AzTrials
AzTrials

Prostate CancerPhase 3TITANNCT02489318

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

A Phase 3 study testing Apalutamide and Androgen Deprivation Therapy (ADT) in people with Prostate Cancer, run by Aragon Pharmaceuticals, Inc. at 220 sites in 22 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 the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
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
1,052 participants
Where
220 sitesin 22 countries
Study dates
27 Nov 2015to 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

  • Diagnosis of prostate adenocarcinoma as confirmed by the investigator
  • Metastatic disease documented by greater than or equal to (>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
  • Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel <=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization
  • Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (<=) 6 months of ADT prior to randomization
  • Allowed prior treatments for localized prostate cancer (all treatments must have been completed >= 1 year prior to randomization) a) <= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies

Who cannot join

  • Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
  • Known brain metastases
  • Lymph nodes as only sites of metastases
  • Visceral (ie, liver or lung) metastases as only sites of metastases
  • Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
  • Prior treatment with other next generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
  • History of seizures or medications known to lower seizure threshold

Trial locations and contacts

220 sites in 22 countries.

220 sites in 22 countries

United States39 sites

  • Study site

    Bala-Cynwyd, Pennsylvania

  • Study site

    Baltimore, Maryland

  • Study site

    Brooklyn, New York

  • Study site

    Bryn Mawr, Pennsylvania

  • Study site

    Burien, Washington

  • Study site

    Charleston, South Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Wayne, Indiana

  • Study site

    Homewood, Alabama

  • Study site

    Houston, Texas

  • Study site

    Jeffersonville, Indiana

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Lansing, Michigan

  • Study site

    Las Vegas, Nevada

  • Study site

    Middleburg Heights, Ohio

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Study site

    Norwalk, Connecticut

  • Study site

    Omaha, Nebraska

  • Study site

    Poughkeepsie, New York

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Rockville, Maryland

  • Study site

    Salisbury, North Carolina

  • Study site

    San Antonio, Texas

  • Study site

    San Bernardino, California

  • Study site

    San Diego, California

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Oregon

  • Study site

    Syracuse, New York

  • Study site

    The Bronx, New York

  • Study site

    Troy, Michigan

  • Study site

    Tucson, Arizona

  • Study site

    Virginia Beach, Virginia

Other trials in United States

Russia16 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

    Saint Petersburg

  • Study site

    Saransk

  • Study site

    Sochi

  • Study site

    Tambov

  • Study site

    Tomsk

  • Study site

    Tyumen

  • Study site

    Ufa

  • Study site

    Vologda

Other trials in Russia

Japan14 sites

  • Study site

    Chūōku

  • Study site

    Hakata-Ku

  • Study site

    Koshigaya

  • Study site

    Matsuyama

  • Study site

    Minamiku

  • Study site

    Miyazaki

  • Study site

    Nagano

  • Study site

    Nagasaki

  • Study site

    Osaka

  • Study site

    Osaka Sayama Shi

  • Study site

    Sakura

  • Study site

    Sapporo

  • Study site

    Yokohama

  • Study site

    Yufu

Other trials in Japan

Ukraine14 sites

  • Study site

    Cherkasy

  • Study site

    Dnipo

  • Study site

    Dnipro

  • Study site

    Ivano-Frankivsk

  • Study site

    Khakhiv

  • Study site

    Kharkiv

  • Study site

    Khmelnytsky

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Poltava

  • Study site

    Uzhhorod

  • Study site

    Vinnitsa

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Argentina12 sites

  • Study site

    Berazategui

  • Study site

    Buenos Aires

  • Study site

    C.a.b.a.

  • Study site

    Capital Federal

  • Study site

    Ciudad Automoma Buenos Aires

  • Study site

    Ciudad de Buenos Aires

  • Study site

    Córdoba

  • Study site

    La Plata

  • Study site

    Pergamino

  • Study site

    Rosario

  • Study site

    San Miguel de Tucumán

  • Study site

    San Salvador de Jujuy

Other trials in Argentina

China12 sites

  • Study site

    Beijing

  • Study site

    Chengdu

  • Study site

    Chongqing

  • Study site

    Fuzhou

  • Study site

    Guangzhou

  • Study site

    Hangzhou

  • Study site

    Nanjing

  • Study site

    Shanghai

  • Study site

    Suzhou

  • Study site

    Wuhan

  • Study site

    Wuxi

  • Study site

    Xi'an

Other trials in China

Brazil11 sites

  • Study site

    Barretos

  • Study site

    Florianópolis

  • Study site

    Goiânia

  • Study site

    Ijuí

  • Study site

    Natal

  • Study site

    Ribeirão Preto

  • Study site

    Rio de Janeiro

  • Study site

    Salvador

  • Study site

    Santo André

  • Study site

    São Paulo

  • Study site

    Sorocaba

Other trials in Brazil

Germany10 sites

  • Study site

    Bonn

  • Study site

    Braunschweig

  • Study site

    Eisleben Lutherstadt

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Leipzig

  • Study site

    Lübeck

  • Study site

    Nürtingen

  • Study site

    Sindelfingen

  • Study site

    Straubing

Other trials in Germany

Poland10 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Krakow

  • Study site

    Kutno

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Siedlce

  • Study site

    Sochaczew

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

United Kingdom10 sites

  • Study site

    Carlisle

  • Study site

    Dundee

  • Study site

    Glasgow

  • Study site

    London

  • Study site

    Newcastle upon Tyne

  • Study site

    Oxford

  • Study site

    Plymouth

  • Study site

    Scunthorpe

  • Study site

    Stockton-on-Tees

  • Study site

    Wolverhampton

Other trials in United Kingdom

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

France7 sites

  • Study site

    Clermont-Ferrand

  • Study site

    Montpellier

  • Study site

    Nancy

  • Study site

    Paris

  • Study site

    Pierre-Bénite

  • Study site

    Strasbourg

  • Study site

    Suresnes

Other trials in France

Israel7 sites

  • Study site

    Beersheba

  • Study site

    Haifa

  • Study site

    Holon

  • Study site

    Kfar Saba

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

  • Study site

    Zrifin

Other trials in Israel

Mexico7 sites

  • Study site

    Durango

  • Study site

    Guadalajara

  • Study site

    León

  • Study site

    México

  • Study site

    Mexico City

  • Study site

    Morelia

  • Study site

    Zapopan

Other trials in Mexico

Sweden7 sites

  • Study site

    Gothenburg

  • Study site

    Malmö

  • Study site

    Örebro

  • Study site

    Stockholm

  • Study site

    Umeå

  • Study site

    Uppsala

  • Study site

    Vaxjo

Other trials in Sweden

Australia6 sites

  • Study site

    Albury

  • Study site

    Elizabeth Vale

  • Study site

    Kogarah

  • Study site

    Port Macquarie

  • Study site

    South Brisbane

  • Study site

    St Leonards

Other trials in Australia

Canada6 sites

  • Study site

    Calgary, Alberta

  • Study site

    Hamilton, Ontario

  • Study site

    Kingston, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

South Korea6 sites

  • Study site

    Daegu

  • Study site

    Daejeon

  • Study site

    Goyang-si

  • Study site

    Jeollanam-do

  • Study site

    Seongnam-si

  • Study site

    Seoul

Other trials in South Korea

Spain5 sites

  • Study site

    Barcelona

  • Study site

    Córdoba

  • Study site

    Jerez de la Frontera

  • Study site

    Madrid

  • Study site

    Pamplona

Other trials in Spain

Turkey (Türkiye)5 sites

  • Study site

    Ankara

  • Study site

    Edirne

  • Study site

    Istanbul

  • Study site

    Izmir

  • Study site

    Mersin

Other trials in Turkey (Türkiye)

Hungary4 sites

  • Study site

    Budapest

  • Study site

    Győr

  • Study site

    Pécs

  • Study site

    Sopron

Other trials in Hungary

Romania4 sites

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Craiova

  • Study site

    Târgu Mureş

Other trials in Romania

About this study

Official title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.

Read the detailed description

This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, multinational, multicenter study of apalutamide in participants with mHSPC. The study consists of 4 Phases: Screening Phase (up to 28 days before randomization), Treatment Phase (28 day treatment cycles until disease progression or the occurrence of unacceptable treatment related toxicity), an End of Treatment Phase (until 30 days after the last dose of study drug), and then a Survival Follow up Phase. In the event of a positive study result and notification of unblinding at either of the interim analyses or at the final analysis, participants in the treatment Phase will have the opportunity to enroll in an Open-label Extension Phase, which will allow participants to receive active drug (apalutamide) for approximately 3 years. Participants who are receiving apalutamide in the Open-label Extension Phase may continue receiving apalutamide in the Long-term Extension (LTE) Phase if they will continue to derive benefit from treatment (based on investigator assessment). Participants' safety will be monitored throughout the study.

Conditions
Prostate Cancer
Being tested
Apalutamide, Placebo, Androgen Deprivation Therapy (ADT)
Keywords
Prostate Cancer, JNJ-56021927, Androgen Deprivation Therapy, ARN-509, Apalutamide, TITAN, Metastatic Hormone-sensitive Prostate Cancer
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, ARN-509

    Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.

