AIM: To compare prospective, long-term quality of life in patients randomised to external beam radiotherapy (EBRT) alone or with a boost of high dose rate (HDR) brachytherapy. MATERIALS AND METHODS: In total, 216 patients participating in the UK randomised trial of EBRT ±HDR brachytherapy were included in this analysis. EBRT delivering 55 Gy in 20 fractions was compared with EBRT followed by HDR brachytherapy of 2 × 8.5 Gy. Quality of life was assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and FACT-G (General) questionnaires, administered before radiotherapy, at 6 months and bi-annually thereafter. Differences in mean FACT global scores and erectile function between treatment arms were compared using chi-squared tests. RESULTS: Over a 10.5 year follow-up, no difference in FACT-G, FACT-P or Trial Outcome Index (TOI) scores was seen between treatments and means were similar to their pretreatment values. Mean erectile function scores in arm 2 were similar to arm 1, but were significantly lower than the pretreatment mean (P ≤ 0.002). There was no evidence that quality of life deteriorated with increasing follow-up time in any of the four FACT domains. CONCLUSIONS: The improved biochemical control of disease seen in these patients with EBRT + HDR brachytherapy coupled with equitoxic early and late urinary and bowel morbidity, indicate a therapeutic advantage, which has now been confirmed by the results for general and prostate-related quality of life changes, despite a decline in erectile function.
RCT Entities:
AIM: To compare prospective, long-term quality of life in patients randomised to external beam radiotherapy (EBRT) alone or with a boost of high dose rate (HDR) brachytherapy. MATERIALS AND METHODS: In total, 216 patients participating in the UK randomised trial of EBRT ± HDR brachytherapy were included in this analysis. EBRT delivering 55 Gy in 20 fractions was compared with EBRT followed by HDR brachytherapy of 2 × 8.5 Gy. Quality of life was assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and FACT-G (General) questionnaires, administered before radiotherapy, at 6 months and bi-annually thereafter. Differences in mean FACT global scores and erectile function between treatment arms were compared using chi-squared tests. RESULTS: Over a 10.5 year follow-up, no difference in FACT-G, FACT-P or Trial Outcome Index (TOI) scores was seen between treatments and means were similar to their pretreatment values. Mean erectile function scores in arm 2 were similar to arm 1, but were significantly lower than the pretreatment mean (P ≤ 0.002). There was no evidence that quality of life deteriorated with increasing follow-up time in any of the four FACT domains. CONCLUSIONS: The improved biochemical control of disease seen in these patients with EBRT + HDR brachytherapy coupled with equitoxic early and late urinary and bowel morbidity, indicate a therapeutic advantage, which has now been confirmed by the results for general and prostate-related quality of life changes, despite a decline in erectile function.