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Purpose: We evaluated whether the presence and severity of baseline prostate atrophy in men with initial biopsy negative for prostate cancer was associated the risk of subsequent prostate cancer detection in a clinical trial with scheduled study mandated biopsies., Materials and Methods: We retrospectively analyzed the records of 3,084 men 50 to 75 years old with prostate specific antigen between 2.5 and 10 ng/ml, and a prior negative biopsy in the placebo arm of the REDUCE (Reduction by Dutasteride of Prostate Cancer Events) study who completed at least 1 per-protocol biopsy. Prostate cancer (defined as present or absent) and prostate atrophy (graded as absent, mild or moderate/marked) was assessed by central pathology review. The association of baseline atrophy with positive 2 and 4-year repeat biopsies was evaluated with logistic regression, controlling for baseline covariates., Results: Baseline prostate atrophy was detected in 2,143 men (70%) and graded as mild and moderate/marked in 1,843 (60%) and 300 (10%) baseline biopsies, respectively. Patients with atrophy were older and had a larger prostate, and more acute and chronic prostate inflammation. At 2-year biopsy the prostate cancer incidence was 17% (508 cases). Baseline atrophy was significantly associated with lower prostate cancer risk (univariable and multivariable OR 0.60, 95% CI 0.50-0.74 and OR 0.67, 95% CI 0.54-0.83, p <0.001, respectively) at the 2-year biopsy. These results were similar at the 4-year biopsy (univariable and multivariable OR 0.70, 95% CI 0.53-0.93 and OR 0.72, 95% CI 0.53-0.97, p = 0.03, respectively). Relative to no atrophy the prostate cancer risk at the 2-year repeat biopsy was lower for mild atrophy (OR 0.69, 95% CI 0.55-0.86) and moderate/marked atrophy (OR 0.51, 95% CI 0.34-0.76, each p <0.001)., Conclusions: Baseline prostate atrophy in men with a prostate biopsy negative for prostate cancer was independently associated with subsequent lower prostate cancer detection., (Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Numerous dietary factors elevate serum levels of insulin and insulin-like growth factor I (IGF-I), both potent prostate cancer mitogens. We tested whether varying dietary carbohydrate and fat, without energy restriction relative to comparison diets, would slow tumor growth and reduce serum insulin, IGF-I, and other molecular mediators of prostate cancer in a xenograft model., Experimental Design: Individually caged male severe combined immunodeficient mice (n = 130) were randomly assigned to one of three diets (described as percent total calories): very high-fat/no-carbohydrate ketogenic diet (NCKD: 83% fat, 0% carbohydrate, 17% protein), low-fat/high-carbohydrate diet (LFD: 12% fat, 71% carbohydrate, 17% protein), or high-fat/moderate-carbohydrate diet (MCD: 40% fat, 43% carbohydrate, 17% protein). Mice were fed to maintain similar average body weights among groups. Following a preliminary feeding period, mice were injected with 1 x 10(6) LNCaP cells (day 0) and sacrificed when tumors were >or=1,000 mm(3)., Results: Two days before tumor injection, median NCKD body weight was 2.4 g (10%) and 2.1 g (8%) greater than the LFD and MCD groups, respectively (P < 0.0001). Diet was significantly associated with overall survival (log-rank P = 0.004). Relative to MCD, survival was significantly prolonged for the LFD (hazard ratio, 0.49; 95% confidence interval, 0.29-0.79; P = 0.004) and NCKD groups (hazard ratio, 0.59; 95% confidence interval, 0.37-0.93; P = 0.02). Median serum insulin, IGF-I, IGF-I/IGF binding protein-1 ratio, and IGF-I/IGF binding protein-3 ratio were significantly reduced in NCKD relative to MCD mice. Phospho-AKT/total AKT ratio and pathways associated with antiapoptosis, inflammation, insulin resistance, and obesity were also significantly reduced in NCKD relative to MCD tumors., Conclusions: These results support further preclinical exploration of carbohydrate restriction in prostate cancer and possibly warrant pilot or feasibility testing in humans.

Objective: Cure rates for cancer are increasing, especially for breast, prostate, and colorectal cancer. Despite positive trends in survivorship, a cancer diagnosis can trigger accelerated functional decline that can threaten independence, reduce quality-of-life and increase healthcare costs, especially among the elderly who comprise the majority of survivors. Lifestyle interventions may hold promise in reorienting functional decline in older cancer survivors, but few studies have been conducted., Methods: We describe the design and methods of a randomized controlled trial, RENEW (Reach out to ENhancE Wellness), that tests whether a home-based multi-behavior intervention focused on exercise, and including a low saturated fat, plant-based diet, would improve physical functioning among 641 older, long-term (>or=5 years post-diagnosis) survivors of breast, prostate, or colorectal cancer. Challenges to recruitment are examined., Results: Twenty thousand and fifteen cases were approached, and screened using a two-step screening process to assure eligibility. This population of long-term, elderly cancer survivors had lower rates of response (approximately 11%) and higher rates of ineligibility (approximately 70%) than our previous intervention studies conducted on adults with newly diagnosed cancer. Significantly higher response rates were noted among survivors who were White, younger, and more proximal to diagnosis and breast cancer survivors (p-values<0.001)., Conclusion: Older cancer survivors represent a vulnerable population for whom lifestyle interventions may hold promise. RENEW may provide guidance in allocating limited resources in order to maximize recruitment efforts aimed at this needy, but hard-to-reach population., ((c) 2008 John Wiley & Sons, Ltd.)

Participant accrual to research studies is a challenge; oftentimes, advertisements are used to supplement cases ascertained through clinic caseloads and cancer registries. It is unknown, however, if cases ascertained through these two sources differ. In this study, we compared self-referred (n = 209) and registry-ascertained (n = 334) participants enrolled in FRESH START, a randomized controlled trial promoting a healthy diet and increased exercise among breast and prostate cancer survivors. The two groups were compared on baseline characteristics, adherence, attrition, and outcomes by study arm. Compared with participants enrolled from registries, self-referrals were significantly younger (54.1 +/- 10.4 versus 58.7 +/- 10.7 years), more likely to have later-stage disease and to have received chemotherapy (40% versus 19%), and more likely to report "fighting spirit" coping styles (50% versus 30%), lower quality-of-life (88.2 +/- 15.1 versus 92.0 +/- 12.9), fewer comorbid conditions (1.87 +/- 1.60 versus 2.24 +/- 1.78), and lower consumption of five or more daily servings of fruits and vegetables (35% versus 45%; P values <0.05). Although no differences in behavior change were observed between self-referred and registry-ascertained cases assigned to the tailored intervention arm, this was not the case within the attention control arm. Among those who received the attention control intervention of standardized materials in the public domain, self-referred versus registry-ascertained participants showed significantly greater increases in exercise at 1-year follow-up and significantly greater increases in fruit and vegetable consumption at both 1- and 2-year follow-up (P values <0.05). Several differences exist between self-referred and registry-ascertained participants, including motivation to respond to standardized educational materials, which appears significantly greater in self-referred populations.

Background: Recent evidence suggests carbohydrate intake may influence prostate cancer biology. We tested whether a no-carbohydrate ketogenic diet (NCKD) would delay prostate cancer growth relative to Western and low-fat diets in a xenograft model., Methods: Seventy-five male SCID mice were fed a NCKD (84% fat-0% carbohydrate-16% protein kcal), low-fat (12% fat-72% carbohydrate-16% protein kcal), or Western diet (40% fat-44% carbohydrate-16% protein kcal). Low-fat mice were fed ad libitum and the other arms fed via a modified-paired feeding protocol. After 24 days, all mice were injected with LAPC-4 cells and sacrificed when tumors approached 1,000 mm(3)., Results: Despite consuming equal calories, NCKD-fed mice lost weight (up to 15% body weight) relative to low-fat and Western diet-fed mice and required additional kcal to equalize body weight. Fifty-one days after injection, NCKD mice tumor volumes were 33% smaller than Western mice (rank-sum, P = 0.009). There were no differences in tumor volume between low-fat and NCKD mice. Dietary treatment was significantly associated with survival (log-rank, P = 0.006), with the longest survival among the NCKD mice, followed by the low-fat mice. Serum IGFBP-3 was highest and IGF-1:IGFBP-3 ratio was lowest among NCKD mice while serum insulin and IGF-1 levels were highest in Western mice. NCKD mice had significantly decreased hepatic fatty infiltration relative to the other arms., Conclusions: In this xenograft model, despite consuming more calories, NCKD-fed mice had significantly reduced tumor growth and prolonged survival relative to Western mice and was associated with favorable changes in serum insulin and IGF axis hormones relative to low-fat or Western diet., ((c) 2007 Wiley-Liss, Inc.)

