A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer
Launched by ARAGON PHARMACEUTICALS, INC. · Sep 17, 2013
Trial Information
Current as of June 03, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called apalutamide (ARN-509) in men who have prostate cancer that is not spreading but is resistant to standard hormone treatments. The goal is to determine how effective and safe this medication is for adult men who are at high risk of their cancer spreading. Participants in the study must be men aged 65 to 74 with a specific type of prostate cancer that has been confirmed through tests and shows signs of growth, meaning their prostate-specific antigen (PSA) levels are rising despite ongoing treatment to lower testosterone.
To be eligible for this trial, men must have certain characteristics, such as having a specific PSA level and maintaining low testosterone levels. They also need to be stable on any bone health treatments they may be receiving. However, the trial excludes men with cancer that has already spread to other parts of the body or those who have had certain previous treatments. Participants can expect to undergo regular health assessments throughout the study, and they will receive the investigational medication while being closely monitored for any side effects or benefits. This trial is currently active but not enrolling new participants.
Gender
MALE
Eligibility criteria
- 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
About Aragon Pharmaceuticals, Inc.
Aragon Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development of innovative therapies for unmet medical needs, particularly in the fields of oncology and rare diseases. With a commitment to advancing precision medicine, Aragon leverages cutting-edge research and a robust pipeline of targeted treatments to improve patient outcomes. The company's expertise in drug development and strategic partnerships enable it to drive forward clinical trials that aim to bring transformative therapies to market, ultimately enhancing the quality of life for patients facing serious health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jacksonville, Florida, United States
Hackensack, New Jersey, United States
San Antonio, Texas, United States
Decatur, Georgia, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Innsbruck, , Austria
Ottawa, Ontario, Canada
Plymouth, , United Kingdom
Quebec, , Canada
Toronto, Ontario, Canada
Tel Aviv, , Israel
Southampton, , United Kingdom
Albuquerque, New Mexico, United States
Anchorage, Alaska, United States
Tucson, Arizona, United States
Denver, Colorado, United States
Boca Raton, Florida, United States
Miami, Florida, United States
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Maywood, Illinois, United States
Winston Salem, North Carolina, United States
Portland, Oregon, United States
Milwaukee, Wisconsin, United States
Vienna, , Austria
Kortrijk, , Belgium
Liege, , Belgium
Victoria, British Columbia, Canada
Strasbourg, , France
Haifa, , Israel
Bialystok, , Poland
Gdansk, , Poland
Szczecin, , Poland
Barcelona, , Spain
Madrid, , Spain
Valencia, , Spain
Umea, , Sweden
Uppsala, , Sweden
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Detroit, Michigan, United States
New York, New York, United States
Dallas, Texas, United States
Vandoeuvre Les Nancy Cedex, , France
Berlin, , Germany
Hamburg, , Germany
Heidelberg, , Germany
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Taipei, , Taiwan
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Bronx, New York, United States
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Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Sherbrooke, Quebec, Canada
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Halifax, Nova Scotia, Canada
Houston, Texas, United States
Jeffersonville, Indiana, United States
Green Bay, Wisconsin, United States
Adelaide, , Australia
Camperdown, , Australia
Melbourne, , Australia
Ryazan, , Russian Federation
St. Petersburg, , Russian Federation
Leeds, , United Kingdom
Daytona Beach, Florida, United States
Greenville, North Carolina, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Saint Petersburg, Florida, United States
Amarillo, Texas, United States
Odense N/A, , Denmark
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Münster, , Germany
Targu Mures, , Romania
Santander, , Spain
Glasgow, , United Kingdom
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Praha, , Czechia
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Tours, , France
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Concord, North Carolina, United States
Kelowna, British Columbia, Canada
Barrie, Ontario, Canada
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Norfolk, Virginia, United States
Heidelberg, , Germany
Barnaul, , Russian Federation
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Akita, , Japan
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Nagano, , Japan
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Linz, , Austria
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Westwood, Kansas, United States
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Kanazawa, , Japan
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Kita Gun, , Japan
Kashiwa, , Japan
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Kutno, , Poland
Taoyuan County, , Taiwan
Opava, , Czechia
Emmendingen, , Germany
Weiden, , Germany
Leuven, Vlaams Brabant, Belgium
Tours, Cedex 9, , France
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Olomouc, , Czechia
Carmel, Indiana, United States
Guildford, , United Kingdom
Hakodate, , Japan
Koshigaya, , Japan
San Sebastian De Los Reyes, , Spain
Olomouc, , Czechia
Le Mans, , France
Seongnam, , Korea, Republic Of
Owen Sound, Ontario, Canada
Hooksett, New Hampshire, United States
Nîmes Cedex 9, , France
Tweed Heads, , Australia
London, , United Kingdom
Mount Laurel, New Jersey, United States
Kfar Saba, , Israel
Meridian, Idaho, United States
Marseille Cedex 5, , France
Reims Cedex, , France
Nice Cedex 2, , France
Seinäjoki, , Finland
Paris 75, , France
Maidstone, , United Kingdom
Mannheim, Baden Württemberg, Germany
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Minneapolis, Minnesota, United States
Vancouver, British Columbia, Canada
Helsinki, , Finland
Lodz, , Poland
Barcelona, , Spain
Kansas City, Kansas, United States
Calgary, Alberta, Canada
Praha, , Czechia
Lodz, , Poland
Warszawa, , Poland
Glenwood Springs, Colorado, United States
Grand Junction, Colorado, United States
Minneapolis, Michigan, United States
Bay Saint Louis, Mississippi, United States
Oneida, New York, United States
Bala Cynwyd, Pennsylvania, United States
South Woodville, , Australia
Montrel, , Canada
Aalborg C, , Denmark
Caen Cédex 05, , France
Hyers, , France
La Roche Sur Yon Cedex 9, , France
Marseille Cedex 9, , France
Saint Gregoire, , France
Heinsberg, , Germany
Kirchheim Unter Teck, , Germany
Mettmann, , Germany
Müllheim, , Germany
Nuertingen, , Germany
Wuppertan, , Germany
Nyíregyhá, , Hungary
Jeruselem, , Israel
Fukuoka Shi, , Japan
Nelson City, , New Zealand
Whangarei, , New Zealand
Cluj Napoca, , Romania
Trenčín, , Slovakia
Jerez De La Frontera, , Spain
Patients applied
Trial Officials
Aragon Pharmaceuticals, Inc. Clinical Trial
Study Director
Aragon Pharmaceuticals, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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