A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01946204 |
Recruitment Status :
Active, not recruiting
First Posted : September 19, 2013
Results First Posted : June 19, 2018
Last Update Posted : April 25, 2024
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Tracking Information | ||||
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First Submitted Date ICMJE | September 17, 2013 | |||
First Posted Date ICMJE | September 19, 2013 | |||
Results First Submitted Date ICMJE | May 18, 2018 | |||
Results First Posted Date ICMJE | June 19, 2018 | |||
Last Update Posted Date | April 25, 2024 | |||
Actual Study Start Date ICMJE | October 2013 | |||
Actual Primary Completion Date | May 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 43 Months ] MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first. The MFS data for participants without metastasis or death were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and computerized tomography [CT] or magnetic resonance imaging [MRI] of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
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Original Primary Outcome Measures ICMJE |
Metastasis-free survival [ Time Frame: Up to death, loss to follow-up, or withdrawal of consent, whichever comes first (up to Month 59) ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer | |||
Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer | |||
Brief 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. | |||
Detailed 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:
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Prostatic Neoplasms | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
1207 | |||
Original Estimated Enrollment ICMJE |
1200 | |||
Estimated Study Completion Date ICMJE | December 2025 | |||
Actual Primary Completion Date | May 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Japan, Korea, Republic of, Netherlands, New Zealand, Norway, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Taiwan, United Kingdom, United States | |||
Removed Location Countries | Czech Republic, Ireland | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01946204 | |||
Other Study ID Numbers ICMJE | CR102931 ARN-509-003 ( Other Identifier: Aragon Pharmaceuticals, Inc. ) 2012-004322-24 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Aragon Pharmaceuticals, Inc. | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Aragon Pharmaceuticals, Inc. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Aragon Pharmaceuticals, Inc. | |||
Verification Date | April 2024 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |