AzTrials
AzTrials

Prostatic NeoplasmsPhase 3PROTEUSNCT03767244

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

A Phase 3 study testing Apalutamide and Androgen Deprivation Therapy (ADT) in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 203 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… 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?
Apalutamide and Androgen Deprivation Therapy (ADT)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,517 participants
Where
203 sitesin 18 countries
Study dates
11 Jun 2019to 13 Oct 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • 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 male participants (and female partners of male participants 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

Who cannot join

  • 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

Trial locations and contacts

203 sites in 18 countries.

203 sites in 18 countries

United States44 sites

  • Albany Medical College

    Albany, New York, 12208

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322-1013

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Isreal Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Ralph H. Johnson Veterans Affairs Medical Center

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • CAMC Memorial Hospital, Charleston Area Medical Center Physicians

    Charleston, West Virginia, 25304

  • Great Lakes Physician PC d/b/a Western New York Urology Associates

    Cheektowaga, New York, 14225

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland VA Medical Center

    Cleveland, Ohio, 44106

  • VA North Texas Health Care System

    Dallas, Texas, 75216

  • AdventHealth Medical Group Urology of Denver

    Denver, Colorado, 80210

  • Duke University School of Medicine

    Durham, North Carolina, 27705

  • Medication Management LLC

    Greensboro, North Carolina, 27403

  • Greenville Health

    Greenville, South Carolina, 29605

  • Urology Specialists LLC

    Hialeah, Florida, 33002

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Carolina Urology Partners, PLLC

    Huntersville, North Carolina, 28078

  • Mayo Clinic - Division Of Hematology/oncology

    Jacksonville, Florida, 32224

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Colorado Clinical Research

    Lakewood, Colorado, 80228

  • University of Southern California

    Los Angeles, California, 90033

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Miami Cancer Institute at Baptist Health / Baptist Health Medical Group

    Miami, Florida, 33176

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Weill Cornell Medical College

    New York, New York, 10065

  • Oklahoma City VAMC

    Oklahoma City, Oklahoma, 73104

  • Urology Cancer Center, PC

    Omaha, Nebraska, 68130

  • University of California Irvine Medical Center Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Advent Health

    Orlando, Florida, 32804

  • Virginia Urology

    Richmond, Virginia, 23235

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Ochsner LSU Health Shreveport - Regional Urology

    Shreveport, Louisiana, 71106

  • Saint Louis University

    St Louis, Missouri, 63110

  • Stamford Hospital

    Stamford, Connecticut, 06904

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Michigan Institute of Urology, PC

    Troy, Michigan, 48084

  • Urology of Virginia, PLCC

    Virginia Beach, Virginia, 23462

  • Omega Medical Research

    Warwick, Rhode Island, 02886

Other trials in United States

Japan23 sites

  • Akita University Hospital

    Akita, 010-8543

  • Chiba University Hospital

    Chiba, 260 8677

  • Chiba Cancer Center

    Chūōku, 260-8717

  • Hakodate Goryoukaku Hospital

    Hakodate, 040 8611

  • Hirosaki University Hospital

    Hirosaki, 036-8203

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, 343-8555

  • Kurume University Hospital

    Kurume, 830-0011

  • Kyoto University Hospital

    Kyoto, 606-8507

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, 791-0280

  • Kitasato University Hospital

    Minamiku, 252-0375

  • University of Miyazaki Hospital

    Miyazaki, 889-1692

  • Nagano Municipal Hospital

    Nagano, 381-8551

  • Osaka International Cancer Institute

    Osaka, 541 8567

  • Kindai University Hospital

    Sakai, 590 0197

  • Toho University Sakura Medical Center

    Sakura, 285-8741

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Iwate Medical University Hospital

    Shiwa-gun, 028-3695

  • Nippon Medical School Hospital

    Tokyo, 113 8603

  • Juntendo University Hospital

    Tokyo, 113-8421

  • Yamaguchi University Hospital

    Ube, 755-8505

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

Italy17 sites

  • Policlinico Abano Terme

    Abano Terme, 35031

  • Generale Regionale F. Miulli

    Acquaviva delle Fonti, 70021

  • Ospedale di Bassano del Grappa

    Bassano del Grappa, 36061

  • ASST Spedali Civili Brescia

    Brescia, 25123

  • ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti

    Chieti, 66100

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico

    Milan, 20127

  • Ospedale San Raffaele

    Milan, 20132

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Clinica di Urologia Policlinico di Modena - Universita di Modena e reggio Emilia

    Modena, 41100

  • Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

    Novara, 28100

  • Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, 10043

  • Universita Campus Bio-Medico di Roma

    Roma, 00128

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

  • Azienda Ospedaliera Sant Andrea

    Roma, 00189

  • Ospedale Molinette, AO Città della Salute e della Scienza di

    Torino, 10126

  • UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento

    Verona, 37126

Other trials in Italy

Spain14 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp Univ Vall D Hebron

    Barcelona, 8035

  • Hosp. Puerta Del Mar

    Cadiz, 11009

  • Hosp. Gral. Univ. de Castellon

    Castellon, 12004

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp Virgen de La Victoria

    Málaga, 29010

  • Fund. Hosp. de Manacor

    Manacor, 07500

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Inst. Valenciano de Oncologia

    Valencia, 46009

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

Other trials in Spain

Germany13 sites

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074

  • Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie

    Braunschweig, 38126

  • Universitaetsklinikum Koelnt

    Cologne, 50937

  • Praxis Dr. med. Ralf Eckert

    Eisleben Lutherstadt, 06295

  • Universitatsklinikum Essen

    Essen, 45147

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Prostata zentrum Nordwest

    Gronau, 48599

  • Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie

    Hamburg, 20246

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66421

  • Universitatsklinikum Schleswig Holstein Campus Lubeck

    Lübeck, 23538

  • Klinikum St. Elisabeth Straubing GmbH

    Straubing, 94315

  • Kliniken Nordoberpfalz, Klinik für Urologie

    Weiden/Opf, 92637

  • Praxisgemeinschaft f. Onkologie u. Urologie - Germany

    Wilhelmshaven, 26389

Other trials in Germany

France11 sites

  • CHU d'Angers

    Angers, 49933

  • CHRU Besancon Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Pellegrin CHU Bordeaux

