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Guideline Use of 5-alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline. 2009
Kramer BS, Hagerty KL, Justman S, Somerfield MR, Albertsen PC, Blot WJ, Ballentine Carter H, Costantino JP, Epstein JI, Godley PA, Harris RP, Wilt TJ, Wittes J, Zon R, Schellhammer P, Anonymous00093, Anonymous00094. · National Institutes of Health, Bethesda, MD, USA. · J Clin Oncol. · Pubmed #19252137 No free full text.
Abstract: PURPOSE To develop an evidence-based guideline on the use of 5-alpha-reductase inhibitors (5-ARIs) for prostate cancer chemoprevention. METHODS The American Society of Clinical Oncology (ASCO) Health Services Committee (HSC), ASCO Cancer Prevention Committee, and the American Urological Association Practice Guidelines Committee jointly convened a Panel of experts, who used the results from a systematic review of the literature to develop evidence-based recommendations on the use of 5-ARIs for prostate cancer chemoprevention. Results The systematic review completed for this guideline identified 15 randomized clinical trials that met the inclusion criteria, nine of which reported prostate cancer period prevalence. CONCLUSION Asymptomatic men with a prostate-specific antigen (PSA) <or= 3.0 ng/mL who are regularly screened with PSA or are anticipating undergoing annual PSA screening for early detection of prostate cancer may benefit from a discussion of both the benefits of 5-ARIs for 7 years for the prevention of prostate cancer and the potential risks (including the possibility of high-grade prostate cancer). Men who are taking 5-ARIs for benign conditions such as lower urinary tract [obstructive] symptoms (LUTS) may benefit from a similar discussion, understanding that the improvement of LUTS relief should be weighed with the potential risks of high-grade prostate cancer from 5-ARIs (although the majority of the Panel members judged the latter risk to be unlikely). A reduction of approximately 50% in PSA by 12 months is expected in men taking a 5-ARI; however, because these changes in PSA may vary across men, and within individual men over time, the Panel cannot recommend a specific cut point to trigger a biopsy for men taking a 5-ARI. No specific cut point or change in PSA has been prospectively validated in men taking a 5-ARI.
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Guideline Use of 5alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline. 2009
Kramer BS, Hagerty KL, Justman S, Somerfield MR, Albertsen PC, Blot WJ, Carter HB, Costantino JP, Epstein JI, Godley PA, Harris RP, Wilt TJ, Wittes J, Zon R, Schellhammer P, Anonymous00066. · National Institutes of Health, Bethesda, MD, USA. · J Urol. · Pubmed #19249063 No free full text.
Abstract: PURPOSE: To develop an evidence-based guideline on the use of 5-alpha-reductase inhibitors (5-ARIs) for prostate cancer chemoprevention. METHODS: The American Society of Clinical Oncology (ASCO) Health Services Committee (HSC), ASCO Cancer Prevention Committee, and the American Urological Association Practice Guidelines Committee jointly convened a Panel of experts, who used the results from a systematic review of the literature to develop evidence-based recommendations on the use of 5-ARIs for prostate cancer chemoprevention. RESULTS: The systematic review completed for this guideline identified 15 randomized clinical trials that met the inclusion criteria, nine of which reported prostate cancer period prevalence. CONCLUSION: Asymptomatic men with a prostate-specific antigen (PSA) </=3.0 ng/mL who are regularly screened with PSA or are anticipating undergoing annual PSA screening for early detection of prostate cancer may benefit from a discussion of both the benefits of 5-ARIs for 7 years for the prevention of prostate cancer and the potential risks (including the possibility of high-grade prostate cancer). Men who are taking 5-ARIs for benign conditions such as lower urinary tract [obstructive] symptoms (LUTS) may benefit from a similar discussion, understanding that the improvement of LUTS relief should be weighed with the potential risks of high-grade prostate cancer from 5-ARIs (although the majority of the Panel members judged the latter risk to be unlikely). A reduction of approximately 50% in PSA by 12 months is expected in men taking a 5-ARI; however, because these changes in PSA may vary across men, and within individual men over time, the Panel cannot recommend a specific cut point to trigger a biopsy for men taking a 5-ARI. No specific cut point or change in PSA has been prospectively validated in men taking a 5-ARI.
