This information is intended for US audiences only
Clinical Research Study For Patients WhoseProstate Cancer Has Not Spread Beyond the Prostate
EVALUATING AN INVESTIGATIONAL MEDICATION THROUGH CLINICAL RESEARCH
THE PURPOSE OF THE STUDY
This clinical trial is an essential step in the evaluation of an investigational medication to see if it can reduce the progression of prostate cancer. The purpose of the SPARTAN study is to evaluate the safety and effectiveness of an investigational medication in delaying prostate cancer from spreading beyond the prostate. Approximately 1,200 participants will be enrolled globally into this study.
KEY ELIGIBILITY CRITERIA
This study is enrolling only men whose cancer has not spread beyond the prostate and who, despite treatment, have rising blood prostate-specific antigen (PSA) levels. Other study requirements will need to be met by those interested in participating in the SPARTAN study. These requirements will be reviewed by the study doctor.
All study participants will continue to receive their current medication for their prostate cancer. In addition, approximately 2 out of 3 study participants will be randomly selected (like flipping a coin) to receive the investigational medication, while 1 out of 3 will receive a matching placebo (inactive capsule). The study medication/placebo will be taken by mouth once a day. Depending on the response, a participant may continue in the study for up to 59 months.
Eligible study participants will receive study-related procedures and study medication at no charge.
Participants may or may not experience a positive effect from the study medication. Additionally, the participant may experience side effects that can range from mild to very serious and life-threatening. While in the study, participants’ condition will be monitored by the study team. Participants are also encouraged to keep their families and primary doctors informed regarding the study.
Participants will be expected to visit the study doctor regularly throughout the study. During these visits, the study team will conduct the required assessments and procedures. These will include health questionnaires, physical examinations, blood draws and tumor scans.
To learn more about the SPARTAN study, and to see if there is a study site near you, click on one of the following links that will take you away from this website for more information:
|District of Columbia||Washington|
|New Port Richey|
|Fort Sam Houston|