An evidence-based approach to understanding the pharmacological class effect in the management of prostatic diseases.
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Adrenergic alpha-Antagonists↗
Biomedical subjects
Neil Fleshner
Publications and source records attributed to Neil Fleshner.
Defining high-risk prostate cancer: current status.
Defining men at high risk for prostate cancer treatment failure and death continues to evolve. Identifying these men allows for better disease prognostication, patient decision treatment making and facilitates accrual for appropriate clinical trials. Men at traditional high risk for prostate cancer progression and death include men with advanced clinical stage, higher levels of PSA and Gleason pattern 4. Utilizing accepted methods of risk stratification including nomograms can aid in case identification. Softer risk factors such as obesity, race, socioeconomic status, and genetic polymorphisms are increasingly being studied. Ultimately high-throughput genomics will aid in identification of these men.
Adult↗
Prostate cancer: chemoprevention update 2005.
INTRODUCTION: If an agent can slow the growth of existing prostate cancer cells, it remains plausible that it may be effective as an adjunct to surgery, radiation or chemotherapy. DISCUSSION: Level-1 evidence will be needed in order to definitively prove the efficacy of agents as chemoprevention strategies for prostate cancer. Currently, only finasteride fulfills this criterion. Two major trials are underway that will assess the role of soy, vitamin E and selenium in prostate cancer prevention. CONCLUSION: Tantalizing prospects for effective chemoprevention of prostate cancer exist. Fortunately, well-conducted randomized trials will allow us to answer many of these questions within the next 2 to 8 years.
Antineoplastic Agents↗
The experiences of men receiving androgen deprivation treatment for prostate cancer: a qualitative study.
OBJECTIVE: This exploratory study was intended to investigate men's ways of integrating and understanding experiences with Androgen Deprivation Therapy (ADT), including how hormone treatment affected their sense of identity. PATIENTS AND METHODS: Twelve men, averaging 61 years of age and treated with ADT, participated in a single interview about their experiences with prostate cancer and hormone treatment. In keeping with a qualitative approach, questions were initially open-ended, with patients encouraged to describe experiences in their own words. RESULTS: Seven prominent themes appeared in the interviews: 1) starting on hormones, 2) matching expectations with reality, 3) tracking changes, 4) dealing with changes in sexuality, 5) navigating relationships, 6) putting things in context, and 7) interpreting gender-relevant changes. CONCLUSION: The effects of ADT on men with prostate cancer were varied and often substantial in their impact. Additionally, men often receive insufficient information to prepare them to deal with side effects. While the physiological situation of the men in our study could be described as "liminal" (i.e., straddled between two categories of gender), interview data showed that they refuse their liminality, claiming to be neither less masculine nor more feminine because of treatment. While men are grateful to receive potentially life-extending treatment, the challenge for the health care system is to provide them with the information and clinical support that will make their remaining years the best that they can be.
Aged↗
Development of prostate cancer quality indicators: a modified Delphi approach.
OBJECTIVES: There is evidence of variation in both the processes and outcomes of prostate cancer care, resulting in possible harm to patients and increased costs to the health system. Care could be improved by first identifying critical, measurable indicators that correlate with quality of care. This work was conducted to develop indicators of prostate cancer care using a modified three-step Delphi approach. METHODS: A 17-member multidisciplinary panel reviewed potential indicators extracted from the medical literature through two consecutive rounds of rating followed by consensus discussion. The panel then prioritized the indicators selected in the previous two rounds. RESULTS: Of 31 possible indicators that emerged from 49 reviewed articles, 11 were prioritized by the panel as benchmarks for assessing the quality of surgical care for prostate cancer. The 11 indicators represent three levels of measurement (regional, hospital, individual provider) across several phases of care (diagnosis, surgery, pathology, and follow-up), as well as broad measures of outcomes. CONCLUSION: A systematic evidence- and consensus-based approach was used to develop quality indicators of prostate cancer care, with a focus on pre-, peri- and post-operative care as well as outcomes. Some of the indicators selected by the panel were also recommended by a similarly structured panel process. These indicators can be used by individual providers and organizations to monitor the quality of their services, and develop interventions to address any variations.
