193 results on '"Chodak, G."'
Search Results
2. Combination hormonal therapy: a reassessment within advanced prostate cancer
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Moul, J W and Chodak, G
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- 2004
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3. Current trends in the management of radical retropubic prostatectomy: is short-stay RRP feasible in the United Kingdom?
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Ramsden, A R, Thurairaja, R, Persad, R, and Chodak, G W
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- 2004
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4. Are Bone Scans Necessary in Men With Low Prostate Specific Antigen Levels Following Localized Therapy?
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Warren, K. S., Chodak, G. W., See, W. A., Iverson, P., McLeod, D., Wirth, M., Morris, C., and Armstrong, J.
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- 2006
5. An analysis of risk factors for biochemical progression in patients with seminal vesicle invasion: validation of Kattanʼs nomogram in a pathological subgroup
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RAMSDEN, A. R. and CHODAK, G.
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- 2004
6. Can leakage at the vesico-urethral anastomosis be predicted after radical retropubic prostatectomy?
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RAMSDEN, A. R. and CHODAK, G. W.
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- 2004
7. PROSTATECTOMY – A RADICAL APPROACH
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RAMSDEN, A. R., PERSAD, R., and CHODAK, G. W.
- Published
- 2003
8. Endocrine effects, efficacy and tolerability of a 10.8-mg depot formulation of goserelin acetate administered every 13 weeks to patients with advanced prostate cancer
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SAROSDY, M. F., SCHELLHAMMER, P. F., SOLOWAY, M. S., VOGELZANG, N. J., CRAWFORD, E. D., PRESTI, J., CHODAK, G. W., MITCHELL, P., and PORTER, L.
- Published
- 1999
9. Treatment of prostate cancer using external beam radiotherapy after laparoscopic pelvic lymph node dissection
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GERBER, G. S., BALES, G. T., GORNIK, H. L., HARAF, D. J., CHODAK, G. W., and RUKSTALIS, D. B.
- Published
- 1996
10. Immunohistochemical evaluation of proliferating cell nuclear antigen, prostate-specific antigen and α1-antichymotrypsin in human prostate cancer
- Author
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IGAWA, M., URAKAMI, S., SHIINA, H., ISHIBE, T., SHIRANE, T., USUI, T., and CHODAK, G. W.
- Published
- 1996
11. 940P - Overall Survival Benefit with Sipuleucel-T by Baseline Prostate-Specific Antigen (PSA): An Exploratory Analysis from Three Phase 3 Trials
- Author
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Kantoff, P., Chodak, G., Sims, R.B., Whitmore, J.B., and Schellhammer, P.
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- 2012
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12. Will the experience with tamoxifen in breast cancer help define the role of antiandrogens in prostate cancer?
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Chodak, G W and Kolvenbag, G J C M
- Subjects
- *
TAMOXIFEN , *BREAST cancer , *ANTIANDROGENS - Abstract
Breast and prostate cancers are the two predominant hormone-responsive tumours. The use of the antioestrogen tamoxifen in the treatment of breast cancer has evolved over the past 30 y from treatment for advanced breast cancer to prevention. Tamoxifen is currently the endocrine treatment of choice for advanced breast cancer and for adjuvant therapy in a broad spectrum of women whose primary tumours have functional oestrogen receptors. It has also been shown to reduce the incidence of breast cancer in high-risk women. Non-steroidal antiandrogen therapy is used in the treatment of prostate cancer, but its role is still being defined. The clinical development of tamoxifen and that of the antiandrogens are reviewed and parallels are uncovered which provide insight into contemporary and future management of hormone-responsive prostate cancer.Prostate Cancer and Prostatic Diseases (2001) 4, 72–80 [ABSTRACT FROM AUTHOR]
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- 2001
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13. Improving knowledge about prostate cancer: the development of an educational program for African-Americans.
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List, M A, Sinner, M, and Chodak, G W
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PROSTATE cancer ,CANCER education ,AFRICAN Americans - Abstract
This study aimed to develop and test a prostate cancer educational program, as well as an electronic keypad survey procedure, among African-Americans. A 1 h seminar and 12-item knowledge questionnaire were reviewed by both professional and lay consultants and then tested among African-American men and women recruited from the city of Chicago. Eight free presentations were delivered to a total of 63 attendees. Mean percent correct rose from 20% pre-program to 57% post-program (P<0.001) and there was an increase on all individual questions. This feasibility study demonstrated: (a) there is a general lack of information about prostate cancer among African-Americans; (b) know-ledge can be significantly increased by means of an hour-long seminar; and (c) electronic keypads provide an easy, acceptable means of collecting data. Finally, the study underscored the need for the development of active and creative recruitment strategies to increase attendance. Such efforts are currently underway. [ABSTRACT FROM AUTHOR]
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- 1999
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14. Adherence by African American men to prostate cancer education and early detection.
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Myers, Ronald E., Chodak, Gerald W., Wolf, Thomas A., Burgh, Desiree Y., McGrory, Gene T., Marcus, Sue M., Diehl, Julie A., Williams, Melissa, Myers, R E, Chodak, G W, Wolf, T A, Burgh, D Y, McGrory, G T, Marcus, S M, Diehl, J A, and Williams, M
- Published
- 1999
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15. Independent prognostic factors in patients with metastatic (stage D2) prostate cancer. The Zoladex Study Group.
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Chodak, G W, Vogelzang, N J, Caplan, R J, Soloway, M, and Smith, J A
- Abstract
The independent prognostic factors affecting survival were assessed in 240 men undergoing treatment for metastatic prostate cancer as part of a randomized clinical trial comparing the gonadotropin releasing hormone analogue Zoladex (goserelin acetate implant) with castration. In a multivariate analysis, the most highly significant predictors were the presence or absence of bone pain, serum testosterone levels, serum alkaline phosphatase levels, and performance status. Patients with all four factors favorable for survival had a 2-year survival rate of 84% as compared with only 8% for patients with none of the four factors favorable for survival. No other factors were significant. A separate analysis of serum testosterone levels revealed that the higher the pretreatment serum testosterone level, the greater the survival rate. Compared with patients with serum testosterone levels less than 6.9 nmol/L, significant differences in survival were observed for patients with serum testosterone levels of 10.4 to 13.9, 13.9 to 17.3, and over 17.3 nmol/L. These results have important implications for the design and analysis of future clinical trials of hormone therapy and for counseling patients regarding the short-term prognosis of their disease. [ABSTRACT FROM AUTHOR]
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- 1991
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16. Disease-specific survival following routine prostate cancer screening by digital rectal examination.
- Author
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Gerber GS, Thompson IM, Thisted R, Chodak GW, Gerber, G S, Thompson, I M, Thisted, R, and Chodak, G W
- Abstract
Objective: To assess prostate cancer mortality in men undergoing routine screening by routine digital rectal examination.Design: Cohort study with a median follow-up period of 75 months.Setting: Population consisted of volunteers at a university clinic and men in an institutional health maintenance clinic.Patients: Fifty-six men with a mean age of 65 years (range, 52 to 79 years) diagnosed with prostate cancer.Interventions: Patients treated initially by observation, external or interstitial radiotherapy, radical prostatectomy, hormone therapy, or combination.Main Outcome Measures: Kaplan-Meier analysis of time to local progression, distant metastases, death from all causes, and death from prostate cancer. Mantel-Haenszel log-rank statistic was used to compare outcome in men diagnosed on initial examination with those diagnosed on subsequent examinations.Results: Clinically localized prostate cancer was diagnosed in 73% during an initial examination and 83% on subsequent examinations and (P.35). Grade distribution of tumors was similar in both groups. Overall 5 and 10 year survival of all cancer patients was 85% and 67%, respectively. Death from prostate cancer was 8% (3/38) in men diagnosed on initial examination and 33% (6/18) during subsequent examinations. Five- and 10-year disease-specific survival was 97% and 86%, respectively, for men diagnosed during the first rectal examination compared with only 81% and 57%, respectively, for men diagnosed on subsequent rectal examinations (P = .02).Conclusion: Routine screening for prostate cancer by annual digital rectal examination alone may be insufficiently frequent and/or sensitive to prevent significant mortality from this disease [corrected]. [ABSTRACT FROM AUTHOR]- Published
- 1993
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17. Prognostic factors in stage D2 prostate cancer treated with a pure nonsteroidal antiandrogen.
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Matzkin, Haim, Soloway, Mark S., Schellhammer, Paul F., Chodak, Gerald, Smith, Joseph A., Caplan, Richard, Kennealey, Gerard T., Matzkin, H, Soloway, M S, Schellhammer, P F, Chodak, G, Smith, J A, Caplan, R, and Kennealey, G T
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- 1993
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18. A PROSPECTIVE STUDY EVALUATING PSYCHOLOGICAL RESPONSES TO RAPID PSA TESTING
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Wilkinson, S., Warren, K., Ramsden, A., Matthews, A., and Chodak, G.
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- 2006
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19. Blindness secondary to prostate cancer.
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Vogelzang, Nicholas, Olson, David, Chodak, Gerald, Vogelzang, N J, Olson, D, and Chodak, G W
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ADENOCARCINOMA ,BLINDNESS ,BONE tumors ,BRAIN tumors ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,OCCIPITAL lobe ,OPTIC nerve ,PROSTATE tumors ,RESEARCH ,EVALUATION research ,CRANIAL nerves ,DISEASE complications ,TUMORS - Abstract
We report a case of blindness, secondary to hormone-refractory prostate cancer, occurring 7 years after the diagnosis of metastatic prostate cancer and 3.5 years after the clinical onset of the hormone-refractory state. Prolonged suppression of the disease with chemotherapy may have contributed to the unusual clinical findings. We discuss the role of supportive care in the management of prostate cancer. [ABSTRACT FROM AUTHOR]
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- 1993
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20. Treatment of Early Prostatic Cancer.
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Chodak, G.
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- 1991
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21. Prostate Cancer: To Screen or not to Screen.
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Chodak, G.
- Published
- 1991
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22. Screening for prostate cancer. The debate continues.
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Chodak, G W
- Subjects
- *
DECISION making , *MEDICAL screening , *PROSTATE tumors , *SURVIVAL , *PREVENTION - Published
- 1994
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23. Cryosurgery of the prostate revisited.
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Chodak, Gerald W. and Chodak, G W
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- 1993
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24. Do 'rapid' PSA assays reduce anxiety and stress of prostate cancer patients undergoing regular review? A prospective evaluation.
- Author
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Wilkinson S, Warren K, Ramsden A, Matthews A, and Chodak G
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- 2008
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25. Denosumab in men receiving androgen-deprivation therapy for prostate cancer
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Blair Egerdie, Teuvo L.J. Tammela, Jiri Heracek, Amy Kupic, Robert G. Feldman, Maciej Szwedowski, Carsten Goessl, Fred Saad, Benjamin Z. Leder, Chunlei Ke, Narciso Hernández Toriz, Matthew R. Smith, Denosumab HALT Prostate Cancer Study Group, Agus, D., Aronoff, D., Axler, M., Baker, K., Brosman, S., Chang, S., Charu, V., Chodak, G., Chu, F., Cochran, J., Colombo, G., Dhillon, G., Dineen, M., Dula, E., Efros, M., Ekbal, S., Feldman, R.G., Fisher, H., Friedel, W., Gittelman, M., Gleason, D., Goldberg, K., Goldfischer, E., Gopalakrishnan, G., Greengold, R., Grossfeld, G., Hahn, N., Hale, B., Hassman, D., Hopkins, S., Iranmanesh, A., Israeli, R., Jepson, B., Jones, W., Kagan, R., Karlin, G., Katz, J., Kaufman, J., Keiller, D., Kim, D., Klimberg, I., Kramolowsky, E., Lanctin, H., Lilly, J., Lugg, J., Lumerman, J., Madorsky, M., McMurray, J., Mehlhaff, B., Mellinger, B., Modiano, M., Moseley, W., Murdock, M., Penson, D., Reed, D., Roberts, B., Saltzstein, D., Sharkey, J., Shepherd, D., Sidhom, A., Sieber, P., Sipio, J., Smith, R., Smith, F., Steidle, C., Tchekmedyian, S., Teigland, C., Thrasher, J., Tomera, K., Updegrove, J., Wachs, B., Wells, W.G., Whitlock, N., Williams, R., Wurzel, R., Yee, L., Aaron, L., Andreou, C., Barkin, J., Bora, B., Buckley, R., Casey, R., Chetner, M., Chin, J., DiConstanzo, G., Donnelly, B., Flax, S., Gleave, M., Goldfarb, B., Hewitt, R., Hirshberg, E., Jansz, K., Kapoor, A., Kinahan, T., Klotz, L., Lacombe, L., Leung, W., Liquornik, M., Love, W., Mathur, A., Morash, C., Okafo, B., Palmer, B., Pommerville, P., Siemens, D.R., Steinhoff, G., Tanguay, S., Trachtenberg, J., Woods, E., Zadra, J., Cruz-Rodriguez, M., Galicia-Samano, R., Hernandez-Ordonez, O., Martinez-Martinez, C., Robles-Avina, J., Octavio-Rovelo-Diaz, C., Suarez-Sahui, T., Vargas-Zamora, H., Bar, K., Darewicz, B., Demkow, T., Jablonska, Z., Jarzemski, P., Kania, P., Niezabitowski, J., Pypno, W., Szwedowski, R., Hanus, M., Hesoun, P., Jansa, J., Pacik, D., Pernicka, J., Richter, J., Urban, M., Zmeskal, P., Barten, E., van den Broeke, P.J., Bruins, J.L., Khoe, G., Kil, P.J., Meier, A.H., van Berkel, J., Body, G., Kondas, J., Koranyi, L., Tenke, P., Torzsok, F., Toth, T., Lamy, O., Lippuner, K., Theiler, R., and Leppilahti, M.
