting
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29403
Ralph H. Johnson Veterans Affairs Medical Center Recruiting
Charleston, South Carolina, United States, 29425
Greenville Health Recruiting
Greenville, South Carolina, United States, 29605
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
VA North Texas Health Care System Recruiting
Dallas, Texas, United States, 75216
Texas Oncology P.A. Withdrawn
Houston, Texas, United States, 77024
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Texas Oncology Withdrawn
Plano, Texas, United States, 75024
United States, Virginia
Virginia Urology Recruiting
Richmond, Virginia, United States, 23235
Urology of Virginia, PLCC Recruiting
Virginia Beach, Virginia, United States, 23462
United States, Washington
University of Washington School of Medicine Withdrawn
Seattle, Washington, United States, 98195
United States, West Virginia
CAMC Memorial Hospital, Charleston Area Medical Center Physicians Recruiting
Charleston, West Virginia, United States, 25304
Hospital Aleman Recruiting
Caba, Argentina, 1118
Hospital Italiano de Buenos Aires Recruiting
Ciudad Autonoma de, Argentina, C1199ABB
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Recruiting
Cordoba, Argentina, 5000
Centro Urologico Profesor Bengio Recruiting
Cordoba, Argentina, X5000KPH
Uroclinica Recruiting
Mendoza, Argentina, 5500
Hospital Italiano de Rosario Withdrawn
Rosario, Argentina, 2000
Clinica Mayo de UMCB Recruiting
San Miguel de Tucuman, Argentina, 4000
Epworth Eastern Hospital Recruiting
Box Hill, Australia, 3128q
St. Vincent's Hospital Sydney Recruiting
Darlinghurst, Australia, 2010
Austin Health Recruiting
Heidelberg, Australia, 3084
Australian Urology Associates Pty Ltd Recruiting
Malvern, Australia, 3144
Royal Melbourne Hospital Recruiting
Parkville, Australia, 3050
Northern Cancer Institute Recruiting
St Leonards, Australia, 2065
Australian Clinical Trials - SAN Clinic Recruiting
Wahroonga, Australia, 2076
Westmead Hospital Recruiting
Westmead, Australia, 2145
Princess Alexandra Hospital Recruiting
Woolloongabba, Australia, 4102
Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará Withdrawn
Fortaleza, Brazil, 60430-230
Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás Recruiting
Goiânia, Brazil, 74605-070
Hospital de Caridade de Ijui - CACON Recruiting
Ijui, Brazil, 98700-000
Liga Norte Riograndense Contra O Cancer Recruiting
Natal, Brazil, 59075-740
Irmandade Santa Casa de Misericordia de Porto Alegre Recruiting
Porto Alegre, Brazil, 90020-090
Hospital Universitário Pedro Ernesto Recruiting
Rio de Janeiro, Brazil, 20551-030
Sao Paulo, Brazil, 01246-000
Hospital Samaritano de São Paulo Recruiting
São Paulo, Brazil, 01243-020
Instituto Do Cancer Brasil Recruiting
Três Lagoas, Brazil, 79601-001
Canada, Alberta
Southern Alberta Institute of Urology / Prostate Cancer Centre Recruiting
Calgary, Alberta, Canada, T2V 1P9
Cross Cancer Institute Withdrawn
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Exdeo Clinical Research Inc Withdrawn
Abbotsford, British Columbia, Canada, V2S 3N5
Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
McMaster Institute of Urology Withdrawn
Hamilton, Ontario, Canada, L8N 4A6
London Health Sciences Center Recruiting
London, Ontario, Canada, N6A 5W9
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
CHUM - Centre hospitalier universitaire de Montreal Recruiting
Montreal, Quebec, Canada, H2X 0A9
CHUQ - CHU de Quebec Recruiting
Quebec, Canada, G1R 2J6
Fakultni nemocnice Hradec Kralove Recruiting
Hradec Králove, Czechia, 500 05
Krajská nemocnice Liberec Recruiting
Liberec, Czechia, 460 63
Uromedical Center s.r.o. Recruiting
Olomouc, Czechia, 77200
Fakultni nemocnice Plzen, Urologicka klinika Recruiting
Plzen, Czechia, 305 99
Thomayerova nemocnice Recruiting
Praha 4, Czechia, 140 59
Vseobecna fakultni nemocnice v Praze Recruiting
Praha, Czechia, 120 00
CHU d'Angers Recruiting
Angers, France, 49933
CHRU Besançon -Hôpital Jean Minjoz Recruiting
Besançon Cedex, France, 25030
Hôpital Pellegrin CHU Bordeaux Recruiting
Bordeaux N/a, France, 33076
APHP - Hopital Henri Mondor Recruiting
Créteil, France, 94010
Hopital Edouard Herriot - CHU Lyon Recruiting
Lyon cedex 03, France, 69437
CHU de Nantes hôtel-Dieu Recruiting
Nantes, France, 44000
Institut Mutualiste Montsouris Recruiting
Paris, France, 75014
Clinique de la Croix du Sud Recruiting
Quint-Fonsegrives, France, 31130
Chu Rennes - Hopital Pontchaillou Recruiting
Rennes Cedex, France, 35033
CHU de Toulouse - Hôpital Rangueil Recruiting
Toulouse Cedex 9, France, 31059
CHRU Tours Hôpital Bretonneau Recruiting
Tours, France, 37000
Universitaetsklinikum der RWTH Aachen Recruiting
Aachen, Germany, 52074
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer Recruiting
Braunschweig, Germany, 38126
Universitatsklinikum Essen Recruiting
Essen, Germany, 45147
Universitatsklinikum Frankfurt Recruiting
Frankfurt am Main, Germany, 60590
Prostata zentrum Nordwest Recruiting
Gronau, Germany, 48599
Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie Recruiting
Hamburg, Germany, 20246
Urologikum Hamburg Withdrawn
Hamburg, Germany, 22399
Universitätsklinikum des Saarlandes Recruiting
Homburg/Saar, Germany, 66421
Universitaetsklinikum Koeln Recruiting
Koeln, Germany, 50937
Universitätsklinikum Schleswig Holstein Campus Lübeck Recruiting
Lubeck, Germany, 23538
Praxis Dr. med. Ralf Eckert Recruiting
Lutherstadt Eisleben, Germany, 06295
Klinikum St. Elisabeth Straubing GmbH Recruiting
Straubing, Germany, 94315
Kliniken Nordoberpfalz, Klinik für Urologie Completed
Weiden/Opf, Germany, 92637
Praxisgemeinschaft f. Onkologie u. Urologie - Germany Recruiting
Wilhelmshaven, Germany, 26389
Asaf Harofe Medical Center Recruiting
Beer Yaakov, Israel, 60930
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC) Recruiting
Kfar Saba, Israel, 4428164
Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
The Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Policlinico Abano Terme Recruiting
Abano Terme, Italy, 35031
Generale Regionale F. Miulli Recruiting
Acquaviva delle Fonti, Italy, 70021
Ospedale di Bassano del Grappa Recruiting
Bassano del Grappa, Italy, 36061
ASST Spedali Civili Brescia Recruiting
Brescia, Italy, 25123
ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti Recruiting
Chieti, Italy, 66100
Azienda Ospedaliero Universitaria Careggi Recruiting
Firenze, Italy, 50134
San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico Completed
MIlano, Italy, 20127
Ospedale San Raffaele Recruiting
Milano, Italy, 20132
Istituto Europeo di Oncologia Recruiting
Milano, Italy, 20141
Clinica di Urologia Policlinico di Modena - Università di Modena e reggio Emilia Recruiting
Modena, Italy, 41100
Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara Recruiting
Novara, Italy, 28100
Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga Recruiting
Orbassano, Italy, 10043
Università Campus Bio-Medico di Roma Recruiting
Roma, Italy, 00128
Istituto Nazionale Tumori Regina Elena Recruiting
Roma, Italy, 00144
Azienda Ospedaliera Sant Andrea Recruiting
Roma, Italy, 00189
Ospedale Molinette, AO Città della Salute e della Scienza di Recruiting
Torino, Italy, 10126
UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento Recruiting
Verona, Italy, 37126
Akita University Hospital Recruiting
Akita, Japan, 010-8543
Chiba University Hospital Recruiting
Chiba, Japan, 260-8677
Chiba Cancer Center Recruiting
Chuo-ku, Chiba-City,, Japan, 260-8717
Hakodate Goryokaku Hospital Recruiting
Hakodate, Japan, 040-8611
Hirosaki University Hospital Recruiting
Hirosaki, Japan, 036-8203
Kanazawa University Hospital Recruiting
Kanazawa, Japan, 920-8641
Kobe City Medical Center General Hospital Recruiting
Kobe, Japan, 650-0047
Dokkyo Medical University Saitama Medical Center Recruiting
Koshigaya, Japan, 343-8555
Kurume University Hospital Recruiting
Kurume, Japan, 830-0011
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
National Hospital Organizaiton Shikoku Cancer Center Recruiting
Matsuyama, Japan, 791-0280
Kitasato University Hospital Recruiting
Minami-Ku, Sagamihara-Shi, Japan, 252-0375
University of Miyazaki Hospital Recruiting
Miyazaki, Japan, 889-1692
Nagano Municipal Hospital Recruiting
Nagano, Japan, 381-8551
Kindai University Hospital Recruiting
Osaka-Sayama, Japan, 589-8511
Osaka International Cancer Institute Recruiting
Osaka, Japan, 541-8567
Toho University Sakura Medical Center Recruiting
Sakura, Japan, 285-8741
Hokkaido University Hospital Recruiting
Sapporo, Japan, 060-8648
Iwate Medical University Hospital Recruiting
Shiwa-gun, Japan, 028-3695
Juntendo University Hospital Recruiting
Tokyo, Japan, 113-8421
Nippon Medical School Hospital Recruiting
Tokyo, Japan, 113-8603
Yamaguchi University Hospital Recruiting
Ube, Japan, 755-8505
Yokohama City University Medical Center Recruiting
Yokohama, Japan, 232-0024
Korea, Republic of
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of, 61469
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 13605
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
NKI-AVL, Amsterdam Recruiting
Amsterdam, Netherlands, 1066 CX
Catharinaziekenhuis Recruiting
Eindhoven, Netherlands, 5623 EJ
St. Antonius Ziekenhuis (St. Antonius Hospital) Recruiting
Nieuwegein, Netherlands, 3430EM
Canisius-Wilhelmina Ziekenhuis Recruiting
Nijmegen, Netherlands, 6524 KD
Samodzielny Publiczny Wielospecjalistyczny Zakład Opieki Zdrowotnej MSWiA w Bydgoszczy Recruiting
Bydgoszcz, Poland, 85-015
Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza Recruiting
Bydgoszcz, Poland, 85-094
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie Recruiting
Koszalin, Poland, 75-581
Pratia MCM Krakow Recruiting
Krakow, Poland, 30-510
City Clinic Sp. z o.o. Recruiting
Warszawa, Poland, 02-473
Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia Recruiting
Wrocław, Poland, 53-413
Russian Federation
Altai Regional Oncology Dispensary Recruiting
Barnaul, Russian Federation, 656049
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine Recruiting
Chelyabinsk, Russian Federation, 454087
Moscow City Clinical Hospital # 62 Recruiting
Moscow, Russian Federation, 125130
Botkin City Clinical Hospital Withdrawn
Moscow, Russian Federation, 125284
Hertzen Oncology Research Institute Recruiting
Moscow, Russian Federation, 125284
Clinical Oncology Dispensary Recruiting
Omsk, Russian Federation, 644013
Medical-sanitary unit 'Neftyanik' Recruiting
Tyumen, Russian Federation, 625000
Vologda Regional Oncological Dispensary Recruiting
Vologda, Russian Federation, 160012
Hosp. Univ. A Coruña Recruiting
A Coruña, Spain, 15006
Hosp. Univ. Vall D Hebron Recruiting
Barcelona, Spain, 8035
Hosp. Puerta Del Mar Recruiting
Cadiz, Spain, 11009
Hosp. Gral. Univ. de Castellon Recruiting
Castellón, Spain, 12004
Hosp. de Jerez de La Frontera Recruiting
Jerez de la Frontera, Spain, 11407
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
Fund. Hosp. de Manacor Recruiting
Manacor, Spain, 07500
Hosp. Virgen de La Victoria Recruiting
Málaga, Spain, 29010
Hosp. Univ. Marques de Valdecilla Recruiting
Santander, Spain, 39008
Hosp. Virgen Del Rocio Recruiting
Sevilla, Spain, 41013
Inst. Valenciano de Oncologia Recruiting
Valencia, Spain, 46009
Hosp. Clinico Univ. de Valencia Recruiting
Valencia, Spain, 46010
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Tungs' Taichung MetroHarbor Hospital Recruiting
Taichung, Taiwan, 435
Chi Mei Medical Center - Yong Kang Recruiting
Tainan, Taiwan, 710
National Taiwan University Hospital. Recruiting
Taipei, Taiwan, 10002
United Kingdom
Southmead Hospital Recruiting
Bristol, United Kingdom, BS10 5NB
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
Ninewells Hospital Recruiting
Dundee, United Kingdom, DD2 1UB
The Royal Marsden NHS Trust Recruiting
London, United Kingdom, SW3 6JJ
University College London Recruiting
London, United Kingdom, WC1E 6BT
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital Recruiting
Preston, United Kingdom, PR2 9HT
Southampton General Hospital Withdrawn
Southampton, United Kingdom, SO16 6YD
Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SM2 5PT
MidYorkshire NHS Trust Recruiting
Wakefield, United Kingdom, WF1 4DG
New Cross Hospital Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC Identifier: NCT03767244    
Other Study ID Numbers: CR108535
56021927PCR3011 ( Other Identifier: Janssen Research & Development, LLC )
2018-001746-34 ( EudraCT Number )
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
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

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs