Ventral bladder hernia following tubal ligation.
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Biomedical subjects
Publications and source records attributed to Ian M Thompson.
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PURPOSE: Metastatic prostate cancer, which is the precursor of most deaths from the disease, is treated most commonly with hormonal therapy. Generally the primary tumor is never treated. Due to evidence that controlling other primary neoplasms affects patient survival we examined the impact of radical prostatectomy and radiotherapy on the outcome in patients with metastatic prostate cancer in the context of a randomized clinical trial. MATERIALS AND METHODS: Southwest Oncology Group Study 8894 randomized 1,286 men with metastatic prostate cancer to orchiectomy and placebo or orchiectomy and flutamide. We performed proportional hazards analysis of variables previously identified to have a significant impact on survival. In this analysis we determined the impact of previous radical prostatectomy or radiotherapy on survival. RESULTS: Previous radical prostatectomy in patients with metastatic prostate cancer was associated with a statistically significant decrease in the risk of death (hazard ratio 0.77, 95% confidence interval 0.53 to 0.89) relative to those who did not undergo earlier prostatectomy. Conversely previous radiotherapy was associated with a greater risk of death in those who had previously undergone prostatectomy and those who received no definitive earlier therapy. CONCLUSIONS: It must be stressed that this intriguing observation was a secondary analysis of a phase III study. Nevertheless, it raises the question of whether control of the primary tumor impacts the ultimate outcome in patients with advanced prostate cancer. The suggestion of the role of radical prostatectomy in locally advanced prostate cancer, the now established role of extirpative therapy for renal cell carcinoma and the suggestion of this phenomenon in ovarian carcinoma should prompt further evaluation of this finding in other data sets. It may provide new opportunities for clinical trials.
OBJECTIVES: To evaluate, in a population of patients with very high risk of diabetes, the natural history of Fournier's gangrene (FG) and to characterize the differences in presentation and outcome. METHODS: Patients with FG were identified during a 6-year period at two tertiary care institutions in San Antonio, Texas. The impact of diabetes on presentation and outcome were evaluated and compared with previous series. RESULTS: We identified 26 patients with FG, of whom 20 (76.9%) had diabetes. Diabetes was the most common risk factor identified and was associated with a younger age. The average hospital stay was not affected by the diagnosis of diabetes. Of 26 patients treated for FG, 3 (11%) died, 1 of whom had diabetes. Although the extent of debridement required was greater among diabetics, the average number of debridements required was not increased (2.55 in diabetic and 2.4 in nondiabetic patients). CONCLUSIONS: Although diabetes is a risk factor for FG, the outcome is not affected by this diagnosis.
OBJECTIVES: To assess the incidence of incontinence and the associated quality of life in men younger than 65 years of age after radical prostatectomy. METHODS: The TRICARE/CHAMPUS database was searched to identify 1000 patients who underwent radical prostatectomy within 2 years before study initiation. All patients were younger than 65 years of age at the time of surgery and had at least 18 months of postoperative follow-up. An eight-part questionnaire focusing on continence after surgery was mailed to the study population. Respondents reported on voiding dysfunction, degree of incontinence, satisfaction with continence, and lifestyle impact of incontinence. RESULTS: A total of 674 eligible patients (78%) completed the survey. Any amount of pad use or changing of underwear to keep dry was reported by 31.7%, leakage once per day occurred in 16.8%, and leakage more than once per day in 9.2%. Severe urgency or urge incontinence occurred in 17.4% and was the primary cause of incontinence in one third of patients with incontinence. Only 8.9% of patients used two or more pads per day, and severe incontinence (more than four pads per day) occurred in 2.7%. Incontinence-corrective surgery was used by 4.9% of patients. Overall, 83.3% of patients reported satisfaction with their continence after surgery, and 12% considered postoperative incontinence to be a problem. CONCLUSIONS: The results of this questionnaire-based outcomes evaluation of a large national sample of prostatectomy patients younger than 65 years of age demonstrate that incontinence rates in this younger population are similar to those in the Medicare population and may be more representative of the national experience than single-center reports.
The use of complementary and alternative medicine (CAM) has been used since antiquity for the relief of symptoms related to many diseases including urologic ailments. CAM is typically defined as those healing philsophies, approaches and therapies that are generally not taught in medical schools and are not usually reimbursed by medical insurance companies. Complementary and alternative medicine therapies are distinguished as those used alone (alternative) or in addition to conventional therapies (complementary). Few studies have focused on the urologic population. In this article, we summarize recent studies assessing the prevalence rate of CAM use with special emphasis in prostate cancer patients.
The Prostate Cancer Prevention Trial (PCPT) is a 7-year randomized trial of 18000 men designed to test a daily dose of finasteride (5 mg/d) for the primary prevention of prostate cancer. Compliance is assessed every 6 months by determining the percentage of pills consumed since the previous visit. In addition, levels of 5 alpha-dihydrotestosterone (DHT) are measured at yearly intervals in a random subset of 5% of participants in the trial as part of a substudy to investigate the potential of this biomarker for monitoring compliance. Motivated by this substudy, we outline three biomarker-based rules for monitoring compliance over time in prevention trials. We make comparisons among the rules using receiver operating characteristic curves. We illustrate the methods using the biomarker DHT in the PCPT substudy with pill counts as a gold standard, and in a simulation study under a hypothetical true gold standard. Our results indicate that simple absolute threshold monitoring rules perform just as well as more complicated rules that utilize the entire biomarker history.
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Prostate-specific antigen (PSA) screening has led to a dramatic increase in prostate cancer detection with a concurrent stage migration. Although the test has revolutionized prostate cancer detection by identifying disease that is potentially curable in the majority of men, only 25% of men receiving test results of PSA > 4 ng/ml will have prostate cancer and many men receiving a normal PSA will have disease, including high-grade disease. There is a need for improved biomarkers for detecting prostate cancer. One such method of cancer detection is surface-enhanced laser desorption and ionization (SELDI). The Early Detection Research Network (EDRN) validation study for SELDI for prostate cancer is described. In a three-stage study, the portability and reproducibility of the technique will be determined; the predictive algorithm will be refined in a multi-institutional case-control population; followed by ultimate validation in the context of a prospective trial with complete disease ascertainment. The unique aspect of the EDRN SELDI validation study is the novel use of two groups of cancer cases: those cases with higher-risk disease (Gleason > or = 7) and those cases with lower-risk disease (Gleason < or = 6). This study will allow the first evaluation of a predictive algorithm that includes prognosis in disease screening. The EDRN SELDI prostate cancer biomarker validation study is a rigorous evaluation of a new detection method for prostate cancer. The methodologies used for this evaluation will prove useful for guiding future biomarker studies in this challenging disease.
The results of the Prostate Cancer Prevention Trial spurred debate because finasteride was found to reduce the period prevalence of prostate cancer by about 25% while also increasing the rate of high-grade prostate cancers. Assessing how finasteride would impact mortality at the population level is key to evaluating the public health implications of these results. Any model for evaluating the impact of chemoprevention at the population level will involve methods for assigning weights to competing outcomes of the chemoprevention. The person-years saved model, which uses survival to weigh outcomes, assesses the impact on population mortality and has particular strengths. The person-years saved model shows that more than 300,000 person-years would be saved during a period of 10 years with the widespread use of finasteride, assuming no change in the rate of high-grade prostate cancers. The rate of high-grade prostate cancers in the population, about 20% in any given year, would have to nearly triple to 60% for the net positive impact of finasteride to be zero. The person-years saved model shows that the administration of finasteride is likely to result in a net positive impact of finasteride on population mortality, even with an increase in the rate of high-grade prostate cancers. Future models may use other outcomes to assess population impact, including economic, quality-of-life, or various combinations of outcomes.
PURPOSE: To compare patient and tumor characteristics, including survival data, between serendipitous and non-serendipitously discovered renal cell carcinoma (RCCA) in an era of more frequent use of CT scanning and ultrasonography. MATERIALS AND METHODS: The Tumor Registry of the Audie L. Murphy VA Hospital in San Antonio, TX, was reviewed for new diagnoses or initial treatment of RCCA from January 1985 through December 1999. Records were evaluated as to whether the initial diagnosis of RCCA was made serendipitously. Prognostic and epidemiological variables, were collected and disease-specific and overall survival data were computed. RESULTS: Of 257 patients with RCCA, 93 (36.2%) presented with serendipitously discovered tumors and 100 presented with metastases at diagnosis. Mean tumor size was smaller in the serendipitous group, compared both pathologically (6.74 cm vs. 4.49 cm, P < 0.0001) and by radiographic measurement (8.04 cm vs. 4.87 cm, P < 0.0001). Sixty-six (71%) of 93 serendipitously discovered tumors were Stage I at diagnosis, vs. only 30 (18.4%) of 163 non-serendipitous tumors (P < 0.0001). When non-serendipitous tumors with metastatic disease at presentation were excluded, the percentage of patients with Stage I disease was lower than for serendipitous tumors (46.8% vs. 71%, P = 0.004). Pathologically confirmed tumor stage was more favorable for serendipitously discovered tumors: 40 of 77 (60%) non-serendipitous tumors were <pT3, vs. 70 of 86 (81.4%) serendipitous tumors (P < 0.0001). Overall and disease-specific survival was better in the serendipitous group as well, with a 5-year disease-specific survival of 94%, contrasted with 35% in the non-serendipitous group (P < 0.0001). CONCLUSIONS: The widespread use of CT scanning and ultrasonography has led to a continued increase in the serendipitous diagnosis of a significant number of all RCCA which are associated with significantly lower stage at diagnosis, and thus with significantly improved survival.
PURPOSE: Growing evidence suggests that both selenium and vitamin E may reduce the risk of prostate cancer. SELECT is a randomized, prospective, double-blind study designed to determine if selenium and vitamin E can reduce the risk of prostate cancer among healthy men. MATERIALS AND METHODS: The preclinical and epidemiologic evidence regarding chemoprevention with selenium and vitamin E were reviewed. Secondary analyses from randomized trials of both agents were included in the analysis. Data from these analyses as well as evidence from the Prostate Cancer Prevention Trial were used to develop the schema of SELECT. RESULTS: Preclinical, epidemiologic, and Phase III data suggest that both selenium and vitamin E have potential efficacy in prostate cancer prevention. The experience of the Prostate Cancer Prevention Trial and the rapid accrual of SELECT during its first year demonstrate the interest and dedication of healthy men to long-term studies of cancer prevention. A total of 32,400 men are planned to be randomized in SELECT. CONCLUSIONS: SELECT is the second large-scale study of chemoprevention for prostate cancer. Enrollment began in 2001 with final results anticipated in 2013.
Since 1991 and the activation of the Prostate Cancer Prevention Trial as well as similar prevention studies in several other organ sites, the interest in prostate cancer prevention has increased substantially. Despite such interest, the challenges to prevention trials-in design, implementation, prioritization, and allocation of resources-are substantial. Simultaneously, there has been an explosion in new targets and agents that may have an effect in the prevention of this disease. In this manuscript, we discuss these challenges to the study of prostate cancer prevention and provide a blueprint for prioritization of future studies.
Using a combination of PSA, Gleason score, and clinical stage, it is possible to identify a group of patients with prostate cancer who have a high risk of relapse following initial treatment (e.g., radiotherapy or radical prostatectomy). For these patients, multi-modal therapy may result in improved outcomes. We reviewed published literature to identify methods to identify high-risk patients as well as options for adjuvant or neoadjuvant therapy to reduce risk of disease recurrence. At the present time, the most promising adjuvant therapy is hormonal therapy following radiotherapy for locally advanced disease (T3-T4, or N1). In phase III trials in these patients, survival is improved. For all other applications, including adjuvant and neoadjuvant hormonal therapy, chemotherapy, or radiotherapy, the benefits are unclear. Perhaps most promising at this time, and the subject of a current phase III trial, is the utility of adjuvant chemotherapy in high-risk patients. It will be through the conduct of phase III trials that the benefits of multi-modal therapy will be evaluated. Patients with high-risk prostate cancer undergoing radiotherapy or surgery should be offered participation in these clinical trials.
Effective treatment of penile carcinoma incorporates three modalities: surgery, radiation and chemotherapy. Surgery alone may offer a high cure rate in early stages of the disease. In certain patients radiation therapy may be utilized to eradicate the tumor and allow organ preservation. For patients with locally advanced disease, multi-modality approaches incorporating adjuvant or neoadjuvant chemotherapy and radiation therapy need to be studied. This approach may confer a survival benefit to a group that would otherwise have a poor prognosis. Finally, in the setting of metastatic disease, less toxic and more effective combination chemotherapy are sought. Novel targeted therapies that have been successful in squamous cell carcinoma at other sites must also be studied in this disease. We believe that multi-institutional trials should be designed in order to obtain prospective benchmark data from which to make valid comparisons of outcome.
This study was designed to use a prospectively analyzed, population-based, multiethnic cohort of men to determine if there is a relationship between one measure of obesity/overweight (Body Mass Index) and Prostate Specific Antigen (PSA). A total of 1565 men without a prior diagnosis of prostate cancer were prospectively enrolled in the San Antonio study of Biomarkers Of Risk (SABOR) Clinical and Epidemiologic Center of the Early Detection Research Network of the National Cancer Institute. Body Mass Index (BMI) was compared with serum PSA levels, stratifying by ethnic group. No relationship was found between BMI and PSA in any ethnic group or in the cohort as a whole. This study suggests that there is no increased risk of overdetection of prostate cancer among obese men due to an elevation in PSA.
Multiple studies have reported that analysis of serum and other bodily fluids using surface enhanced laser desorption/ionization time of flight mass spectroscopy (SELDI-TOF-MS) can identify a "fingerprint" or "signature" of spectral peaks that can separate patients with a specific disease from normal control patients. Ultimately, classification by SELDI-TOF-MS relies on spectral differences in position and amplitude of resolved peaks. Since the reproducibility of quantitation, resolution and mass accuracy of the SELDI-TOF-MS, or any high throughput mass spectrometric technique, has never been determined this method has come under some skepticism as to its clinical usefulness. This manuscript describes a detailed design of a three-phase study to validate the clinical usefulness of SELDI-TOF-MS in the identification of patients with prostatic adenocarcinoma (PCA). At the end of this validation study, the usefulness of the general SELDI-TOF-MS approach to identifying patients with PCA will be demonstrated and how it compares with PCA diagnosis by measuring prostate specific antigen.