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Promising drug may delay prostate cancer spread in High-Risk patients

NCT ID NCT01946204

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 6 times

Summary

This study tested a drug called apalutamide in over 1,200 men with a type of prostate cancer that has stopped responding to hormone therapy but has not yet spread. The goal was to see if the drug could delay the cancer from spreading to bones or other organs. Participants took either apalutamide or a placebo daily, and the main measure was how long they lived without the cancer spreading.

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

1,207 people

The number who actually took part.

Started

Oct 2013

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: * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features with high risk for development of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or equal to (\<=) 10 months. PSADT is calculated using at least 3 prostate-specific antigen (PSA) values obtained during continuous ADT (androgen deprivation therapy) * Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3 PSA rises, at least 1 week apart, with the last PSA greater than (\>) 2 nanogram per milliliter (ng/mL) * Maintain castrate levels of testosterone within 4 weeks prior to randomization and throughout the study * Patients currently receiving bone loss prevention treatment with bone-sparing agents must be on stable doses for at least 4 weeks prior to randomization * Patients who received a first generation anti-androgen (for example, bicalutamide, flutamide, nilutamide) must have at least a 4-week washout prior to randomization AND must show continuing disease (PSA) progression (an increase in PSA) after washout * At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors, estrogens, and any other anti-cancer therapy prior to randomization * At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization * Eastern Cooperative Oncology Group Performance Status 0 or 1 * Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade \<= 1 or baseline prior to randomization * Adequate organ function according to protocol-defined criteria * Administration of growth factors or blood transfusions will not be allowed within 4 weeks of the hematology labs required to confirm eligibility Exclusion Criteria: * Presence of confirmed distant metastases, including central nervous system and vertebral or meningeal involvement * Symptomatic local or regional disease requiring medical intervention * Prior treatment with second generation anti-androgens * Prior treatment with CYP17 inhibitors * Prior treatment with radiopharmaceutical agents, or any other investigational agent for non-metastatic castration-resistant prostate cancer * Prior chemotherapy for prostate cancer except if administered in the adjuvant/neoadjuvant setting * History of seizure or condition that may pre-dispose to seizure * Concurrent therapy with protocol-defined excluded medications * History or evidence of any of the following conditions: any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization; severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias within 6 months prior to randomization; uncontrolled hypertension; gastrointestinal disorder affecting absorption; active infection; and, any other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures

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Conditions

The condition(s) this trial relates to.

