(UroToday.com) At the 2021 EAU annual meeting, Dr. Klara Kvorning Ternov presented data from the HEAT randomized trial assessing fatigue, quality-of-life and metabolic changes in men treated with enzalutamide versus abiraterone + prednisone. Men with metastatic castration-resistant prostate cancer (mCRPC) often experience fatigue, impaired quality of life and have an increased risk of cardiovascular disease and type 2 diabetes mellitus. These highly burdensome symptoms and the increased risk of morbidity are often treatment associated and may be reduced by opting for a particular treatment. In this study, fatigue, quality of life and metabolic changes were compared between enzalutamide and abiraterone acetate plus prednisone.
This was an investigator-initiated single-center (Herlev and Gentofte Hospital, Denmark) open-labelled randomized (1:1) phase IV trial, comparing enzalutamide (160 mg/day) with abiraterone acetate plus prednisone (1000 mg abiraterone acetate and 10 mg prednisone/day). Eligible patients had progressive metastatic prostate cancer on androgen deprivation therapy, without prior mCRPC treatment or diabetes. The primary outcome was the between-group difference in changed fatigue assessed by the questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Secondary outcomes included treatment differences in changed quality of life, weight, body composition assessed with dual x-ray absorptiometry, blood pressure, glycated hemoglobin (Hb1AC), and cholesterols and incidence of type 2 diabetes mellitus defined as HbA1c >48 mmol/mol. 
Follow-up was 12 weeks. The between-group differences in changes and incidence were analyzed with mixed models and Fisher's exact analyses, respectively.
From June 2017 to September 2019, 170 participants were randomized to receive enzalutamide (n=84 analyzed) or abiraterone acetate plus prednisone (n=85 analyzed). Treatment differences in fatigue (-3.4 points [95% confidence interval -5.6; -1.2], p=0.003), quality of life and cholesterols were in favor of abiraterone acetate plus prednisone. A higher incidence of type 2 diabetes mellitus (8 versus 0 patients, p=0.004) and a greater increase in in HbA1c, weight, and visceral fat mass was found for abiraterone acetate plus prednisone than enzalutamide. The remaining comparison outcomes from this trial are summarized in the following table:
Dr. Kvorning Ternov concluded this presentation of the HEAT trial with the following summary statements:
- Abiraterone acetate plus prednisone should be considered the first choice for men where fatigue is a concern
- However, receiving abiraterone acetate plus prednisone may be at the expense of metabolic worsening compared with enzalutamide
Presented by: Klara Kvorning Ternov, MD, Herlev and Gentofte University Hospital, Dept. of Urology, Herlev, Denmark
Co-Authors: Sønksen J.1, Fode M.1, Lindberg H.1, Kistorp C.2, Bisbjerg R.1, Faber J.3, Klausen T.W.4, Palapattu G.5, Østergren P.B.1
1Herlev and Gentofte University Hospital, Dept. of Urology, Herlev, Denmark, 2Copenhagen University Hospital, Rigshospitalet, Dept. of Endocrinology, Copenhagen, Denmark, 3Herlev and Gentofte University Hospital, Dept. of Endocrinology, Herlev, Denmark, 4Herlev and Gentofte Hospital, Dept. of Haematology, Herlev, Denmark, 5Michigan Medicine, Dept. of Urology, Ann Arbor, United States of America
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2021 European Association of Urology, EAU 2021- Virtual Meeting, July 8-12, 2021.