Delphi Technique↗
Remission of hormone-refractory prostate cancer attributed to Essiac.
Essiac is a popular complementary and alternative medicine (CAM) that is utilized by many cancer patients in North America. Much anecdotal reporting exists about its cancer-fighting qualities, but so far no clinical trials have been preformed to validate those claims. We describe here the case of a 64-year-old man whose hormone-refractory prostate cancer responded well to Essiac tea.
Humans↗
First International Conference on Chemoprevention of Prostate Cancer. Overview consensus statement.
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Anticarcinogenic Agents↗
Dietary fat and prostate cancer.
PURPOSE: Data from histopathological and migratory studies suggest that 1 or more late stage environmental promoters are involved in the development of clinical carcinoma of the prostate. Laboratory investigations and variously designed epidemiological studies in man have suggested that dietary fat may be one of these candidate tumor promoters but other studies have questioned this association. The biologically plausible associations that have been hypothesized include total energy consumption, altered androgen metabolism, oxidative stress, specific fatty acid consumption and pesticide intake. We provide a critical appraisal of the existing evidence for an association between dietary fat consumption and prostate cancer, and review the biologically plausible relationships. MATERIALS AND METHODS: All 33 published case-control and cohort studies that examined the relationship between prostate cancer and dietary fat or specific fatty food types were critically appraised. Eight studies suggested a statistically significant association, and many studies noted significant associations for specific types of fatty foods (eg milk or meat) and prostate cancer. RESULTS: In light of the inherent biases in the methodology of studying dietary fat intake and carcinoma of the prostate, we conclude that the evidence is consistent. CONCLUSIONS: Corroborative studies in humans are required to better define this relationship. Prospective studies of dietary intervention should be encouraged.
Androgens↗
Publication rate of abstracts presented at the annual meeting of the American Urological Association.
OBJECTIVE: To determine the rate and time-course of peer-reviewed publication of abstracts presented at the annual meetings of the American Urological Association (AUA). METHODS: All abstracts presented at the annual meetings of the AUA from 1998 to 2000 were searched in the PubMed database. To assess any significant predictors of ultimate peer-reviewed publication, abstract number, meeting year, presentation type (podium vs poster), type of research (basic vs clinical), date of publication and session name (i.e. prostate cancer: advanced) were entered into a database. RESULTS: The overall rate of publication was 37.8%. Survival analysis indicated that most abstracts were published within 2 years of their respective meetings. Univariate and multivariate techniques showed that none of the tested covariates were significant predictors of publication. CONCLUSIONS: Information presented at the AUA annual meetings should be carefully considered by physicians before implementation into their clinical practice. Researchers are encouraged to publish their data.
Bibliometrics↗
Variation in patterns of practice in diagnosing screen-detected prostate cancer.
OBJECTIVE: To determine the practice pattern of repeat prostate biopsies to detect prostate cancer, as there is growing evidence to support the recommendation that a repeat prostate biopsy should be taken after an initially negative prostate biopsy, the rate of cancer detection then being approximately 30%. PATIENTS AND METHODS: We examined the practice patterns of taking a repeat prostate biopsy after an initial negative biopsy and the predictors for cancer at repeat biopsy among 1536 patients who had an initial prostate biopsy because of an elevated prostate-specific antigen (PSA) level (>4.0 ng/mL) or abnormal digital rectal examination. RESULTS: Of the 1536 men, 712 (46.4%) had cancer detected on the first biopsy; of the remaining 824 with no cancer detected, 268 (32.5%) had a repeat biopsy within a year, and 68 of these (25.4%) had cancer detected. Of the cancers detected at repeat biopsy, 31% were high-grade. Men with abnormal histology (prostatic intraepithelial neoplasia or atypia) had an odds ratio of 3.2 (P < 0.001) for having a repeat biopsy. For men with normal initial prostate histology, those with an initial PSA of 10.0-20.0 and >20.0 ng/mL had an odds ratio of 3.6 and 4.5 (both P < 0.001), respectively, for a repeat prostate biopsy, compared with patients with a PSA of <10.0 ng/mL. However, the PSA level was not predictive of prostate cancer at repeat biopsy, but age and prostate volume were. CONCLUSIONS: A third of patients had a repeat biopsy after a negative biopsy. The most important factors influencing whether a patient was to have a repeat biopsy were initial biopsy histology and PSA level. However, the latter was not an important factor for predicting prostate cancer at repeat biopsy.
Aged↗
The role of bisphosphonates in the management of bone metastases in prostate cancer.
Bone metastases are associated with significant skeletal-related morbidity that negatively correlates with quality of life and survival in patients with prostate cancer. Once prostate cancer has metastasized to bone, the median survival of patients is approximately 30 to 53 months; therefore, the chronic consequences of bone complications must be taken into consideration when developing long-term therapeutic strategies in this patient population. In addition to the bone-damaging effects of metastases, bone loss related to long-term hormonal therapy, as well as age-related bone loss, further compromise bone integrity in patients with advanced prostate cancer. This article reviews the burden of skeletal complications in patients with prostate cancer, and the evidence for the use of bisphosphonates for the treatment of skeletal morbidity in this patient population.
Bone Neoplasms↗
Radical prostatectomy as treatment for prostate cancer.
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Aged↗
Use of complementary/alternative medicine by men diagnosed with prostate cancer: prevalence and characteristics.
OBJECTIVES: To ascertain the prevalence of the use of complementary/alternative medicine (CAM) among a random sample of Ontario (Canadian) men diagnosed with prostate cancer and to explore in what way users of CAM differ from nonusers. METHODS: A questionnaire was mailed to a random sample of 696 men diagnosed with prostate cancer. RESULTS: The final response rate was 78.8%. Almost one third (29.8%) reported using CAM for their prostate cancer care. Natural health products (most commonly vitamin E, saw palmetto, and selenium) were used by 26.5% of the respondents. CAM therapies were used by 17.0% of the men (most commonly dietary changes), and only 9.1% visited CAM practitioners. Three characteristics appear to differentiate CAM users from nonusers. Men who had attended support groups were much more likely to use CAM. Men who had more advanced disease, and those who believed in the efficacy of CAM, but were not concerned about potential adverse effects of CAM, were also more likely to use CAM. CAM use was not related to education, income, or geographic location. CONCLUSIONS: The data suggest that CAM use is no longer a phenomenon restricted to a unique segment of the population that is highly educated and enjoys a high family income. CAM use appears to be more related to other factors such as support group attendance, disease characteristics, and beliefs about CAM. Our findings highlight the need for urologists to ask all their patients about their use of CAM.
Adenocarcinoma↗
Soy consumption and phytoestrogens: effect on serum prostate specific antigen when blood lipids and oxidized low-density lipoprotein are reduced in hyperlipidemic men.
PURPOSE: Herbal remedies high in phytoestrogens have been shown to reduce serum prostate specific antigen (PSA) and have been proposed as a treatment for prostate cancer. Soy proteins used to lower serum cholesterol are rich sources of phytoestrogens. Therefore, we assessed the effect of soy consumption on serum PSA in men who had participated in cholesterol lowering studies. MATERIALS AND METHODS: For 3 to 4 weeks 46 healthy middle-aged men with a range of starting PSA values took soy (mean 44 gm. soy protein daily, 116 mg. isoflavones daily) or control foods, and a subgroup of men took a lower level of soy supplements for 3 months. PSA was measured at the start and end of each treatment. RESULTS: Soy had no significant effect on serum total or free PSA, independent of PSA starting value or isoflavone intake. The lack of effect on PSA was seen, although soy intake was sufficient to reduce low-density lipoprotein cholesterol (5.8 +/- 2.2%, p = 0.012), the estimated coronary heart disease risk (6.1 +/- 2.8% for 10 years, p = 0.032) and the serum concentration of oxidized low-density lipoprotein measured as conjugated dienes (9.5 +/- 3.4%, p = 0.008) in the 3 to 4-week study. In addition, the lack of effect of soy on PSA persisted for the 3 months of the extended study. CONCLUSIONS: At levels of soy intake which reduce low-density lipoprotein cholesterol any potential benefits of soy consumption on prostate cancer are likely to occur for reasons other than alterations in hormone activity.
Adult↗
An oncology perspective on the benefits and cost of combined androgen blockade in advanced prostate cancer.
OBJECTIVES: To provide context in oncology for the significance of the benefits and cost of combined androgen blockade (CAB) in the treatment of advanced prostate cancer. METHODS: Canadian drug costs for the survival benefit with CAB in advanced prostate cancer were compared with the costs of benefit with new treatments in advanced non-small-cell lung cancer (NSCLC), metastatic colorectal cancer, and metastatic breast cancer. Clinical toxicities were also compared. RESULTS: The survival benefit with CAB in advanced prostate cancer appears to be approximately 3 months. The survival benefit with the addition of vinorelbine to cisplatin for the treatment of advanced NSCLC is approximately 2 months, and the survival benefit with the addition of irinotecan to fluorouracil (and leucovorin) for the treatment of metastatic colorectal cancer is approximately 2 to 3 months. The survival benefit with anastrozole or exemestane in advanced breast cancer, or with the addition of trastuzumab to standard chemotherapy in metastatic breast cancer that overexpresses human epidermal growth factor receptor 2 (HER2), is approximately 4 to 5 months. The calculated cost per month of survival benefit with bicalutamide in CAB for prostate cancer is 437 US dollars to 1107 US dollars. The cost per month of survival benefit with vinorelbine for NSCLC is 1241 US dollars and with irinotecan for colorectal cancer is 6812 to 11,214 US dollars. The calculated cost per month of survival benefit with anastrozole for breast cancer is 170 US dollars, for exemestane is 185 US dollars, and the cost per month with the addition of trastuzumab is 5230 US dollars. Vinorelbine and irinotecan are associated with severe grade 3 or 4 clinical toxicities, and an increased frequency of heart failure has been observed when trastuzumab is added to anthracyclines. Anastrozole, exemestane and nonsteroidal antiandrogens are associated with mild to moderate side effects. CONCLUSIONS: The advantages offered by CAB (including the cost per month of survival benefit and minimal associated clinical toxicities) are comparable to the reported advantages of new treatments for other common cancers such as NSCLC, colorectal cancer, and breast cancer.
Androgen Antagonists↗
Intraindividual variation of PSA, free PSA and complexed PSA in a cohort of patients with prostate cancer managed with watchful observation.
OBJECTIVE: To determine the intraindividual variation of prostate-specific antigen (PSA) isoforms in prostate cancer patients managed conservatively with watchful observation. METHODS: Patients with favorable clinical parameters (stage T1b-T2b N0 M0, Gleason score </= 7, and PSA </= 15) were recruited to participate in a watchful observation program. Specimens were drawn for measurement of total (tPSA), free (fPSA) and complexed (cPSA) prostate-specific antigen isoforms. Total biologic variation and between-day analytical variation were used to calculate intraindividual variation. RESULTS: Total variation for each isoform and two ratios were not greatly affected by the time window for measurements in the interval 6 months to 2.7 yr. Analytical variation made only a small contribution to the total biologic variation. Intraindividual variation for a 1-yr time interval for tPSA, fPSA, cPSA and the ratios of fPSA and cPSA to tPSA was, respectively, 21.6, 19.3, 25.4, 20.0 and 13.1%. The amount of change required for a significant difference between two readings (with 95% confidence) was, respectively, 59.8, 53.4, 70.4, 55.3 and 36.2%. CONCLUSIONS: There is a significantly higher intraindividual variation of cPSA (25.4%), and a significantly lower intraindividual variation of the ratio cPSA to tPSA (13.1%) compared to the other individual PSA isoforms and to the ratio of fPSA to tPSA. The amount of change required for a significant difference between two concentrations is large for all variables studied, but the lowest is the ratio of cPSA to tPSA (36.2%). These results have significance for diagnosis and monitoring of patients with prostate cancer.
Cohort Studies↗
Role of "saturation biopsy" in the detection of prostate cancer among difficult diagnostic cases.
OBJECTIVES: To determine the role of extensive prostate biopsy ("saturation biopsy") among selected men with unexplained worrisome prostate-specific antigen (PSA) parameters. Clinicians are commonly faced with the dilemma of elevating PSA levels despite negative prostate biopsy results in patients without symptoms of prostatitis. METHODS: Thirty-seven patients underwent saturation biopsy. This consisted of 24 peripheral zone cores, 6 to 12 transition zone cores, and 2 lateral lobe transurethral samples. All procedures were done under anesthesia. Patients were discharged home with catheters in situ. All patients had undergone at least three prior sets of transrectal ultrasound-guided prostate biopsies, including transition zone assessment. Twelve, eight, and five patients had had four, five, and six prior prostate biopsies, respectively. Specimens were sent for pathologic examination in groups of six to determine the marginal benefit of the additional sampling. RESULTS: The mean age of the cohort was 62.4 years (range 39 to 75). The median PSA and percent free PSA was 22.4 ng/mL (range 7.8 to 73.8) and 0.11 (range 0.04 to 0.17), respectively. Five patients (13.5%) had detectable carcinoma at saturation biopsy. The grade distribution was Gleason score 8 for 1 patient, Gleason score 7 for 2 patients, and Gleason score 6 for 2 patients. In all cases, carcinoma was detected in the first 18 peripheral zone cores. Acute prostatitis was noted in 19% of specimens. The procedure was well tolerated, although 4 patients required prolonged (greater than 1 week) catheter drainage for urinary retention. All patients were spontaneously voiding by week 3. CONCLUSIONS: Most men with multiple previous biopsies and increasingly worrisome PSA parameters do not have cancer. The marginal utility of the saturation biopsy is low. Although rare additional cases will be detected using this technique, 18-core peripheral sampling is recommended for these difficult diagnostic cases.
Acute Disease↗
Controversies in the management of testicular seminoma.
Tremendous progress has been made in the treatment of testicular seminoma over the past 25 years. The advent of curative cytotoxic chemotherapy, even for patients with advanced metastatic disease, has led to a paradigm shift toward minimizing additional oncologic therapies and their potential side effects. Despite these advances, controversial issues still exist in managing patients with this disease. Patients with stage I disease can now be managed successfully with close surveillance or postoperative radiotherapy (RT). Although deemed safe, considerable debate persists about surveillance including issues of compliance, cost, and secondary effects of routine RT. Aside from RT, patients with stage I disease also can be managed with one- or 2-dose single-agent carboplatin. Although this appears safe and efficacious, an ongoing randomized study is underway to compare its effectiveness with that of RT. Residual mass after chemotherapy for seminoma is not uncommon and therapeutic options include observation, RT, or retroperitoneal lymphadenectomy. Although most agree that patients with small (<3 cm) or ill-defined masses can be observed, debate persists as to the optimal management of patients with well-defined masses greater than 3 cm. For many years, patients with bulky retroperitoneal disease (>5 cm) were treated with up-front radiotherapy and chemotherapy at relapse. The high failure rate outside the treatment field has now changed this paradigm to one of up-front chemotherapy.
Humans↗