- Subjects
Bone mineral ,medicine.medical_specialty ,Bone density ,business.industry ,Osteoporosis ,General Medicine ,Aged ,Aged, 80 and over ,Androgen Antagonists/adverse effects ,Androgen Antagonists/therapeutic use ,Antibodies, Monoclonal/adverse effects ,Antibodies, Monoclonal/pharmacology ,Antibodies, Monoclonal/therapeutic use ,Antibodies, Monoclonal, Humanized ,Bone Density/drug effects ,Bone Density Conservation Agents/adverse effects ,Bone Density Conservation Agents/pharmacology ,Bone Density Conservation Agents/therapeutic use ,Bone Remodeling/drug effects ,Denosumab ,Double-Blind Method ,Fractures, Bone/epidemiology ,Fractures, Bone/prevention & control ,Gonadotropin-Releasing Hormone/agonists ,Humans ,Incidence ,Injections, Subcutaneous ,Lumbar Vertebrae/drug effects ,Lumbar Vertebrae/injuries ,Lumbar Vertebrae/physiology ,Male ,Middle Aged ,Orchiectomy ,Osteoporosis/chemically induced ,Osteoporosis/drug therapy ,Prostatic Neoplasms/drug therapy ,Prostatic Neoplasms/physiopathology ,Prostatic Neoplasms/surgery ,RANK Ligand/adverse effects ,RANK Ligand/pharmacology ,RANK Ligand/therapeutic use ,Spinal Fractures/epidemiology ,Spinal Fractures/prevention & control ,medicine.disease ,Article ,Bone remodeling ,Surgery ,Androgen deprivation therapy ,Prostate cancer ,medicine.anatomical_structure ,medicine ,business ,Femoral neck ,medicine.drug - Abstract
Androgen-deprivation therapy is well-established for treating prostate cancer but is associated with bone loss and an increased risk of fracture. We investigated the effects of denosumab, a fully human monoclonal antibody against receptor activator of nuclear factor-kappaB ligand, on bone mineral density and fractures in men receiving androgen-deprivation therapy for nonmetastatic prostate cancer. In this double-blind, multicenter study, we randomly assigned patients to receive denosumab at a dose of 60 mg subcutaneously every 6 months or placebo (734 patients in each group). The primary end point was percent change in bone mineral density at the lumbar spine at 24 months. Key secondary end points included percent change in bone mineral densities at the femoral neck and total hip at 24 months and at all three sites at 36 months, as well as incidence of new vertebral fractures. At 24 months, bone mineral density of the lumbar spine had increased by 5.6% in the denosumab group as compared with a loss of 1.0% in the placebo group (P
- Published
- 2009
26. HTTP-level e-commerce data based on server access logs for an online store.
- Author
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Chodak G, Suchacka G, and Chawla Y
- Abstract
Web server logs have been extensively used as a source of data on the characteristics of Web traffic and users' navigational patterns. In particular, Web bot detection and online purchase prediction using methods from artificial intelligence (AI) are currently key areas of research. However, in reality, it is hard to obtain logs from actual online stores and there is no common dataset that can be used across different studies. Moreover, there is a lack of studies exploring Web traffic over a longer period of time, due to the unavailability of long-term data from server logs. The need to develop reliable models of Web traffic, Web user navigation, and e-customer behaviour calls for an up-to-date, large-volume e-commerce dataset on Web traffic. Similarly, AI problems require a sufficient amount of solid, real-life data to train and validate new models and methods. Thus, to meet a demand of a publicly available long-term e-commerce dataset, we collected access log data describing the operation of an online store over a six-month period. Using a program written in the C# language, data were aggregated, transformed, and anonymized. As a result, we release this EClog dataset in CSV format, which covers 183 days of HTTP-level e-commerce traffic. The data will be beneficial for research in many areas, including computer science, data science, management, and sociology., Competing Interests: The authors declare no competing interests., (© 2020 The Authors. Published by Elsevier B.V.)
- Published
- 2020
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27. American Cancer Society prostate cancer survivorship care guidelines.
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Skolarus TA, Wolf AM, Erb NL, Brooks DD, Rivers BM, Underwood W 3rd, Salner AL, Zelefsky MJ, Aragon-Ching JB, Slovin SF, Wittmann DA, Hoyt MA, Sinibaldi VJ, Chodak G, Pratt-Chapman ML, and Cowens-Alvarado RL
- Subjects
- American Cancer Society, Evidence-Based Medicine, Health Promotion standards, Humans, Male, Population Surveillance, Quality of Life, United States, Continuity of Patient Care standards, Primary Health Care standards, Prostatic Neoplasms therapy, Survivors
- Abstract
Prostate cancer survivors approach 2.8 million in number and represent 1 in 5 of all cancer survivors in the United States. While guidelines exist for timely treatment and surveillance for recurrent disease, there is limited availability of guidelines that facilitate the provision of posttreatment clinical follow-up care to address the myriad of long-term and late effects that survivors may face. Based on recommendations set forth by a National Cancer Survivorship Resource Center expert panel, the American Cancer Society developed clinical follow-up care guidelines to facilitate the provision of posttreatment care by primary care clinicians. These guidelines were developed using a combined approach of evidence synthesis and expert consensus. Existing guidelines for health promotion, surveillance, and screening for second primary cancers were referenced when available. To promote comprehensive follow-up care and optimal health and quality of life for the posttreatment survivor, the guidelines address health promotion, surveillance for prostate cancer recurrence, screening for second primary cancers, long-term and late effects assessment and management, psychosocial issues, and care coordination among the oncology team, primary care clinicians, and nononcology specialists. A key challenge to the development of these guidelines was the limited availability of published evidence for management of prostate cancer survivors after treatment. Much of the evidence relies on studies with small sample sizes and retrospective analyses of facility-specific and population databases., (© 2014 American Cancer Society.)
- Published
- 2014
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28. Lower baseline prostate-specific antigen is associated with a greater overall survival benefit from sipuleucel-T in the Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT) trial.
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Schellhammer PF, Chodak G, Whitmore JB, Sims R, Frohlich MW, and Kantoff PW
- Subjects
- Adenocarcinoma pathology, Adult, Aged, Aged, 80 and over, Alkaline Phosphatase blood, Hemoglobins metabolism, Humans, Immunotherapy, Kaplan-Meier Estimate, L-Lactate Dehydrogenase blood, Male, Middle Aged, Neoplasm Grading, Predictive Value of Tests, Proportional Hazards Models, Prostatic Neoplasms pathology, Adenocarcinoma blood, Adenocarcinoma therapy, Cancer Vaccines therapeutic use, Prostate-Specific Antigen blood, Prostatic Neoplasms blood, Prostatic Neoplasms therapy, Tissue Extracts therapeutic use
- Abstract
Objective: To explore the prognostic and predictive value of baseline variables in 512 patients with metastatic castration-resistant prostate cancer from the phase III Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT) trial who were randomized to receive sipuleucel-T or control., Methods: The most powerful of these prognostic factors, baseline prostate-specific antigen (PSA), was subdivided into quartiles to evaluate treatment effect patterns. Cox regression analyses were used to assess predictors of overall survival (OS) and sipuleucel-T treatment effect within PSA quartiles. Median OS was estimated by the Kaplan-Meier method., Results: PSA was the strongest baseline prognostic factor (P <.0001). Furthermore, the sipuleucel-T treatment effect appeared greater with decreasing baseline PSA. The OS hazard ratio for patients in the lowest baseline PSA quartile (≤22.1 ng/mL) was 0.51 (95% confidence interval, 0.31-0.85) compared with 0.84 (95% confidence interval, 0.55-1.29) for patients in the highest PSA quartile (>134 ng/mL). Estimated improvement in median survival varied from 13.0 months in the lowest baseline PSA quartile to 2.8 months in the highest quartile. Estimated 3-year survival in the lowest PSA quartile was 62.6% for sipuleucel-T patients and 41.6% for control patients, representing a 50% relative increase., Conclusion: The greatest magnitude of benefit with sipuleucel-T treatment in this exploratory analysis was observed among patients with better baseline prognostic factors, particularly those with lower baseline PSA values. These findings suggest that patients with less advanced disease may benefit the most from sipuleucel-T treatment and provide a rationale for immunotherapy as an early treatment strategy in sequencing algorithms for metastatic castration-resistant prostate cancer., (Copyright © 2013 Elsevier Inc. All rights reserved.)
- Published
- 2013
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29. Combined androgen blockade in advanced prostate cancer: looking back to move forward.
