Phase 3 Prostate Cancer Trial, Completed NCT00554229 Sponsor: AstraZeneca 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 enrolled 299 people in the ZD4054 group and 295 people in the placebo (dummy treatment) group — a total of 594 participants. The trial was studying men with a form of advanced prostate cancer that had spread to the bones, and it was primarily measuring how long participants lived overall. It also tracked a number of secondary measurements, including how long before the cancer visibly grew, how long before stronger pain medicines (opiates) were needed, how long before bone-related complications occurred, how long before new bone lesions appeared, and how long before quality of life declined. The reported data shows that, for the main measurement — overall survival — the median time from joining the trial until death was 24.5 months in the ZD4054 group and 22.5 months in the placebo group. (Median means half the participants in each group had this outcome before that time, and half after.) For the secondary measurements, the reported data shows: the median time before the cancer showed signs of growing was 6.2 months (ZD4054) versus 6.5 months (placebo); the median time before opiate pain medicines were used was 16.7 months (ZD4054) versus 14.8 months (placebo); the median time before a bone-related complication occurred was 18.4 months (ZD4054) versus 17.1 months (placebo); the median time before four or more new bone lesions appeared was 15.1 months (ZD4054) versus 11.9 months (placebo); and the median time before a meaningful decline in quality of life was recorded was 5.5 months in both groups. 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

NCT00554229
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 that has spread to the bones
  • Your PSA (a protein measured in a blood test related to prostate cancer) has been rising over the past month
  • You have no pain, or only mild pain, caused by your prostate cancer
  • You are currently having treatment to lower testosterone levels, either through surgery or medication

Who may not be able to join:

  • You are currently taking strong (opiate-based) painkillers, such as morphine or codeine
  • You have previously had chemotherapy with paclitaxel, docetaxel, or mitoxantrone
  • You have heart failure, or you have had a heart attack in the last 6 months
  • You have a history of epilepsy or seizures

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 16 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.

Contact this trial

Principal Investigator: Martin Gleave, MD, FRCSC, FACS, The Prostate Centre at Vancouver General Hospital

Australian sites

Research Site, Hornsby, New South Wales
Research Site, St Leonards, New South Wales
Research Site, Redcliffe, Queensland
Research Site, Ashford, South Australia
Research Site, Subiaco, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
1 November 2007
Est. completion
1 July 2010

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇳 India 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇷🇸 Serbia 🇸🇬 Singapore 🇿🇦 South Africa 🇰🇷 South Korea 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Overall Survival

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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: 16 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