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AzTrials

Prostatic NeoplasmsPhase 3NCT02531516

An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

A Phase 3 study testing Apalutamide, Bicalutamide and GnRH (agonist) in people with Prostatic Neoplasms, run by Aragon Pharmaceuticals, Inc. at 263 sites in 23 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) based on conventional imaging… 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, Bicalutamide and GnRH (agonist)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,503 participants
Where
263 sitesin 23 countries
Study dates
19 Nov 2015to 29 Dec 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

  • Age >= 18 years
  • Indicated and planned to receive primary radiation therapy for prostate cancer
  • Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score >=8 and >=cT2c, 2) Gleason score 7, PSA >=20 nanogram per milliliters (ng/mL), and >=cT2c
  • Charlson index (CCI) <=3
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1
  • Adequate organ function: (1) aspartate aminotransferase (AST), alanine aminotransferase (ALT), within normal limits (WNL), (2) serum creatinine less than (<) 1.5 milligram/deciliter (mg/dL) (<133 micromoles/Liter [mcmol/L]), (3) platelets greater than or equal to (>=)140,000/microLiter (mcL), independent of transfusion and/or growth factors within 3 months prior to randomization, (4) Hemoglobin >= 12.0 gram/deciliter (g/dL) (7.4 millimloes [mmol], independent of transfusion and/or growth factors within 3 months prior to randomization
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  • Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
  • Signed, written, informed consent
  • Be able to swallow whole study drug tablets

Who cannot join

  • Presence of distant metastasis, (clinical stage M1). Isolated pelvic 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. Patients are considered eligible only if the central radiological review confirms clinical stage M0
  • Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen or both for >3 months prior to randomization
  • Bilateral orchiectomy
  • History of pelvic radiation
  • Prior systemic (example [e.g.], chemotherapy) or local (e.g. radical prostatectomy, cryotherapy) treatment for prostate cancer
  • History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness <= 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
Show all 17Show fewer
  • Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents (including cyproterone acetate) for prostate cancer
  • Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy (e.g., sipuleucel-T) for prostate cancer
  • Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study
  • Use of 5-alpha reductase inhibitors (e.g., dutasteride, finasteride) <=4 weeks prior to randomization
  • Use of any investigational agent <=4 weeks prior to randomization
  • Current chronic use of opioid analgesics for >=3 weeks for oral or >= 7 days for non-oral formulations
  • Major surgery <=4 weeks prior to randomization
  • Current or prior treatment with anti-epileptic medications for the treatment of seizures
  • Gastrointestinal conditions affecting absorption
  • Known or suspected contraindications or hypersensitivity to apalutamide, bicalutamide or GnRH agonists or any of the components of the formulations
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject

Trial locations and contacts

263 sites in 23 countries.

263 sites in 23 countries

United States60 sites

  • Study site

    Albany, New York

  • Study site

    Ashland, Kentucky

  • Study site

    Aurora, Colorado

  • Study site

    Bakersfield, California

  • Study site

    Bala-Cynwyd, Pennsylvania

  • Study site

    Baltimore, Maryland

  • Study site

    Boston, Massachusetts

  • Study site

    Bradenton, Florida

  • Study site

    Brooklyn, New York

  • Study site

    Bryn Mawr, Pennsylvania

  • Study site

    Burien, Washington

  • Study site

    Cary, North Carolina

  • Study site

    Chandler, Arizona

  • Study site

    Charleston, South Carolina

  • Study site

    Dallas, Texas

  • Study site

    Daytona Beach, Florida

  • Study site

    Denver, Colorado

  • Study site

    East Greenwich, Rhode Island

  • Study site

    Evergreen Park, Illinois

  • Study site

    Fairfax, Virginia

  • Study site

    Fort Myers, Florida

  • Study site

    Harvey, Illinois

  • Study site

    Hialeah, Florida

  • Study site

    Homewood, Alabama

  • Study site

    Houston, Texas

  • Study site

    Jeffersonville, Indiana

  • Study site

    Lakewood Rch, Florida

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Los Angeles, California

  • Study site

    Meridian, Idaho

  • Study site

    Middlebury, Connecticut

  • Study site

    Morgantown, West Virginia

  • Study site

    Morristown, New Jersey

  • Study site

    Myrtle Beach, South Carolina

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Orange, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Plantation, Florida

  • Study site

    Portland, Oregon

  • Study site

    Poughkeepsie, New York

  • Study site

    Raleigh, North Carolina

  • Study site

    Rochester, New York

  • Study site

    San Antonio, Texas

  • Study site

    San Bernardino, California

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Scarborough, Maine

  • Study site

    Scottsdale, Arizona

  • Study site

    Shreveport, Louisiana

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Oregon

  • Study site

    St Louis, Missouri

  • Study site

    Syracuse, New York

  • Study site

    The Bronx, New York

  • Study site

    Tucson, Arizona

  • Study site

    Virginia Beach, Virginia

  • Study site

    Wichita, Kansas

Other trials in United States

France28 sites

  • Study site

    Amiens

  • Study site

    Angers

  • Study site

    Avignon

  • Study site

    Bayonne

  • Study site

    Besançon

  • Study site

    Bordeaux

  • Study site

    Brest

  • Study site

    Dijon

  • Study site

    Évry-Courcouronnes

  • Study site

    Hyères

  • Study site

    La Tronche

  • Study site

    Le Mans

  • Study site

    Lille

  • Study site

    Marseille

  • Study site

    Marseilli

  • Study site

    Montpellier

  • Study site

    Neuilly-sur-Seine

  • Study site

    Paris

  • Study site

    Ris-Orangis

  • Study site

    Saint-Brieuc

  • Study site

    Saint-Herblain

  • Study site

    Saint-Mandé

  • Study site

    Saint-Priest-en-Jarez

  • Study site

    Strasbourg

  • Study site

    Toulouse

  • Study site

    Tours

  • Study site

    Vandœuvre-lès-Nancy

  • Study site

    Villejuif

Other trials in France

Brazil16 sites

  • Study site

    Barretos

  • Study site

    Belo Horizonte

  • Study site

    Campinas

  • Study site

    Curitiba

  • Study site

    Florianópolis

  • Study site

    Goiânia

  • Study site

    Ijuí

  • Study site

    Natal

  • Study site

    Porto Alegre

  • Study site

    Ribeirão Preto

  • Study site

    Rio de Janeiro

  • Study site

    Salvador

  • Study site

    Santo André

  • Study site

    São José do Rio Preto

  • Study site

    São Paulo

  • Study site

    Sorocaba

Other trials in Brazil

Russia15 sites

  • Study site

    Barnaul

  • Study site

    Ivanovo

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Obninsk

  • Study site

    Omsk

  • Study site

    Pyatigorsk

  • Study site

    Rostov-on-Don

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Saransk

  • Study site

    Tambov

  • Study site

    Tyumen

  • Study site

    Ufa

  • Study site

    Vologda

Other trials in Russia

Canada12 sites

  • Study site

    Calgary, Alberta

  • Study site

    Gatineau, Quebec

  • Study site

    Laval, Quebec

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Sherbrooke, Quebec

  • Study site

    Surrey, British Columbia

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Victoria, British Columbia

Other trials in Canada

Belgium11 sites

  • Study site

    Aalst

  • Study site

    Antwerp

  • Study site

    Bonheiden

  • Study site

    Brussels

  • Study site

    Haine Saint Paul La Louviere

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Namur

  • Study site

    Roeselare

  • Study site

    Sint-Niklaas

  • Study site

    Turnhout

Other trials in Belgium

China11 sites

  • Study site

    Beijing

  • Study site

    Chengdu

  • Study site

    Chongqing

  • Study site

    Guangzhou

  • Study site

    Hangzhou

  • Study site

    Nanchang

  • Study site

    Nanjing

  • Study site

    Ningbo

  • Study site

    Shanghai

  • Study site

    Wuhan

  • Study site

    Xi'an

Other trials in China

United Kingdom11 sites

  • Study site

    Aberdeen

  • Study site

    Birmingham

  • Study site

    Bristol

  • Study site

    Derby

  • Study site

    Glasgow

  • Study site

    Oxford

  • Study site

    Plymouth

  • Study site

    Preston

  • Study site

    Sheffield

  • Study site

    Sutton

  • Study site

    Wolverhampton

Other trials in United Kingdom

Germany10 sites

  • Study site

    Braunschweig

  • Study site

    Chemnitz

  • Study site

    Dessau

  • Study site

    Frankfurt

  • Study site

    Gronau

  • Study site

    Jena

  • Study site

    Münster

  • Study site

    Nürtingen

  • Study site

    Ulm

  • Study site

    Weiden/Opf

Other trials in Germany

Spain10 sites

  • Study site

    Barakaldo

  • Study site

    Barcelona

  • Study site

    Castellon

  • Study site

    L'Hospitalet de Llobregat

  • Study site

    Las Palmas de Gran Canaria

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Reus

