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Prostate Cancer · Medical Oncology

PEACE-1

In de novo metastatic castration-sensitive prostate cancer, does abiraterone + prednisone added to ADT ± docetaxel improve rPFS and OS?

Population
1,172 randomized men with de novo metastatic disease; 2×2 factorial design testing abiraterone and prostate radiotherapy.
Treatment
ADT ± docetaxel 75 mg/m² every 3 weeks for 6 cycles, with or without abiraterone 1,000 mg daily + prednisone 5 mg twice daily; prostate RT was a separate factorial intervention.
Overall population
rPFS HR 0.54 (99.9% CI 0.41–0.71); OS HR 0.82 (95.1% CI 0.69–0.98).
ADT + docetaxel subgroup
rPFS HR 0.50 (99.9% CI 0.34–0.71); OS HR 0.75 (95.1% CI 0.59–0.95), P=.017.

Absolute Effect

Fixed-time OS/rPFS percentages were not used to manufacture an NNT from hazard ratios. The clinically relevant effect is therefore presented as HRs plus the treatment population and follow-up rather than a misleading median-derived NNT.

Key result: In the docetaxel population, the OS HR was 0.75. The trial also found no interaction between abiraterone and radiotherapy, supporting pooled assessment of abiraterone efficacy.

Safety: Grade ≥3 adverse events in the docetaxel population were 63% with abiraterone versus 52% without; hypertension was 22% versus 13%.

Interpretation & limitations

The factorial design simultaneously addresses systemic intensification and prostate radiotherapy. It is important not to use the abiraterone result as evidence that prostate RT and abiraterone are interchangeable interventions.

Primary source

Fizazi K, et al. Lancet. 2022;399:1695–1707.

Read the primary publication →

Additional randomized comparison · prostate radiotherapy

PEACE-1: adding prostate RT to modern systemic therapy

PEACE-1 also tested prostate radiotherapy in de novo metastatic castration-sensitive disease using a 2 × 2 factorial design. This is the comparison relevant to the prostate-primary RT question; it is distinct from the abiraterone comparison summarized above.

Low-volume disease receiving abiraterone: median radiographic PFS was 7.5 years with prostate RT versus 4.4 years without RT (adjusted HR 0.65; 99.9% CI 0.36–1.19; reported p=0.019). The trial reported a qualitative interaction between RT and abiraterone for rPFS, so these groups should not be indiscriminately pooled.

Low-volume rPFS · abiraterone-treated subgroup
RT + SOC + abiraterone
7.5 years
SOC + abiraterone
4.4 years

Reported median rPFS; bars scaled to the larger median. This is not an NNT.

Overall survival in low-volume disease: median OS was 7.5 years with RT versus 6.9 years without RT; HR 0.98 (95.1% CI 0.74–1.28; p=0.86), showing no OS improvement in this analysis.

Primary source: Bossi A, et al. Lancet. 2024;404:2065–2076. Read PEACE-1 radiotherapy analysis →

Current-practice context · reviewed 14 October 2026

In de novo metastatic hormone-sensitive prostate cancer, adding abiraterone to ADT plus docetaxel improved radiographic PFS and delayed castration resistance; OS benefit was most evident in the docetaxel-treated subgroup. This supports triplet therapy for suitable patients, particularly when fit for docetaxel, while ARPI doublets remain appropriate for many others. Prostate RT should be considered separately according to metastatic burden and symptoms.

PEACE-1 primary report ↗ · Current guideline guidance ↗