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Promising combo aims to stall prostate cancer growth

NCT ID NCT02257736

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 01, 2026 · Updated 5 times

Summary

This phase 3 trial tests whether adding apalutamide to standard treatment (abiraterone and prednisone) can delay cancer growth in men with advanced prostate cancer that no longer responds to hormone therapy. About 982 participants who have not had chemotherapy are randomly assigned to receive either the combo or a placebo plus standard treatment. The main goal is to see how long the cancer stays under control.

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) combined with abiraterone acetate (Zytiga) and prednisone
What this could lead to
If successful, this combination could delay cancer progression and extend survival for men with advanced prostate cancer who have not yet had chemotherapy.
What could go wrong
This is an advanced trial, but the added drug may increase side effects without guaranteeing better survival. Results may not apply to all patients.

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

982 people

The number who actually took part.

Started

Nov 2014

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: * 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. Exclusion Criteria: * 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)

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma 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

    Phoenix, Arizona, United States

  • Study site

    La Mesa, California, United States

  • Study site

    Los Angeles, California, United States

  • Study site

    Modesto, California, United States

  • Study site

    San Diego, California, United States

  • Study site

    San Francisco, California, United States

  • Study site

    Santa Barbara, California, United States

  • Study site

    Aurora, Colorado, United States

  • Study site

    Denver, Colorado, United States

  • Study site

    Jensen Beach, Florida, United States

  • Study site

    Lakeland, Florida, United States

  • Study site

    New Port Richey, Florida, United States

  • Study site

    Ocala, Florida, United States

  • Study site

    Atlanta, Georgia, United States

  • Study site

    Melrose, Illinois, United States

  • Study site

    Niles, Illinois, United States

  • Study site

    Marrero, Louisiana, United States

  • Study site

    New Orleans, Louisiana, United States

  • Study site

    Shreveport, Louisiana, United States

  • Study site

    Auburn, Maine, United States

  • Study site

    Baltimore, Maryland, United States

  • Study site

    St Louis, Missouri, United States

  • Study site

    Omaha, Nebraska, United States

  • Study site

    Las Vegas, Nevada, United States

  • Study site

    Albany, New York, United States

  • Study site

    Johnson City, New York, United States

  • Study site

    New York, 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

    Columbus, Ohio, United States

  • Study site

    Tualatin, Oregon, United States

  • Study site

    Lancaster, Pennsylvania, United States

  • Study site

    Pittsburgh, Pennsylvania, 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

    Austin, Texas, United States

  • Study site

    Houston, Texas, United States

  • Study site

    Norfolk, Virginia, United States

  • Study site

    Richmond, Virginia, United States

  • Study site

    Auburn, Washington, United States

  • Study site

    Seattle, Washington, United States

  • Study site

    Spokane, Washington, United States

  • Study site

    Wenatchee, Washington, United States

  • Study site

    Madison, Wisconsin, United States

  • Study site

    Ciudad Automoma Buenos Aires, Argentina

  • Study site

    Ciudad de Buenos Aires, Argentina

  • Study site

    Córdoba, Argentina

  • Study site

    La Rioja, Argentina

  • Study site

    Mendoza, Argentina

  • Study site

    Rosario, Argentina

  • Study site

    Adelaide, Australia

  • Study site

    Ashford, Australia

  • Study site

    Camperdown, Australia

  • Study site

    Herston, Australia

  • Study site

    Liverpool, Australia

  • Study site

    Malvern, Australia

  • Study site

    Melbourne, Australia

  • Study site

    Southport, Australia

  • Study site

    Wahroonga, Australia

  • Study site

    West Heidelberg, Australia

  • Study site

    Woolloongabba, Australia

  • Study site

    Antwerp, Belgium

  • Study site

    Brussels, Belgium

  • Study site

    Ghent, Belgium

  • Study site

    Gosselies, Belgium

  • Study site

    Leuven, Belgium

  • Study site

    Liège, Belgium

  • Study site

    Namur, Belgium

  • Study site

    Ottignies, Belgium

  • Study site

    Roeselare, Belgium

  • Study site

    Sint-Niklaas, Belgium

  • Study site

    Barretos, Brazil

  • Study site

    Ijuí, Brazil

  • Study site

    Natal, Brazil

  • Study site

    Porto Alegre, Brazil

  • Study site

    São José do Rio Preto, Brazil

  • Study site

    São Paulo, Brazil

  • Study site

    Abbotsford British Columbia, British Columbia, Canada

  • Study site

    Kelowna, British Columbia, Canada

  • Study site

    Vancouver, British Columbia, Canada

  • Study site

    Halifax, Nova Scotia, Canada

  • Study site

    Barrie, Ontario, Canada

  • Study site

    London, Ontario, Canada

  • Study site

    Oakville, Ontario, Canada

  • Study site

    Toronto, Ontario, Canada

  • Study site

    Weston, Ontario, Canada

  • Study site

    Montreal, Quebec, Canada

  • Study site

    Québec, Quebec, Canada

  • Study site

    Sherbrooke, Quebec, Canada

  • Study site

    Angers, France

  • Study site

    Caen, France

  • Study site

    Dijon, France

  • Study site

    Le Mans, France

  • Study site

    Lyon, France

  • Study site

    Montpellier, France

  • Study site

    Paris, France

  • Study site

    Saint-Herblain, France

  • Study site

    Toulouse, France

  • Study site

    Berlin, Germany

  • Study site

    Dresden, Germany

  • Study site

    Freiburg im Breisgau, Germany

  • Study site

    Hamburg, Germany

  • Study site

    Heidelberg, Germany

  • Study site

    Münster, Germany

  • Study site

    Nürtingen, Germany

  • Study site

    Wuppertal, Germany

  • Study site

    Fukuoka, Japan

  • Study site

    Kanazawa, Japan

  • Study site

    Kashiwa, Japan

  • Study site

    Kita-Gun, Japan

  • Study site

    Kumamoto, Japan

  • Study site

    Kurume, Japan

  • Study site

    Matsuyama, Japan

  • Study site

    Miyazaki, Japan

  • Study site

    Nagasaki, Japan

  • Study site

    Osaka, Japan

  • Study site

    Ōsaka-sayama, Japan

  • Study site

    Sakura, Japan

  • Study site

    Sapporo, Japan

  • Study site

    Ube, Japan

  • Study site

    Yokohama, Japan

  • Study site

    Chihuahua City, Mexico

  • Study site

    Cuernavaca, Mexico

  • Study site

    Culiacán, Mexico

  • Study site

    México, Mexico

  • Study site

    Oaxaca City, Mexico

  • Study site

    Zapopan, Mexico

  • Study site

    Amsterdam, Netherlands

  • Study site

    Amsterdam-Zuidoost, Netherlands

  • Study site

    Blaricum, Netherlands

  • Study site

    Dordrecht, Netherlands

  • Study site

    Groningen, Netherlands

  • Study site

    Heerlen, Netherlands

  • Study site

    Nieuwegein, Netherlands

  • Study site

    Nijmegen, Netherlands

  • Study site

    Rotterdam, Netherlands

  • Study site

    The Hague, Netherlands

  • Study site

    Kursk, Russia

  • Study site

    Moscow, Russia

  • Study site

    Omsk, Russia

  • Study site

    Pyatigorsk, Russia

  • Study site

    Rostov-on-Don, Russia

  • Study site

    Saint Petersburg, Russia

  • Study site

    Ufa, Russia

  • Study site

    Bloemfontein, South Africa

  • Study site

    Cape Town, South Africa

  • Study site

    Johannesburg, South Africa

  • Study site

    Pretoria, South Africa

  • Study site

    Goyang-si, South Korea

  • Study site

    Seongnam, South Korea

  • Study site

    Seoul, South Korea

  • Study site

    Alcorcón, Spain

  • Study site

    Barcelona, Spain

  • Study site

    Cadiz, Spain

  • Study site

    Córdoba, Spain

  • Study site

    Madrid, Spain

  • Study site

    San Sebastián de los Reyes, Spain

  • Study site

    Valencia, Spain

  • Study site

    Ayr, United Kingdom

  • Study site

    Belfast, United Kingdom

  • Study site

    Birmingham, United Kingdom

  • Study site

    Edinburgh, United Kingdom

  • Study site

    Glasgow, United Kingdom

  • Study site

    London, United Kingdom

  • Study site

    Manchester, United Kingdom

  • Study site

    Metropolitan Borough of Wirral, United Kingdom

  • Study site

    Plymouth, United Kingdom

  • Study site

    Preston, United Kingdom

  • Study site

    Stevenage, United Kingdom

  • Study site

    Sutton, United Kingdom

  • Study site

    Westcliff-on-Sea, United Kingdom

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Other studies related to the condition(s) this trial covers.