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Can a new drug combo stop prostate cancer from spreading?

NCT ID NCT02531516

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether adding apalutamide (a hormone-blocking drug) to standard hormone therapy and radiation can delay the spread of prostate cancer in high-risk patients. About 1,500 men with localized or locally advanced prostate cancer are participating. The main goal is to see if the combination improves metastasis-free 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 male hormones) plus GnRH agonist (hormone therapy) and radiation therapy
What this could lead to
If successful, this combination could delay or prevent the spread of prostate cancer to other parts of the body, offering a new standard of care for high-risk patients.
What could go wrong
This is a large phase 3 trial, but results are not yet final. The drug may not significantly improve outcomes, and side effects from hormone therapy and radiation can be significant.

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

1,503 people

The number who actually took part.

Started

Nov 2015

Expected to finish

Dec 2028

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: * 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 * 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 Exclusion Criteria: - * 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) * 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

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate neoplasm

As listed by the trial registrant

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

Prostatic neoplasms

Contacts and locations

Locations

  • Study site

    Homewood, Alabama, United States

  • Study site

    Chandler, Arizona, United States

  • Study site

    Scottsdale, Arizona, United States

  • Study site

    Tucson, Arizona, United States

  • Study site

    Bakersfield, California, United States

  • Study site

    Los Angeles, California, United States

  • Study site

    Orange, California, United States

  • Study site

    San Bernardino, California, United States

  • Study site

    San Diego, California, United States

  • Study site

    San Francisco, California, United States

  • Study site

    Aurora, Colorado, United States

  • Study site

    Denver, Colorado, United States

  • Study site

    Middlebury, Connecticut, United States

  • Study site

    Bradenton, Florida, United States

  • Study site

    Daytona Beach, Florida, United States

  • Study site

    Fort Myers, Florida, United States

  • Study site

    Hialeah, Florida, United States

  • Study site

    Lakewood Rch, Florida, United States

  • Study site

    Naples, Florida, United States

  • Study site

    Plantation, Florida, United States

  • Study site

    Meridian, Idaho, United States

  • Study site

    Evergreen Park, Illinois, United States

  • Study site

    Harvey, Illinois, United States

  • Study site

    Jeffersonville, Indiana, United States

  • Study site

    Wichita, Kansas, United States

  • Study site

    Ashland, Kentucky, United States

  • Study site

    New Orleans, Louisiana, United States

  • Study site

    Shreveport, Louisiana, United States

  • Study site

    Scarborough, Maine, United States

  • Study site

    Baltimore, Maryland, United States

  • Study site

    Boston, Massachusetts, United States

  • Study site

    St Louis, Missouri, United States

  • Study site

    Morristown, New Jersey, United States

  • Study site

    Albany, New York, United States

  • Study site

    Brooklyn, New York, United States

  • Study site

    New York, New York, United States

  • Study site

    Poughkeepsie, New York, United States

  • Study site

    Rochester, New York, United States

  • Study site

    Syracuse, New York, United States

  • Study site

    The Bronx, New York, United States

  • Study site

    Cary, North Carolina, United States

  • Study site

    Raleigh, North Carolina, United States

  • Study site

    Portland, Oregon, 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

