Prospective evaluation of quality of life in prostate cancer patients receiving combined treatment of postoperative radiotherapy plus androgen suppression for PT3 or positive resection margin after radical prostatectomy.

Objectives: To examine the effect of postoperative radiotherapy (RT) plus 2-yr androgen suppression (AS) on quality of life (QOL) in patients with pathologic T3 or positive resection margins after radical prostatectomy (RP).

Methods: Seventy-eight patients underwent postoperative RT followed by 2-yr AS, in a phase 2 study, between 1998 and 2002. Median age was 61 yr at the time of RP. QOL was prospectively assessed with the European Organization for Research and Treatment of Cancer (EORTC) QOL Questionnaire 30-item version 3.0 with the added prostate cancer-specific module at baseline and predefined follow-up visits.

Results: Patients experienced a significant increase in bowel dysfunction score (22%) by the end of RT, which would be considered a major change in QOL. This bowel dysfunction resolved after RT and showed no difference from baseline in the subsequent 2-yr AS period. A similar, but less pronounced, pattern of change occurred for the diarrhea domain. Urinary dysfunction score also increased at the end of RT by 6.6%, considered a clinically minor change in QOL. It then returned to baseline in the post-RT period. The cohort had poor erectile function at baseline; thus, it was difficult to assess any further decline in this domain brought on by RT or AS. In the remaining QOL domains, a change of minor or moderate clinical significance was observed at occasional time points for global health status, fatigue, pain, and insomnia.

Conclusions: Postoperative RT plus 2-yr AS after RP did not result in any major, persistent, adverse effect on QOL.