1. In secondary analysis of a previous phase III randomized controlled trial of over 1,000 patients with prostate cancer, radiotherapy plus androgen deprivation therapy for locally advanced prostate cancer was associated with significant decrease in patient reported health-related quality of life compared to ADT alone at 6 months.
2. There were no significant differences in any health-related quality of life domains by 3 years following treatment.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Prostate cancer is one of the leading causes of cancer-related mortality in the United States. Previous randomized controlled trials have demonstrated improved survival with the use of radiotherapy (RT) in addition to hormone therapy for locally advanced disease. However, there have been no previous trials analyzing the quality of life changes associated with the use of RT. The purpose of this trial was to examine patient-reported outcomes for patients undergoing combination RT with hormone therapy versus hormone therapy alone. The authors conducted a secondary analysis on health-related quality of life (HRQOL) outcomes of a previous phase III randomized trial that compared androgen-deprivation therapy (ADT) alone versus ADT with RT in patients with locally advanced prostate cancer. After analyzing the survey responses of over 1,000 prostate cancer patients, the authors found that the RT and ADT group had significantly lower HRQOL scores in the first 6 months in the domains of bowel, urinary, and sexual functions compared to ADT alone. However, these differences were not observed at the three-year follow-up. The results of this trial support the hypothesis that RT use in combination with ADT lead to transient negative impact in HRQOL in prostate cancer patients. These results are strengthened by the randomized controlled design of the original trial and minimal loss to follow-up. However, methods of ADT and radiotherapy have changed since this trial; additional large randomized trials with current RT and ADT regimens are needed to confirm this effect.
In-Depth [randomized controlled trial]: This was a secondary analysis of patient-reported outcomes (PRO) from the NCIC CTG PR3/MRC clinical trial. This was an open-label, randomized controlled trial that compared androgen deprivation therapy (ADT) alone versus ADT plus radiotherapy (RT) in patients with locally advanced prostate cancer. The primary outcome of the original trial was overall survival, while secondary outcomes included disease-specific survival, toxicity, and health related quality of life (HRQOL). HRQOL was assessed by two separate instruments in a sub-study, Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P) and European Organization for Research and Treatment of Cancer (EORTC) core questionnaire. A total of 1,028 patients were included. At 6 months of follow-up, there were significant differences between the ADT and ADT + RT arms in EORTC global function (p = 0.03), FACT-P physical well-being (p = 0.001), functional well-being (p = 0.002), FACT-P total score (p = 0.001), EORTC diarrhea (p < 0.001), FACT-P urinary function (p=0.003), and FACT-P erections (p = 0.008). By 12 months, significant differences were seen EORTC bowel symptoms (p = 0.02), EORTC diarrhea (p = 0.03), and FACT-P erections (p = 0.03). By 36 months, there were no significant differences were in FACT-P emotional function (p = 0.15), FACT-P global assessment (p = 0.17), or EORTC urinary incontinence (p = 0.1).
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