castration-resistant 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

    Birmingham, Alabama, United States

  • Study site

    Anchorage, Alaska, United States

  • Study site

    Chandler, Arizona, United States

  • Study site

    Tucson, Arizona, United States

  • Study site

    Duarte, California, United States

  • Study site

    Fullerton, California, United States

  • Study site

    Laguna Woods, California, United States

  • Study site

    Los Angeles, California, United States

  • Study site

    Orange, California, United States

  • Study site

    Roseville, California, United States

  • Study site

    Sacramento, 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

    Santa Monica, California, United States

  • Study site

    Sherman Oaks, California, United States

  • Study site

    Stanford, California, United States

  • Study site

    Tarzana, California, United States

  • Study site

    Torrance, California, United States

  • Study site

    Denver, Colorado, United States

  • Study site

    Englewood, Colorado, United States

  • Study site

    Glenwood Springs, Colorado, United States

  • Study site

    Grand Junction, Colorado, United States

  • Study site

    Washington D.C., District of Columbia, United States

  • Study site

    Aventura, Florida, United States

  • Study site

    Boca Raton, Florida, 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

    Jacksonville, Florida, United States

  • Study site

    Miami, Florida, United States

  • Study site

    New Port Richey, Florida, United States

  • Study site

    Orlando, Florida, United States

  • Study site

    Sarasota, Florida, United States

  • Study site

    St. Petersburg, Florida, United States

  • Study site

    Wellington, Florida, United States

  • Study site

    Meridian, Idaho, United States

  • Study site

    Chicago, Illinois, United States

  • Study site

    Decatur, Illinois, United States

  • Study site

    Maywood, Illinois, United States

  • Study site

    Melrose Park, Illinois, United States

  • Study site

    Carmel, Indiana, United States

  • Study site

    Jeffersonville, Indiana, United States

  • Study site

    Muncie, Indiana, United States

  • Study site

    West Des Moines, Iowa, United States

  • Study site

    Westwood, Kansas, United States

  • Study site

    Wichita, Kansas, United States

  • Study site

    Metairie, Louisiana, United States

  • Study site

    New Orleans, Louisiana, United States

  • Study site

    Annapolis, Maryland, United States

  • Study site

    Baltimore, Maryland, United States

  • Study site

    Rockville, Maryland, United States

  • Study site

    Towson, Maryland, United States

  • Study site

    Boston, Massachusetts, United States

  • Study site

    Detroit, Michigan, United States

  • Study site

    Lansing, Michigan, United States

  • Study site

    Minneapolis, Michigan, United States

  • Study site

    Royal Oak, Michigan, United States

  • Study site

    Duluth, Minnesota, United States

  • Study site

    Bay Saint Louis, Mississippi, United States

  • Study site

    Southaven, Mississippi, United States

  • Study site

    Kansas City, Missouri, United States

  • Study site

    Missoula, Montana, United States

  • Study site

    Omaha, Nebraska, United States

  • Study site

    Las Vegas, Nevada, United States

  • Study site

    Hooksett, New Hampshire, United States

  • Study site

    Hackensack, New Jersey, United States

  • Study site

    Lawrenceville, New Jersey, United States

  • Study site

    Morristown, New Jersey, United States

  • Study site

    Mount Laurel, New Jersey, United States

  • Study site

    New Brunswick, New Jersey, United States

  • Study site

    Voorhees Township, New Jersey, United States

  • Study site

    Albuquerque, New Mexico, United States

  • Study site

    Albany, New York, United States

  • Study site

    Mineola, New York, United States

  • Study site

    New York, New York, United States

  • Study site

    Oneida, 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

    Concord, North Carolina, United States

