Sternberg, C. N., Molina, A., North, S., Mainwaring, P., Fizazi, K., Hao, Y., . . . Scher, H. I. (2013). Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy. Annals of Oncology, 24, 1017–1025.

To evaluate fatigue outcomes in patients who participated in a phase II trial of abiraterone acetate and prednisone versus placebo and prednisone in patients after docetaxel therapy for metastatic castration-resistant prostate cancer.

In the phase III trial, patients were randomized to receive either abiraterone acetate and prednisone or placebo and prednisone; they later were crossed over to the other intervention arm.  Abiraterone inhibits synthesis of testosterone and other androgens, leading to suppression of prostate cancer growth.  Patient-reported fatigue was evaluated at baseline and on the first day of each treatment cycle until treatment discontinuation.  Median treatment durations were eight and four months across study groups, and median duration of follow-up was 20.2 months.

• The study included 1,196 participants.
• Participant ages were not stated.
• All participants had failed docetaxel for metastatic prostate cancer.

• Multi-site
• Outpatient
• Multiple countries

Patients were undergoing multiple phases of care.

This was a randomized, controlled, single-blind, crossover study.

• The Brief Fatigue Inventory (BFI) showed fatigue intensity defined as the score for worst level of fatigue in the last 24 hours. 
• Fatigue interference was the average score of all interference scores on the BFI.

• Among patients with clinically significant baseline fatigue, more patients in the abiraterone acetate arm experienced improvement in fatigue intensity (58.1% versus 40.3%; p = 0.0001) and  fatigue interference (p = 0.0075). 
• Time to improvement in fatigue was shorter in the abiraterone acetate arm (p = 0.0117).

Treatment with abiraterone acetate and prednisone in this group of patients was associated with improvement in fatigue symptoms.

• The study had a risk of bias because blinding was not used; only patient blinding was used.
• The findings were not generalizable.
• Findings were specific to patients with castration-resistant metastatic prostate cancer.  Various analyses were performed between those with clinically significant fatigue at baseline and those without; however, the fatigue level considered significant was not defined specific to this study, and relevant differences in sample size per analysis were not provided. 
• No information was provided about whether patients used any other activities or interventions that could have affected fatigue outcomes.

Findings demonstrated that treatment with abiraterone acetate in addition to prednisone was effective in improving fatigue in patients with metastatic castration-resistant prostate cancer. This is an important step forward to manage fatigue in this group of patients. This approach can only be expected to be of benefit for this disease, based on the understood actions of the drug.  Nurses can advocate for the use of this approach in patients with severe fatigue.