Abiraterone Acetate for High-Risk Non-Metastatic Prostate Cancer

Primary Survival Outcomes

The American Society of Clinical Oncology recommends abiraterone acetate 1000 mg daily plus prednisone 5 mg daily for 2 years, combined with ADT for 3 years and radiotherapy, as a new standard of care for high-risk non-metastatic prostate cancer, with a hazard ratio of 0.60 (95% CI 0.48-0.73, p<0.0001), representing a 40% reduction in risk of death 1

The National Comprehensive Cancer Network notes that combination therapy (ADT + abiraterone + prednisolone) significantly improved failure-free survival, with a hazard ratio of 0.21 (95% CI 0.15-0.31, p<0.05) in non-metastatic patients, representing a 79% relative improvement 1

The non-metastatic cohort included 915 patients with advanced prostate cancer (N0 or N1) without distant metastases, comprising 455 patients assigned to ADT alone and 460 to ADT plus abiraterone, with high-risk defined as node-positive disease OR, if node-negative, having at least 2 of the following 3 factors 1

Radiotherapy was mandatory for node-negative non-metastatic disease and strongly encouraged for node-positive non-metastatic disease, delivered at 6-9 months after randomization, with abiraterone plus prednisolone given for 2 years when combined with curative-intent radiotherapy 1, 2

A critical finding was significant heterogeneity by age: the survival benefit was substantially larger in men <70 years (HR 0.51) compared to men ≥70 years (HR 0.94), with older men experiencing significantly higher toxicities 2, 3, 4

Severe hypertension or cardiac disorders occurred in 10% of patients, with grade 3-5 liver toxicity occurring in 7% of patients 2, 3, 4

Patient-reported outcomes were improved with abiraterone, including pain intensity progression, fatigue reduction, functional decline prevention, prostate cancer-related symptom improvement, and overall health-related quality of life enhancement 2, 3

The American Society of Clinical Oncology and National Comprehensive Cancer Network recommend abiraterone acetate 1000 mg daily plus prednisone 5 mg daily for 2 years, combined with ADT for 3 years and radiotherapy, as a new standard of care for high-risk non-metastatic prostate cancer, with mandatory monitoring requirements including baseline and ongoing assessment of blood pressure, serum potassium, liver function tests, and cardiac evaluation 1, 5, 6