  • Study site

    Santiago de Compostela

  • Study site

    Seville

Other trials in Spain

Poland9 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Gdynia

  • Study site

    Gliwice

  • Study site

    Kielce

  • Study site

    Lodz

  • Study site

    Olsztyn

  • Study site

    Poznan

  • Study site

    Wałbrzych

Other trials in Poland

Romania9 sites

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Floreşti

  • Study site

    Iași

  • Study site

    Otopeni

  • Study site

    Ploieşti

  • Study site

    Sibiu

  • Study site

    Târgu Mureş

  • Study site

    Timișoara

Other trials in Romania

Czechia8 sites

  • Study site

    Hradec Králove

  • Study site

    Liberec

  • Study site

    Nový Jicin

  • Study site

    Olomouc

  • Study site

    Opava

  • Study site

    Pardubice

  • Study site

    Prague

  • Study site

    Zlín

Other trials in Czechia

Israel8 sites

  • Study site

    Beer Yaakov

  • Study site

    Beersheba

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

  • Study site

    Tel Aviv

Other trials in Israel

Turkey (Türkiye)7 sites

  • Study site

    Adana

  • Study site

    Ankara

  • Study site

    Edirne

  • Study site

    Istanbul

  • Study site

    Izmir

  • Study site

    Kayseri

  • Study site

    Kocaeli

Other trials in Turkey (Türkiye)

Argentina6 sites

  • Study site

    Buenos Aires

  • Study site

    C.a.b.a.

  • Study site

    Caba

  • Study site

    Pergamino

  • Study site

    Rosario

  • Study site

    San Salvador de Jujuy

Other trials in Argentina

Mexico6 sites

  • Study site

    Culiacán

  • Study site

    Guadalajara

  • Study site

    León

  • Study site

    México

  • Study site

    Morelia

  • Study site

    Zapopan

Other trials in Mexico

Netherlands5 sites

  • Study site

    Alkmaar

  • Study site

    Amsterdam

  • Study site

    Nijmegen

  • Study site

    Rotterdam

  • Study site

    The Hague

Other trials in Netherlands

South Korea5 sites

  • Study site

    Buk Gu

  • Study site

    Gyeonggi-do

  • Study site

    Jeollanam-do

  • Study site

    Seoul

  • Study site

    Suwon

Other trials in South Korea

Taiwan5 sites

  • Study site

    Kaohsiung City

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

Malaysia4 sites

  • Study site

    George Town

  • Study site

    Kuala Lumpur

  • Study site

    Kuching

  • Study site

    Putrajaya

Other trials in Malaysia

Ukraine4 sites

  • Study site

    Dnipro

  • Study site

    Khakhiv

  • Study site

    Kyiv

  • Study site

    Lviv

Other trials in Ukraine

Sweden3 sites

  • Study site

    Örebro

  • Study site

    Stockholm

  • Study site

    Umeå

Other trials in Sweden

About this study

Official title: ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy

The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) based on conventional imaging assessed by blinded independent central review (BICR).

Being tested
Apalutamide, Bicalutamide, Bicalutamide Placebo, Apalutamide Placebo, GnRH (agonist)
Keywords
Prostatic neoplasms, Prostate Cancer, High-Risk prostate cancer, JNJ-56021927, Apalutamide, ATLAS, Radiation, Long-term hormone therapy, Localized or locally advanced prostate cancer, Janssen
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

  • BicalutamideDrug

  • Bicalutamide PlaceboDrug

  • Apalutamide PlaceboDrug

  • GnRH (agonist)Drug

  • 74-80 Grays (units of radiation)Radiation

Study groups in NCT02531516
Study groupRoleWhat they receive
ApalutamideExperimentalParticipants will receive apalutamide (240 mg), by mouth, once daily for overall 30 months, plus bicalutamide placebo, by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.
Receives: Drug: Apalutamide; Drug: Bicalutamide Placebo; Drug: GnRH (agonist); Radiation: 74-80 Grays (units of radiation)
Control groupActive comparatorParticipants will receive apalutamide placebo, by mouth, once daily for overall 30 months, plus bicalutamide (50 mg), by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.
Receives: Drug: Bicalutamide; Drug: Apalutamide Placebo; Drug: GnRH (agonist); Radiation: 74-80 Grays (units of radiation)

What is being measured

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

  1. Metastasis-Free Survival (MFS)

    MFS is defined as the time from randomization to the date of the first occurrence of radiographic bone or soft tissue distant metastasis based on conventional imaging assessed by blinded independent central review (BICR), histopathologic diagnosis of distant metastasis, or death from any cause, whichever occurs first.

    Measured: 108 Months

Secondary outcomes (8)

  1. Event-Free Survival (EFS) Based on Conventional Imaging Assessed By BICR

    EFS is defined as the time from randomization to the date of the first occurrence of prostate specific antigen (PSA) failure by the Phoenix definition, local or regional disease recurrence based on conventional imaging assessed by BICR or histopathologic diagnosis, distant metastasis based on conventional imaging assessed by BICR or histopathologic diagnosis, or death.

    Measured: 108 Months

  2. Time to PSA Progression

    Time to PSA progression is defined as the time from randomization to the date of PSA nadir plus (+) 0.5 nanograms per milliliter (ng/mL) and rising.

    Measured: 108 Months

  3. MFS Based on Conventional Imaging or Prostate-Specific Membrane Antigen (PSMA)-Positron Emission Tomography (PET) Imaging Assessed by BICR

    MFS is defined as the time from randomization to the date of the first occurrence of radiographic bone or soft tissue distant metastasis based on conventional imaging assessed by BICR or PSMA-PET imaging assessed by BICR, histopathologic diagnosis of distant metastasis, or death from any cause, whichever occurs first.

    Measured: 108 Months

  4. No Evidence of Disease (NED) Based on Conventional Imaging or PSMA PET Imaging Assessed by BICR

    NED is defined as: alive; no PSA progression; no distant metastasis based on conventional imaging assessed by BICR or PSMA-PET imaging assessed by BICR or histopathologic diagnosis; no local or regional recurrence based on conventional imaging assessed by BICR or PSMA-PET imaging assessed by BICR, or histopathologic diagnosis; no subsequent therapy for prostate cancer; testosterone recovery to age-related pre-androgen deprivation therapy (pre-ADT)/baseline or greater than (>) 200 nanogram per deciliter (ng/dL).

    Measured: 108 Months

  5. Overall Survival (OS)

    OS is defined as the time from randomization to date of death from any cause.

    Measured: 108 Months

  6. Time to Distant Metastasis Based on Conventional Imaging Assessed by BICR

    Time to distant metastasis is defined as the time from randomization to the date of the first occurrence of radiographic or pathological bone or soft tissue distant metastasis based on conventional imaging assessed by BICR or histopathologic diagnosis of distant metastasis.

    Measured: 108 Months

  7. EFS Based on Conventional Imaging or PSMA-PET Imaging Assessed by BICR

    EFS is defined as the time from randomization to the date of the first occurrence of PSA failure by the Phoenix definition, local or regional disease recurrence based on conventional imaging assessed by BICR or PSMA-PET imaging assessed by BICR or histopathologic diagnosis, distant metastasis based on conventional imaging assessed by BICR or PSMA-PET imaging assessed by BICR or histopathologic diagnosis, or death.

    Measured: 108 Months

  8. Time to Next Local or Systemic Treatment

    Time to next local or systemic treatment is defined as the time from randomization to the first subsequent therapy, including re-initiation of androgen deprivation therapy (ADT) and local treatments for local-regional recurrence or distant metastasis.

    Measured: 108 Months

Timeline

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

  1. First posted24 Aug 2015 (estimated)
  2. Study start19 Nov 2015
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion29 Dec 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
Double blind
Who is masked
Participant, Investigator
Enrolment
1,503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02531516
Sponsor's protocol ID
CR106935
Other IDs
56021927PCR3003, 2015-003007-38, 2023-505246-26-00, 2023, 2015
Status last verified
Nov 2026
First submitted
21 Aug 2015
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Poterala JE, Wisinski KB. Abbreviated endocrine therapy duration for low estrogen receptor-positive breast cancer: The counter to extended endocrine therapy. Cancer. 2022 May 1;128(9):1724-1726. doi: 10.1002/cncr.34158. Epub 2022 Feb 25. No abstract available.

    PubMed 35213039

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apalutamide, Bicalutamide and GnRH (agonist) in people with Prostatic Neoplasms, run by Aragon Pharmaceuticals, Inc. at 263 sites in 23 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 9 inclusion and 17 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 263 sites in United States, France, Brazil, Russia, Canada and 18 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?

Metastasis-Free Survival (MFS) (time frame: 108 Months). 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 NCT02531516, which also lists 1 linked publication.

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; AzTrials last refreshed its copy on 8 Nov 2026.

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