CRPC: Evidence
Multicentre, open-label, phase III trial
Population
- mCRPC
- ≥3 cycles of DOC, before of after AR-targeted tx
- Progression ≤12 mo on prior alternative AR-targeted tx
- ECOG PS ≤2
- PSA ≥2 ng/ml
- Serum testosterone <0.5 ng/ml
Design
Endpoints
Primary endpoint: rPFS
Key secondary endpoints:
- OS
- PFS
- PSA response (confirmed PSA reduction ≥ 5% from baseline)
- Tumour response
The control arm of ARPI switch is not recommended by the international guidelines.
CABA significantly improved outcomes vs ARPI switch
| CABA (N=129) | ARPI switch (N=126) | HR (95% CI) | P | |
|---|---|---|---|---|
| Median imaging-based PFS (mo) | 8 | 4 | 0.54 (0.40-0.73) | <0.001 |
| Median OS (mo) | 14 | 11 | 0.64 (0.46-0.89) | 0.008 |
| CABA (N=129) | ARPI switch (N=111) | P | ||
|---|---|---|---|---|
| PSA response (%) | 36 | 14 | <0.001 |
Key messages:
- CABA significantly improved imaging-based PFS, OS and PSA response vs ARPI switch
- ARPI switch is not recommended by the international guidelines
5. de Wit R, de Bono J, Sternberg CN, et al. N Engl J Med 2019;381:2506-18