Factors influencing southern Taiwanese men's acceptance of prostate‐specific antigen screening

Prostate‐specific antigen (PSA) testing is a common screening among adult men for early awareness of prostate cancer. Although prostate cancer is the seventh most common cause of death from cancer in males in Taiwan in 2008, this testing is still unpopular in Taiwanese society. The purpose of this study was to explore the prevalence of acceptance of PSA testing and related factors in Taiwanese males. A cross‐sectional study was conducted. The sample population was recruited from two counties in southern Taiwan. Three hundred and thirty male participants completed the structured questionnaire. The following outcomes were studied: patient profiles, knowledge of PSA screening, acceptance of PSA testing, the reasons for acceptance of PSA testing and history of benign prostate hypertrophy (BPH). The results indicated that 29·4% of the respondents reported having had a PSA test. The logistic regression model showed age, having heard of PSA testing, BPH history and annual income to be the statistically significant factors. The odds of accepting PSA testing increased 9·56‐fold in men with a history of BPH compared with men without a BPH history. Acceptance of PSA testing increased 7·98‐fold in patients who had heard of PSA testing compared with those participants who had not heard of PSA testing. The odds of accepting PSA testing increased 4·43‐fold in patients aged 56–65 years, 8·14‐fold in those aged 66–75 years and 11·20‐fold in those older than 76 years when compared with men younger than 55 years. This study shows that male acceptance of PSA testing is still not popular in Taiwan. The results can help health care providers to take the responsibility for seeking appropriate strategies to improve the rate of acceptance of PSA testing.     

Is there a link between BPH and prostate cancer?

BPH is one of the most common diseases of older men, with more than 70% of men over 70 years affected, and prostate cancer is the most common cancer in men in the UK. Prostate cancer generally presents in one of three ways: asymptomatic patients who are screened (usually by a PSA test); men with LUTS who are investigated and undergo prostate biopsy; or patients with symptoms of metastasis such as bone pain. Men can be reassured that the main cause of LUTS is BPH. Only a small proportion of men have LUTS that are directly attributable to prostate cancer. Digital rectal examination (DRE) gives an evaluation of prostate size, which is relevant in particular to BPH management, and along with PSA testing it is one of the only ways of differentiating clinically between BPH and prostate cancer. If a nodular abnormality is present there is around a 50% chance of a diagnosis of prostate cancer being made on biopsy. Raised levels of serum PSA may be suggestive of prostate cancer, but diagnosis requires histological confirmation in almost every case. A normal PSA, PSA density and DRE can give reasonable confidence with regards to excluding clinically significant prostate cancer. BPH is not a known risk factor for prostate cancer, although the two frequently coexist. Age is the strongest predictor of prostate cancer risk, along with family history. BPH is not considered to be a precursor of prostate cancer. It is likely that although BPH may not make prostate cancer more likely to occur, it may increase the chance of diagnosing an incidental cancer.     

Exploring patient perceptions of PSA screening for prostate cancer: Risks, effectiveness, and importance

Objective

To study the beliefs of a group of Canadian men regarding the risks, effectiveness, and importance of routine prostate-specific antigen (PSA) testing when used as a screening tool for prostate cancer.

Design

A 1-page questionnaire designed to gauge patient beliefs about PSA screening.

Setting

Two primary care clinics in Kingston, Ont.

Participants

Seventy-two men aged 41 to 80.

Main outcome measures

Whether men believed that the PSA blood test was not risky when used as a screening test for prostate cancer, was effective at preventing death from prostate cancer, and was important for their health.

Results

Fifteen men reported having visited their physicians because of difficulty urinating in the past 2 years, or a personal history of prostate cancer, and were excluded; for these men, the use of the PSA blood test would not be for screening. Of the 57 men considered in the study, 54 (95%) believed that using the PSA blood test as a screening tool for prostate cancer was not risky, 39 (68%) believed that the PSA blood test was good or very good at preventing death from prostate cancer, and 45 (79%) believed that the routine use of the PSA blood test was important or very important for their health. Men in the suggested screening age group of 51 to 70 years (n = 32) had an equally positive impression of PSA screening.

Conclusion

Despite a limited body of evidence showing its effectiveness, Canadian men continue to have a favourable impression of PSA screening and remain largely unaware of potential adverse events associated with PSA testing.     

Prostate-specific antigen: how to advise patients as the screening debate continues

There is still no consensus on whether prostate-specific antigen (PSA) measurement should be used as a screening test for prostate cancer, but patients have the right to be informed about its risks and possible benefits. PSA testing is more likely to be beneficial in relatively young men and men at higher risk (ie, African Americans and men with a family history of prostate cancer). A possible schedule is to test at age 40, age 45, and every 2 to 3 years from age 50 until about age 75.     

Prostate Cancer in Primary Care

Prostate cancer is a common malignancy seen worldwide. The incidence has risen in recent decades, mainly fuelled by more widespread use of prostate-specific antigen (PSA) testing, although prostate cancer mortality rates have remained relatively static over that time period. A man’s risk of prostate cancer is affected by his age and family history of the disease. Men with prostate cancer generally present symptomatically in primary care settings, although some diagnoses are made in asymptomatic men undergoing opportunistic PSA screening. Symptoms traditionally thought to correlate with prostate cancer include lower urinary tract symptoms (LUTS), such as nocturia and poor urinary stream, erectile dysfunction and visible haematuria. However, there is significant crossover in symptoms between prostate cancer and benign conditions affecting the prostate such as benign prostatic hypertrophy (BPH) and prostatitis, making it very challenging to distinguish between them on the basis of symptoms. The evidence for the performance of PSA in asymptomatic and symptomatic men for the diagnosis of prostate cancer is equivocal. PSA is subject to false positive and false negative results, affecting its clinical utility as a standalone test. Clinicians need to counsel men about the risks and benefits of PSA testing to inform their decision-making. Digital rectal examination (DRE) by primary care clinicians has some evidence to show discrimination between benign and malignant conditions affecting the prostate. Patients referred to secondary care for diagnostic testing for prostate cancer will typically undergo a transrectal or transperineal biopsy, where a number of samples are taken and sent for histological examination. These biopsies are invasive procedures with side effects and a risk of infection and sepsis, and alternative tests such as multiparametric magnetic resonance imaging (mpMRI) are currently being trialled for their accuracy and safety in diagnosing clinically significant prostate cancer.     

Estimate of population coverage with the prostate specific antigen (PSA) test to screen for prostate cancer in a metropolitan area of northern Italy

The use of the prostate specific antigen (PSA) test in the period 1999-2000 in a population of 311 822 men, aged 40 years or more, resident in Milan, Italy, was examined. Data were drawn from the outpatient database of the local health information system. A total of 139 350 PSA tests were used in 83 943 subjects. Overall, 26.9% of the male population aged 40 or older, with no history of prostate cancer, received a PSA test in the 2 year study period. For subjects older than 50 the rate rose to 34%. Results show a high coverage of the male population in northern Italy with screening using the PSA test for prostate cancer.     

Continuity of care and cancer screening among health plan enrollees

CONTEXT: Although having a usual source of care has been associated with cancer screening, whether there is additional benefit from continuity with a specific physician is uncertain. In addition, little is known about the relationship between continuity of care and receipt of colorectal and prostate cancer screening. METHODS: Subjects were enrolled in a Washington State health plan that operates an integrated delivery system that emphasizes access to primary care. Among patients age 50-78 years old with 2 or more primary care visits in 2002-2003 (N = 67,633), we determined whether higher continuity (>/=50% of visits with the most visited primary care provider) was associated with colorectal, breast, and prostate cancer screening. Random-effects logistic regression estimated adjusted percentages of patients who received fecal occult blood testing, lower endoscopy (sigmoidoscopy or colonoscopy), screening mammography, and prostate specific antigen (PSA) testing. RESULTS: Patients with higher continuity were more likely to receive fecal occult blood testing than patients with lower continuity (28.9% vs. 26.8%; P < 0.001) but less likely to receive lower endoscopy (12.9% vs. 14.3%; P < 0.001). Although higher continuity was not significantly associated with screening mammography (P = 0.38), men with higher continuity were more likely to receive PSA testing than men with lower continuity (39.4% vs. 37.4%; P = 0.008). CONCLUSIONS: In an insured population with a high degree of primary care access, continuity with a specific primary care physician was associated with the selection of less invasive colorectal cancer screening tests by patients and physicians and greater likelihood of PSA testing.     

Has there been a change in practice of screening for prostate cancer with prostate-specific antigen in Ontario?

OBJECTIVE: To determine whether there has been a change in the rate of screening in Ontario in 2002 compared to 1995. METHODS: A questionnaire was mailed to 520 physicians, associated with PSA records selected randomly from the database of a large community laboratory. Physicians were asked to consult their records as to the reasons for PSA testing. RESULTS: There were 285 usable responses from 520 mailings (response rate 55%), mostly (91%) from family or general practice. Reasons for testing, expressed as proportions of responses, were as follows (this study, 1995 study and P value for the differences): screening for prostate cancer (74%, 63%; P = 0.059), diagnosis of urinary symptoms (30%, 40%; P = 0.027), follow-up of a medical procedure or drug therapy (14%, 32%; P = 0.001), confirmation of a previous PSA result (14%, 6%; P = 0.015) and other reasons (7%, 8%; P = 0.73). Of those records with screening as one reason for testing, 80% vs. 66% (P = 0.003) indicated it was the only reason; 86% vs. 73% (P = 0.003) indicated that it was part of a routine examination, and 54% vs. 64% (P = 0.052) indicated that the test was requested by the patient. CONCLUSION: These findings are consistent with increased screening for prostate cancer with PSA.     

Preoperative serum prostate-specific antigen (PSA) below 10 microg/l predicts neither the presence of prostate cancer nor the rate of postoperative PSA failure

Recent information on the relationship of serum prostate-specific antigen (PSA) to prostate cancer and new reports on death rates in men warrant a reassessment of how we diagnose and treat prostate cancer. We now know for the first time that the annual death rate from prostate cancer in men > or =65 years of age is only 226 per 100 000 men. At least 40 000 of 100 000 men over age 65 (40%) have invasive prostate cancer as judged by examination of prostates in 3- to 4-mm step-sections. Thus, only 1 of every 177 men 65 years of age or older (226 in 40 000) with invasive prostate cancer dies annually from his cancer. Serum PSA between 2 and 10 microg/L is used almost universally as an indication to biopsy the prostate. When 10-20 biopsies are commonly taken, it is not surprising that approximately 40% of men are biopsy-positive for prostate cancer. Despite this reliance on serum PSA as an indication for biopsy, data at Stanford show no clinically useful relationship between preoperative serum PSA (in the range 2-10 mg/L) and the volume of Gleason grade 4/5 cancer or the volume of Gleason grades 3, 2, and 1 cancer, nor can we show any useful relationship of such preoperative PSA concentrations (2-10 microg/L) to biochemical PSA failure rates after radical prostatectomy. We urgently need a better serum marker for prostate cancer. Because PSA biochemical failure rates after radical prostatectomy are directly proportional to the amount of Gleason grade 4/5 cancer in the prostate, a serum marker of Gleason grade 4/5 carcinoma could be ideal.     

Compliance with Recommended Cancer Screening among Emergency Department Patients: A Multicenter Survey

Objectives: The objectives were to measure compliance with, and possible sociodemographic disparities for, cancer screening among emergency department (ED) patients. Methods: This was a cross‐sectional survey in three academic EDs in Boston. The authors enrolled consecutive adult patients during two 24‐hour periods at each site. Self‐reported compliance with standard recommendations for cervical, breast, testicular, and prostate cancer screening were measured. The chi‐square test was used test to evaluate associations between demographic variables and cancer screening compliance. Results: The authors enrolled 387 patients (81% of those eligible). The participants had a mean (±standard deviation) age of 44 (±18) years and were 52% female, 16% Hispanic, and 65% white. Sixty‐seven percent (95% confidence interval [CI] = 60% to 73%) of all women reported Pap smear examinations in the past 3 years, 92% (95% CI = 85% to 96%) of women aged ≥40 years reported clinical breast examinations, and 88% (95% CI = 81% to 94%) of women aged ≥40 years reported mammography. Fifty‐one percent (95% CI = 40% to 61%) of men aged 18–39 years reported testicular self‐examinations, and among men aged ≥40 years, 79% (95% CI = 69% to 87%) reported digital rectal examinations (DREs) and 51% (95% CI = 40% to 61%) reported prostate‐specific antigen (PSA) testing. Racial and ethnic minorities reported slightly lower rates of clinical breast examinations and testicular self‐examinations. Conclusions: Most women and a majority of men in our ED‐based study were compliant with recommended measures of cervical, breast, testicular, and prostate cancer screening. No large sociodemographic disparities in our patient population were identified. Based on these data, and the many other pressing public health needs of our ED population, the authors would be reluctant to promote ED‐based cancer screening initiatives at this time.     

Interest in genetic prostate cancer susceptibility testing among african American men

Six regions for prostate cancer genes have been identified, and it is anticipated that prostate cancer susceptibility testing will be available in the future. This correlational study identified predictors for interest in prostate cancer susceptibility testing among African American men. Participants were 320 African American men from the African American Hereditary Prostate Cancer Study and the South Carolina Prostate Cancer Education and Screening Study participated. Two questions measured interest in genetic prostate cancer susceptibility testing and family history of prostate cancer. Chi-square analyses by family history as well as demographics (age, education, marital status) were performed. Most of the men (277 [87%]) indicated an interest in genetic prostate cancer susceptibility testing. Interest in undergoing testing did not vary by family history, age, or education. Marital status was the only significant demographic predictor. Men who were married were significantly more likely to respond with a "yes" to interest in prostate cancer susceptibility testing than were men who were not married. The high "yes" response rate and the men's confusion between the genetic prostate cancer susceptibility testing and prostate cancer screening highlight the need for public education once prostate cancer genes are identified and available for public testing.     

Prostate-specific antigen screening: friend or foe?

Prostate cancer is the most frequently diagnosed cancer among men in the United States. The prostate-specific antigen (PSA) blood test is the most commonly utilized test to detect early prostate malignancy. Elevated PSA levels suggest to providers the possibility that their patients are at a higher statistical risk of harboring asymptomatic, organ-confined prostate cancer. Although PSA testing has become a primary screening method for prostate cancer in the United States, this test has come under scrutiny. PSA screening lacks a high level of specificity due to frequent false-positive results. Additionally, major health organizations differ in their screening recommendations for use of the PSA test. However, the medical community, and more importantly, patients, must understand the benefits and possible detriments of this screening test. Providers should approach each man individually when recommending a PSA test, noting that many risk factors must be considered in a screening protocol for prostate cancer.     

