1. Trial at a Glance
PEACE-1 was a phase 3 randomized treatment trial in patients with metastatic hormone-naïve prostate cancer. The registry lists a four-arm design evaluating combinations involving abiraterone acetate, radiotherapy, androgen deprivation therapy, and docetaxel.
| Feature | PEACE-1 |
|---|---|
| Status | Active, not recruiting |
| Sponsor | UNICANCER |
| Condition | Metastatic Prostate Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None |
| Primary purpose | Treatment |
2. Clinical Question
Population
Patients with metastatic hormone-naïve prostate cancer.
Interventions
Abiraterone acetate, radiotherapy, androgen deprivation therapy, and docetaxel were evaluated within the four-arm design.
Comparator
The randomized parallel-arm structure compares treatment strategies defined within the trial design.
Primary Question
The registry evaluates survival outcomes in patients treated with androgen deprivation therapy and docetaxel, including analyses involving additional treatment strategies.
3. Trial Design
Randomization
Four-arm treatment comparison
Survival assessment
Long-term follow-up
4. Endpoints
| Endpoint | Time Frame | Description |
|---|---|---|
| Survival | 7.5 years after the first inclusion | Overall and radiographic progression-free survival in patients with metastatic hormone-naïve prostate cancer treated by androgen deprivation therapy and docetaxel |
| Survival | 9.5 years after the first inclusion | Overall and radiographic progression-free survival in hormone-naïve prostate cancer patients with low metastatic burden whatever the standard of care received |
5. Planned Analysis
The registry identifies survival and radiographic progression-free survival as primary endpoints. Time-to-event endpoints of this type are commonly analyzed using methods such as Kaplan-Meier estimation, comparison tests between randomized groups, and regression models estimating relative event rates.
6. Statistical Methodology
Time-to-event analysis
Overall survival and radiographic progression-free survival are time-to-event outcomes. These outcomes account for both whether an event occurred and when it occurred. Patients without an observed event at the analysis time are typically handled through censoring methods.
Randomized comparisons
Randomization is designed to create comparable treatment groups at baseline. The parallel randomized structure supports comparison of survival outcomes between assigned treatment strategies.
Four-arm factorial considerations
A multi-arm randomized design allows investigators to examine multiple treatment strategies within one trial framework. Interpretation depends on the prespecified comparisons and statistical control of multiple treatment questions.
7. Statistical Methods Explained
Why is survival analyzed differently from a simple percentage?
Survival outcomes include follow-up time. A patient followed for several years without an event contributes different information from a patient followed briefly.
What does a hazard ratio represent?
A hazard ratio compares estimated event rates over time between groups. It does not represent the percentage of patients who benefit or the probability that an individual patient will experience an outcome.
Why is censoring important?
Censoring allows patients with incomplete event information to contribute available follow-up while avoiding the assumption that their later outcomes are known.
Why does a four-arm trial require careful interpretation?
Multiple randomized comparisons increase the importance of prespecified analysis plans and appropriate interpretation of statistical uncertainty.
8. Limitations
- The registry does not report posted statistical analyses or numerical endpoint results.
- The registry does not report treatment-effect estimates, confidence intervals, or p-values.
- Without posted analyses, the magnitude and precision of treatment effects cannot be evaluated from the registry record alone.
- Multiple treatment comparisons require careful consideration of statistical multiplicity.
9. Why This Trial Matters Statistically
| Concept | Application in PEACE-1 |
|---|---|
| Randomization | Randomized parallel phase 3 design |
| Time-to-event analysis | Survival and radiographic progression-free survival endpoints |
| Multi-arm design | Four treatment arms |
| Long follow-up | Primary endpoint assessments at 7.5 and 9.5 years after first inclusion |
10. Related Tutorials
Learn more about the methods used in this trial: