A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN)
|ClinicalTrials.gov Identifier: NCT01946204|
Recruitment Status : Active, not recruiting
First Posted : September 19, 2013
Results First Posted : June 19, 2018
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: Apalutamide Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1207 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer|
|Actual Study Start Date :||October 14, 2013|
|Actual Primary Completion Date :||May 19, 2017|
|Estimated Study Completion Date :||November 29, 2022|
|Experimental: Treatment Arm A: Apalutamide||
240 mg tablets administered by mouth on a continuous once daily dosing regimen
|Placebo Comparator: Treatment Arm B: Placebo||
Matched placebo tablets administered by mouth on a continuous once daily dosing regimen
- 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.
- Time to Metastasis (TTM) [ Time Frame: Up to approximately 43 Months ]Time to metastasis (TTM) was defined as the time from randomization to the time of the scan that showed first evidence of BICR-confirmed radiographically detected bone or soft tissue distant metastasis. The TTM data for participants without metastasis were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and CT or MRI of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
- Progression-free Survival (PFS) [ Time Frame: Up to approximately 43 Months ]PFS defined as time from randomization to first documentation of BICR-confirmed radiographic progressive disease (PD) (development of distant/local/regional metastasis)/death due to any cause whichever occurred first. PFS data for participants without loco-regional disease were performed for US/ex-US regulatory purposes. Radiographic scans (bone scans and CT/MRI of chest,abdomen,pelvis) performed for detection of metastasis throughout study. PD based on RECIST v1.1; Subjects with one measurable lesion, At least 20% increase in sum of diameters of target lesions taking as reference smallest sum on study. In addition, sum must demonstrate an absolute increase of at least 5 millimeter(mm). Also, appearance of one/more new lesions was also considered PD. Subjects with non-measurable disease as per CT/MRI scans, unequivocal progression/appearance of one or more new lesions was considered PD. For new bone lesions detected on bone scans, second imaging (CT/MRI) was required to confirm PD.
- Time to Symptomatic Progression [ Time Frame: Up to approximately 43 Months ]Time to symptomatic progression was defined as the time from randomization to documentation in the CRF of any of the following (whichever occurred earlier): a) development of a skeletal-related event (pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone); b) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy; or c) development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.
- Overall Survival [ Time Frame: Up to approximately 43 months ]Overall survival was defined as the time from randomization to the date of death due to any cause.
- Time to Initiation of Cytotoxic Chemotherapy [ Time Frame: Up to approximately 43 months ]Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946204
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|Study Director:||Aragon Pharmaceuticals, Inc. Clinical Trial||Aragon Pharmaceuticals, Inc.|