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Editorial Getting over testosterone: postulating a fresh start for etiologic studies of prostate cancer. free! 2008
Carpenter WR, Robinson WR, Godley PA. · No affiliation provided · J Natl Cancer Inst. · Pubmed #18230791 links to free full text
This publication has no abstract.
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Review Systematic review of prostate cancer's association with body size in childhood and young adulthood. 2008
Robinson WR, Poole C, Godley PA. · Department of Epidemiology, University of North Carolina, CB# 7435, McGavran-Greenberg, Chapel Hill, NC 27599-7435, USA. · Cancer Causes Control. · Pubmed #18347923 No free full text.
Abstract: Body size relatively early in life may influence men's later rate of prostate cancer. We searched for published, English-language studies of the association between prostate cancer incidence or mortality and body size between ages 5 and 29 years. We summarized analyses of childhood body size, early-adult waist circumference, and early-adult body mass index (BMI). Most study designs were case-control or retrospective cohort studies, in which body size was self-reported and recalled. The few studies of childhood body size and early-adult waist circumference indicated null or weak associations. The results from studies of early-adult BMI were heterogeneous (p = 0.04) and showed evidence of funnel plot asymmetry. The random-effects rate ratio (RR) was 1.06 (95% confidence interval [CI]: 0.99, 1.14) per five-unit increase in BMI. Studies using measured (as opposed to self-recalled) height and weight (n = 3) tended to produce stronger associations: fixed-effects summary RR = 1.22 (1.06, 1.39). The same was true for studies that did not adjust for later-life BMI (n = 13): fixed-effects RR = 1.13 (1.06, 1.21). Examining only analyses of advanced or high-grade prostate cancers, results were heterogeneous (p < 0.01). The random-effects summary RR per five units of BMI was 1.01 (95% CI: 0.89, 1.15). In all the reviewed studies, the vast majority of men were of normal weight in childhood and early adulthood. Few studies presented data describing the association between prostate cancer and obesity (e.g., early-adult BMI > or = 30). The exact relationships between early-life body size and prostate cancer remain unclear but appear to be weak.
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Review Prostate cancer screening: promise and peril--a review. 1999
Godley PA. · Department of Medicine and the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, 27599-7305, USA. · Cancer Detect Prev. · Pubmed #10403903 No free full text.
Abstract: This review summarizes the current status of and recommendations for prostate cancer screening with prostate-specific antigen in light of recent reductions in prostate cancer incidence and mortality. It describes how the uncertain effectiveness of aggressive treatment for prostate cancer and a reservoir of unsuspected indolent cancers make prostate cancer fit poorly into conventional screening models. The large proportion of men with unsuspected prostate cancers that may not cause morbidity or mortality and are unlikely to benefit from aggressive treatment decrease the effectiveness of a screening program. In addition, indolent, unsuspected prostate cancers in the screening population accentuate the detrimental effects of length bias on studies evaluating the effectiveness of prostate cancer screening. Screening tests for prostate cancer will continue to improve, but chemoprevention or nutritional prevention with vitamins and micronutrients such as tocopherols or selenium may prove to be effective methods of reducing prostate cancer incidence and should be aggressively investigated.
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Clinical Conference A phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory prostate carcinoma: Cancer and Leukemia Group B 99813. free! 2003
Oh WK, Halabi S, Kelly WK, Werner C, Godley PA, Vogelzang NJ, Small EJ, Anonymous00009. · Lank Center for Geritourinary Oncology, Dana Farber Cancer Institute, Boston, Massachusetts 02115, USA. · Cancer. · Pubmed #14669278 links to free full text
Abstract: BACKGROUND: The authors determined the safety and efficacy of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor (G-CSF) support in patients with hormone-refractory prostate carcinoma. METHODS: In the current multicenter, cooperative group study, patients with advanced prostate carcinoma whose disease progressed despite androgen deprivation therapy were treated with a combination of oral estramustine(240 mg three times per day for 5 days), 70 mg/m2 of docetaxel, and carboplatin at a dose of (area under the curve) 5. G-CSF was used to minimize the neutropenia associated with this regimen. Each cycle was repeated every 21 days. RESULTS: Forty patients were treated with a median of 7 cycles of therapy. Of the 34 evaluable patients with elevated pretreatment prostate-specific antigen (PSA) levels, 23 (68%) had a > or = 50% decline in PSA and 20 (59%) had a > or = 75% decline. Twenty-one patients had measurable disease, with 1 complete response (5%) and 10 partial responses (47%), for an overall measurable response rate of 52% (95% confidence interval [95% CI], 30-74%). The most common Grade 3 or Grade 4 toxicities (according to the National Cancer Institute Common Toxicity Criteria) included neutropenia in 23% of patients, thrombocytopenia in 13%, and fatigue in 13%. Febrile neutropenia occurred in 1 patient (3%). The overall median time to disease progression was 8.1 months (95% CI, 6-10 months) and the overall survival period was 19 months (95% CI, 13-26 months). CONCLUSIONS: The combination of estramustine, docetaxel, and carboplatin with G-CSF support was found to have significant clinical activity with an acceptable toxicity profile in patients with progressive hormone-refractory prostate carcinoma.
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Clinical Conference The impact of docetaxel, estramustine, and low dose hydrocortisone on the quality of life of men with hormone refractory prostate cancer and their partners: a feasibility study. free! 2001
Kornblith AB, Herndon JE, Zuckerman E, Godley PA, Savarese D, Vogelzang NJ, Anonymous00281. · Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, NYC, New York, USA. · Ann Oncol. · Pubmed #11432621 links to free full text
Abstract: OBJECTIVES: The quality of life (QoL) of 44 men with HRPC and 37 partners (primary caregivers, most residing with the patient) was assessed in a multicenter Phase II trial of docetaxel, estramustine and low dose hydrocortisone (CALGB 9780). A secondary objective was to test the feasibility of assessing partners' QoL in a cooperative group setting. PATIENTS AND METHODS: Patients and partners were separately interviewed by telephone at baseline, two, four and six months by a single trained research interviewer. Patients' QoL was measured by the FACT-P, Mental Health Inventory-17 (MHI-17), Brief Pain Inventory (BPI), a two-day log of pain medications, and the OARS for co-morbid conditions. Partners' QoL was measured by the MHI-17, Caregiver Burden Interview, and co-morbid conditions. RESULTS: The QoL study refusal rates were low for patients (4%) and partners (3%). Although patients tended to experience greater treatment side effects in the first two months (FACT Physical Well-Being item, P = 0.057), their cancer-specific emotions (e.g., worrying about worsening health) significantly improved at two and four months (FACT-Emotional Well-Being, P = 0.003, P = 0.03, respectively), as did their prostate cancer-specific physical problems (e.g., urination, pain), at two and four months (FACT-P, P = 0.001, P = 0.005, respectively). Partners' anxiety significantly decreased over time (MHI, P < 0.05). Patients' quality of life at two months was significantly related to their clinical response (FACT-P total and prostate cancer-specific problems, P < 0.05), and their clinical response was significantly related to a decrease in their partners' anxiety at two months (MHI, P < 0.05). CONCLUSIONS: Despite feeling worse from side effects, patients' prostate cancer-specific problems and emotional state significantly improved in the first four months of treatment. With treatment significantly affecting both patients' and partners' lives. and the successful assessment of partners' QoL, QoL of both patients and partners could be used as important endpoints in selected clinical trials.