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Chodak G, Gomella L, and Phung de H
- Subjects
- Combined Modality Therapy, Humans, Male, Orchiectomy, Prostatic Neoplasms pathology, Prostatic Neoplasms surgery, Androgen Antagonists therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Prostatic Neoplasms drug therapy
- Abstract
In 1989, Crawford and colleagues suggested that combined androgen blockade with castration plus antiandrogen therapy provided significantly improved survival compared with castration alone. Since then, some studies have supported these results, whereas others have not. To resolve this discrepancy, the Prostate Cancer Trialists' Collaborative Group conducted a metaanalysis of 27 randomized trials to evaluate whether combined androgen blockade has benefits compared with castration alone. The results published in 2000 showed that combined androgen blockade using a nonsteroidal antiandrogen treatment (nilutamide or flutamide) improved survival compared with castration alone, whereas combined androgen blockade using a steroidal antiandrogen agent (cyproterone acetate) reduced survival compared with castration alone. In 2004, an analysis was carried out to evaluate the nonsteroidal antiandrogen agent bicalutamide in the combined androgen blockade setting, by incorporating the data from a trial of combined androgen blockade with bicalutamide versus combined androgen blockade with flutamide with the Prostate Cancer Trialists' Collaborative Group metaanalysis data for combined androgen blockade with flutamide versus castration. This analysis showed that combined androgen blockade with bicalutamide was associated with a 20% reduction in the risk of death compared with castration alone. The survival benefit associated with combined androgen blockade using a nonsteroidal antiandrogen agent should be weighed against the potential for increased toxicity and expense compared with castration alone. Studies have shown that bicalutamide has a better tolerability profile than flutamide or nilutamide. Furthermore, cost-benefit analyses of combined androgen blockade with bicalutamide suggest it is a cost-effective option versus castration alone and versus combined androgen blockade with flutamide. In summary, the present evidence suggests that combined androgen blockade with a nonsteroidal antiandrogen agent should be a first-line therapy option in patients with advanced disease.
- Published
- 2007
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30. The bicalutamide 150 mg early prostate cancer program: findings of the North American trial at 7.7-year median followup.
- Author
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McLeod DG, See WA, Klimberg I, Gleason D, Chodak G, Montie J, Bernstein G, Morris C, and Armstrong J
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- Adult, Aged, Aged, 80 and over, Androgen Antagonists adverse effects, Anilides adverse effects, Antineoplastic Agents, Hormonal adverse effects, Combined Modality Therapy, Disease Progression, Disease-Free Survival, Double-Blind Method, Follow-Up Studies, Humans, Male, Middle Aged, Nitriles, Prostatic Neoplasms mortality, Survival Rate, Tosyl Compounds, Androgen Antagonists administration & dosage, Anilides administration & dosage, Antineoplastic Agents, Hormonal administration & dosage, Prostatic Neoplasms therapy
- Abstract
Purpose: We describe the results of North American Trial 23 of the bicalutamide (Casodex) early prostate cancer program in the context of the overall early prostate cancer program findings., Materials and Methods: In Trial 23, 3,292 men with T1b-4, N0-Nx (N+ not allowed) M0 prostate cancer who had undergone radical prostatectomy or radiotherapy at 96 specialist referral centers in the United States (2,974) and Canada (318) were randomized 1:1 to 150 mg bicalutamide daily or placebo in addition to standard care for 2 years., Results: In Trial 23 at a 7.7-year median followup there were few clinical events in the bicalutamide or standard care groups and the rates of objective progression were 15.4% and 15.3%, respectively. Mortality rates were 12.9% in the treatment group and 12.3% in the standard care group, including 11.2% and 11.0% for nonprostate cancer deaths in the absence of objective progression and 1.6% and 0.9%, respectively, for mortality due to prostate cancer. No differences in the primary end points (objective progression-free and overall survival) were seen between patients treated with bicalutamide and those treated with standard care alone. Bicalutamide (150 mg) significantly improved time to PSA progression (HR 0.80, 95% CI 0.72 to 0.90, p <0.001). The tolerability profile of bicalutamide was similar to that previously described., Conclusions: In Trial 23 the current data suggest that early or adjuvant therapy may not benefit patients at low risk for recurrence, such as those with localized disease. The findings of Trial 23 contrast with the results in the overall early prostate cancer program and in other published literature, in which bicalutamide has been shown to provide significant clinical benefit for locally advanced disease.
- Published
- 2006
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31. Prostate cancer: epidemiology, screening, and biomarkers.
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Chodak G
- Abstract
Carcinoma of the prostate continues to be a major health problem in the United States. Beginning in 1988, a marked increase in detection of prostate cancer occurred due to the development of a test for prostate-specific antigen (PSA). Controversy exists, however, about the value of PSA as a tumor marker. Although it has prognostic significance both before and after definitive therapy for prostate cancer, it is unclear whether routine PSA screening will translate into a survival advantage for patients. Because of its limitations, PSA may not ultimately be a good enough marker to be used as a screening tool. However, molecular biology has led to a rapid rise in the number of potential new prostate tumor markers, which may eventually overcome the weaknesses of PSA. Considerable progress has occurred in the diagnosis and management of prostate cancer: more is understood about the risk factors for the disease, possible ways to prevent it, and new ways to diagnose and monitor it. These developments have already translated into better patient care, while also identifying where further improvements are needed.
- Published
- 2006
32. Re: Cytoreductive nephrectomy in patients with metastatic renal cancer: a combined analysis.
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Osborn JR, Chodak GW, Kommu S, and Persad RA
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- Humans, Kidney Neoplasms secondary, Quality of Life, Kidney Neoplasms surgery, Nephrectomy methods
- Published
- 2005
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33. The role of 111indium-capromab pendetide imaging for assessing biochemical failure after radical prostatectomy.
- Author
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Wilkinson S and Chodak G
- Subjects
- Aged, Aged, 80 and over, Humans, Male, Middle Aged, Neoplasm Staging, Prostate-Specific Antigen blood, Prostatectomy, Prostatic Neoplasms blood, Prostatic Neoplasms pathology, Radionuclide Imaging, Retrospective Studies, Antibodies, Monoclonal, Indium Radioisotopes, Neoplasm Recurrence, Local diagnostic imaging, Prostatic Neoplasms diagnostic imaging
- Abstract
Purpose: Conventional imaging modalities, such as computerized tomography and magnetic resonance imaging, lack sensitivity and specificity for detecting recurrent prostate cancer after radical surgery. We evaluated the role of the indium-capromab pendetide scan, otherwise known as the ProstaScint (Cytogen Corp., Princeton, New Jersey) scan, in this setting., Materials and Methods: A retrospective review was performed of 42 patients undergoing ProstaScint imaging for biochemical progression after radical prostatectomy. Of these patients 16 (38.1%) subsequently completed a course of salvage radiation therapy., Results: Median prostate specific antigen (PSA) immediately prior to ProstaScint imaging was 1.2 ng/ml (range 0.2 to 4.8). Abnormal accumulation on the ProstaScint scan was detected in 36 patients (85.7%). Of the 16 patients undergoing salvage radiation therapy 15 had uptake isolated to the prostatic fossa on ProstaScint imaging. Ten of these 15 patients (66.7%) achieved undetectable PSA after radiation therapy, while 5 (33.3%) had little or no response. Using American Society for Therapeutic Radiology and Oncology criteria 3 of 10 responders had relapse after an average of 9 months. The remaining 7 patients remained biochemically free of disease at last followup., Conclusions: ProstaScint imaging is capable of detecting recurrent prostate cancer at low PSA levels. However, only 7 of 15 men (46.7%) with ProstaScint uptake isolated to the prostatic fossa showed a durable response to salvage radiation therapy. Based on these findings patients might be better treated based on the rate of increase in PSA rather than on routine scanning with this test.
- Published
- 2004
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34. Is the efficacy of hormonal therapy affected by lymph node status? data from the bicalutamide (Casodex) Early Prostate Cancer program.
