Phase 3 Prostate Cancer Trial, Completed NCT02043678 Sponsor: Bayer Condition: Prostate Cancer
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT02043678) enrolled 806 people in total — 401 in the group receiving Radium-223 Dichloride combined with abiraterone/prednisone, and 405 in the group receiving a placebo combined with abiraterone/prednisone. The trial was measuring several time-based outcomes in people with prostate cancer that had spread to the bones, including how long before certain serious bone-related events occurred, how long people lived overall, and how long before pain or disease worsened. It is worth noting that the reported data shows zero participants were recorded as having "completed" the study in the conventional sense, meaning all participants either experienced an event or left the study before its end. The reported data shows that for the main outcome — the time until a serious bone-related event or death — the Radium-223 group had a reported median (the midpoint value for the group) of 22.3 months, compared with 26.0 months in the placebo group. For overall survival, the reported median was 30.1 months in the Radium-223 group and 34.8 months in the placebo group. For the time until scans showed disease progression or death, the figures were 11.2 months and 12.4 months respectively. The time until pain worsened was reported as 14.4 months for the Radium-223 group and 18.7 months for the placebo group, and the time until opiate pain medicines were needed was 19.0 months versus 22.6 months. The reported data also shows that the time until chemotherapy was started was 29.5 months in the Radium-223 group and 28.5 months in the placebo group — the only outcome where the numbers were closer together and where the Radium-223 group's figure was slightly higher. Across all the time-based outcomes reported, the placebo-combination group's figures were the same or higher than the Radium-223-combination group's figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Prostate Cancer Trial, Completed

NCT02043678
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with prostate cancer (a specific type called adenocarcinoma, confirmed by a lab test on tissue)
  • You are male and at least 18 years old
  • Your prostate cancer has been shown to be getting worse, either through rising PSA blood test results or through imaging scans showing tumor growth
  • You have 2 or more bone metastases (cancer that has spread to the bones) shown on a bone scan taken within the last 4 weeks, and the cancer has not spread to the lungs, liver, other organs, or brain
  • Your cancer symptoms are absent or only mild
  • If you previously took a certain type of hormone-blocking medication (anti-androgen), your PSA levels must have continued to rise after stopping that medication before joining
  • Your testosterone levels are being kept very low (below 50 ng/dL), either through ongoing medication or surgery
  • You are generally in good physical health and able to carry out daily activities with little or no limitation (confirm with trial site)

Who may not be able to join:

  • You have previously had chemotherapy to treat castration-resistant prostate cancer (including drugs such as taxanes, mitoxantrone, or estramustine)
  • You need to take more than a low daily dose of steroid medication (such as prednisone or prednisolone) for an ongoing health condition
  • Your prostate cancer has been identified as a specific rare type called small cell carcinoma
  • You have a history of cancer spreading to internal organs (such as the liver or lungs), or this is found during screening scans
  • You have a history of cancer spreading to the brain, or this is currently known to be the case
  • You have enlarged cancerous lymph nodes measuring more than 3 cm (confirm with trial site)
  • You have received a blood transfusion or medications to boost red blood cell production in the 4 weeks before screening or during the screening period
  • There are signs that the spinal cord may be at risk of being compressed by the cancer (confirm with trial site)
  • You are currently using, or have used in the past 4 weeks, opioid-based painkillers for cancer pain (including codeine)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
30 March 2014
Est. completion
15 February 2018

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇷🇺 Russia 🇸🇬 Singapore 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Symptomatic Skeletal Event Free Survival (SSE-FS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov