Logothetis, C.J., Basch, E., Molina, A., Fizazi, K., North, S.A., Chi, K.N., . . . de Bono, J.S. (2012). Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: Exploratory analysis of data from the COU-AA-301 randomised trial. The Lancet Oncology, 13, 1210–1217.

To assess data to determine the effect of abiraterone acetate on pain and skeletal events in patients with castration-resistant prostate cancer

Patients were randomized to receive either 1 g abiraterone acetate or placebo orally once a day, along with 5 mg prednisone twice daily for 28-day cycles. Concomitant bisphosphonates were allowed during the study, if patients were already taking them or if a skeletal event indicated their use. Assessments occurred at baseline, on day 15, and on day 1 of the first 28-day cycle and during each subsequent 28-day cycle until the end of the study or treatment discontinuation.

• The sample was composed of 1,195 patients.
• Mean patient age was 69 years. Age range was 39–95 years.
• All the patients in the sample were male.
• All patients had castration-resistant prostate cancer. Overall, 43% of patients were using bisphosphonates and 89.4% had bone metastases.

• Multisite
• Outpatient
• Multiple countries

• Phases of care: late effects and survivorship
• Clinical application: palliative care

Randomized double-blind, placebo-controlled trial

Brief Pain Inventory

• Compared to patients taking placebo, a significantly larger proportion of patients receiving abiraterone acetate (p < 0.005) reported palliation of pain and pain interference.
• Median duration of pain palliation, 4.2 months, was longer in the abiraterone group (p = 0.0056).
• The proportion of patients to experience skeletal events was similar in both groups.
• Time to skeletal events was longer for patients taking abiraterone acetate (p = 0.0001).
• Both groups showed decline in pain intensity and interference over time.
• Median follow-up period for varied outcomes was 1–9.3 months. Follow-up survival curve analysis outcomes were better for those receiving abiraterone (p = 0.05).

Compared to placebo, abiraterone acetate and prednisone were associated with favorable effects on pain and a longer time to skeletal events in patients with metastatic castration-resistant prostate cancer.

• The findings of this analysis are not generalizable.
• The study was not stratified by use or nonuse of bisphosphonates.
• Authors provided very limited information and analysis regarding analgesic use and changes in analgesic use over the course of the study.

Findings show that prednisone and abiraterone acetate appeared to improve pain control in patients with castration-resistant prostate cancer. Chronic bone-related pain can be a severe problem for late-stage patients with prostate cancer. For these patients, abiraterone acetate and prednisone can be helpful in reducing pain and delaying skeletal events.