Purpose: Cancer survivors are at increased risk for cardiovascular disease, diabetes, osteoporosis, and second primary tumors. Healthful lifestyle practices may improve the health and well-being of survivors. The FRESH START trial tested the efficacy of sequentially tailored versus standardized mailed materials on improving cancer survivors' diet and exercise behaviors., Methods: Five hundred forty-three individuals with newly diagnosed locoregional breast or prostate cancer were recruited from 39 states and two provinces within North America. Participants were randomly assigned either to a 10-month program of tailored mailed print materials promoting fruit and vegetable (F&V) consumption, reducing total/saturated fat intake, and/or increasing exercise or to a 10-month program of nontailored mailed materials on diet and exercise available in the public domain. Telephone surveys conducted at baseline and 1 year assessed body mass index (BMI), dietary consumption, physical activity, and other psychosocial/behavioral indices. Clinical assessments were conducted on a 23% subsample; information was used to validate self-reports., Results: Five hundred nineteen participants completed the 1-year follow-up (4.4% attrition; sample characteristics: 57 +/- 10.8 years old, 83% white, 56% female, 64% overweight/obese, and 0% underweight). Although both arms significantly improved their lifestyle behaviors (P < .05), significantly greater gains occurred in the FRESH START intervention versus the control arm (practice of two or more goal behaviors: +34% v +18%, P < .0001; exercise minutes per week: +59.3 v +39.2 minutes, P = .02; F&V per day: +1.1 v +0.6 servings, P = .01; total fat: -4.4% v -2.1%, P < .0001; saturated fat: -1.3% v -0.3%, P < .0001; and BMI: -0.3 v +0.1 kg/m2, respectively, P = .004)., Conclusion: Mailed material interventions, especially those that are tailored, are effective in promoting healthful lifestyle changes among cancer survivors. Further study is needed to determine sustainability, cost to benefit, and generalizability to other cancer populations.

Objectives: To characterize supplement use within a sample population of men diagnosed with prostate cancer., Methods: A census of men diagnosed with prostate cancer at Duke University Medical Center from 1997 to 2002 (n = 1402) was mailed a survey that ascertained data on health status, education, diet, exercise, smoking status, and information on supplement use. Differences between demographic and treatment subgroups were described and tested, as was change in supplement use after diagnosis., Results: Data from 805 respondents indicated that a majority (73%) used supplements, and 68% claimed that this information was shared with their cancer care provider. The most commonly reported supplements were multivitamins (56%), vitamin E (43%), vitamin C (33%), and calcium (26%). On average, 2.7 +/- 2.8 supplements per day were taken, and use increased significantly after diagnosis for most supplements. Use was significantly higher among men who were white (P = 0.043), were more highly educated (P = 0.002), exercise regularly (P = 0.020), and who consume five or more daily servings of fruits and vegetables (P = 0.040)., Conclusions: A high percentage of men with prostate cancer take supplements, especially those who are white, more educated, and who pursue healthful behaviors. Systematic means of capturing these data are necessary to begin to understand the potential impact of supplements on disease outcome, especially because no data exist to suggest that supplements are of any benefit after diagnosis.

