The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) by investigator assessment compared to enzalutamide single agent in castration resistant prostate cancer (CRPC) patients metastatic to bone
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Myocardial infarction within 6 months prior to screening
. Uncontrolled angina within 3 months prior to screening
. Congestive heart failure New York Heart Association (NYHA) class III or IV, or patients with history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%
. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
. Uncontrolled hypertension as indicated by a resting systolic blood pressure \> 170 mm Hg or diastolic blood pressure \> 105 mm Hg at screening
. Hypotension as indicated by systolic blood pressure \< 86 millimeters of mercury (mm Hg) at screening
. Bradycardia as indicated by a heart rate of \< 45 beats per minute on the screening ECG and on physical examination
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
radiological progression-free survival
Timeframe: 46 months after first patient entry
2
progression-free survival per Blinded Independent Central Review (PFS1B)
Timeframe: 96 months after first patient entry
Trial details
NCT IDNCT02194842
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC