Purpose: Combined androgen blockade (CAB) and luteinizing hormone-releasing hormone (LHRH) agonist monotherapy are commonly used in androgen deprivation therapy (ADT). In this randomized clinical trial, we aimed to compare the two methods of ADT in terms of quality of life (QOL).
Methods: Eighty patients who underwent primary ADT for newly diagnosed prostate cancer were randomly assigned to CAB group (Group 1) and LHRH agonist monotherapy group (Group 2). Leuprolide and anti-androgen (bicalutamide 50 mg) were used to minimize the confounding effects caused by medication. QOL was evaluated at baseline, 3 months and 6 months post-ADT using validated EORTC QLQ-C30, PR25, and depression questionnaires. A difference of > 10 points in the EORTC domain scores was defined as 'clinically significant'.
Results: In the baseline characteristics, there was no significant difference between the two groups. At 3 months after ADT, Group 1 had significantly lower pain scores than Group 2 (p = 0.004), while Group 1 had significantly poorer diarrhea symptom score than Group 2, without clinical significance (p = 0.047). No significant differences were observed in the C30, PR25 domains, and the depression score at 3 months. At 6 months, the QOL scores of all the groups were similar.
Conclusions: There was no difference in the patient's QOL, except that CAB group was associated with significantly better pain relief than LHRH agonist monotherapy at 3 months following ADT, which was not sustained thereafter. Our results suggest that the benefit of prolonged (≥ 3 months) CAB is questionable in terms of patients' QOL.
Keywords: Androgen deprivation therapy; Combined androgen blockade; Luteinizing hormone-releasing hormone agonist; Prostate cancer; Quality of life.