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Prostatic NeoplasmsPhase 3NCT02257736

An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Phase 3 study testing Apalutamide, Abiraterone acetate and Prednisone in people with Prostatic Neoplasms, run by Aragon Pharmaceuticals, Inc. at 173 sites in 16 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 compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using… 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, Abiraterone acetate and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
982 participants
Where
173 sitesin 16 countries
Study dates
26 Nov 2014to 31 Dec 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Adenocarcinoma of the prostate
  • Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest diameter
  • Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)
  • Participants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period
  • Prostate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2
  • Participants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2.

Who cannot join

  • Small cell or neuroendocrine carcinoma of the prostate
  • Known brain metastases
  • Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting
  • Previously treated with ketoconazole for prostate cancer for greater than 7 days
  • Therapies that must be discontinued or substituted at least 4 weeks prior to randomization include the following: a) Medications known to lower the seizure threshold, b) Herbal and non-herbal products that may decrease PSA levels (example [eg], saw palmetto, pomegranate) or c) Any investigational agent
  • At Screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)

Trial locations and contacts

173 sites in 16 countries.

173 sites in 16 countries

United States46 sites

  • Study site

    Albany, New York

  • Study site

    Atlanta, Georgia

  • Study site

    Auburn, Maine

  • Study site

    Auburn, Washington

  • Study site

    Aurora, Colorado

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Charleston, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Houston, Texas

  • Study site

    Jensen Beach, Florida

  • Study site

    Johnson City, New York

  • Study site

    La Mesa, California

  • Study site

    Lakeland, Florida

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Las Vegas, Nevada

  • Study site

    Los Angeles, California

  • Study site

    Madison, Wisconsin

  • Study site

    Marrero, Louisiana

  • Study site

    Melrose, Illinois

  • Study site

    Modesto, California

  • Study site

    Myrtle Beach, South Carolina

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Study site

    New Port Richey, Florida

  • Study site

    New York, New York

  • Study site

    Niles, Illinois

  • Study site

    Norfolk, Virginia

  • Study site

    Ocala, Florida

  • Study site

    Omaha, Nebraska

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Poughkeepsie, New York

  • Study site

    Richmond, Virginia

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Santa Barbara, California

  • Study site

    Seattle, Washington

  • Study site

    Shreveport, Louisiana

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Syracuse, New York

  • Study site

    The Bronx, New York

  • Study site

    Tualatin, Oregon

  • Study site

    Wenatchee, Washington

Other trials in United States

Japan15 sites

  • Study site

    Fukuoka

  • Study site

    Kanazawa

  • Study site

    Kashiwa

  • Study site

    Kita-Gun

  • Study site

    Kumamoto

  • Study site

    Kurume

  • Study site

    Matsuyama

  • Study site

    Miyazaki

  • Study site

    Nagasaki

  • Study site

    Osaka

  • Study site

    Ōsaka-sayama

  • Study site

    Sakura

  • Study site

    Sapporo

  • Study site

    Ube

  • Study site

    Yokohama

Other trials in Japan

United Kingdom13 sites

  • Study site

    Ayr

  • Study site

    Belfast

  • Study site

    Birmingham

  • Study site

    Edinburgh

  • Study site

    Glasgow

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Metropolitan Borough of Wirral

  • Study site

    Plymouth

  • Study site

    Preston

  • Study site

    Stevenage

  • Study site

    Sutton

  • Study site

    Westcliff-on-Sea

Other trials in United Kingdom

Canada12 sites

  • Study site

    Abbotsford British Columbia, British Columbia

  • Study site

    Barrie, Ontario

  • Study site

    Halifax, Nova Scotia

  • Study site

    Kelowna, British Columbia

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Oakville, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Sherbrooke, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Weston, Ontario

Other trials in Canada

Australia11 sites

  • Study site

    Adelaide

  • Study site

    Ashford

  • Study site

    Camperdown

  • Study site

    Herston

  • Study site

    Liverpool

  • Study site

    Malvern

  • Study site

    Melbourne

  • Study site

    Southport

  • Study site

    Wahroonga

  • Study site

    West Heidelberg

  • Study site

    Woolloongabba

Other trials in Australia

Belgium10 sites

  • Study site

    Antwerp

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Gosselies

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Namur

  • Study site

    Ottignies

  • Study site

    Roeselare

  • Study site

    Sint-Niklaas

Other trials in Belgium

Netherlands10 sites

  • Study site

    Amsterdam

  • Study site

    Amsterdam-Zuidoost

  • Study site

    Blaricum

  • Study site

    Dordrecht

  • Study site

    Groningen

  • Study site

    Heerlen

  • Study site

    Nieuwegein

  • Study site

    Nijmegen

  • Study site

    Rotterdam

  • Study site

    The Hague

Other trials in Netherlands

France9 sites

  • Study site

    Angers

  • Study site

    Caen

  • Study site

    Dijon

  • Study site

    Le Mans

  • Study site

    Lyon

  • Study site

    Montpellier

  • Study site

    Paris

  • Study site

    Saint-Herblain

  • Study site

    Toulouse

Other trials in France

Germany8 sites

  • Study site

    Berlin

  • Study site

    Dresden

  • Study site

    Freiburg im Breisgau

  • Study site

    Hamburg

  • Study site

    Heidelberg

  • Study site

    Münster

  • Study site

    Nürtingen

  • Study site

    Wuppertal

Other trials in Germany

Russia7 sites

  • Study site

    Kursk

  • Study site

    Moscow

  • Study site

    Omsk

  • Study site

    Pyatigorsk

  • Study site

    Rostov-on-Don

  • Study site

    Saint Petersburg

  • Study site

    Ufa

Other trials in Russia

Spain7 sites

  • Study site

    Alcorcón

  • Study site

    Barcelona

  • Study site

    Cadiz

  • Study site

    Córdoba

  • Study site

    Madrid

  • Study site

    San Sebastián de los Reyes

  • Study site

    Valencia

Other trials in Spain

Argentina6 sites

  • Study site

    Ciudad Automoma Buenos Aires

  • Study site

    Ciudad de Buenos Aires

  • Study site

    Córdoba

  • Study site

    La Rioja

  • Study site

    Mendoza

  • Study site

    Rosario

Other trials in Argentina

Brazil6 sites

  • Study site

    Barretos

  • Study site

    Ijuí

  • Study site

    Natal

  • Study site

    Porto Alegre

  • Study site

    São José do Rio Preto

  • Study site

    São Paulo

Other trials in Brazil

Mexico6 sites

  • Study site

    Chihuahua City

  • Study site

    Cuernavaca

  • Study site

    Culiacán

  • Study site

    México

  • Study site

    Oaxaca City

  • Study site

    Zapopan

Other trials in Mexico

South Africa4 sites

  • Study site

    Bloemfontein

  • Study site

    Cape Town

  • Study site

    Johannesburg

  • Study site

    Pretoria

Other trials in South Africa

South Korea3 sites

  • Study site

    Goyang-si

  • Study site

    Seongnam

  • Study site

    Seoul

Other trials in South Korea

About this study

Official title: A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).

Read the detailed description

This is a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know the treatment) placebo-controlled and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to determine if participants with chemotherapy-naive mCRPC will benefit from the addition of apalutamide to AAP compared with AAP alone. The study consists of 3 phases: Screening phase; Treatment phase, and Follow-up phase. At the final analysis, the study will be unblinded. After the Independent Data Monitoring Committee (IDMC) review and the sponsor's subsequent decision participants will be offered to receive treatment either in the Open-Label Extension Phase or the Long-Term Extension Phase of study. Participants' safety will be monitored throughout the study.

Being tested
Apalutamide, Abiraterone acetate, Prednisone, Placebo
Keywords
Prostatic neoplasms, JN56021927, ZYTIGA, Prednisone, Abiraterone acetate, Apalutamide
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

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

  • Abiraterone acetateDrug

    Also called ZYTIGA

    Participants will receive 1000 mg (4*250 mg tablets) of abiraterone acetate (AA) once daily orally.