- Author
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Iversen P, Wirth MP, See WA, McLeod DG, Klimberg I, Gleason D, Chodak G, Montie J, Tyrrell C, Wallace DM, Delaere KP, Lundmo P, Tammela TL, Johansson JE, Morris T, and Carroll K
- Subjects
- Adult, Aged, Aged, 80 and over, Androgen Antagonists therapeutic use, Disease Progression, Humans, Lymphatic Metastasis pathology, Male, Middle Aged, Neoplasm Staging, Nitriles, Prostate-Specific Antigen blood, Prostatectomy, Prostatic Neoplasms blood, Regression Analysis, Tosyl Compounds, Anilides therapeutic use, Antineoplastic Agents therapeutic use, Prostatic Neoplasms pathology, Prostatic Neoplasms therapy
- Abstract
Objectives: To report an exploratory subgroup analysis assessing the extent to which the overall benefit found in the Early Prostate Cancer program is dependent on lymph node status at randomization. The program is ongoing, and the overall survival data are immature. The first combined analysis of the bicalutamide (Casodex) Early Prostate Cancer program at 3 years' median follow-up showed that bicalutamide, 150 mg once daily, plus standard care (radical prostatectomy, radiotherapy, or watchful waiting), significantly reduced the risk of objective progression and prostate-specific antigen (PSA) doubling in patients with localized/locally advanced prostate cancer., Methods: Men (n = 8113) with localized/locally advanced disease received bicalutamide 150 mg or placebo once daily, plus standard care. The time to event data (objective progression, PSA doubling) was analyzed by lymph node status at randomization., Results: Compared with standard care alone, bicalutamide significantly reduced the risk of objective progression, irrespective of lymph node status, with the most pronounced reduction in patients with N+ (hazard ratio [HR] 0.29; 95% confidence interval [CI] 0.15 to 0.56) compared with those with N0 (HR 0.59; 95% CI 0.48 to 0.73) and Nx (HR 0.60; 95% CI 0.50 to 0.72) disease. The largest decrease in risk of PSA doubling with bicalutamide was observed in N+ disease (HR 0.16; 95% CI 0.09 to 0.29), with significantly reduced risks seen in N0 (HR 0.45; 95% CI 0.40 to 0.51) and Nx (HR 0.38; 95% CI 0.33 to 0.44) disease., Conclusions: The greatest reduction in the risk of objective progression and PSA doubling with bicalutamide was seen in patients with N+ disease. However, bicalutamide also provided a statistically significant benefit in those with N0 and Nx disease.
- Published
- 2004
- Full Text
- View/download PDF
35. An evaluation of intermediate-dose ketoconazole in hormone refractory prostate cancer.
- Author
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Wilkinson S and Chodak G
- Subjects
- Aged, Aged, 80 and over, Androgen Antagonists therapeutic use, Humans, Male, Middle Aged, Treatment Failure, Androgen Antagonists administration & dosage, Ketoconazole administration & dosage, Prostatic Neoplasms drug therapy
- Abstract
Objectives: The management of hormone refractory prostate cancer remains controversial. Among the options, second-line hormonal therapy is commonly used. We investigated the efficacy of ketoconazole, an inhibitor of testicular and adrenal androgen biosynthesis, for treating patients with advanced hormone refractory prostate cancer., Methods: The study comprised 38 patients with progressive disease despite combined androgen blockade. Treatment consisted of intermediate-dose ketoconazole (300mg three times daily) and replacement hydrocortisone. Patients were monitored clinically and with serial psa measurements every 3 months. the principal endpoint was psa response., Results: Of the 38 patients, 21 (55.3%) showed a decrease in PSA >50% (95% confidence interval 38.3%-71.4%) with a median duration of 6 months (range 3-48 months). A PSA reduction >50% was seen in 21 of 34 patients (61.8%) with established metastases. Thirteen patients (34.2%), all of whom had metastases, exhibited a PSA decrease >80% (95% confidence interval 19.6%-51.4%) with a median duration of 9 months (range 3-48 months). Age, PSA at diagnosis, Gleason score and bone scan result were not significantly associated with response to ketoconazole treatment in univariate or multivariate analyses. For the entire study group, the median time to progression was 5 months (range 0-27 months) and the median survival was 12 months (range 3-48 months). Overall, 12 patients (31.6%) reported toxicity related to intermediate-dose ketoconazole but only 6 patients (15.8%) discontinued therapy due to intolerable side effects., Conclusion: It is apparent from this study that a reasonable percentage of patients failing standard hormonal therapy respond favourably to intermediate-dose ketoconazole and that toxicity is mild. In the absence of studies demonstrating better survival with chemotherapy, we believe that a trial of ketoconazole should be considered when progression occurs on hormone therapy.
- Published
- 2004
- Full Text
- View/download PDF
36. Editorial panel on informed consent for PSA screening.
- Author
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Ramsden AR and Chodak G
- Subjects
- Consent Forms, Humans, Male, Patient Education as Topic, Prostatic Neoplasms diagnosis, United States, Informed Consent, Mass Screening, Prostate-Specific Antigen blood, Prostatic Neoplasms prevention & control
- Published
- 2003
- Full Text
- View/download PDF
37. Educating African-American men about prostate cancer: impact on awareness and knowledge.
- Author
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Wilkinson S, List M, Sinner M, Dai L, and Chodak G
- Subjects
- Adult, Black or African American psychology, Black or African American statistics & numerical data, Aged, Black People, Female, Health Knowledge, Attitudes, Practice, Humans, Male, Mass Screening psychology, Middle Aged, Prostate-Specific Antigen, Sex Factors, Surveys and Questionnaires, Black or African American education, Attitude to Health ethnology, Health Education methods, Prostatic Neoplasms
- Abstract
Objectives: To determine whether an education program on prostate cancer could improve awareness and knowledge among African-American men. African-American men have the world's highest incidence of prostate cancer and more than twice the mortality compared with white men. Screening programs for prostate cancer have not been successful in attracting African-American participation. One explanation is a poor awareness and knowledge about the disease among this high-risk population., Methods: We surveyed 900 African-American adults attending prostate cancer education seminars in community settings throughout Illinois between March 1998 and January 2001. Participants were asked to complete a multiple-choice questionnaire on topics related to prostate cancer. The main outcome measures were a change in awareness and knowledge of prostate cancer after the 1-hour educational seminar., Results: The mean survey score improved from 26.0% before the seminar to 73.3% after it (P <0.0001). Every multiple-choice question was answered correctly more often after the seminar than before it. Increasing levels of education and income were associated with higher before and after scores (P <0.001). Men achieved a significantly greater score improvement (mean 48.1%) compared with women (mean 41.1%; P = 0.006). Previous screening for prostate cancer was reported by 23% of the participants. Using logistic regression analyses, higher levels of education and income correlated with higher rates of screening. After the seminar, 63.1% stated the intention to undergo screening., Conclusions: Our results demonstrate that prostate cancer awareness and knowledge can improve dramatically after a 1-hour seminar on the topic. Additional studies to evaluate the long-term retention of knowledge and impact on behavior are warranted.
- Published
- 2003
- Full Text
- View/download PDF
38. Informed consent for prostate-specific antigen screening.
- Author
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Wilkinson S and Chodak G
- Subjects
- Consent Forms statistics & numerical data, Humans, Male, Mass Screening statistics & numerical data, Prognosis, Prostatic Neoplasms blood, Prostatic Neoplasms mortality, Risk Factors, United States, Informed Consent legislation & jurisprudence, Mass Screening standards, Prostate-Specific Antigen blood, Prostatic Neoplasms diagnosis
- Published
- 2003
- Full Text
- View/download PDF
39. Bicalutamide as immediate therapy either alone or as adjuvant to standard care of patients with localized or locally advanced prostate cancer: first analysis of the early prostate cancer program.