Minority issues in prostate disease

This article has discussed the increased incidence and disproportionately increased mortality of prostate cancer among African American men.Although the exact reasons are unknown, genetics may play a role, in addition to health care practices. Morbidity from other disease states, such as diabetes, obesity, or hypertension, may influence the overall survival of patients with prostate cancer. Current research tools will continue to explore biologic differences between the races; however, socioeconomic status and access to health care must not be overlooked. Several studies have demonstrated that similar disease stages and equal access to health care will result in similar outcomes.It is recognized that screening for prostate cancer will remain a controversial topic. Several influential professional societies recommend against screening and other professional societies endorse screening. Large-scale trials are currently underway hoping to answer this critical question.Since the advent of current screening tools, however, it seems that the overall mortality for prostate cancer has decreased and this cannot be ignored. Certainly, screening programs and clinical trials have traditionally had difficulty in recruiting minority participants, although more recent trials seem to be finding success. A primary care physician who is viewed as competent by their patients can certainly have a positive impact on their African American patients' willingness to participate in studies and screening programs. Most importantly, on the individual level, primary care physicians can provide a great service to their minority patients by offering educational materials on prostate cancer and by offering screening to qualified patients. The current American Urologic Association and National Cancer Institute guidelines recommend offering screening to all men age 50 and above. African American men or men with a first-degree relative with prostate cancer should be offered screening beginning at age 40.Proper screening consists of both a digital rectal examination to assess for asymmetry or nodules of the prostate and a serum PSA. Current recommendations are that individuals with a serum PSA greater than 4 ng/mL ora prostate nodule or asymmetric prostate should be referred to an urologist,where a biopsy can be performed easily in the office setting.The PSA cutoff of 4 has recently been questioned. A study by Thompson et al [31] evaluated 2950 men with a PSA of 4 or less with prostate biopsy.They found that the risk of prostate cancer in men with a PSA between 3.1 and 4 was 26.9% and that 25% of these men with prostate cancer had high-grade disease. All men found to have cancer had T1 disease. The clinical relevance of this surprisingly high rate of prostate cancer in men with a normal PSA is yet to be determined and is pending in studies on the ultimate effect of screening on mortality from prostate cancer. This information is not intended to confuse the issue, but intended to provide the most up-to-date information and allow for the best clinical decision making by the primary care physician. What can currently be recommended is if a patient is concerned about his possibility of having prostate cancer despite a normal PSA, a referral to an urologist to at least further discuss the issue may be in order. This may be especially true if the patient is African American or has a family history of prostate cancer at an early age.     

Estimation of prostate cancer probability by logistic regression: free and total prostate-specific antigen, digital rectal examination, and heredity are significant variables.

BACKGROUND: Despite low specificity, serum prostate-specific antigen (PSA) is widely used in screening for prostate cancer. Specificity can be improved by measuring free and total PSA and by combining these results with clinical findings. Methods such as neural networks and logistic regression are alternatives to multistep algorithms for clinical use of the combined findings. METHODS: We compared multilayer perceptron (MLP) and logistic regression (LR) analysis for predicting prostate cancer in a screening population of 974 men, ages 55-66 years. The study sample comprised men with PSA values >3 microg/L. Explanatory variables considered were age, free and total PSA and their ratio, digital rectal examination (DRE), transrectal ultrasonography, and a family history of prostate cancer. RESULTS: When at least 90% sensitivity in the training sets was required, the mean sensitivity and specificity obtained were 87% and 41% with LR and 85% and 26% with MLP, respectively. The cancer specificity of an LR model comprising the proportion of free to total PSA, DRE, and heredity as explanatory variables was significantly better than that of total PSA and the proportion of free to total PSA (P <0.01, McNemar test). The proportion of free to total PSA, DRE, and heredity were used to prepare cancer probability curves. CONCLUSION: The probability calculated by logistic regression provides better diagnostic accuracy for prostate cancer than the presently used multistep algorithms for estimation of the need to perform biopsy.     

Analytic bias specifications based on the analysis of effects on performance of medical guidelines

Laboratory tests are key indicators for certain practice guidelines, and analytic bias can significantly alter the performance of these guidelines. Three clinical paradigms are described: serum cholesterol testing for risk assessment of cardiac disease, serum thyroid-stimulating hormone (TSH) measurement for the detection of hypothyroidism, and serum prostate-specific antigen (PSA) testing for prostate cancer risk assessment. Maximum tolerance limits for analytic bias are calculated by assessing the subgroup population fluctuations in the number of patients exceeding the guideline threshold values and limiting the analytic bias to one-half of these fluctuations. Our calculated maximum bias limits are +/-1% for cholesterol and +/-6% for TSH and PSA. Our recommended +/-1% bias limit for cholesterol allows for a -6.5% to + 5.8% change in the number of patients designated as at risk for cardiac disease, whereas the +/-3% National Cholesterol Education Program limits permit a -18.4% to +16.7% variation. Similarly, our +/-6% bias limits for TSH allow a -17.7% to +26.6% change in patients flagged for hypothyroidism, whereas the +/-10% bias values found with many commercial reagents permit a -28.2% to +49.2% variation in patient classification. Our +/-6% PSA bias limits correspond to changes from -14.2% to +11.4% in the number of men classified as at risk for prostate cancer. The +/-10% bias ranges for PSA correspond to -19.9% to +20.4% variation in patient classification. The larger tolerance limits of the CLIA-88 standards for proficiency testing would cause even wider variations in patient classifications.     

Initial experience of a community‐based prostate cancer risk assessment clinic for men of black and minority ethnicity background

We designed and implemented a community‐based prostate cancer risk assessment clinic targeting men from black and minority ethnicity (BME) background. This service had the dual aims of optimizing detection of prostate cancer within a local BME population, with a secondary goal of encouraging longer‐term engagement with primary care for follow‐up prostate‐specific antigen (PSA) testing in order to facilitate early diagnosis of future disease. “Drop‐in” clinics were set up in strategic locations and, staffed by experienced urology nurses. Risk assessment was offered in the form of a PSA test, and digital rectal examination (DRE). We targeted men of BME background aged between 45 and 75 but all attending individuals were given access to counselling and assessment as appropriate. In total, 312 men attended clinics for risk assessment. We diagnosed nine prostate cancers with histological confirmation, with a further two individuals considered to have prostate cancer based on clinical/biochemical parameters. These findings were consistent with similar previously published reports. Nurse‐led, community‐based targeted risk assessment is feasible, leads to the detection of significant numbers of prostate cancers and is well received by patients.     

Prevalence of lower urinary tract symptoms and prostate enlargement in the primary care setting

PURPOSE: Men with lower urinary tract symptoms (LUTS) from benign prostatic hyperplasia often do not discuss their symptoms with their primary care physicians (PCPs). The primary objectives of this study were to estimate the prevalence of LUTS, prostate enlargement, and prostate-specific antigen (PSA) > or = 1.5 ng/ml in men visiting their PCP and to assess patients' intent to discuss LUTS with their PCP. METHODS: Men over age 50 presenting for a routine office visit at one of six PCP offices during the 8-week data collection period were invited to participate in this cross-sectional study. Men with prostate cancer, bladder cancer, indwelling urethral catheter or previous pelvic irradiation were excluded. Four hundred and forty-four men were enrolled and completed a self-administered questionnaire [including the International Prostate Symptom Score (IPSS)], provided a blood sample for PSA, and underwent a digital rectal examination (DRE), with the prostate classified as enlarged or non-enlarged by their PCP. RESULTS: Forty-two per cent of men had IPSS > 7; 48% had an enlarged prostate based on DRE and 43% had PSA > or = 1.5 ng/ml. Twenty-nine per cent (n = 129) of men had IPSS > 7 and enlarged prostate or PSA > or = 1.5 ng/ml. Of these men, 33% (n = 42) intended to discuss their symptoms with their PCP. CONCLUSIONS: Although a significant percentage of men in this older population had enlarged prostate and LUTS, only one-third of them intended to discuss their symptoms with their physician. PCPs may need to increase efforts to detect LUTS and enlarged prostate in older men.     

The Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer

BackgroundProstate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. Ninety percent of men with prostate cancer are over aged 60 years, diagnosed by early detection with the prostate specific antigen (PSA) blood test and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting surgery to remove the prostate gland (radical prostatectomy), external beam radiation therapy and interstitial radiation therapy (brachytherapy) and androgen deprivation. Little is known about the relative effectiveness and harms of treatments due to the paucity of randomized controlled trials. The VA/NCI/AHRQ Cooperative Studies Program Study #407: Prostate cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy to watchful waiting in men with clinically localized prostate cancer.MethodsWe describe the study rationale, design, recruitment methods and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy versus watchful waiting conducted in Scandinavia.ResultsWe screened 13,022 men with prostate cancer at 52 United States medical centers for potential enrollment. From these, 5023 met initial age, comorbidity and disease eligibility criteria and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African-American. Approximately 85% reported they were fully active. The median prostate specific antigen (PSA) was 7.8 ng/mL (mean 10.2 ng/mL). In three-fourths of men the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk categorizations incorporating PSA levels, Gleason histologic grade and tumor stage, approximately 43% had low risk, 36% had medium risk and 20% had high-risk prostate cancer. Comparison to our national sample of eligible men declining PIVOT participation as well as to men enrolled in the Scandinavian trial indicated that PIVOT enrollees are representative of men being diagnosed and treated in the U.S. and quite different from men in the Scandinavian trial.ConclusionsPIVOT enrolled an ethnically diverse population representative of men diagnosed with prostate cancer in the United States. Results will yield important information regarding the relative effectiveness and harms of surgery compared to watchful waiting for men with predominately PSA detected clinically localized prostate cancer.     