  • PlaceboDrug

    Participants will receive Placebo orally once daily in each 28 day treatment cycles.

  • Androgen Deprivation Therapy (ADT)Drug

    All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog [GnRHa] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.

Study groups in NCT02489318
Study groupRoleWhat they receive
Apalutamide plus ADTExperimentalParticipants will receive apalutamide 240 milligram (mg) (4X 60 mg tablets) with ADT.
Receives: Drug: Apalutamide; Drug: Androgen Deprivation Therapy (ADT)
Placebo plus ADTExperimentalParticipants will receive matching Placebo with ADT.
Receives: Drug: Placebo; Drug: Androgen Deprivation Therapy (ADT)

What is being measured

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

  1. Radiographic Progression-free Survival (rPFS)

    rPFS as assessed by the investigator was defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurred first. Radiographic progressive disease was defined as progression of soft tissue lesions measured by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by modified Response evaluation criteria in solid tumors (RECIST) 1.1.

    Measured: Up to 35 months

  2. Overall Survival (OS)

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

    Measured: Up to 57 months

Secondary outcomes (4)

  1. 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 for prostate cancer.

    Measured: Up to 57 months

  2. Time to Pain Progression

    Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (>=) 3 weeks apart or initiation of chronic opioids, 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.

    Measured: Up to 57 months

  3. Time to Chronic Opioid Use

    Time to chronic opioid use was defined as the time from date of randomization to the first date of confirmed chronic opioid use. For participants entering the study without receiving opioids, chronic opioid use was defined as administration of opioid analgesics lasting for greater than or equal to (>=) 3 weeks for oral or >=7 days for non-oral formulations. For participants entering the study already receiving opioids, chronic opioid use was defined as a >=30 percent (%) increase in total daily dose of the opioid analgesics lasting for >= 3 weeks for oral or >= 7 days for non-oral formulation.

    Measured: Up to 57 months

  4. Time to Skeletal-related Event (SRE)

    Time to SRE was defined as the time from the date of randomization to the date of the first observation of an SRE. A SRE was defined as the occurrence of either a pathological fracture, or spinal cord compression, or radiation to bone, or surgery to bone.

    Measured: Up to 57 months

Timeline

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

  1. First posted3 Jul 2015 (estimated)
  2. Study start27 Nov 2015
  3. Primary completion7 Sep 2020
  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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,052 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02489318
Sponsor's protocol ID
CR107614
Other IDs
56021927PCR3002, 2015-000735-32, 2015
Acronym
TITAN
Status last verified
Nov 2026
First submitted
1 Jul 2015
Last updated
4 Nov 2026
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • Hori T, Iwamoto H, Inaba T, Nakagawa R, Kamijima T, Kano H, Makino T, Naito R, Yaegashi H, Shigehara K, Nohara T, Izumi K, Mizokami A. Association Between Castration-resistant Prostate Cancer Progression Patterns and Survival Outcomes in Metastatic Castration-sensitive Prostate Cancer: A Post Hoc Analysis of the TITAN Trial. Eur Urol Focus. 2026 Sep 11:S2405-4569(26)00149-5. doi: 10.1016/j.euf.2026.07.003. Online ahead of print.

    PubMed 42728112

  • Hori T, Iwamoto H, Inaba T, Nakagawa R, Kamijima T, Makino T, Naito R, Kadomoto S, Yaegashi H, Shigehara K, Nohara T, Izumi K, Mizokami A. Integrating NCCN and LATITUDE in metastatic castration-sensitive prostate cancer: a TITAN analysis. World J Urol. 2026 Aug 19;44(1):585. doi: 10.1007/s00345-026-06695-5.

    PubMed 42616151

  • Karsh LI, Bevans KB, Saad F, Chung BH, Oudard S, Brookman-May SD, McCarthy SA, Smith MR, Chi KN, Small EJ, Agarwal N. Prostate-specific antigen and health-related quality of life in individuals with advanced prostate cancer treated with apalutamide: a plain language summary of the SPARTAN and TITAN studies. Future Oncol. 2024;20(35):2689-2698. doi: 10.1080/14796694.2024.2384257. Epub 2024 Aug 20.

    PubMed 39163505

  • Roy S, Sun Y, Chi KN, Ong M, Malone S, Wallis CJD, Kishan AU, Malone J, Swami U, Gebrael G, Brown JR, Jia AY, Morgan SC, Saad F, Chowdhury S, Agarwal N, Spratt DE. Early Prostate-Specific Antigen Response by 6 Months Is Predictive of Treatment Effect in Metastatic Hormone Sensitive Prostate Cancer: An Exploratory Analysis of the TITAN Trial. J Urol. 2024 Nov;212(5):672-681. doi: 10.1097/JU.0000000000004158. Epub 2024 Jul 26.

    PubMed 39058790

  • Merseburger AS, Agarwal N, Bjartell A, Uemura H, Soto AJ, Bhaumik A, Bohm J, Tran N, Krochmann N, Nematian-Samani M, Mundle SD, Brookman-May SD, Lopez-Gitlitz A, McCarthy SA, Chi K, Chowdhury S. Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) study: ultralow prostate-specific antigen decline with apalutamide plus androgen-deprivation therapy. BJU Int. 2024 Dec;134(6):982-991. doi: 10.1111/bju.16449. Epub 2024 Jun 28.

    PubMed 38940282

  • Shen J, Chowdhury S, Agarwal N, Karsh LI, Oudard S, Gartrell BA, Feyerabend S, Saad F, Pieczonka CM, Chi KN, Brookman-May SD, Rooney B, Bhaumik A, McCarthy SA, Bevans KB, Mundle SD, Small EJ, Smith MR, Graff JN. Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from Phase 3 randomised clinical studies TITAN and SPARTAN. Br J Cancer. 2024 Jan;130(1):73-81. doi: 10.1038/s41416-023-02492-8. Epub 2023 Nov 11.

    PubMed 37951974

  • Merseburger AS, Agarwal N, Bhaumik A, Lefresne F, Karsh LI, Pereira de Santana Gomes AJ, Soto AJ, Given RW, Brookman-May SD, Mundle SD, McCarthy SA, Uemura H, Chowdhury S, Chi KN, Bjartell A. Apalutamide plus androgen deprivation therapy in clinical subgroups of patients with metastatic castration-sensitive prostate cancer: A subgroup analysis of the randomised clinical TITAN study. Eur J Cancer. 2023 Nov;193:113290. doi: 10.1016/j.ejca.2023.113290. Epub 2023 Aug 11.

    PubMed 37708629

  • Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Ozguroglu M, Juarez Soto A, Merseburger AS, Uemura H, Ye D, Given R, Basch E, Miladinovic B, Lopez-Gitlitz A, Chi KN. Apalutamide plus Androgen Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study. J Urol. 2021 Oct;206(4):914-923. doi: 10.1097/JU.0000000000001841. Epub 2021 May 27.

    PubMed 34039013

  • Chi KN, Chowdhury S, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juarez A, Merseburger AS, Ozguroglu M, Uemura H, Ye D, Brookman-May S, Mundle SD, McCarthy SA, Larsen JS, Sun W, Bevans KB, Zhang K, Bandyopadhyay N, Agarwal N. Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. J Clin Oncol. 2021 Jul 10;39(20):2294-2303. doi: 10.1200/JCO.20.03488. Epub 2021 Apr 29.

    PubMed 33914595

  • Uemura H, Koroki Y, Iwaki Y, Imanaka K, Kambara T, Lopez-Gitlitz A, Smith A, Uemura H. Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study. BMC Urol. 2020 Sep 2;20(1):139. doi: 10.1186/s12894-020-00689-0.

    PubMed 32878613

  • Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Ozguroglu M, Juarez Soto A, Merseburger AS, Uemura H, Ye D, Given R, Cella D, Basch E, Miladinovic B, Dearden L, Deprince K, Naini V, Lopez-Gitlitz A, Chi KN; TITAN investigators. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2019 Nov;20(11):1518-1530. doi: 10.1016/S1470-2045(19)30620-5. Epub 2019 Sep 29.

    PubMed 31578173

  • Chi KN, Agarwal N, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juarez Soto A, Merseburger AS, Ozguroglu M, Uemura H, Ye D, Deprince K, Naini V, Li J, Cheng S, Yu MK, Zhang K, Larsen JS, McCarthy S, Chowdhury S; TITAN Investigators. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019 Jul 4;381(1):13-24. doi: 10.1056/NEJMoa1903307. Epub 2019 May 31.

    PubMed 31150574

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apalutamide and Androgen Deprivation Therapy (ADT) in people with Prostate Cancer, run by Aragon Pharmaceuticals, Inc. at 220 sites in 22 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 7 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 220 sites in United States, Russia, Japan, Ukraine, Argentina and 17 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?

Yes. Results are posted in the registry (first posted 18 Jan 2022). 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 35 months). 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 NCT02489318, which also lists 12 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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