  • Study site

    Greensboro, North Carolina, United States

  • Study site

    Greenville, North Carolina, United States

  • Study site

    Salisbury, North Carolina, United States

  • Study site

    Winston-Salem, North Carolina, United States

  • Study site

    Cincinnati, Ohio, United States

  • Study site

    Cleveland, Ohio, United States

  • Study site

    Middleburg Heights, Ohio, United States

  • Study site

    Middletown, Ohio, United States

  • Study site

    Bend, Oregon, United States

  • Study site

    Portland, Oregon, United States

  • Study site

    Tualatin, 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

    Pittsburgh, Pennsylvania, United States

  • Study site

    Warwick, Rhode Island, United States

  • Study site

    Charleston, South Carolina, United States

  • Study site

    Greenville, South Carolina, United States

  • Study site

    Myrtle Beach, South Carolina, United States

  • Study site

    West Columbia, South Carolina, United States

  • Study site

    Memphis, Tennessee, United States

  • Study site

    Nashville, Tennessee, United States

  • Study site

    Abilene, Texas, United States

  • Study site

    Amarillo, Texas, United States

  • Study site

    Dallas, Texas, United States

  • Study site

    Fort Sam Houston, Texas, United States

  • Study site

    Houston, Texas, United States

  • Study site

    McAllen, Texas, United States

  • Study site

    San Antonio, Texas, United States

  • Study site

    Norfolk, Virginia, United States

  • Study site

    Richmond, Virginia, United States

  • Study site

    Virginia Beach, Virginia, United States

  • Study site

    Burien, Washington, United States

  • Study site

    Edmonds, Washington, United States

  • Study site

    Seattle, Washington, United States

  • Study site

    Tacoma, Washington, United States

  • Study site

    Green Bay, Wisconsin, United States

  • Study site

    Madison, Wisconsin, United States

  • Study site

    Milwaukee, Wisconsin, United States

  • Study site

    Adelaide, Australia

  • Study site

    Box Hill, Australia

  • Study site

    Camperdown, Australia

  • Study site

    Darlinghurst, Australia

  • Study site

    Geelong, Australia

  • Study site

    Gosford, Australia

  • Study site

    Hobart, Australia

  • Study site

    Kogarah, Australia

  • Study site

    Liverpool, Australia

  • Study site

    Melbourne, Australia

  • Study site

    Nedlands, Australia

  • Study site

    Parkville, Australia

  • Study site

    South Woodville, Australia

  • Study site

    Southport, Australia

  • Study site

    Sydney, Australia

  • Study site

    Tweed Heads, Australia

  • Study site

    Wollongong, Australia

  • Study site

    Graz, Austria

  • Study site

    Innsbruck, Austria

  • Study site

    Linz, Austria

  • Study site

    Vienna, Austria

  • Study site

    Brussels, Belgium

  • Study site

    Ghent, Belgium

  • Study site

    Kortrijk, Belgium

  • Study site

    Leuven, Belgium

  • Study site

    Liège, Belgium

  • Study site

    Ottignies, Belgium

  • Study site

    Calgary, Alberta, Canada

  • Study site

    Edmonton, Alberta, Canada

  • Study site

    Abbotsford British Columbia, British Columbia, Canada

  • Study site

    Kelowna, British Columbia, Canada

  • Study site

    Vancouver, British Columbia, Canada

  • Study site

    Victoria, British Columbia, Canada

  • Study site

    Moncton, New Brunswick, Canada

  • Study site

    Saint John, New Brunswick, Canada

  • Study site

    Halifax, Nova Scotia, Canada

  • Study site

    Barrie, Ontario, Canada

  • Study site

    Brampton, Ontario, Canada

  • Study site

    Brantford, Ontario, Canada

  • Study site

    Hamilton, Ontario, Canada

  • Study site

    London, Ontario, Canada

  • Study site

    North York, Ontario, Canada

  • Study site

    Oakville, Ontario, Canada

  • Study site

    Ottawa, Ontario, Canada

  • Study site

    Owen Sound, Ontario, Canada

  • Study site

    Toronto, Ontario, Canada

  • Study site

    Gatineau, Quebec, Canada

  • Study site

    Granby, Quebec, Canada

  • Study site

    Greenfield Park, Quebec, Canada

  • Study site

    Laval, Quebec, Canada

  • Study site

    Montreal, Quebec, Canada

  • Study site

    Pointe-Claire, Quebec, Canada

  • Study site

    Québec, Quebec, Canada

  • Study site

    Sherbrooke, Quebec, Canada

  • Study site

    Liberec, Czechia

  • Study site

    Olomouc, Czechia

  • Study site

    Opava, Czechia

  • Study site

    Pilsen, Czechia

  • Study site

    Prague, Czechia

  • Study site

    Aalborg C, Denmark

  • Study site

    Copenhagen, Denmark

  • Study site

    Odense, Denmark

  • Study site

    Roskilde, Denmark

  • Study site

    Helsinki, Finland

  • Study site

    Oulu, Finland

  • Study site

    Seinäjoki, Finland

  • Study site

    Tampere, Finland

  • Study site

    Turku, Finland

  • Study site

    Angers, France

  • Study site

    Besançon, France

  • Study site

    Bordeaux, France

  • Study site

    Caen Cédex 05, France

  • Study site

    Clermont-Ferrand, France

  • Study site

    Hyers, France

  • Study site

    La Roche-sur-Yon, France

  • Study site

    Le Mans, France

  • Study site

    Lille Cedex N/a, France

  • Study site

    Lyon, France

  • Study site

    Marseille, France

  • Study site

    Nice, France

  • Study site

    Nîmes, France

  • Study site

    Paris, France

  • Study site

    Reims, France

  • Study site

    Rennes, France

  • Study site

    Rouen, France

  • Study site

    Saint-Grégoire, France

  • Study site

    Saint-Herblain, France

  • Study site

    Strasbourg, France

  • Study site

    Suresnes, France

  • Study site

    Tours, France

  • Study site

    Vandœuvre-lès-Nancy, France

  • Study site

    Aachen, Germany

  • Study site

    Bergisch Gladbach, Germany

  • Study site

    Berlin, Germany

  • Study site

    Braunschweig, Germany

  • Study site

    Cologne, Germany

  • Study site

    Duisburg, Germany

  • Study site

    Emmendingen, Germany

  • Study site

    Frankfurt am Main, Germany

  • Study site

    Göttingen, Germany

  • Study site

    Greifswald, Germany

  • Study site

    Hamburg, Germany

  • Study site

    Hanover, Germany

  • Study site

    Heidelberg, Germany

  • Study site

    Heinsberg, Germany

  • Study site

    Homburg/Saar, Germany

  • Study site

    Jena, Germany

  • Study site

    Kiel, Germany

  • Study site

    Kirchheim unter Teck, Germany

  • Study site

    Magdeburg, Germany

  • Study site

    Mainz, Germany

  • Study site

    Mannheim, Germany

  • Study site

    Marburg, Germany

  • Study site

    Mettmann, Germany

  • Study site

    Müllheim, Germany

  • Study site

    Münster, Germany

  • Study site

    Nürtingen, Germany

  • Study site

    Regensburg, Germany

  • Study site

    Rostock, Germany

  • Study site

    Tübingen, Germany

  • Study site

    Weiden, Germany

  • Study site

    Wilhelmshaven, Germany

  • Study site

    Wuppertan, Germany

  • Study site

    Zirndorf, Germany

  • Study site

    Budapest, Hungary

  • Study site

    Miskolc, Hungary

  • Study site

    Nyíregyhá, Hungary

  • Study site

    Sopron, Hungary

  • Study site

    Szentes, Hungary

  • Study site

    Haifa, Israel

  • Study site

    Jeruselem, Israel

  • Study site

    Kfar Saba, Israel

  • Study site

    Petah Tikva, Israel

  • Study site

    Ramat Gan, Israel

  • Study site

    Tel Aviv, Israel

  • Study site

    Ẕerifin, Israel

  • Study site

    Akita, Japan

  • Study site

    Fukuoka, Japan

  • Study site

    Gifu, Japan

  • Study site

    Hakodate, Japan

  • Study site

    Hiroshima, Japan

  • Study site

    Hokkaido, Japan

  • Study site

    Kanazawa, Japan

  • Study site

    Kashiwa, Japan

  • Study site

    Kita-Gun, Japan

  • Study site

    Kobe, Japan

  • Study site

    Koshigaya, Japan

  • Study site

    Kumamoto, Japan

  • Study site

    Kurume, Japan

  • Study site

    Matsuyama, Japan

  • Study site

    Nagano, Japan

  • Study site

    Nagasaki, Japan

  • Study site

    Nagoya, Japan

  • Study site

    Niigata, Japan

  • Study site

    Osaka, Japan