  • PrednisoneDrug

    Participants will receive 5 mg tablet of prednisone twice daily orally.

  • PlaceboDrug

    Participants will receive matching placebo to apalutamide once daily orally.

Study groups in NCT02257736
Study groupRoleWhat they receive
Group 1: AAP and apalutamideExperimentalParticipants will receive apalutamide 240 milligram (mg) (4*60 mg tablets) and abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily, until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the Open-Label Extension (OLE) or Long-Term Extension (LTE) phase (AAP + open label apalutamide or AAP alone).
Receives: Drug: Apalutamide; Drug: Abiraterone acetate; Drug: Prednisone
Group 2: AAP and PlaceboPlacebo comparatorParticipants will receive matching Placebo of apalutamide and abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the OLE or LTE phase (AAP + open label apalutamide or AAP alone).
Receives: Drug: Abiraterone acetate; Drug: Prednisone; Drug: Placebo

What is being measured

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

  1. Radiographic Progression-free Survival (rPFS)

    The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

    Measured: Up to 3 years and 4 months

Secondary outcomes (4)

  1. Overall Survival (OS)

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

    Measured: Up to 5 years and 10 months

  2. Time to Chronic Opioid Use

    Time to chronic opioid use was defined as the time from date of randomization to the first date of opioid use.

    Measured: Up to 5 years and 10 months

  3. Time to Initiation of Cytotoxic Chemotherapy

    Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy.

    Measured: Up to 5 years and 10 months

  4. Time to Pain Progression

    Time to pain progression: time from randomization to first date that participant either experienced an increase by 2 points from baseline in Brief Pain Inventory Short Form (BPI-SF) worst pain intensity item (item 3) or Case Report Form (CRF) pain, observed at 2 consecutive evaluations >=4 wks apart, or initiation of chronic opioids as defined in time to chronic opioid use, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3(worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.CRF pain refers to participant's response to global pain assessment "How would you rate your pain over the past 7 days?"with a scale of 0("No pain") to 10("Pain as bad as you can imagine"),that is systematically reported and recorded on the eCRF.

    Measured: Up to 5 years and 10 months

Timeline

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

  1. First posted6 Oct 2014 (estimated)
  2. Study start26 Nov 2014
  3. Primary completion19 Mar 2018
  4. Study completion31 Dec 2027 (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
982 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02257736
Sponsor's protocol ID
CR105505
Other IDs
56021927PCR3001, 2014-001718-25, 2023-508606-26-00, 2023, 2014
Status last verified
Nov 2026
First submitted
2 Oct 2014
Last updated
4 Nov 2026
Data monitoring committee
No
FDA-regulated drug
Yes

Publications

  • Roy S, Wallis CJD, Morgan SC, Kishan AU, Le ATT, Malone J, Sun Y, Spratt DE, Saad F, Malone S. Implications of metastatic stage at presentation in docetaxel naive metastatic castrate resistant prostate cancer. Prostate. 2023 Jul;83(10):912-921. doi: 10.1002/pros.24512. Epub 2023 Apr 18.

    PubMed 37071764

  • Saad F, Efstathiou E, Attard G, Flaig TW, Franke F, Goodman OB Jr, Oudard S, Steuber T, Suzuki H, Wu D, Yeruva K, De Porre P, Brookman-May S, Li S, Li J, Thomas S, Bevans KB, Mundle SD, McCarthy SA, Rathkopf DE; ACIS Investigators. Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2021 Nov;22(11):1541-1559. doi: 10.1016/S1470-2045(21)00402-2. Epub 2021 Sep 30.

    PubMed 34600602

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apalutamide, Abiraterone acetate and Prednisone in people with Prostatic Neoplasms, run by Aragon Pharmaceuticals, Inc. at 173 sites in 16 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 4 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 173 sites in United States, Japan, United Kingdom, Canada, Australia and 11 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 16 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Radiographic Progression-free Survival (rPFS) (time frame: Up to 3 years and 4 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 NCT02257736, 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 4 Nov 2026.

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