A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer

Last updated: April 25, 2025
Sponsor: Aragon Pharmaceuticals, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

Placebo

Apalutamide

Clinical Study ID

NCT01946204
CR102931
ARN-509-003
ARN-509-003; 56021927PCR1007
2012-004322-24
  • Ages > 18
  • Male

Study Summary

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate withoutneuroendocrine differentiation or small cell features with high risk for developmentof metastases, defined as prostate-specific antigen doubling time (PSADT) less thanor equal to (<=) 10 months. PSADT is calculated using at least 3 prostate-specificantigen (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 nanogramper milliliter (ng/mL)

  • Maintain castrate levels of testosterone within 4 weeks prior to randomization andthroughout the study

  • Patients currently receiving bone loss prevention treatment with bone-sparing agentsmust 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 randomizationAND must show continuing disease (PSA) progression (an increase in PSA) afterwashout

  • 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 torandomization

  • Eastern Cooperative Oncology Group Performance Status 0 or 1

  • Resolution of all acute toxic effects of prior therapy or surgical procedure toGrade <= 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 4weeks of the hematology labs required to confirm eligibility

Exclusion

Exclusion Criteria:

  • Presence of confirmed distant metastases, including central nervous system andvertebral 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 agentfor non-metastatic castration-resistant prostate cancer

  • Prior chemotherapy for prostate cancer except if administered in theadjuvant/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 (otherthan adequately treated basal cell or squamous cell skin cancer, superficial bladdercancer, or any other cancer in situ currently in complete remission) within 5 yearsprior to randomization; severe/unstable angina, myocardial infarction, symptomaticcongestive heart failure, arterial or venous thromboembolic events, or clinicallysignificant ventricular arrhythmias within 6 months prior to randomization;uncontrolled hypertension; gastrointestinal disorder affecting absorption; activeinfection; and, any other condition that, in the opinion of the investigator, wouldimpair the patient's ability to comply with study procedures

Study Design

Total Participants: 1207
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 14, 2013
Estimated Completion Date:
December 31, 2027

Study Description

This Phase 3 clinical trial is an essential step in the evaluation of an investigational medication to see if it may be useful in treating prostate cancer. The purpose of the SPARTAN study is to compare the safety and effectiveness of the investigational medication to placebo in delaying prostate cancer from spreading to other parts of the body. A placebo is a pill that looks like the investigational medication but does not contain any active medication, a dummy pill.

Phase 3 studies are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in previous Phase 2 studies. These studies are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

Study participants will take the oral investigational medication daily. One cycle of study treatment lasts 4 weeks or 28 days. The number of cycles will depend on how you and your cancer respond to the study medication.

In order for the researchers to evaluate and compare the study results, there are two different study groups. Study participants will be randomly (like flipping a coin) assigned to one of these groups:

  • One group will receive their current treatment along with the investigational medication

  • One group will receive their current medications along with a placebo

The investigational medication will be given to 2 out of every 3 study participants. Neither you nor the study staff will know which group you are in. However, in case of a medical emergency, your study doctor can quickly find out which treatment group you are in.

All participants will continue to receive their current treatment along with either the investigational medication or a placebo. The selections will be random, and you may remain on investigational treatment until your disease worsens, or until significant side effects occur or you can no longer tolerate treatment.

Connect with a study center

  • Adelaide,
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    Adelaide North,
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    Assaf Harofeh Medical Centre,
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    United States