Objectives: To evaluate the late health-related quality of life (HRQOL) after radical perineal prostatectomy (RPP) and identify the predictors of outcome., Methods: We performed a cross-sectional study of 266 consecutive patients who underwent RPP for clinically localized prostate cancer between July 1998 and December 2000. Of the 236 patients successfully contacted, 187 (79.2%) returned a validated patient self-assessment questionnaire, the Expanded Prostate Cancer Index Composite, a mean of 42.1 months (range 29 to 64) months after surgery. The median HRQOL scores were calculated in four disease-specific domains: urinary, bowel, sexual, and hormonal. Preoperative baseline information from a separate group of 144 consecutive RPP candidates from January 2002 to May 2003 was used for comparison. Univariate and multivariate logistic regression analyses were used to identify predictors of more favorable long-term HRQOL outcomes., Results: No statistically significant differences were found in any of the domain-specific summary scores between the study and reference groups, except in the sexual domain (median score 19.2 versus 56.4; P = 0.001). The number of medical comorbidities was a statistically significant predictor of HRQOL summary scores in all domains (P <0.05). In addition, the urinary summary score was statistically significantly associated with income (P = 0.03), sexual summary with the use of erectile aids (P = 0.003), bowel summary with secondary radiotherapy (P = 0.001) and income (P = 0.002), and hormonal summary with androgen ablation (P = 0.004)., Conclusions: The results of this study have shown that the long-term HRQOL of RPP patients in the urinary, bowel, and hormonal domains is favorable. HRQOL outcomes depend on a spectrum of factors, including the presence of comorbid disease, socioeconomic status, and secondary cancer treatments. Future studies should seek to address the efficacy of preserving the sexual domain HRQOL in patients undergoing bilateral nerve-sparing RPP.

Mailed surveys are widely used to collect epidemiological and health service data on cancer populations. Nonresponse can threaten the validity of surveys and various strategies, including the enclosure of modest incentives, are often used to increase response rates. A study was undertaken to determine whether response rate to a mailed survey differed with provision of immediate versus delayed incentives. A six-page mailed survey to ascertain dietary supplement use was sent to 1402 men who had been diagnosed with prostate cancer. Subjects were block randomized into two groups based on age (< or =65 years versus >65 years), race (white versus nonwhite), and disease status (locoregional versus distant). One group received a 30-min prepaid phone card concurrently with their blank survey (unconditional incentive), whereas the other group received the incentive only on receipt of their completed survey (conditional incentive). A 60% overall response rate was achieved, and no differences in response rates were noted between conditional and unconditional incentive groups (overall, as well as within defined age, race, and disease-defined strata). Nonwhites, however, were significantly less likely to respond than whites (P < 0.0001). In conclusion, acceptable response rates to a mailed survey can be achieved in a general population of cancer survivors using modest incentives. Given no differences in response rates using conditional versus unconditional incentives, the decision to provide immediate versus delayed incentives is one that should be considered on a study-specific basis, and a decision based primarily on cost. Other means, however, appear necessary to achieve acceptable response rates among minority group cancer survivors.

Purpose: FRESH START is a randomized controlled trial that will test whether a personally tailored, distance-medicine-based program will increase exercise and fruit and vegetable consumption, and decrease fat intake of individuals recently diagnosed with breast or prostate cancer., Methods: Early-stage breast and prostate cancer cases (N= 530) will be identified within 9 months of diagnosis from hospital cancer registries and large oncologic practices throughout the United States. These individuals will be sent a letter of invitation and screened for eligibility. After a baseline telephone interview, participants will be randomized into one of two arms that receive materials aimed at increasing exercise and fruit and vegetable intake, and decreasing dietary fat: 1). an experimental arm that receives a workbook and a series of six 4-page newsletters delivered every 7 wk and personally tailored on type of cancer, cancer coping style, race, age, self-efficacy, stage of readiness, and barriers and/or progress toward goal behavior (i.e., >or= 30 min of exercise at least 5 d.wk, >or= 5 servings of vegetables and fruit per day, and