- Author
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See WA, Wirth MP, McLeod DG, Iversen P, Klimberg I, Gleason D, Chodak G, Montie J, Tyrrell C, Wallace DM, Delaere KP, Vaage S, Tammela TL, Lukkarinen O, Persson BE, Carroll K, and Kolvenbag GJ
- Subjects
- Adult, Aged, Aged, 80 and over, Androgen Antagonists adverse effects, Anilides adverse effects, Antineoplastic Agents adverse effects, Chemotherapy, Adjuvant, Combined Modality Therapy, Disease Progression, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Humans, Male, Middle Aged, Neoplasm Staging, Nitriles, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Survival Rate, Tosyl Compounds, Androgen Antagonists administration & dosage, Anilides administration & dosage, Antineoplastic Agents administration & dosage, Prostatic Neoplasms drug therapy
- Abstract
Purpose: We determine the efficacy and tolerability of bicalutamide as immediate therapy, either alone or as adjuvant to treatment of curative intent, in patients with clinically localized or locally advanced prostate cancer., Materials and Methods: This international program consists of 3 ongoing, randomized, double-blind, placebo controlled clinical trials (trials 23, 24, and 25). Men with localized or locally advanced (T1-T4, Nx/N0, M0) prostate cancer were randomized to receive 150 mg. bicalutamide daily or placebo, in addition to standard care with radical prostatectomy, radiotherapy or watchful waiting. Primary end points are time to objective progression and overall survival. In this first analysis data from the trials were combined in a single overview analysis according to protocol., Results: Data are available for 8,113 patients (4,052 randomized to bicalutamide, 4,061 to standard care alone) at a median followup of 3.0 years. Treatment with bicalutamide provided a highly significant reduction of 42% in the risk of objective progression compared with standard care alone (9.0% versus 13.8%, hazards ratio 0.58; 95% confidence interval 0.51, 0.66; p <<0.0001). The overall result was reflected in 2 of the 3 trials (trials 24 and 25) with trial 3 (trial 23) showing a nonsignificant difference at this time. Reductions in the risk of disease progression were seen across the entire patient population, irrespective of primary treatment or disease stage. Overall survival data are currently immature and longer followup will determine if there is also a survival benefit with bicalutamide. The most frequently reported side effects of bicalutamide were gynecomastia and breast pain., Conclusions: Immediate treatment with 150 mg. bicalutamide daily, either alone or as adjuvant to treatment of curative intent, significantly reduces the risk of disease progression in patients with localized or locally advanced prostate cancer. This benefit must be balanced with the morbidity associated with long-term hormonal therapy. Followup is ongoing to determine potential survival benefits of this treatment approach.
- Published
- 2002
40. Intention to be tested for prostate cancer risk among African-American men.
- Author
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Myers RE, Hyslop T, Jennings-Dozier K, Wolf TA, Burgh DY, Diehl JA, Lerman C, and Chodak GW
- Subjects
- Adult, Age Factors, Aged, Analysis of Variance, Confidence Intervals, Humans, Logistic Models, Male, Middle Aged, Odds Ratio, Prostatic Neoplasms blood, Prostatic Neoplasms psychology, Risk Assessment, Surveys and Questionnaires, Black or African American psychology, Attitude to Health, Patient Acceptance of Health Care, Prostatic Neoplasms diagnosis
- Abstract
This study was conducted to identify factors associated with intention to be tested for prostate cancer risk among African-American men. Participants in this study included African-American men (n = 548) who were patients at the University Health Service at the University of Chicago, were 40 to 70 years of age, and did not have a personal history of prostate cancer. Baseline telephone survey data were collected for 413 (75%) men. Respondents were asked if they intended to have a blood test to assess prostate cancer risk. Univariate and multivariate analyses of intention to be tested for risk were performed. Eighty-six percent of the men said that they intended to be tested. Multivariate analysis results show that belief in the efficacy of prostate cancer screening [odds ratio (OR) = 3.6; 95% confidence interval (CI) = 1.4, 9.1] and intention to undergo a prostate cancer-screening (i.e., digital rectal examination and prostate-specific antigen testing; OR = 2.8; 95% CI = 1.3, 6.3) were positively associated with intention to be tested for prostate cancer risk. Being older (OR = 0.4; 95% CI = 0.2, 0.9), having had a prostate cancer-screening examination in the past year (OR = 0.5; 95% CI = 0.2, 1.0), perceiving one's prostate cancer susceptibility to be high (OR = 0.4; 95% CI = 0.2, 0.8), and being fatalistic about prostate cancer prevention (OR = 0.3; 95% CI = 0.2, 0.7) were negatively associated with intention to be tested for risk. Intention to be tested for prostate cancer risk was high among men in the study. Past screening, perceived susceptibility, and beliefs related to early detection might influence receptivity to genetic testing for prostate cancer risk.
- Published
- 2000
41. Using outcome data and patient satisfaction surveys to develop policies regarding minimum length of hospitalization after radical prostatectomy.
- Author
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Kirsh EJ, Worwag EM, Sinner M, and Chodak GW
- Subjects
- Adult, Aged, Humans, Male, Middle Aged, Surveys and Questionnaires, Time Factors, Treatment Outcome, Length of Stay statistics & numerical data, Patient Satisfaction, Postoperative Complications epidemiology, Prostatectomy
- Abstract
Objectives: Changes in health care economics have prompted new clinical pathways for radical prostatectomy to reduce length of hospitalization after surgery to 1 day. We evaluated satisfaction, outcomes, and short-term morbidity in 187 consecutive patients with overnight hospitalization after radical retropubic prostatectomy (RRP)., Methods: In 1995, we initiated a critical pathway for RRP that included epidural anesthesia with or without spinal anesthesia and postoperative methadone, acetaminophen, and ibuprofen for pain control. Patients were discharged when they were afebrile, tolerating a regular diet, ambulating without assistance, and using oral medications for analgesia. An 18-item satisfaction survey was mailed to each patient 3 weeks after discharge. Responses to the postoperative survey, morbidity, blood loss, and use of transfusions were recorded., Results: Of 252 patients who underwent RRP, 187 (74. 2%) were discharged 1 day after surgery. The mean age of patients was 61.4 years (range 42 to 73). A pelvic lymphadenectomy was performed in addition to the RRP in 32 men (17%). Epidural anesthesia with or without spinal anesthesia was used for all but 3 patients. The mean estimated blood loss was 1166 mL, and 24 patients (12.8%) required transfusion, with a mean of 1.9 U (range 1 to 6) of packed red blood cells. The postoperative complication rate was 11. 8%, of which 2.1% (n = 4) were definitely or probably related to our protocol. These complications included clot retention (n = 2), gastrointestinal bleeding (n = 1), and spinal headache (n = 1). Three of 187 patients were readmitted to the hospital within 30 days but only one (0.5%) required admission because of our protocol. The survey response rate was 91.4%. No patient was dissatisfied with his overall care, and only 10.5% of patients would have preferred to stay in the hospital longer., Conclusions: One-day hospitalization after RRP is associated with minimal postoperative morbidity and high patient satisfaction. Similar data are needed for RRP from other centers before policy decisions regarding the length of stay after this procedure are made.
- Published
- 2000
- Full Text
- View/download PDF
42. African-American men and intention to adhere to recommended follow-up for an abnormal prostate cancer early detection examination result.
