Quality of Life and Toxicity after SBRT for Organ-Confined Prostate Cancer, a 7-Year Study.

In 1996 the American Society for Therapeutic Radiology and Oncology (ASTRO) sponsored a Consensus Conference to establish a definition of biochemical failure after external beam radiotherapy (EBRT). The ASTRO definition defined prostate specific antigen (PSA) failure as occurring after three consecutive PSA rises after a nadir with the date of failure as the point halfway between the nadir date and the first rise or any rise great enough to provoke initiation of therapy. This definition was not linked to clinical progression or survival; it performed poorly in patients undergoing hormonal therapy (HT), and backdating biased the Kaplan-Meier estimates of event-free survival. A second Consensus Conference was sponsored by ASTRO and the Radiation Therapy Oncology Group in Phoenix, Arizona, on January 21, 2005, to revise the ASTRO definition. The panel recommended: (1) a rise by 2 ng/mL or more above the nadir PSA be considered the standard definition for biochemical failure after EBRT with or without HT; (2) the date of failure be determined "at call" (not backdated). They recommended that investigators be allowed to use the ASTRO Consensus Definition after EBRT alone (no hormonal therapy) with strict adherence to guidelines as to "adequate follow-up." To avoid the artifacts resulting from short follow-up, the reported date of control should be listed as 2 years short of the median follow-up. For example, if the median follow-up is 5 years, control rates at 3 years should be cited. Retaining a strict version of the ASTRO definition would allow comparisons with a large existing body of literature.

Health-related quality of life (HRQOL) is an increasingly important endpoint in prostate cancer care. However, pivotal issues that are not fully assessed in existing HRQOL instruments include irritative urinary symptoms, hormonal symptoms, and multi-item scores quantifying bother between urinary, sexual, bowel, and hormonal domains. We sought to develop a novel instrument to facilitate more comprehensive assessment of prostate cancer-related HRQOL. Instrument development was based on advice from an expert panel and prostate cancer patients, which led to expanding the 20-item University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) to the 50-item Expanded Prostate Index Composite (EPIC). Summary and subscale scores were derived by content and factor analyses. Reliability and validity were assessed by test-retest correlation, Cronbach's alpha coefficient, interscale correlation, and EPIC correlation with other validated instruments. Test-retest reliability and internal consistency were high for EPIC urinary, bowel, sexual, and hormonal domain summary scores (each r >/=0.80 and Cronbach's alpha >/=0.82) and for most domain-specific subscales. Correlations between function and bother subscales within domains were high (r >0.60). Correlations between different primary domains were consistently lower, indicating that these domains assess distinct HRQOL components. EPIC domains had weak to modest correlations with the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12), indicating rationale for their concurrent use. Moderate agreement was observed between EPIC domains relevant to the Functional Assessment of Cancer Therapy Prostate module (FACT-P) and the American Urological Association Symptom Index (AUA-SI), providing criterion validity without excessive overlap. EPIC is a robust prostate cancer HRQOL instrument that complements prior instruments by measuring a broad spectrum of urinary, bowel, sexual, and hormonal symptoms, thereby providing a unique tool for comprehensive assessment of HRQOL issues important in contemporary prostate cancer management.

To assess the prevalence of erectile dysfunction and to quantify associations between putative risk factors and erectile dysfunction in the US adult male population. Cross-sectional analysis of data from 2126 adult male participants in the 2001-2002 National Health and Nutrition Examination Survey (NHANES). Erectile dysfunction assessed by a single question during a self-paced, computer-assisted self-interview. These data are nationally representative of the noninstitutionalized adult male population in the US. The overall prevalence of erectile dysfunction in men aged >/=20 years was 18.4% (95% confidence interval [CI], 16.2-20.7), suggesting that erectile dysfunction affects 18 million men (95% CI, 16-20) in the US. The prevalence of erectile dysfunction was highly positively related to age but was also particularly high among men with one or more cardiovascular risk factors, men with hypertension, and men with a history of cardiovascular disease, even after age adjustment. Among men with diabetes, the crude prevalence of erectile dysfunction was 51.3% (95% CI, 41.9-60.7). In multivariable analyses, erectile dysfunction was significantly and independently associated with diabetes, lower attained education, and lack of physical activity. The high prevalence of erectile dysfunction among men with diabetes and hypertension suggests that screening for erectile dysfunction in these patients may be warranted. Physical activity and other measures for the prevention of cardiovascular disease and diabetes may prevent decrease in erectile function.