  • Study site

    Ōsaka-sayama, Japan

  • Study site

    Sagamihara, Japan

  • Study site

    Sakura, Japan

  • Study site

    Sapporo, Japan

  • Study site

    Shinjuku-Ku, Japan

  • Study site

    Tokushima, Japan

  • Study site

    Tokyo, Japan

  • Study site

    Ube, Japan

  • Study site

    Wakayama, Japan

  • Study site

    Yokohama, Japan

  • Study site

    Alkmaar, Netherlands

  • Study site

    Eindhoven, Netherlands

  • Study site

    Hoofddorp, Netherlands

  • Study site

    Leidschendam, Netherlands

  • Study site

    Nijmegen, Netherlands

  • Study site

    Rotterdam, Netherlands

  • Study site

    Auckland, New Zealand

  • Study site

    Christchurch, New Zealand

  • Study site

    Hamilton, New Zealand

  • Study site

    Nelson, New Zealand

  • Study site

    Tauranga, New Zealand

  • Study site

    Whangarei, New Zealand

  • Study site

    Nordbyhagen, Norway

  • Study site

    Bialystok, Poland

  • Study site

    Bydgoszcz, Poland

  • Study site

    Gdansk, Poland

  • Study site

    Kutno, Poland

  • Study site

    Lodz, Poland

  • Study site

    Poznan, Poland

  • Study site

    Szczecin, Poland

  • Study site

    Torun, Poland

  • Study site

    Warsaw, Poland

  • Study site

    Wroclaw, Poland

  • Study site

    Baia Mare, Romania

  • Study site

    Brasov, Romania

  • Study site

    Bucharest, Romania

  • Study site

    Cluj-Napoca, Romania

  • Study site

    Târgu Mureş, Romania

  • Study site

    Barnaul, Russia

  • Study site

    Ivanovo, Russia

  • Study site

    Moscow, Russia

  • Study site

    Obninsk, Russia

  • Study site

    Omsk, Russia

  • Study site

    Ryazan, Russia

  • Study site

    Saint Petersburg, Russia

  • Study site

    Ufa, Russia

  • Study site

    Yaroslavl, Russia

  • Study site

    Yekaterinburg, Russia

  • Study site

    Banská Bystrica, Slovakia

  • Study site

    Bratislava, Slovakia

  • Study site

    Martin, Slovakia

  • Study site

    Nitra, Slovakia

  • Study site

    Trenčín, Slovakia

  • Study site

    Daegu, South Korea

  • Study site

    Gwangju, South Korea

  • Study site

    Pusan, South Korea

  • Study site

    Seongnam, South Korea

  • Study site

    Seoul, South Korea

  • Study site

    A Coruña, Spain

  • Study site

    Badalona, Spain

  • Study site

    Barcelona, Spain

  • Study site

    Castellon, Spain

  • Study site

    Girona, Spain

  • Study site

    Guadalajara, Spain

  • Study site

    Jerez de la Frontera, Spain

  • Study site

    Las Palmas de Gran Canaria, Spain

  • Study site

    Madrid, Spain

  • Study site

    Málaga, Spain

  • Study site

    Murcia, Spain

  • Study site

    Palma de Mallorca, Spain

  • Study site

    Pamplona, Spain

  • Study site

    Sabadell, Spain

  • Study site

    Salamanca, Spain

  • Study site

    San Sebastián de los Reyes, Spain

  • Study site

    Santander, Spain

  • Study site

    Seville, Spain

  • Study site

    Valencia, Spain

  • Study site

    Gothenburg, Sweden

  • Study site

    Örebro, Sweden

  • Study site

    Stockholm, Sweden

  • Study site

    Umeå, Sweden

  • Study site

    Uppsala, Sweden

  • Study site

    Kaohsiung City, Taiwan

  • Study site

    Taichung, Taiwan

  • Study site

    Taipei, Taiwan

  • Study site

    Taoyuan County, Taiwan

  • Study site

    Blackburn, United Kingdom

  • Study site

    Cambridge, United Kingdom

  • Study site

    Cardiff, United Kingdom

  • Study site

    Dundee, United Kingdom

  • Study site

    Glasgow, United Kingdom

  • Study site

    Guildford, United Kingdom

  • Study site

    Leeds, United Kingdom

  • Study site

    London, United Kingdom

  • Study site

    Maidstone, United Kingdom

  • Study site

    Metropolitan Borough of Wirral, United Kingdom

  • Study site

    Nottingham, United Kingdom

  • Study site

    Plymouth, United Kingdom

  • Study site

    Southampton, United Kingdom

  • Study site

    Surrey, United Kingdom

  • Study site

    Swansea, United Kingdom

  • Study site

    Wolverhampton, United Kingdom

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