Aims: Clinical trials in early prostate cancer (EPC) have used a variety of outcome measures, including patient-reported outcomes (PROs) and physician-reported data. We review published studies and suggest a set of outcome measures and a portfolio of more detailed questionnaire options to produce a more homologous data set for future clinical trials.
Materials and methods: A literature search combining the terms 'quality of life' or 'symptoms' and 'prostate cancer' or 'prostate adenocarcinoma' was carried out. Relevant papers were reviewed to assess key areas of toxicity and quality of life (QoL). These were discussed by a panel with a special interest in the assessment of QoL measures and PROs.
Results: Twenty-one validated candidate questionnaires were identified. The Short Form 12 was recommended due to its combination of brevity and assessment of pain, general and mental health, physical, social and emotional function. Specific questionnaires should assess localised symptoms after treatment, including sexual function, erectile dysfunction, bowel function and lower urinary tract symptoms (LUTS). The modular use of separate symptom indices was recommended. For sexual function, the International Index of Erectile Function and the International Continence Society questionnaire were considered the best available. The International Continence Society Male Short Form questionnaire best addressed LUTS. Incontinence of stool (solid, liquid or gas) and its effect on function should be assessed. The Vaizey questionnaire is recommended. The Radiation Therapy Oncology Group scale, which is physician administered, remains helpful in studies including radiotherapy, as it places current trials within appropriate historical context. Rates of procedures to treat complications and pharmaceutical interventions for treatment-related symptoms should be recorded at the time of each questionnaire follow-up.
Conclusion: Although novel therapies may produce different toxicities, the current recommendations should help to produce trial protocols that will allow comparable data to be generated within clinical trials comparing outcome from surgery, radiotherapy and other targeted ablative therapies for EPC.