OBJECTIVES: It is currently estimated that worldwide, prostate cancer will affect around 1 in 7 men during their lifetime. After lung cancer, it is the second highest cause of cancer deaths in men. This presents a widespread need for effective treatments. Patient reported outcomes (PROs) data provide useful insights into the symptoms and impacts experienced by patients, which can add supporting value to clinical trial endpoints when evaluating interventions. A number of PRO measures have been designed specifically for prostate cancer populations. This study provides a brief evaluation of the PROs most commonly used in current prostate cancer clinical trials.
METHODS: Clinicaltrials.gov was used to identify prostate cancer trials that include PROs as primary, secondary or exploratory endpoints. Search criteria were set to ensure that only interventional trials, currently recruiting and without results were included.
RESULTS: From the search, 188 trials were identified. These included both generic and prostate cancer specific PROs. The five most common PROs were reviewed in accordance with regulatory guidelines. These were; the EPIC (n=38), the EORTC QLQ-C30 (n=31), the FACT-P (n=26), the IPSS (n=16) and the EORTC QLQ PR-25 (n=9). A review of these identified key features regarding their use. For example, although the EPIC is the most frequently used PRO, the recall period of four weeks may not always be appropriate depending on illness progression. Furthermore, the IPSS is just eight-items long, this can be beneficial as it reduces patient burden and thus increases compliance. However, it is important to evaluate whether this brief measure has sufficient conceptual coverage to assess total patient experience.
CONCLUSIONS: Several validated measures exist in prostate cancer populations. Comparisons have been made between those most commonly used; their benefits and drawbacks have been summarized in this study. These findings should be considered when selecting an appropriate PRO to include in clinical trials.