    Philadelphia, Pennsylvania, United States

  • Study site

    East Greenwich, Rhode Island, United States

  • Study site

    Charleston, South Carolina, United States

  • Study site

    Myrtle Beach, 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

    Fairfax, Virginia, United States

  • Study site

    Virginia Beach, Virginia, United States

  • Study site

    Burien, Washington, United States

  • Study site

    Spokane, Washington, United States

  • Study site

    Morgantown, West Virginia, United States

  • Study site

    Buenos Aires, Argentina

  • Study site

    C.a.b.a., Argentina

  • Study site

    Caba, Argentina

  • Study site

    Pergamino, Argentina

  • Study site

    Rosario, Argentina

  • Study site

    San Salvador de Jujuy, Argentina

  • Study site

    Aalst, Belgium

  • Study site

    Antwerp, Belgium

  • Study site

    Bonheiden, Belgium

  • Study site

    Brussels, Belgium

  • Study site

    Haine Saint Paul La Louviere, Belgium

  • Study site

    Leuven, Belgium

  • Study site

    Liège, Belgium

  • Study site

    Namur, Belgium

  • Study site

    Roeselare, Belgium

  • Study site

    Sint-Niklaas, Belgium

  • Study site

    Turnhout, Belgium

  • Study site

    Barretos, Brazil

  • Study site

    Belo Horizonte, Brazil

  • Study site

    Campinas, Brazil

  • Study site

    Curitiba, Brazil

  • Study site

    Florianópolis, Brazil

  • Study site

    Goiânia, Brazil

  • Study site

    Ijuí, Brazil

  • Study site

    Natal, Brazil

  • Study site

    Porto Alegre, Brazil

  • Study site

    Ribeirão Preto, Brazil

  • Study site

    Rio de Janeiro, Brazil

  • Study site

    Salvador, Brazil

  • Study site

    Santo André, Brazil

  • Study site

    São José do Rio Preto, Brazil

  • Study site

    São Paulo, Brazil

  • Study site

    Sorocaba, Brazil

  • Study site

    Calgary, Alberta, Canada

  • Study site

    Surrey, British Columbia, Canada

  • Study site

    Vancouver, British Columbia, Canada

  • Study site

    Victoria, British Columbia, Canada

  • Study site

    London, Ontario, Canada

  • Study site

    Ottawa, Ontario, Canada

  • Study site

    Toronto, Ontario, Canada

  • Study site

    Gatineau, Quebec, Canada

  • Study site

    Laval, Quebec, Canada

  • Study site

    Montreal, Quebec, Canada

  • Study site

    Québec, Quebec, Canada

  • Study site

    Sherbrooke, Quebec, Canada

  • Study site

    Beijing, China

  • Study site

    Chengdu, China

  • Study site

    Chongqing, China

  • Study site

    Guangzhou, China

  • Study site

    Hangzhou, China

  • Study site

    Nanchang, China

  • Study site

    Nanjing, China

  • Study site

    Ningbo, China

  • Study site

    Shanghai, China

  • Study site

    Wuhan, 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

    Amiens, France

  • Study site

    Angers, France

  • Study site

    Avignon, France

  • Study site

    Bayonne, France

  • Study site

    Besançon, France

  • Study site

    Bordeaux, France

  • Study site

    Brest, France

  • Study site

    Dijon, France

  • Study site

    Évry-Courcouronnes, France

  • Study site

    Hyères, France

  • Study site

    La Tronche, France

  • Study site

    Le Mans, France

  • Study site

    Lille, France

  • Study site

    Marseille, France

  • Study site

    Marseilli, France

  • Study site

    Montpellier, France

  • Study site

    Neuilly-sur-Seine, France

  • Study site

    Paris, France

  • Study site

    Ris-Orangis, France

  • Study site

    Saint-Brieuc, France

  • Study site

    Saint-Herblain, France

  • Study site

    Saint-Mandé, France

  • Study site

    Saint-Priest-en-Jarez, France

  • Study site

    Strasbourg, France

  • Study site

    Toulouse, France

  • Study site

    Tours, France

  • Study site

    Vandœuvre-lès-Nancy, France

  • Study site

    Villejuif, France

  • Study site

    Braunschweig, Germany

  • Study site

    Chemnitz, Germany

  • Study site

    Dessau, Germany