APTIMA PCA3 molecular urine test: development of a method to aid in the diagnosis of prostate cancer

BACKGROUND: Prostate cancer gene 3 (PCA3) encodes a prostate-specific mRNA that has shown promise as a prostate cancer diagnostic tool. This report describes the characterization of a prototype quantitative PCA3-based test for whole urine. METHODS: Whole-urine specimens were collected after digital rectal examination from 3 groups: men scheduled for prostate biopsy (n = 70), healthy men (<45 years of age with no known prostate cancer risk factors; n = 52), and men who had undergone radical prostatectomy (n = 21). PCA3 and prostate-specific antigen (PSA) mRNAs were isolated, amplified, and quantified by use of Gen-Probe DTS400 Systems. Prostate biopsy results were correlated with the PCA3/PSA mRNA ratio, and PSA mRNA concentrations were used to normalize PCA3 signals and confirm the yield of prostate-specific RNA. Assay precision, specimen stability, and mRNA yield were also evaluated. RESULTS: The specimen informative rate (fraction of specimens yielding sufficient RNA for analysis) was 98.2%. In this clinical research study, ROC curve analysis of prebiopsy specimens yielded an area under the curve of 0.746; sensitivity was 69% and specificity 79%. Serum PSA assay specificity was 28% for this same group. PCA3 and PSA mRNAs were undetectable in postprostatectomy specimens except for one man with recurrent prostate cancer. Assay interrun CVs were < or =12%. Both mRNAs were stable in processed urine up to 5 days at 4 degrees C and after 5 freeze-thaw cycles. CONCLUSION: The APTIMA PCA3 assay combines simple specimen processing with precise assays and existing instruments and could add specificity to the current algorithm for prostate cancer diagnosis.     

The diagnostic value of abdominal ultrasound,urine cytology and prostate‐specific antigen testing in the lower urinary tract symptoms clinic

Introduction: Lower urinary tract symptoms (LUTS) affect 18–26% of men aged 40–79 years, many of whom present with a fear of having cancer. Current guidelines for the assessment of LUTS focus mainly upon benign prostatic hypertrophy. It has been our practice to perform an abdominal ultrasound scan (USS), a prostate‐specific antigen (PSA) blood test and urine cytology during the assessment of males presenting with LUTS to investigate the alternative potentially life‐threatening causes for LUTS. We report on the added value of these tests during the assessment of men with LUTS. Results: A total of 263/3976 (6.6%) patients investigated for LUTS were found to have incidental urological malignancies, urinary tract calculi or abdominal aortic aneurysms (AAA). Abdominal USSs resulted in the incidental diagnosis of four renal carcinomas (0.1%), 45 AAAs (incidence = 1.1%) and 44 urinary tract calculi (1.1%). Urine cytology testing and bladder USSs helped diagnose 17 new bladder cancers (0.4%), five of which did not present with haematuria. Patients found to have an elevated age‐specific PSA had a 23.6% chance of being diagnosed with prostate cancer (3.8%). Conclusion: The addition of abdominal ultrasound scanning, urine cytology and PSA testing as part of an LUTS assessment protocol can help to diagnose significant, potentially life‐threatening conditions in up to 6.6% of patients. While the pick up rate of each individual condition is not higher in the LUTS patient than in the general population, the combined pick up rate may justify these additional investigations.