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    United States

    Site Not Available

  • Daytona Beach, Florida
    United States

    Site Not Available

  • Fort Myers, Florida
    United States

    Site Not Available

  • Hialeah, Florida
    United States

    Site Not Available

  • Jacksonville, Florida
    United States

    Site Not Available

  • Miami, Florida
    United States

    Site Not Available

  • New Port Richey, Florida
    United States

    Site Not Available

  • Orlando, Florida
    United States

    Site Not Available

  • Saint Petersburg, Florida
    United States

    Site Not Available

  • Sarasota, Florida
    United States

    Site Not Available

  • empty

    St Petersburg, Florida
    United States

    Site Not Available

  • Wellington, Florida
    United States

    Site Not Available

  • Meridian, Idaho
    United States

    Site Not Available

  • Chicago, Illinois
    United States

    Site Not Available

  • Decatur, Illinois
    United States

    Site Not Available

  • Maywood, Illinois
    United States

    Site Not Available

  • Melrose Park, Illinois
    United States

    Site Not Available

  • empty

    Skokie, Illinois
    United States

    Site Not Available

  • Carmel, Indiana
    United States

    Site Not Available

  • Jeffersonville, Indiana
    United States

    Site Not Available

  • Muncie, Indiana
    United States

    Site Not Available

  • empty

    Munice, Indiana
    United States

    Site Not Available

  • West Des Moines, Iowa
    United States

    Site Not Available

  • Westwood, Kansas
    United States

    Site Not Available

  • Wichita, Kansas
    United States

    Site Not Available

  • empty

    Marrero, Louisiana
    United States

    Site Not Available

  • Metairie, Louisiana
    United States

    Site Not Available

  • New Orleans, Louisiana
    United States

    Site Not Available

  • Annapolis, Maryland
    United States

    Site Not Available

  • Baltimore, Maryland
    United States

    Site Not Available

  • empty

    Bethesda, Maryland
    United States

    Site Not Available

  • Rockville, Maryland
    United States

    Site Not Available

  • Towson, Maryland
    United States

    Site Not Available

  • Boston, Massachusetts
    United States

    Site Not Available

  • Detroit, Michigan
    United States

    Site Not Available

  • empty

    Kalamazoo, Michigan
    United States

    Site Not Available

  • Lansing, Michigan
    United States

    Site Not Available

  • Minneapolis, Michigan
    United States

    Site Not Available

  • Royal Oak, Michigan
    United States

    Site Not Available

  • Duluth, Minnesota
    United States

    Site Not Available

  • Bay Saint Louis, Mississippi
    United States

    Site Not Available

  • Southaven, Mississippi
    United States

    Site Not Available

  • empty

    St. Louis, Mississippi
    United States

    Site Not Available

  • Kansas City, Missouri
    United States

    Site Not Available

  • Missoula, Montana
    United States

    Site Not Available

  • Omaha, Nebraska
    United States

    Site Not Available

  • Las Vegas, Nevada
    United States

    Site Not Available

  • Hooksett, New Hampshire
    United States

    Site Not Available

  • Hackensack, New Jersey
    United States

    Site Not Available

  • Lawrenceville, New Jersey
    United States

    Site Not Available

  • Morristown, New Jersey
    United States

    Site Not Available

  • Mount Laurel, New Jersey
    United States

    Site Not Available

  • New Brunswick, New Jersey
    United States

    Site Not Available

  • Voorhees, New Jersey
    United States

    Site Not Available

  • Albuquerque, New Mexico
    United States

    Site Not Available

  • Albany, New York
    United States

    Site Not Available

  • Bronx, New York
    United States

    Site Not Available

  • Mineola, New York
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • empty

    New York City, New York
    United States

    Site Not Available

  • Oneida, New York
    United States

    Site Not Available

  • Poughkeepsie, New York
    United States

    Site Not Available

  • Syracuse, New York
    United States

    Site Not Available

  • empty

    The Bronx, New York
    United States

    Site Not Available

  • Concord, North Carolina
    United States

    Site Not Available

  • Greensboro, North Carolina
    United States

    Site Not Available

  • Greenville, North Carolina
    United States

    Site Not Available

  • Salisbury, North Carolina
    United States

    Site Not Available

  • empty

    Winston Salem, North Carolina
    United States

    Site Not Available

  • Winston-Salem, North Carolina
    United States

    Site Not Available

  • Cincinnati, Ohio
    United States

    Site Not Available

  • Cleveland, Ohio
    United States

    Site Not Available

  • Middleburg Heights, Ohio
    United States

    Site Not Available

  • Middletown, Ohio
    United States

    Site Not Available

  • Bend, Oregon
    United States

    Site Not Available

  • Portland, Oregon
    United States

    Site Not Available

  • Tualatin, Oregon
    United States

    Site Not Available

  • empty

    Bala Cynwyd, Pennsylvania
    United States

    Site Not Available

  • Bala-Cynwyd, Pennsylvania
    United States

    Site Not Available

  • Bryn Mawr, Pennsylvania
    United States

    Site Not Available

  • Lancaster, Pennsylvania
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • Warwick, Rhode Island
    United States

    Site Not Available

  • Charleston, South Carolina
    United States

    Site Not Available

  • Myrtle Beach, South Carolina
    United States

    Site Not Available

  • empty

    Spartanburg, South Carolina
    United States

    Site Not Available

  • West Columbia, South Carolina
    United States

    Site Not Available

  • Memphis, Tennessee
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Abilene, Texas
    United States

    Site Not Available

  • Amarillo, Texas
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • Fort Sam Houston, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • empty

    Mc Allen, Texas
    United States

    Site Not Available

  • McAllen, Texas
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • Norfolk, Virginia
    United States

    Site Not Available

  • Richmond, Virginia
    United States

    Site Not Available

  • empty

    Virgiania Beach, Virginia
    United States

    Site Not Available

  • Virginia Beach, Virginia
    United States

    Site Not Available

  • Burien, Washington
    United States

    Site Not Available

  • Edmonds, Washington
    United States

    Site Not Available

  • Seattle, Washington
    United States

    Site Not Available

  • Tacoma, Washington
    United States

    Site Not Available

  • Green Bay, Wisconsin
    United States

    Site Not Available

  • Madison, Wisconsin
    United States

    Site Not Available

  • Milwaukee, Wisconsin
    United States

    Site Not Available

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