- Author
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Myers RE, Hyslop T, Wolf TA, Burgh D, Kunkel EJ, Oyesanmi OA, and Chodak GJ
- Subjects
- Adult, Aged, Follow-Up Studies, Humans, Male, Middle Aged, Multivariate Analysis, Time Factors, Black or African American statistics & numerical data, Patient Compliance statistics & numerical data, Prostatic Neoplasms diagnosis
- Abstract
Objectives: To assess the intention of African-American men to have the recommended follow-up in the event of an abnormal prostate cancer early detection examination and to identify the variables that help to explain adherence intention., Methods: In the spring of 1995, we selected a random sample of 548 African-American men who were patients at the University of Chicago Health Service. The sample included men who were 40 to 70 years of age, did not have a personal history of prostate cancer, and had a working telephone number. A total of 413 men who completed the telephone survey received an invitation to consider undergoing a prostate cancer early detection examination. The survey provided data on personal background characteristics, knowledge, attitudes, and beliefs related to prostate cancer and early detection. Respondents were asked whether they would choose to have the recommended follow-up in the event of an abnormal early detection examination result. Univariate and multivariate analyses of intention to have follow-up were performed., Results: An intention to have the recommended follow-up was reported by 77% of the survey respondents. The results of multivariate analyses revealed that the intention to have the follow-up was positively associated with education beyond high school (odds ratio [OR] 1.9); perceived self-efficacy related to prostate cancer screening (OR 2.1); the belief that prostate cancer can be cured (OR 3.3); the belief that prostate cancer screening should be done in the absence of prostate problems (OR 2.3); and physician support for prostate cancer screening (OR 2.1)., Conclusions: African-American men who have a high school education or less may be at risk of nonadherence to recommended follow-up. Adherence also may be low among men who do not have favorable views of early detection or do not perceive strong physician support for early detection. Research is needed to determine whether intention and other factors predict actual adherence to follow-up in this population group.
- Published
- 2000
- Full Text
- View/download PDF
43. Comparing treatments for localized prostate cancer--persisting uncertainty.
- Author
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Chodak GW
- Subjects
- Humans, Male, Risk Factors, Survival Analysis, Prostatic Neoplasms mortality, Prostatic Neoplasms therapy
- Published
- 1998
- Full Text
- View/download PDF
44. Overnight hospitalization after radical prostatectomy: the impact of two clinical pathways on patient satisfaction, length of hospitalization, and morbidity.
- Author
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Worwag E and Chodak GW
- Subjects
- Aged, Analgesia, Epidural, Analgesics, Opioid, Anesthesia, Epidural, Humans, Male, Methadone, Middle Aged, Morphine, Prostatectomy adverse effects, Treatment Outcome, Length of Stay, Patient Satisfaction, Prostatectomy methods
- Abstract
Unlabelled: Changes in health care have prompted efforts to reduce length of hospitalization while maintaining quality care. Therefore, we evaluated short-term outcomes after radical retropubic prostatectomy on 100 consecutive men undergoing surgery for clinically localized prostate cancer performed under epidural anesthesia followed by epidural morphine or combined with spinal anesthesia using bupivacaine and fentanyl (25 micrograms) and followed by i.m. methadone (10-20 mg). All patients received oral acetaminophen and ibuprofen beginning 4 h after surgery. Length of hospital stay, responses to written satisfaction survey, postoperative morbidity and readmission to the hospital were recorded. Using either pathway, 83% of the patients were discharged after one night in the hospital. The mean hospital stay was 1.34 +/- 1.10 and 1.28 +/- 1.0 days, respectively. Although three men were rehospitalized, it was not because of the early discharge. More than 95% of patients were satisfied with pain control, and patients discharged after one night were not more likely to be dissatisfied than patients hospitalized longer., Implications: Both clinical pathways provide excellent anesthesia and analgesia and allow discharge 1 day after radical retropubic prostatectomy. Shortened hospital stay does not increase patient dissatisfaction or add to postoperative morbidity. Patients undergoing other pelvic and abdominal operations may also derive similar benefits using these pathways.
- Published
- 1998
- Full Text
- View/download PDF
45. Comparison of goserelin and leuprolide in combined androgen blockade therapy.
- Author
-
Sarosdy MF, Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Vogelzang NJ, Chodak GW, Klein EA, Schellenger JJ, and Kolvenbag GJ
- Subjects
- Adult, Aged, Aged, 80 and over, Androgen Antagonists administration & dosage, Anilides administration & dosage, Antineoplastic Agents, Hormonal administration & dosage, Disease Progression, Double-Blind Method, Flutamide administration & dosage, Goserelin administration & dosage, Humans, Leuprolide administration & dosage, Male, Middle Aged, Nitriles, Prostatic Neoplasms mortality, Survival Rate, Tosyl Compounds, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Prostatic Neoplasms drug therapy
- Abstract
Objectives: To perform exploratory analyses of data from a controlled trial that assessed the efficacy and tolerability of two antiandrogens, bicalutamide and flutamide, each combined with monthly depot preparations of leuprolide or goserelin, in patients with Stage D2 prostate cancer. One analysis compared goserelin plus antiandrogen therapy with leuprolide plus antiandrogen therapy; a second analysis compared the four combined androgen blockade (CAB) regimens., Methods: This was a randomized, multicenter trial, open-label for luteinizing hormone releasing hormone analogue (LHRH-A) therapy, double-blind for antiandrogen therapy, with a two-by-two factorial design. Eight-hundred thirteen patients were allocated in a ratio of 2:1 to goserelin therapy (3.6 mg every 28 days) or leuprolide therapy (7.5 mg every 28 days) and 1:1 to bicalutamide therapy (50 mg once a day) or flutamide therapy (250 mg three times a day). The end points of time to progression and survival were assessed with a median of 160 weeks of follow-up., Results: The percentages of progression events (70.9% versus 73.3%) and deaths (54.3% versus 56.8%) were similar for goserelin plus antiandrogen and leuprolide plus antiandrogen therapies. The hazard ratios for goserelin plus antiandrogen therapy to leuprolide plus antiandrogen therapy were 0.99 (95% confidence interval [CI] 0.84 to 1.18; P = 0.92) and 0.91 (95% CI 0.75 to 1.11; P = 0.34) for time to progression and survival, respectively. Goserelin plus antiandrogen and leuprolide plus antiandrogen therapies were generally well tolerated, and the side effects associated with depot administration occurred with a low frequency in the two groups. There were no significant differences among the goserelin plus bicalutamide, goserelin plus flutamide, or leuprolide plus bicalutamide therapy groups, but leuprolide plus flutamide therapy had a significantly poorer outcome than the other three therapies. The side-effect profiles for the four CAB groups were generally similar; diarrhea was more common among patients treated with flutamide and hematuria was more common among patients treated with bicalutamide., Conclusions: Although the results of these exploratory analyses should be interpreted with caution, they indicate that goserelin plus antiandrogen and leuprolide plus antiandrogen therapies are similarly well tolerated and have equivalent time to progression and survival, and that leuprolide plus flutamide therapy appears to be the least effective of the four CAB regimens.
- Published
- 1998
- Full Text
- View/download PDF
46. Saw palmetto (Serenoa repens) in men with lower urinary tract symptoms: effects on urodynamic parameters and voiding symptoms.
- Author
-
Gerber GS, Zagaja GP, Bales GT, Chodak GW, and Contreras BA
- Subjects
- Aged, Aged, 80 and over, Humans, Male, Middle Aged, Prostatic Hyperplasia complications, Urinary Bladder Neck Obstruction etiology, Plant Extracts therapeutic use, Prostatic Hyperplasia physiopathology, Urinary Bladder Neck Obstruction drug therapy, Urinary Bladder Neck Obstruction physiopathology, Urodynamics
- Abstract
Objectives: To assess the effects of saw palmetto on voiding symptoms and urodynamic parameters in men with lower urinary tract symptoms (LUTS) presumed secondary to benign prostatic hyperplasia (BPH)., Methods: Fifty men with previously untreated LUTS and a minimum International Prostate Symptom Score (IPSS) of 10 or greater were treated with a commercially available form of saw palmetto (160 mg twice per day) for 6 months. The initial evaluation included measurement of peak urinary flow rate, postvoid residual urine volume, pressure-flow study, and serum prostate-specific antigen (PSA) level. Patients completed an IPSS, serum PSA was determined, and flow rate was measured every 2 months during the course of the study. A urodynamic evaluation was repeated at the completion of the 6-month trial., Results: The mean IPSS (+/-SD) improved from 19.5+/-5.5 to 12.5+/-7.0 (P <0.001) among the 46 men who completed the study. Significant improvement in the symptom score was noted after treatment with saw palmetto for 2 months. An improvement in symptom score of 50% or greater after treatment with saw palmetto for 2, 4, and 6 months was noted in 21% (10 of 48), 30% (14 of 47), and 46% (21 of 46) of patients, respectively. There was no significant change in peak urinary flow rate, postvoid residual urine volume, or detrusor pressure at peak flow among patients completing the study. No significant change in mean serum PSA level was noted., Conclusions: Saw palmetto is a well-tolerated agent that may significantly improve lower urinary tract symptoms in men with BPH. However, we were unable to demonstrate any significant improvement in objective measures of bladder outlet obstruction. Placebo-controlled trials of saw palmetto are needed to evaluate the true effectiveness of this compound.
- Published
- 1998
- Full Text
- View/download PDF
47. Evaluation of changes in prostate specific antigen in clinically localized prostate cancer managed without initial therapy.
- Author
-
Gerber GS, Gornik HL, Goldfischer ER, Chodak GW, and Rukstalis DB
- Subjects
- Aged, Aged, 80 and over, Humans, Male, Middle Aged, Regression Analysis, Retrospective Studies, Prostate-Specific Antigen blood, Prostatic Neoplasms blood
- Abstract
Purpose: We define changes in prostate specific antigen (PSA) measurements with time in 49 men 71.9 +/- 7.0 years old (mean plus or minus standard deviation) with clinically localized prostate cancer who remain untreated., Materials and Methods: We retrospectively analyzed PSA changes in prostate cancer patients managed by watchful waiting. In all patients a minimum of 3 PSA levels were measured at intervals of at least 6 months after malignancy was diagnosed. The rate of change in serum PSA level with time (PSA velocity) was determined using an exponential, log linear model., Results: In 49 patients treated conservatively mean initial PSA level plus or minus standard deviation was 12.3 +/- 11.1 ng./ml. and mean PSA followup during which no therapy for prostate cancer was introduced was 32.1 +/- 13.2 months. PSA levels decreased during the observation period in 11 of the 49 patients (22%) and median PSA doubling time in the remaining 38 was 55.7 months (range 15.1 to 994.5). There was no significant correlation between age at diagnosis, Gleason sum, initial PSA level or clinical stage and PSA velocity. The short-term rate of change in PSA during the first 9 months after prostate cancer was diagnosed correlated poorly with overall PSA velocity. The short-term rate of PSA change was greater than the overall rate of change in 14 of 37 patients (38%)., Conclusions: There is significant variability in the rate of change of PSA with time in men with clinically localized prostate cancer who remain untreated. The usefulness of serial PSA measurements in the management of watchful waiting is unclear. Changes in PSA may not be helpful or appropriate in determining the need for therapy after a period of observation.
- Published
- 1998
48. Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument.
- Author
-
Esper P, Mo F, Chodak G, Sinner M, Cella D, and Pienta KJ
- Subjects
- Aged, Aged, 80 and over, Chicago, Humans, Male, Michigan, Middle Aged, Reproducibility of Results, Sensitivity and Specificity, Prostatic Neoplasms therapy, Quality of Life, Surveys and Questionnaires
- Abstract
Objectives: As the incidence of prostate cancer in the United States exceeds 330,000 in 1997, increasingly more men are faced with treatment choices for which there is no clear approach. At every stage of disease, these treatment choices may involve clinically equivalent modalities that differ in side effects and impact upon quality of life (QOL). Comprehensive, yet efficient, questionnaires are needed to measure QOL in patients with prostate cancer., Methods: Developed as a disease-specific adjunct to the Functional Assessment of Cancer Therapy (FACT) measurement system, a 12-item prostate cancer subscale (PCS) was developed and tested in three independent samples: a subscale development sample (n = 43), validity sample 1 (n = 34), and validity sample 2 (n = 96). The 12 items ask about symptoms and problems specific to prostate cancer. These questions are added to the general (FACT-G) instrument, thereby comprising a 47-item questionnaire., Results: Internal consistency of the PCS ranged from 0.65 to 0.69, with coefficients for FACT-G subscales and aggregated scores ranging from 0.61 to 0.90. Concurrent validity was confirmed by the ability to discriminate patients by disease stage, performance status, and baseline prostate-specific antigen (PSA) level. Sensitivity to change in performance status and PSA score over a 2-month period suggested that some subscales of the FACT-Prostate (P) (including the PCS) are sensitive to meaningful clinical change., Conclusions: Our findings support use of the FACT-P as a meaningful component of QOL evaluation in men undergoing therapy for prostate cancer.
- Published
- 1997
- Full Text
- View/download PDF
49. Bicalutamide-associated fulminant hepatic failure.
- Author
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Chodak GW
- Subjects
- Flutamide adverse effects, Hepatic Encephalopathy enzymology, Humans, Liver drug effects, Liver enzymology, Nitriles, Tosyl Compounds, Androgen Antagonists adverse effects, Anilides adverse effects, Hepatic Encephalopathy chemically induced
- Published
- 1997
50. Improved detection of recurrent bladder cancer using the Bard BTA stat Test.
- Author
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Sarosdy MF, Hudson MA, Ellis WJ, Soloway MS, deVere White R, Sheinfeld J, Jarowenko MV, Schellhammer PF, Schervish EW, Patel JV, Chodak GW, Lamm DL, Johnson RD, Henderson M, Adams G, Blumenstein BA, Thoelke KR, Pfalzgraf RD, Murchison HA, and Brunelle SL
- Subjects
- Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Neoplasm Recurrence, Local diagnosis, Neoplasm Staging, Sensitivity and Specificity, Urinary Bladder Neoplasms diagnosis, Antigens, Neoplasm urine, Neoplasm Recurrence, Local urine, Urinary Bladder Neoplasms urine
- Abstract
Objectives: To evaluate the BTA stat Test in the detection of recurrent bladder cancer., Methods: Sensitivity and specificity were determined using frozen voided urine samples from patients with recurrent bladder cancer, volunteers, patients with nonurologic conditions, and patients with a history of bladder cancer but free of disease. Results of cytology and the original BTA Test were compared with the sensitivity of the BTA stat Test in a large subgroup of the patients with cancer., Results: The BTA stat Test detected 147 (67%) of 220 recurrent cancers. For those urine samples with previous cytologic and BTA Test results available, cytology had a sensitivity of 23%, the BTA Test 44%, and the BTA stat Test 58% for detection of recurrent cancer (P < 0.001, stat versus cytology). The specificity of the BTA stat Test was 72% for benign genitourinary disease and 95% in healthy volunteers., Conclusions: The BTA stat Test has high sensitivity and is significantly superior to voided urine cytologic analysis in the detection of recurrent bladder cancer.
- Published
- 1997
- Full Text
- View/download PDF
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