    Bordeaux, 33076

  • APHP - Hopital Henri Mondor

    Créteil, 94010

  • Hopital Edouard Herriot - CHU Lyon

    Lyon, 69437

  • CHU de Nantes hotel Dieu

    Nantes, 44000

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Clinique de la Croix du Sud

    Quint-Fonsegrives, 31130

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35033

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse, 31059

  • CHRU Tours Hopital Bretonneau

    Tours, 37000

Other trials in France

Australia9 sites

  • Eastern Health - Box Hill Hospital

    Box Hill, 3128q

  • St Vincent s Hospital Sydney

    Darlinghurst, 2010

  • Austin Health

    Heidelberg, 3084

  • Australian Urology Associates Pty Ltd

    Malvern, 3144

  • Royal Melbourne Hospital

    Parkville, 3052

  • Northern Cancer Institute

    St Leonards, 2065

  • Sydney Adventist Hospital

    Wahroonga, 2076

  • Westmead Hospital

    Westmead, 2145

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

United Kingdom9 sites

  • Southmead Hospital

    Bristol, BS10 5NB

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Ninewells Hospital

    Dundee, DD2 1UB

  • The Royal Marsden NHS Trust

    London, SW3 6JJ

  • University College London

    London, WC1E 6BT

  • Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

    Preston, PR2 9HT

  • Royal Marsden Hospital

    Sutton, SM2 5PT

  • Mid Yorkshire NHS Trust

    Wakefield, WF1 4DG

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Brazil8 sites

  • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

    Goiânia, 74605-070

  • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

    Ijuí, 98700-000

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59075-740

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090

  • Universidade do Estado do Rio de Janeiro - UERJ

    Rio de Janeiro, 20551-030

  • Hospital Samaritano de Sao Paulo

    São Paulo, 01243 020

  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246 000

  • Instituto Do Cancer Brasil

    Três Lagoas, 79601-001

Other trials in Brazil

Canada8 sites

  • Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9

  • London Health Sciences Center

    London, Ontario, N6A 5W9

  • CHUM - Centre hospitalier universitaire de Montreal

    Montreal, Quebec, H2X 0A9

  • CHU de Quebec Universite Laval Hopital de l Enfant Jesus

    Québec, Quebec, G1R 2J6

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G2M9

  • Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Russia7 sites

  • Altai Regional Oncology Dispensary

    Barnaul, 656049

  • Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

    Chelyabinsk, 454087

  • Moscow City Oncology Hospital No 62

    Moscow, 121205

  • Hertzen Oncology Research Institute

    Moscow, 125284

  • Clinical Oncology Dispensary

    Omsk, 644013

  • Medical-sanitary unit 'Neftyanik'

    Tyumen, 625000

  • Vologda Regional Oncological Dispensary

    Vologda, 160012

Other trials in Russia

Argentina6 sites

  • Hospital Aleman

    Caba, 1118

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de, C1199ABB

  • Centro Urologico Profesor Bengio

    Córdoba, X5000KPH

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, X5008AAC

  • Uroclinica

    Mendoza, 5500

  • Clinica Mayo de UMCB

    San Miguel de Tucumán, 4000

Other trials in Argentina

Czechia6 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králove, 500 05

  • Krajská nemocnice Liberec

    Liberec, 460 63

  • Uromedical Center s.r.o.

    Olomouc, 77200

  • Fakultni nemocnice Plzen, Urologicka klinika

    Pilsen, 305 99

  • Vseobecna fakultni nemocnice v Praze

    Prague, 120 00

  • Thomayerova nemocnice

    Prague, 140 59

Other trials in Czechia

Israel6 sites

  • Asaf Harofe Medical Center

    Beer Yaakov, 60930

  • Rambam Health Care Campus

    Haifa, 31096

  • Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Poland6 sites

  • Samodzielny Publiczny Wielospecjalistyczny Zaklad Opieki Zdrowotnej Mswia W Bydgoszczy

    Bydgoszcz, 85 015

  • Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza

    Bydgoszcz, 85 094

  • Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie

    Koszalin, 75 581

  • Pratia MCM Krakow

    Krakow, 30-727

  • City Clinic Sp. z o.o.

    Warsaw, 02-473

  • Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia

    Wroclaw, 53-413

Other trials in Poland

South Korea6 sites

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13605

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center 1

    Seoul, 05505

  • Asan Medical Center

    Seoul, 05505

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Taiwan6 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Tungs' Taichung MetroHarbor Hospital

    Taichung, 435

  • Chi Mei Medical Center Yong Kang

    Tainan, 710

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

Netherlands4 sites

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX

  • Catharinaziekenhuis

    Eindhoven, 5623 EJ

  • St. Antonius Ziekenhuis (St. Antonius Hospital)

    Nieuwegein, 3430EM

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6524 KD

Other trials in Netherlands

About this study

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

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) as compared to placebo plus ADT.

Being tested
Apalutamide, Androgen Deprivation Therapy (ADT), Placebo
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApalutamideDrug

    Also called JNJ-56021927

    Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.

  • Androgen Deprivation Therapy (ADT)Drug

    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]).

  • PlaceboDrug

    Participants will receive matching placebo oral tablets daily.

Study groups in NCT03767244
Study groupRoleWhat they receive
Apalutamide + ADTExperimentalParticipants 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. A Long-Term Extension (LTE) may be initiated at sponsor's discretion after completion of the primary endpoint analysis.
Receives: Drug: Apalutamide; Drug: Androgen Deprivation Therapy (ADT)
Placebo + ADTExperimentalParticipants 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. A LTE may be initiated at sponsor's discretion after completion of the primary endpoint analysis.
Receives: Drug: Androgen Deprivation Therapy (ADT); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Pathologic complete response (pCR)

    pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter.

    Measured: Approximately 4 years

  2. Metastasis-Free Survival (MFS)

    MFS is defined as the time from randomization to the date of the occurrence of radiographic distant metastasis evaluated by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.

