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New pill combo could extend life for men with advanced prostate cancer

NCT ID NCT02489318

Disease control Sponsor: Aragon Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether adding apalutamide (a daily pill) to standard hormone therapy helps men with metastatic hormone-sensitive prostate cancer live longer and delay disease progression. Over 1,000 participants received either apalutamide plus hormone therapy or a placebo plus hormone therapy. The study measures how long until the cancer worsens on scans and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
apalutamide (a drug that blocks androgen receptors, taken as a pill)
What this could lead to
If successful, adding apalutamide to standard hormone therapy could help men with advanced prostate cancer live longer and delay the need for chemotherapy.
What could go wrong
This is a large phase 3 trial, but results may not apply to all patients. Side effects of apalutamide can include fatigue, high blood pressure, and falls. The drug does not cure the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,052 people

The number who actually took part.

Started

Nov 2015

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Study site

    Homewood, Alabama, United States

  • Study site

    Tucson, Arizona, United States

  • Study site

    San Bernardino, California, United States

  • Study site

    San Diego, California, United States

  • Study site

    Denver, Colorado, United States

  • Study site

    Norwalk, Connecticut, United States

  • Study site

    Fort Myers, Florida, United States

  • Study site

    Chicago, Illinois, United States

  • Study site

    Fort Wayne, Indiana, United States

  • Study site

    Jeffersonville, Indiana, United States

  • Study site

    New Orleans, Louisiana, United States

  • Study site

    Baltimore, Maryland, United States

  • Study site

    Rockville, Maryland, United States

  • Study site

    Lansing, Michigan, United States

  • Study site

    Troy, Michigan, United States

  • Study site

    Omaha, Nebraska, United States

  • Study site

    Las Vegas, Nevada, United States

  • Study site

    Brooklyn, New York, United States

  • Study site

    Poughkeepsie, New York, United States

  • Study site

    Syracuse, New York, United States

  • Study site

    The Bronx, New York, United States

  • Study site

    Raleigh, North Carolina, United States

  • Study site

    Salisbury, North Carolina, United States

  • Study site

    Cleveland, Ohio, United States

  • Study site

    Middleburg Heights, Ohio, United States

  • Study site

    Springfield, Oregon, United States

  • Study site

    Bala-Cynwyd, Pennsylvania, United States

  • Study site

    Bryn Mawr, Pennsylvania, United States

  • Study site

    Lancaster, Pennsylvania, United States

  • Study site

    Charleston, South Carolina, United States

  • Study site

    Nashville, Tennessee, United States

  • Study site

    Dallas, Texas, United States

  • Study site

    Houston, Texas, United States

  • Study site

    San Antonio, Texas, United States

  • Study site

    Richmond, Virginia, United States

  • Study site

    Virginia Beach, Virginia, United States

  • Study site

    Burien, Washington, United States

  • Study site

    Spokane, Washington, United States

  • Study site

    Milwaukee, Wisconsin, United States

  • Study site

    Berazategui, Argentina

  • Study site

    Buenos Aires, Argentina

  • Study site

    C.a.b.a., Argentina

  • Study site

    Capital Federal, Argentina

  • Study site

    Ciudad Automoma Buenos Aires, Argentina

  • Study site

    Ciudad de Buenos Aires, Argentina

  • Study site

    Córdoba, Argentina

  • Study site

    La Plata, Argentina

  • Study site

    Pergamino, Argentina

  • Study site

    Rosario, Argentina

  • Study site

    San Miguel de Tucumán, Argentina

  • Study site

    San Salvador de Jujuy, Argentina

  • Study site

    Albury, Australia

  • Study site

    Elizabeth Vale, Australia

  • Study site

    Kogarah, Australia

  • Study site

    Port Macquarie, Australia

  • Study site

    South Brisbane, Australia

  • Study site

    St Leonards, Australia

  • Study site

    Barretos, Brazil

  • Study site

    Florianópolis, Brazil

  • Study site

    Goiânia, Brazil

  • Study site

    Ijuí, Brazil

  • Study site

    Natal, Brazil

  • Study site

    Ribeirão Preto, Brazil

  • Study site

    Rio de Janeiro, Brazil

  • Study site

    Salvador, Brazil

  • Study site

    Santo André, Brazil

  • Study site

    São Paulo, Brazil

  • Study site

    Sorocaba, Brazil

  • Study site

    Calgary, Alberta, Canada

  • Study site

    Vancouver, British Columbia, Canada

  • Study site

    Hamilton, Ontario, Canada

  • Study site

    Kingston, Ontario, Canada

  • Study site

    Toronto, Ontario, Canada

  • Study site

    Québec, Quebec, Canada

  • Study site

    Beijing, China

  • Study site

    Chengdu, China

  • Study site

    Chongqing, China

  • Study site

    Fuzhou, China

  • Study site

    Guangzhou, China

  • Study site

    Hangzhou, China

  • Study site

    Nanjing, China

  • Study site

    Shanghai, China

  • Study site

    Suzhou, China

  • Study site

    Wuhan, China

  • Study site

    Wuxi, China

  • Study site

    Xi'an, China

  • Study site

    Hradec Králove, Czechia

  • Study site

    Liberec, Czechia

  • Study site

    Nový Jicin, Czechia

  • Study site

    Olomouc, Czechia

  • Study site

    Opava, Czechia

  • Study site

    Pardubice, Czechia

  • Study site

    Prague, Czechia

  • Study site

    Zlín, Czechia

  • Study site

    Clermont-Ferrand, France

  • Study site

    Montpellier, France

  • Study site

    Nancy, France

  • Study site

    Paris, France

  • Study site

    Pierre-Bénite, France

  • Study site

    Strasbourg, France

  • Study site

    Suresnes, France

  • Study site

    Bonn, Germany

  • Study site

    Braunschweig, Germany

  • Study site

    Eisleben Lutherstadt, Germany

  • Study site

    Hamburg, Germany

  • Study site

    Hanover, Germany

  • Study site

    Leipzig, Germany

  • Study site

    Lübeck, Germany

  • Study site

    Nürtingen, Germany

  • Study site

    Sindelfingen, Germany

  • Study site

    Straubing, Germany

  • Study site

    Budapest, Hungary

  • Study site

    Győr, Hungary

  • Study site

    Pécs, Hungary

  • Study site

    Sopron, Hungary

  • Study site

    Beersheba, Israel

  • Study site

    Haifa, Israel

  • Study site

    Holon, Israel

  • Study site

    Kfar Saba, Israel

  • Study site

    Petah Tikva, Israel

  • Study site

    Ramat Gan, Israel

  • Study site

    Zrifin, Israel

  • Study site

    Chūōku, Japan

  • Study site

    Hakata-Ku, Japan

  • Study site

    Koshigaya, Japan

  • Study site

    Matsuyama, Japan

  • Study site

    Minamiku, Japan

  • Study site

    Miyazaki, Japan

  • Study site

    Nagano, Japan

  • Study site

    Nagasaki, Japan

  • Study site

    Osaka, Japan

  • Study site

    Osaka Sayama Shi, Japan

  • Study site

    Sakura, Japan

  • Study site

    Sapporo, Japan

  • Study site

    Yokohama, Japan

  • Study site

    Yufu, Japan

  • Study site

    Durango, Mexico

  • Study site

    Guadalajara, Mexico

  • Study site

    León, Mexico

  • Study site

    Mexico City, Mexico

  • Study site

    México, Mexico

  • Study site

    Morelia, Mexico

  • Study site

    Zapopan, Mexico

  • Study site

    Bialystok, Poland

  • Study site

    Bydgoszcz, Poland

  • Study site

    Krakow, Poland

  • Study site

    Kutno, Poland

  • Study site

    Lodz, Poland

  • Study site

    Lublin, Poland

  • Study site

    Siedlce, Poland

  • Study site

    Sochaczew, Poland

  • Study site

    Warsaw, Poland

  • Study site

    Wroclaw, Poland

  • Study site

    Bucharest, Romania

  • Study site

    Cluj-Napoca, Romania

  • Study site

    Craiova, Romania

  • Study site

    Târgu Mureş, Romania

  • Study site

    Barnaul, Russia

  • Study site

    Ivanovo, Russia

  • Study site

    Moscow, Russia

  • Study site

    Nizhny Novgorod, Russia

  • Study site

    Obninsk, Russia

  • Study site

    Omsk, Russia

  • Study site

    Pyatigorsk, Russia

  • Study site

    Rostov-on-Don, Russia

  • Study site

    Saint Petersburg, Russia

  • Study site

    Saransk, Russia

  • Study site

    Sochi, Russia

  • Study site

    Tambov, Russia

  • Study site

    Tomsk, Russia

  • Study site

    Tyumen, Russia

  • Study site

    Ufa, Russia

  • Study site

    Vologda, Russia

  • Study site

    Daegu, South Korea

  • Study site

    Daejeon, South Korea

  • Study site

    Goyang-si, South Korea

  • Study site

    Jeollanam-do, South Korea

  • Study site

    Seongnam-si, South Korea

  • Study site

    Seoul, South Korea

  • Study site

    Barcelona, Spain

  • Study site

    Córdoba, Spain

  • Study site

    Jerez de la Frontera, Spain

  • Study site

    Madrid, Spain

  • Study site

    Pamplona, Spain

  • Study site

    Gothenburg, Sweden

  • Study site

    Malmö, Sweden

  • Study site

    Örebro, Sweden

  • Study site

    Stockholm, Sweden

  • Study site

    Umeå, Sweden

  • Study site

    Uppsala, Sweden

  • Study site

    Vaxjo, Sweden

  • Study site

    Ankara, Turkey (Türkiye)

  • Study site

    Edirne, Turkey (Türkiye)

  • Study site

    Istanbul, Turkey (Türkiye)

  • Study site

    Izmir, Turkey (Türkiye)

  • Study site

    Mersin, Turkey (Türkiye)

  • Study site

    Cherkasy, Ukraine

  • Study site

    Dnipo, Ukraine

  • Study site

    Dnipro, Ukraine

  • Study site

    Ivano-Frankivsk, Ukraine

  • Study site

    Khakhiv, Ukraine

  • Study site

    Kharkiv, Ukraine

  • Study site

    Khmelnytsky, Ukraine

  • Study site

    Kyiv, Ukraine

  • Study site

    Lviv, Ukraine

  • Study site

    Odesa, Ukraine

  • Study site

    Poltava, Ukraine

  • Study site

    Uzhhorod, Ukraine

  • Study site

    Vinnitsa, Ukraine

  • Study site

    Zaporizhzhya, Ukraine

  • Study site

    Carlisle, United Kingdom

  • Study site

    Dundee, United Kingdom

  • Study site

    Glasgow, United Kingdom

  • Study site

    London, United Kingdom

  • Study site

    Newcastle upon Tyne, United Kingdom

  • Study site

    Oxford, United Kingdom

  • Study site

    Plymouth, United Kingdom

  • Study site

    Scunthorpe, United Kingdom

  • Study site

    Stockton-on-Tees, United Kingdom

  • Study site

    Wolverhampton, United Kingdom

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