  • Study site

    Frankfurt, Germany

  • Study site

    Gronau, Germany

  • Study site

    Jena, Germany

  • Study site

    Münster, Germany

  • Study site

    Nürtingen, Germany

  • Study site

    Ulm, Germany

  • Study site

    Weiden/Opf, Germany

  • Study site

    Beer Yaakov, Israel

  • Study site

    Beersheba, Israel

  • Study site

    Haifa, Israel

  • Study site

    Jerusalem, Israel

  • Study site

    Kfar Saba, Israel

  • Study site

    Petah Tikva, Israel

  • Study site

    Ramat Gan, Israel

  • Study site

    Tel Aviv, Israel

  • Study site

    George Town, Malaysia

  • Study site

    Kuala Lumpur, Malaysia

  • Study site

    Kuching, Malaysia

  • Study site

    Putrajaya, Malaysia

  • Study site

    Culiacán, Mexico

  • Study site

    Guadalajara, Mexico

  • Study site

    León, Mexico

  • Study site

    México, Mexico

  • Study site

    Morelia, Mexico

  • Study site

    Zapopan, Mexico

  • Study site

    Alkmaar, Netherlands

  • Study site

    Amsterdam, Netherlands

  • Study site

    Nijmegen, Netherlands

  • Study site

    Rotterdam, Netherlands

  • Study site

    The Hague, Netherlands

  • Study site

    Bialystok, Poland

  • Study site

    Bydgoszcz, Poland

  • Study site

    Gdynia, Poland

  • Study site

    Gliwice, Poland

  • Study site

    Kielce, Poland

  • Study site

    Lodz, Poland

  • Study site

    Olsztyn, Poland

  • Study site

    Poznan, Poland

  • Study site

    Wałbrzych, Poland

  • Study site

    Bucharest, Romania

  • Study site

    Cluj-Napoca, Romania

  • Study site

    Floreşti, Romania

  • Study site

    Iași, Romania

  • Study site

    Otopeni, Romania

  • Study site

    Ploieşti, Romania

  • Study site

    Sibiu, Romania

  • Study site

    Târgu Mureş, Romania

  • Study site

    Timișoara, 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

    Ryazan, Russia

  • Study site

    Saint Petersburg, Russia

  • Study site

    Saransk, Russia

  • Study site

    Tambov, Russia

  • Study site

    Tyumen, Russia

  • Study site

    Ufa, Russia

  • Study site

    Vologda, Russia

  • Study site

    Buk Gu, South Korea

  • Study site

    Gyeonggi-do, South Korea

  • Study site

    Jeollanam-do, South Korea

  • Study site

    Seoul, South Korea

  • Study site

    Suwon, South Korea

  • Study site

    Barakaldo, Spain

  • Study site

    Barcelona, Spain

  • Study site

    Castellon, Spain

  • Study site

    L'Hospitalet de Llobregat, Spain

  • Study site

    Las Palmas de Gran Canaria, Spain

  • Study site

    Madrid, Spain

  • Study site

    Málaga, Spain

  • Study site

    Reus, Spain

  • Study site

    Santiago de Compostela, Spain

  • Study site

    Seville, Spain

  • Study site

    Örebro, Sweden

  • Study site

    Stockholm, Sweden

  • Study site

    Umeå, Sweden

  • Study site

    Kaohsiung City, Taiwan

  • Study site

    Taichung, Taiwan

  • Study site

    Tainan, Taiwan

  • Study site

    Taipei, Taiwan

  • Study site

    Taoyuan, Taiwan

  • Study site

    Adana, Turkey (Türkiye)

  • Study site

    Ankara, Turkey (Türkiye)

  • Study site

    Edirne, Turkey (Türkiye)

  • Study site

    Istanbul, Turkey (Türkiye)

  • Study site

    Izmir, Turkey (Türkiye)

  • Study site

    Kayseri, Turkey (Türkiye)

  • Study site

    Kocaeli, Turkey (Türkiye)

  • Study site

    Dnipro, Ukraine

  • Study site

    Khakhiv, Ukraine

  • Study site

    Kyiv, Ukraine

  • Study site

    Lviv, Ukraine

  • Study site

    Aberdeen, United Kingdom

  • Study site

    Birmingham, United Kingdom

  • Study site

    Bristol, United Kingdom

  • Study site

    Derby, United Kingdom

  • Study site

    Glasgow, United Kingdom

  • Study site

    Oxford, United Kingdom

  • Study site

    Plymouth, United Kingdom

  • Study site

    Preston, United Kingdom

  • Study site

    Sheffield, United Kingdom

  • Study site

    Sutton, United Kingdom

  • Study site

    Wolverhampton, United Kingdom

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