- Final analysis of the LATITUDE trial confirmed a survival advantage for adding abiraterone acetate+prednisone to androgen deprivation therapy (ADT) for newly diagnosed, high-risk castration-sensitive metastatic prostate cancer (mCSPC).
- No new safety concerns were identified.
Why this matters
- Findings highlight the importance of early introduction of abiraterone acetate plus prednisone in addition to ADT in high-risk patients.
- Randomized, double-blind, phase 3 LATITUDE trial.
- Final OS analysis of 1199 patients with newly diagnosed high-risk metastatic CSPC, randomly assigned to either ADT+abiraterone acetate+prednisone or ADT+placebo.
- Crossover to abiraterone+prednisone was allowed in the open-label extension phase of the study (up to 18 months).
- Funding: Janssen Research & Development.
- Median follow-up was 51.8 months.
- Median treatment duration in the crossover group was 11.9 months.
- The abiraterone acetate group had significantly longer median OS vs placebo (53.3 vs 36.5 months; HR, 0.66; P<.0001>
- Grade 3-4 adverse event rate was 68% in abiraterone acetate, 50% in placebo, and 19% in crossover group; most common were hypertension (21% vs 10% vs 4%), hypokalemia (12% vs 2% vs 2%).
- Grade 3-4 serious adverse event rate was 27%, 20%, and 4%, respectively.
- Next-generation imaging was not routinely used.