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Clinical Conference Phase II study of docetaxel, estramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: a final report of CALGB 9780. Cancer and Leukemia Group B. 2001
Savarese DM, Halabi S, Hars V, Akerley WL, Taplin ME, Godley PA, Hussain A, Small EJ, Vogelzang NJ. · University of Massachusetts Memorial Health Care, Worcester, and Boston Medical Center, Boston, MA 01655, USA. · J Clin Oncol. · Pubmed #11331330 No free full text.
Abstract: PURPOSE: To investigate the combination of docetaxel, estramustine (EM), and low-dose hydrocortisone in men with hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: Combinations of EM with other antimitotic agents such as docetaxel are synergistic in vitro and show significant clinical activity in patients with HRPC. We studied intravenous administration of docetaxel 70 mg/m(2), oral estramustine, and low-dose daily hydrocortisone in men with HRPC who demonstrated progression after initial hormone therapy. RESULTS: Of the 47 men enrolled onto this multicenter cooperative group study, 46 were assessable for response and/or toxicity. In the 24 patients with measurable disease, there were three complete and nine partial responses for a measurable disease response rate of 50% (12 of 24 patients; 95% confidence interval [CI], 27% to 73%). In the 44 patients in whom pretreatment prostate-specific antigen (PSA) was elevated, 30 (68%) had a 50% or greater decrease, and 25 (57%) had a 75% or greater decrease in PSA. The combined measurable disease and biochemical response rate in all 46 assessable patients was 54% (three complete responses, 22 partial responses, 95% CI, 37% to 71%). The predominant toxicity was neutropenia, with 26% of patients having grade 3 and 30% having grade 4 granulocytopenia; there were no episodes of febrile neutropenia. Other common but mild adverse effects included malaise/fatigue, peripheral edema, and hyperglycemia. The incidence of thromboembolic events during therapy was 9%. With a median follow-up of 17 months, the median survival was 20 months. The median time to disease progression was 8 months for all patients, and 10 months for those with measurable disease. CONCLUSION: This therapy is efficacious and moderately well tolerated in HRPC and should be compared in a phase III trial with mitoxantrone and prednisone.
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Article The effect of hospital and surgeon volume on racial differences in recurrence-free survival after radical prostatectomy. 2008
Gooden KM, Howard DL, Carpenter WR, Carson AP, Taylor YJ, Peacock S, Godley PA. · The Institute for Health, Social, and Community Research, Shaw University, Raleigh, North Carolina 27601, USA. · Med Care. · Pubmed #18953228 No free full text.
Abstract: OBJECTIVE: This study investigates associations between hospital and surgeon volume, and racial differences in recurrence after surgery for prostate cancer. METHODS: Data from the 1991 to 2002 Surveillance, Epidemiology, and End-Results-Medicare database were examined for 962 black and 7387 white men who received surgery for prostate cancer within 6 months of diagnosis during 1993-1999. Cox regression models were used to estimate the relationships between volume (grouped in tertiles), recurrence or death, and race, controlling for age, Gleason grade, and comorbidity score. RESULTS: Prostate cancer recurrence-free survival rates improved with hospital and surgical volume. Black men were more likely to experience recurrence than white men [hazard ratio (HR) = 1.34; 95% confidence interval (CI): 1.20-1.50]. Stratification by hospital volume revealed that racial differences persisted for medium and high volume hospitals, even after covariate adjustments (medium HR = 1.30, 95% CI: 1.04-1.61; high HR = 1.36, 95% CI: 1.07-1.73). Racial differences persisted within medium and high levels of surgeon volume as well (medium HR = 1.43, 95% CI: 1.10-1.85; high HR = 1.57, 95% CI: 1.14-2.16). CONCLUSIONS: High hospital and physician volumes were not associated with reduced racial differences in recurrence-free survival after prostate cancer surgery, contrary to expectation. This study suggests that social and behavioral characteristics, and some aspects of access, may play a larger role than organizational or systemic characteristics with regard to recurrence-free survival for this population.
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Article A decision aid for teaching limitations of prostate cancer screening. 2008
Weinrich SP, Seger RE, Rao GS, Chan EC, Hamm RM, Godley PA, Moul JW, Powell IJ, Chodak GW, Taylor KL, Weinrich MC. · School of Nursing, Medical College of Georgia, Augusta, USA. · J Natl Black Nurses Assoc. · Pubmed #18807773 No free full text.
Abstract: There is minimal research regarding men's knowledge of the limitations of prostate cancer screening. This study measured knowledge of prostate cancer screening based on exposure to one of two decision aids that were related to prostate cancer screening (enhanced versus usual care). The sample consisted primarily of low income (54%) African-American men (81%) (n=230). The enhanced decision aid was compared against the usual care decision aid that was developed by the American Cancer Society. The enhanced decision aid was associated with higher post-test knowledge scores, but statistically significant differences were observed only in the men who reported having had a previous DRE (p = 0.013) in the multivariable analyses. All the men were screened, regardless of which decision aid they received. This study highlights the impact of previous screening on education of the limitations of prostate screening, and challenges the assumption that increased knowledge of the limitations of prostate cancer screening will lead to decreased screening.
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Article Perceived family history risk and symptomatic diagnosis of prostate cancer: the North Carolina Prostate Cancer Outcomes study. 2008
Spain P, Carpenter WR, Talcott JA, Clark JA, Do YK, Hamilton RJ, Galanko JA, Jackman A, Godley PA. · Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27709-2194, USA. · Cancer. · Pubmed #18798229 No free full text.
Abstract: BACKGROUND: Prostate cancer (PrCA) is the most common cancer and the second leading cause of cancer death among US men. African American (AA) men remain at significantly greater risk of PrCA diagnosis and mortality than other men. Many factors contribute to the experienced disparities. METHODS: Guided by the Health Belief Model, the authors surveyed a population of AA and Caucasian men newly diagnosed with PrCA to describe racial differences in perceived risk of PrCA and to examine whether 1) perceived high risk predicts greater personal responsibility for prostate care; and 2) greater personal responsibility for prostate care predicts earlier, presymptomatic diagnosis. Multivariate general linear modeling was performed. RESULTS: The authors found that men with a PrCA family history appreciated their increased risk, but AA men with a family history were less likely to appreciate their increased risk. Nevertheless, neither reporting a PrCA family history nor perceived increased risk significantly predicted screening and preventive behaviors. Furthermore, higher physician trust predicted increased likelihood to have regular prostate exams and screening, indicating that the racial differences in seeking prostate care may be mediated through physician trust. Expressed personal responsibility for screening and more frequent preventive behaviors were associated with more frequent screening diagnoses, fewer symptomatic diagnoses, and less frequent advanced cancers. CONCLUSIONS: Together, these results indicate that appreciating greater risk for PrCA is not sufficient to ensure that men will intend, or be able, to act. Increased trust in physicians may be a useful, central marker that efforts to reduce disparities in access to medical care are succeeding.
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Article Hidden barriers between knowledge and behavior: the North Carolina prostate cancer screening and treatment experience. free! 2007
Talcott JA, Spain P, Clark JA, Carpenter WR, Do YK, Hamilton RJ, Galanko JA, Jackman A, Godley PA. · Center for Outcomes Research, Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, Massachusetts 02114, USA. · Cancer. · Pubmed #17354220 links to free full text
Abstract: BACKGROUND: Prostate cancer (PC) mortality is much greater for African American than for Caucasian men. To identify patient factors that might account for some of this disparity, men within 6 months of diagnosis were surveyed about health attitudes and behavior. METHODS: Using Rapid Identification in the North Carolina Cancer Registry, 207 African American and 348 Caucasian recently diagnosed PC patients were identified and surveyed. RESULTS: African American men were younger and less often currently married, and had lesser education, job status, and income than Caucasian men (all P < .001). African American men were at no greater distance to medical care, but had less access: poorer medical insurance coverage, more use of public clinics and emergency wards, less continuity with a primary physician, and more often omitted physician visits they felt they needed. They also expressed less trust in physicians. African American men acknowledged their greater risk of PC, accepted greater responsibility for their health, and reported more personal failures that delayed diagnosis. African American men more often requested the tests that diagnosed their cancers, which resulted more often from routinely ordered screening tests for Caucasian men. African American men expressed less interest in nontraditional treatments. CONCLUSIONS: Despite lesser education, African American men in North Carolina are aware of their increased risk of cancer, the importance of treatment, and their responsibility for their health. Obstacles to timely diagnosis and appropriate care, including greater physician distrust, appear more likely to arise from reduced access and continuity of medical care arising from their worse socioeconomic position.
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Article Case-control prostate cancer screening studies should not exclude subjects with lower urinary tract symptoms. 2007
Godley PA, Carpenter WR. · Department of Epidemiology, School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA. · J Clin Epidemiol. · Pubmed #17208124 No free full text.
Abstract: OBJECTIVE: Prostate-specific antigen (PSA)/digital rectal exam (DRE) screening for prostate cancer has become standard medical practice; however, its effectiveness in terms of reducing prostate cancer mortality remains undetermined. Case-control screening studies may help determine screening efficacy, though the proper disposition of symptomatic subjects is unclear. This paper presents a prostate cancer-specific methodological modification for analyzing symptomatic case-control screening subjects. METHODS: Prostate cancer detection studies and case-control studies of PSA/DRE screening were reviewed, and the results for symptomatic and asymptomatic subjects were compared. RESULTS: Most PSA/DRE detection studies have found that the prostate cancer detection rate among symptomatic patients is the same as or lower than that among asymptomatic patients. Lower urinary tract symptoms (LUTS), often referred to as early prostate cancer symptoms, occur more often in benign prostatic hyperplasia (BPH), a more commonly diagnosed, nonmalignant disease. Screened symptomatic subjects are usually removed from the "screened" category in case-control studies even though BPH-related symptoms do not confer increased prostate cancer risk and odds ratios do not change with inclusion of symptomatic subjects in the analysis. CONCLUSION: Screened subjects with LUTS should remain in the "screened" category in case-control prostate cancer screening studies since these symptoms may not be associated with increased risk of prostate cancer or validity of the odds ratio.
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Article Racial differences in clinical progression among Medicare recipients after treatment for localized prostate cancer (United States). 2006
Cohen JH, Schoenbach VJ, Kaufman JS, Talcott JA, Schenck AP, Peacock S, Symons M, Amamoo MA, Carpenter WR, Godley PA. · Department of Urology, SUNY Downstate Medical School, Brooklyn, NY, USA. · Cancer Causes Control. · Pubmed #16783608 No free full text.
Abstract: OBJECTIVE: Prostate cancer recurrence impacts patient quality of life and risk of prostate-cancer specific death following definitive treatment. We investigate differences in disease-free survival among white, black, Hispanic, and Asian patients in a large, population-based database. METHODS: Merged Surveillance, Epidemiology, and End Results Program (SEER) and Medicare files provided data on 23,353 white patients, 2,814 black patients, 480 Hispanic patients, and 566 Asian patients diagnosed at age 65-84 years with clinically localized prostate cancer between 1986 and 1996 in five SEER sites. Patients were followed through 1998. Racial differences in disease-free survival were assessed using Kaplan-Meier survival curves and Cox regression models. RESULTS: The 75th percentile disease-free survival time for black patients was 13 months less than that for white patients (95% confidence interval [CI]: 6.2-19.8 months), 29.7 months less than that for Hispanic patients (95% CI: 4.4-55.0 months), and 39.1 months less than that for Asian patients (95% CI: 12.1-66.1 months). In multivariate analysis, black race predicted shorter disease-free survival among surgery patients, but not among radiation patients. CONCLUSIONS: Black patients experienced shorter disease-free survival compared to white, Hispanic, and Asian patients, and the disease-free survival of white, Hispanic, and Asian patients were not statistically different. Earlier recurrence of prostate cancer may help explain black patients' increased risk of mortality from prostate cancer.
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Article The North Carolina-Louisiana Prostate Cancer Project (PCaP): methods and design of a multidisciplinary population-based cohort study of racial differences in prostate cancer outcomes. 2006
Schroeder JC, Bensen JT, Su LJ, Mishel M, Ivanova A, Smith GJ, Godley PA, Fontham ET, Mohler JL. · Department of Epidemiology, UNC Linebarger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, 1700 Airport Road, Chapel Hill, NC 27599, USA. · Prostate. · Pubmed #16676364 No free full text.
Abstract: BACKGROUND: The North Carolina-Louisiana Prostate Cancer Project (PCaP) is a multidisciplinary study of social, individual, and tumor-level causes of racial differences in prostate cancer aggressiveness. METHODS: A population-based sample of incident prostate cancer cases from North Carolina and Louisiana will include 1,000 African Americans and 1,000 Caucasian Americans. Study nurses administer structured questionnaires and collect blood, adipose tissue, urine, and toenail samples during an in-home visit. Clinical data are abstracted from medical records, diagnostic biopsies are reviewed and assayed, and tissue microarrays are constructed from prostatectomy samples. Prostate cancer aggressiveness is classified based on PSA, clinical stage, and Gleason grade. RESULTS: Preliminary data demonstrate between- and within-group differences in patient characteristics, screening, and treatment by race and state. Participation exceeds 70% in all groups. CONCLUSIONS: Preliminary data support the feasibility of this comprehensive study to help determine the focus of public health efforts to reduce racial disparities in prostate cancer mortality.
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Article For the patient. Improving participation of African-American men in research studies. 2003
Hoyo C, Reid ML, Godley PA, Parrish T, Smith L, Gammon M. · No affiliation provided · Ethn Dis. · Pubmed #14632278 No free full text.
This publication has no abstract.
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Article Barriers and strategies for sustained participation of African-American men in cohort studies. 2003
Hoyo C, Reid ML, Godley PA, Parrish T, Smith L, Gammon M. · Department of Health Education, North Carolina Central University, Durham 27707, USA. · Ethn Dis. · Pubmed #14632266 No free full text.
Abstract: BACKGROUND: Prostate cancer incidence is about 70% higher among African Americans compared to Whites. Factors associated with this differential remain unclear, although several studies suggest that genetic factors may play a role. Before epidemiologic research can adequately identify factors associated with this differential, we need studies to determine the feasibility of recruiting and retaining African-American men in cohort studies, especially those that collect biological and questionnaire data. METHODS: We conducted 4 focus group discussions among African-American men aged 40 to 64 years in North Carolina, and an additional group comprised of their partners, using a semi-structured interview protocol (total N=55 subjects). Data were analyzed with QRS NU*DIST to identify themes. RESULTS: Participants' willingness to participate in cohort studies seemed to be motivated by a perceived risk of prostate cancer. Barriers to participation included mistrust of the research community, poor knowledge of cancer-site specific heterogeneity, anticipated time commitment, and the invasive nature of disease detection procedures. To foster trust and increase disease knowledge, recommended strategies included: partnering with known civic organizations that provide education on risk factors; discussing early signs and symptoms at the point of recruitment; recruiting participants from community clusters; and providing periodic feedback on biologic samples (if collected) to reassure participants of their proper usage. CONCLUSION: Observational cohort studies focused on African-American men are feasible if certain barriers to participation are addressed.