    Measured: Up to 7 years and 5 months

Secondary outcomes (10)

  1. Prostate Specific Antigen (PSA)-Free Survival

    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.

    Measured: Approximately 4 years

  2. Event Free Survival (EFS)

    EFS defined as time from randomization to any of the following events: biochemical failure (BCF); or local or regional recurrence by BICR or histopathological assessment; or distant metastasis by BICR or histopathological assessment; or death.

    Measured: Up to 7 years and 5 months

  3. Time to Subsequent First Treatments (TTST-1)

    TTST-1 is defined as the time from randomization to the date of first subsequent therapy.

    Measured: Up to 7 years and 5 months

  4. Time to Distant Metastasis (TTDM)

    TTDM is defined as the time from the date of enrollment until the first date of distant metastasis.

    Measured: Up to 7 years and 5 months

  5. MFS Based on Conventional Imaging

    MFS based on conventional imaging, defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis on CT/MRI and bone scan by radiology BICR, pathologic finding of distant metastasis, or death from any cause, whichever occurs first.

    Measured: Up to 7 years and 5 months

  6. Number of Participants with No Evidence of Disease (NED) at 4 Years

    Number of participants with NED at 4 years will be reported. NED at 4 years is defined as: (a) alive, (b) Undetectable prostate-specific antigen (PSA), (c) No distant metastasis, (d) No local or regional recurrence, (e) No subsequent therapy for prostate cancer, (f) Testosterone recovery to physiological testosterone levels, defined as 200 nanograms per deciliter (ng/dL).

    Measured: Up to 4 years

  7. Number of Participants with Vital Signs Abnormalities as a Measure of Safety and Tolerability

    Number of participants with vital signs (including body temperature, heart rate, respiratory rate, and blood pressure) abnormalities will be reported.

    Measured: Up to 30 days after last dose of study drug (Approximately 8 years)

  8. Number of Participants with Physical Examinations Abnormalities as a Measure of Safety and Tolerability

    Number of participants with physical examinations (including general appearance of the participant, 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.

    Measured: Up to 30 days after last dose of study drug (Approximately 8 years)

  9. Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability

    Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing.

    Measured: Up to 30 days after last dose of study drug (Approximately 8 years)

  10. Number of Participants with Treatment Compliance Rate

    Number of participants who are complaint with study treatment will be assessed.

    Measured: Up to 30 days after last dose of study drug (Approximately 8 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2018
  2. Study start11 Jun 2019
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion13 Oct 2028 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,517 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03767244
Sponsor's protocol ID
CR108535
Other IDs
56021927PCR3011, 2018-001746-34, 2023-506153-38-00, 2023, 2018
Acronym
PROTEUS
Status last verified
Nov 2026
First submitted
5 Dec 2018
Last updated
3 Nov 2026
Results posted
No
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

  • Taplin ME, Gleave M, Shore ND, Lopez-Gitlitz A, Kretschmer A, Efstathiou E, Nguyen PL, Damiao R, Kamoto T, Ross A, Briganti A, Hadaschik BA, Heidenreich A, Juarez Soto A, Ye H, Gotto G, Rooney B, Tian SK, Wetherhold L, Miladinovic B, McCarthy SA, Evans CP, Kibel AS; PROTEUS Investigators. Perioperative Apalutamide in High-Risk Localized Prostate Cancer. N Engl J Med. 2026 Aug 6;395(6):546-560. doi: 10.1056/NEJMoa2603878. Epub 2026 May 31.

    PubMed 42223077

  • Ravi P, Kwak L, Xie W, Kelleher K, Acosta AM, McKay RR, Kibel AS, Taplin ME. Neoadjuvant Novel Hormonal Therapy Followed by Prostatectomy versus Up-Front Prostatectomy for High-Risk Prostate Cancer: A Comparative Analysis. J Urol. 2022 Oct;208(4):838-845. doi: 10.1097/JU.0000000000002803. Epub 2022 Sep 9.

    PubMed 36082554

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apalutamide and Androgen Deprivation Therapy (ADT) in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 203 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 203 sites in United States, Japan, Italy, Spain, Germany and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Pathologic complete response (pCR) (time frame: Approximately 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03767244, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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