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

June 4, 2026 updated by: Aragon Pharmaceuticals, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1052

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Berazategui, Argentina
      • Buenos Aires, Argentina
      • C.a.b.a., Argentina
      • Capital Federal, Argentina
      • Ciudad Automoma Buenos Aires, Argentina
      • Ciudad de Buenos Aires, Argentina
      • Córdoba, Argentina
      • La Plata, Argentina
      • Pergamino, Argentina
      • Rosario, Argentina
      • San Miguel de Tucumán, Argentina
      • San Salvador de Jujuy, Argentina
  • Australia
      • Albury, Australia
      • Elizabeth Vale, Australia
      • Kogarah, Australia
      • Port Macquarie, Australia
      • South Brisbane, Australia
      • St Leonards, Australia
  • Brazil
      • Barretos, Brazil
      • Florianópolis, Brazil
      • Goiânia, Brazil
      • Ijuí, Brazil
      • Natal, Brazil
      • Ribeirão Preto, Brazil
      • Rio de Janeiro, Brazil
      • Salvador, Brazil
      • Santo André, Brazil
      • Sorocaba, Brazil
      • São Paulo, Brazil
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Québec, Quebec, Canada
  • China
      • Beijing, China
      • Chengdu, China
      • Chongqing, China
      • Fuzhou, China
      • Guangzhou, China
      • Hangzhou, China
      • Nanjing, China
      • Shanghai, China
      • Suzhou, China
      • Wuhan, China
      • Wuxi, China
      • Xi'an, China
  • Czechia
      • Hradec Králove, Czechia
      • Liberec, Czechia
      • Nový Jicin, Czechia
      • Olomouc, Czechia
      • Opava, Czechia
      • Pardubice, Czechia
      • Prague, Czechia
      • Zlín, Czechia
  • France
      • Clermont-Ferrand, France
      • Montpellier, France
      • Nancy, France
      • Paris, France
      • Pierre-Bénite, France
      • Strasbourg, France
      • Suresnes, France
  • Germany
      • Bonn, Germany
      • Braunschweig, Germany
      • Eisleben Lutherstadt, Germany
      • Hamburg, Germany
      • Hanover, Germany
      • Leipzig, Germany
      • Lübeck, Germany
      • Nürtingen, Germany
      • Sindelfingen, Germany
      • Straubing, Germany
  • Hungary
      • Budapest, Hungary
      • Győr, Hungary
      • Pécs, Hungary
      • Sopron, Hungary
  • Israel
      • Beersheba, Israel
      • Haifa, Israel
      • Holon, Israel
      • Kfar Saba, Israel
      • Petah Tikva, Israel
      • Ramat Gan, Israel
      • Zrifin, Israel
  • Japan
      • Chūōku, Japan
      • Hakata-Ku, Japan
      • Koshigaya, Japan
      • Matsuyama, Japan
      • Minamiku, Japan
      • Miyazaki, Japan
      • Nagano, Japan
      • Nagasaki, Japan
      • Osaka, Japan
      • Osaka Sayama Shi, Japan
      • Sakura, Japan
      • Sapporo, Japan
      • Yokohama, Japan
      • Yufu, Japan
  • Mexico
      • Durango, Mexico
      • Guadalajara, Mexico
      • León, Mexico
      • Mexico City, Mexico
      • Morelia, Mexico
      • México, Mexico
      • Zapopan, Mexico
  • Poland
      • Bialystok, Poland
      • Bydgoszcz, Poland
      • Krakow, Poland
      • Kutno, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Siedlce, Poland
      • Sochaczew, Poland
      • Warsaw, Poland
      • Wroclaw, Poland
  • Romania
      • Bucharest, Romania
      • Cluj-Napoca, Romania
      • Craiova, Romania
      • Târgu Mureş, Romania
  • Russia
      • Barnaul, Russia
      • Ivanovo, Russia
      • Moscow, Russia
      • Nizhny Novgorod, Russia
      • Obninsk, Russia
      • Omsk, Russia
      • Pyatigorsk, Russia
      • Rostov-on-Don, Russia
      • Saint Petersburg, Russia
      • Saransk, Russia
      • Sochi, Russia
      • Tambov, Russia
      • Tomsk, Russia
      • Tyumen, Russia
      • Ufa, Russia
      • Vologda, Russia
  • South Korea
      • Daegu, South Korea
      • Daejeon, South Korea
      • Goyang-si, South Korea
      • Jeollanam-do, South Korea
      • Seongnam-si, South Korea
      • Seoul, South Korea
  • Spain
      • Barcelona, Spain
      • Córdoba, Spain
      • Jerez de la Frontera, Spain
      • Madrid, Spain
      • Pamplona, Spain
  • Sweden
      • Gothenburg, Sweden
      • Malmö, Sweden
      • Stockholm, Sweden
      • Umeå, Sweden
      • Uppsala, Sweden
      • Vaxjo, Sweden
      • Örebro, Sweden
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
      • Edirne, Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
      • Izmir, Turkey (Türkiye)
      • Mersin, Turkey (Türkiye)
  • Ukraine
      • Cherkasy, Ukraine
      • Dnipo, Ukraine
      • Dnipro, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Khakhiv, Ukraine
      • Kharkiv, Ukraine
      • Khmelnytsky, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Odesa, Ukraine
      • Poltava, Ukraine
      • Uzhhorod, Ukraine
      • Vinnitsa, Ukraine
      • Zaporizhzhya, Ukraine
  • United Kingdom
      • Carlisle, United Kingdom
      • Dundee, United Kingdom
      • Glasgow, United Kingdom
      • London, United Kingdom
      • Newcastle upon Tyne, United Kingdom
      • Oxford, United Kingdom
      • Plymouth, United Kingdom
      • Scunthorpe, United Kingdom
      • Stockton-on-Tees, United Kingdom
      • Wolverhampton, United Kingdom
  • United States
    • Alabama
      • Homewood, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • San Bernardino, California, United States
      • San Diego, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Norwalk, Connecticut, United States
    • Florida
      • Fort Myers, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Fort Wayne, Indiana, United States
      • Jeffersonville, Indiana, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Rockville, Maryland, United States
    • Michigan
      • Lansing, Michigan, United States
      • Troy, Michigan, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New York
      • Brooklyn, New York, United States
      • Poughkeepsie, New York, United States
      • Syracuse, New York, United States
      • The Bronx, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
      • Salisbury, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Middleburg Heights, Ohio, United States
    • Oregon
      • Springfield, Oregon, United States
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States
      • Bryn Mawr, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Richmond, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Burien, Washington, United States
      • Spokane, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Apalutamide plus ADT
Participants will receive apalutamide 240 milligram (mg) (4X 60 mg tablets) with ADT.
Drug: Apalutamide
Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.
Other Names:
  • ARN-509
  • JNJ-56021927
Drug: Androgen Deprivation Therapy (ADT)
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.
Experimental: Placebo plus ADT
Participants will receive matching Placebo with ADT.
Drug: Androgen Deprivation Therapy (ADT)
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.
Drug: Placebo
Participants will receive Placebo orally once daily in each 28 day treatment cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Radiographic Progression-free Survival (rPFS)
Time Frame: Up to 35 months
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.
Up to 35 months
Overall Survival (OS)
Time Frame: Up to 57 months
OS was defined as the time from date of randomization to date of death from any cause.
Up to 57 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Initiation of Cytotoxic Chemotherapy
Time Frame: Up to 57 months
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.
Up to 57 months
Time to Pain Progression
Time Frame: Up to 57 months
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.
Up to 57 months
Time to Chronic Opioid Use
Time Frame: Up to 57 months
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.
Up to 57 months
Time to Skeletal-related Event (SRE)
Time Frame: Up to 57 months
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.
Up to 57 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aragon Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 7, 2020

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR107614
  • 2015-000735-32 (EudraCT Number)
  • 56021927PCR3002 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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