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Article Racial differences in mortality among Medicare recipients after treatment for localized prostate cancer. free! 2003
Godley PA, Schenck AP, Amamoo MA, Schoenbach VJ, Peacock S, Manning M, Symons M, Talcott JA. · Division of Hematology/Oncology, School of Medicine and the Center for Health Promotion and Disease Prevention, The University of North Carolina at Chapel Hill, 27599-7305, USA. · J Natl Cancer Inst. · Pubmed #14625261 links to free full text
Abstract: BACKGROUND: Prostate cancer mortality is higher among black American men than among white American men. We investigated whether racial disparities in outcomes of clinically localized prostate cancer vary by treatment (surgery, radiation therapy, or nonaggressive treatment). METHODS: Merged Surveillance, Epidemiology, and End Results Program (SEER) and Medicare files provided data (on treatment modality, age, race, cancer stage, tumor grade, census tract socioeconomic status, and date of death) on 5747 black and 38 242 white patients diagnosed at age 65-84 years with clinically localized prostate cancer between 1986 and 1996 in five SEER sites. Patients were followed through 1998. Racial differences in survival outcomes were assessed using Kaplan-Meier survival curves and Cox regression models. RESULTS: The median survival time for black patients was 1.7 years (95% confidence interval [CI] = 1.6 to 1.9 years) less than that for white patients. Median survival in black patients relative to white patients was 1.8 years (95% CI = 1.5 to 2.0 years) less among those who had surgery, 0.7 years (95% CI = 0.5 to 1.0 years) less among those who had radiation therapy, and 1.0 years (95% CI = 0.7 to 1.1 years) less among those who had nonaggressive treatment. Racial disparities were evident both in overall survival and in prostate cancer-specific survival, before and after statistical adjustment for covariates. CONCLUSIONS: Black patients' poorer overall survival from localized prostate cancer varies by initial treatment, with the survival gap being largest among patients undergoing surgery. Investigating these treatment-specific differences may clarify the mechanisms underlying worse outcomes for black patients in the health care system.
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Article Retrospective classification of prostate-specific antigen tests: differentiating screening from diagnostic clinical encounters. 2001
Godley PA, Rathore SS, Kshirsagar AV, Amamoo MA, Schell MJ, Freeman J, Harris RP. · Division of Hematology and Oncology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC 27599, USA. · J Clin Epidemiol. · Pubmed #11520647 No free full text.
Abstract: To assess the validity of retrospective medical chart review as a method of classifying prostate-specific antigen (PSA) tests as screening or diagnostic services, we reviewed PSA tests ordered at a university hospital (n = 95). PSA tests were reviewed by four raters: medicine resident (RES), oncologist (ONC), urologist (UR), medicine attending (GM)-and the physician who ordered the PSA test (ATTEND) using predefined standardized criteria. Agreement rates by individual rater and ATTEND were 0.79 (GM), 0.80 (ONC), 0.74 (UR), 0.83 (RES), for a composite percent agreement of 0.79. ATTEND incorrectly classified seven tests; exclusion of these tests raised agreement rates to 0.86 (GM), 0.86 (ONC), 0.80 (UR), 0.90 (RES), for a group composite percent agreement of 0.86. Of note, two raters had higher agreement rates when evaluating screening PSA tests than when evaluating diagnostic PSA tests. Standardized criteria applied to medical charts provide a valid method of retrospectively classifying PSA tests.
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Article Adjusted odds ratios under nondifferential misclassification: application to prostate cancer. 1999
Godley PA, Schell MJ. · Department of Medicine, Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, 27599-7305, USA. · J Clin Epidemiol. · Pubmed #10201653 No free full text.
Abstract: The high prevalence of unsuspected prostate cancer among middle-aged and elderly men is unique among cancers. With their uncertain natural history, unsuspected prostate cancer cases may be misclassified into control groups in which they can obscure the identification of prostate cancer risk factors in case-control studies. Assuming that the exposure experience of diagnosed and of unsuspected prostate cancers is the same (nondifferential misclassification), case-control odds ratios are biased toward the null, which may provide a rationale for reexamining findings in negative case-control studies of prostate cancer. This article reviews the evidence supporting a high prevalence of prostate cancer and describes formulae that can be used to adjust for misclassification bias in completed case-control studies and to estimate required sample sizes in proposed studies.
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