Randomized, double-blinded, placebo-controlled crossover trial of treating erectile dysfunction with sildenafil after radiotherapy and short-term androgen deprivation therapy: results of RTOG 0215.

INTRODUCTION: Erectile dysfunction (ED) may be the most commonly observed adverse event (AE) associated with the combination of radiation therapy (RT) and androgen deprivation therapy (ADT). A significant number of men are trying phosphodiesterase type 5 inhibitors (PDE5s) such as sildenafil to treat ED, yet sildenafil studies to date shed little light on the response to ED after ADT. AIM: The purpose of this trial was to evaluate sildenafil in the treatment of ED in prostate cancer patients previously treated with external beam RT and neoadjuvant and concurrent ADT. METHODS: In this randomized, double-blinded crossover trial, eligible patients received RT/ADT for intermediate risk prostate cancer and currently had ED as defined by the International Index of Erectile Function (IIEF). Patients were randomized to 12 weeks of sildenafil or placebo followed by 1 week of no treatment then 12 weeks of the alternative. Treatment differences were evaluated using a marginal model for binary crossover data. MAIN OUTCOME MEASURES: The primary end point was improved erectile function, as measured by the IIEF. RESULTS: The study accrued 115 patients and 61 (55%) completed all three IIEF assessments. Sildenafil effect was significant (P = 0.009) with a difference in probabilities of erectile response of 0.17 (95% confidence interval: 0.06, 0.29), and 0.21 (0.06, 0.38) for patients receiving ≤ 120 days of ADT. However, as few as 21% of patients had a treatment-specific response, only improving during sildenafil but not during the placebo phase. CONCLUSIONS: This is the first controlled trial to suggest a positive sildenafil response for ED treatment in patients previously treated with RT/ADT, however, only a minority of patients responded to treatment. ADT duration may be associated with response and requires further study. The overall low response rate suggests the need for study of additional or preventative strategies for ED after RT/ADT for prostate cancer.

Using focus groups to adapt ethnically appropriate, information-seeking and recruitment messages for a prostate cancer screening program for men at high risk.

PURPOSE: To adapt ethnically appropriate radio and newspaper messages in order to increase information-seeking and recruitment to the high-risk Prostate Cancer Risk Assessment Program (PRAP) using input from focus groups. METHODS: We conducted four gender- and ethnic specific-focus groups composed of up to eight participants each. Group participants ranged in age from 35-69 and were either at risk for prostate cancer or were married to someone at risk. Participants evaluated both print and radio advertisements for a PRAP media recruitment campaign, and their recommendations were used to adapt the advertisements. RESULTS: Trigger words, e.g,, "research program," were found to be a particular issue for African-American men who cited concerns about "experimentation," while the other groups cited concerns about time commitments and cost. In the print messages, familial themes garnered an overall favorable response, but Caucasian-American participants responded negatively to the use of photos of age-appropriate models. CONCLUSION: Focus groups are useful in checking health professional assumptions about health messages prior to developing awareness or recruitment advertisements or materials. There was an implied preference for "younger" models among Caucasian Americans. Radio and print messages were adapted using the focus group recommendations, i.e., focusing on familial themes, adding race-specific risk estimates and using younger-than-target group models.

A comparison of baseline sociodemographic and clinical characteristics between major depressive disorder patients with and without diabetes: a STAR*D report.

BACKGROUND: Patients with major depressive disorder (MDD) have high rates of medical comorbidities which can impair MDD treatment. Yet little is known regarding associations between the presence of a serious comorbidity and MDD treatment. The purpose of this study was to examine the baseline sociodemographic and clinical characteristics of MDD outpatients with and without diabetes mellitus to evaluate possible associations between these characteristics and the presence of comorbid diabetes. METHODS: We gathered baseline sociodemographic and clinical data for 4041 participants with non-psychotic MDD who enrolled in the STAR*D, a large-scale depression treatment protocol, and made comparisons between participants with and without diabetes. RESULTS: Participants with diabetes were more likely to be male, older, black, Hispanic, unemployed, and have less education, a lower income, higher mental functioning, lower physical functioning, atypical features, increased appetite, psychomotor slowing and leaden paralysis, and were less likely to have concurrent alcohol abuse/dependence, mood reactivity or problems with concentration. We found no significant differences between groups regarding depression severity. LIMITATIONS: The primary limitation is the lack of a clinical diagnosis of diabetes. CONCLUSIONS: We found no difference in depression severity between participants with and without diabetes. Diabetes was associated with physical symptoms of depression. Thus treatments for these participants should be directed toward these symptoms.

Issues and challenges with integrating patient-reported outcomes in clinical trials supported by the National Cancer Institute-sponsored clinical trials networks.

PURPOSE: The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. METHODS: An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. RESULTS: There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. CONCLUSION: The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.