Patient, Family Member and Physician Perspectives and Experiences with AML Treatment Decision-Making.

INTRODUCTION: Treatment decisions in older adults with acute myeloid leukemia (AML) are challenging, particularly for those who are not candidates for intensive chemotherapy (IC), and the trade-offs patients, their families and physicians consider when choosing a treatment option are not well understood. This qualitative research explored the value of extending survival and the treatment decision-making process from a multi-stakeholder perspective. METHODS: Overall, 28 patients with AML (≥ 65 years old, unsuitable for IC), 25 of their relatives and 10 independent physicians from the US, UK and Canada took part in one-on-one, 60-minute qualitative interviews. RESULTS: Across all stakeholders, improved health-related quality of life (HRQoL), extended survival and relief of AML symptoms were recognized as most important in AML treatment decision-making. However, extending survival in 'good health' was more important than extending survival alone, particularly because of the extra time it gives patients and their relatives together, and allows patients to achieve important goals. Patients' limited understanding of available treatment options, paired with incorrect perceptions of treatment side effects, impacted their involvement in the treatment decision-making process. Patients and physicians perceived physicians to have the most influence in the decision-making process despite their priorities not always aligning. CONCLUSION: These findings illustrate the importance of having structured discussions which explicitly assess patients' goals and their understanding and expectations of treatments and also the need for patient friendly resources about the lived experience of AML and available treatment options. These measures will help to ensure that patients are fully involved in the shared decision-making process.

Pilot trial of telemedicine in urology: Video vs. telephone consultations.

INTRODUCTION: In the past year, due to the COVID-19 pandemic, in-person clinical activities have been drastically restricted, driving the already growing interest in the use of telemedicine in the urban setting to reduce unnecessary commute. Therefore, there has been a rapid shift to telephone and video consultations in outpatient practice. We sought to conduct a pilot trial to establish feasibility and acceptability of video consultations as an alternative to telephone consultations in urology patients to inform the design of a future randomized controlled trial. METHODS: We conducted a single-center, prospective, non-randomized pilot trial comparing telephone consultations (TC) vs. video consultations (VC) for urology outpatient visits. Two patient questionnaires were used to collect demographic information, as well as data about acceptability, feasibility, satisfaction, cost, and issues with telemedicine. Questions were identical for both VC and TC except for certain questions inquiring about issues specific to each technology. RESULTS: Forty-eight TC and 66 VC urology patients were included in this study. Patients believed that telemedicine visits did not significantly hinder their ability to communicate with their urologists and that these visits would be associated with cost savings. There was 1/48 (2.1%) failed TC and 16/66 (24.2%) failed VC. VC failures were concentrated at the beginning of the trial prior to giving feedback to the VC platform creators, with only one failure occurring thereafter. When comparing TC to VC, differences between the two patient groups were small but tended to be in favor of VC. Patients' satisfaction was greater with VC compared to TC. Both modalities were associated with many cost benefits for patients. CONCLUSIONS: Despite more technical issues with VC, this modality is feasible and acceptable to patients, likely due to improved shared decision-making with VC. Future considerations for trials comparing VC and TC should include adequate Wi-Fi infrastructure and choice of platform. For the VC, continuous knowledge transfer between investigators and platform engineers plays an important role in limiting failed encounters.

Health and Economic Impact of Routine Pediatric Pneumococcal Immunization Programs in Canada: A Retrospective Analysis.

OBJECTIVE: A model was developed to estimate the historical impact (including total societal health and economic benefit) of pneumococcal conjugate vaccine (PCV) programs in the overall Canadian population between 2005 and 2015, inclusively. METHODS: Historical incidence of invasive pneumococcal disease (IPD), pneumonia, and acute otitis media (AOM) were obtained from epidemiologic databases supplemented with published and unpublished data. Two scenarios were considered: (1) the observed historical incidence from 2005 to 2015 in the setting of PCV use; (2) a hypothetical scenario in which we estimated the number of disease cases assuming no PCV use. Disease cases averted as a result of PCV programs were calculated by subtracting the number of observed historical cases from the number of estimated cases expected in the absence of PCV use. RESULTS: PCV programs were estimated to have saved 6631 lives and averted 14,990 IPD cases, 735,700 pneumonia episodes, and 3,697,993 AOM episodes. Positive clinical outcomes resulted in total cost savings of CAD $1.76 billion over 11 years. Vaccination costs were offset by the direct medical cost savings from fewer cases of IPD, pneumonia, and AOM. CONCLUSIONS: Canadian PCV programs have provided significant health benefits and resulted in a substantial value for money. Net savings achieved over the reviewed period would have provided funding for $1.76 billion in other health care costs or public health initiatives. These findings highlight the importance of considering the total value of a vaccination program, rather than vaccine acquisition costs only, when assessing the value of immunization programs.

Patient-Centered Insights on Treatment Decision Making and Living with Acute Myeloid Leukemia and Other Hematologic Cancers.

Expectations relating to treatment and survival, and factors influencing treatment decisions are not well understood in adult patients with acute myeloid leukemia. This study analyzed combined findings from a targeted literature review with patient-reported information shared on YouTube to further understand patient perspectives in hematologic cancers and, in particular, acute myeloid leukemia. The targeted literature review included articles concerning patient (aged ≥ 18 years) experiences or perspectives in acute myeloid leukemia or other hematologic cancers. YouTube video selection criteria included patients (aged ≥ 60 years) with self-reported acute myeloid leukemia. In total, 26 articles (13 acute myeloid leukemia-specific and 14 other hematologic cancers, with one relevant to both populations) and 28 videos pertaining to ten unique patients/caregivers were identified. Key concepts reported by patients included the perceived value of survival for achieving personal and/or life milestones, the emotional/psychological distress of their diagnosis, and the uncertainties about life expectancy/prognosis. Effective therapies that could potentially delay progression and extend life were of great importance to patients; however, these were considered in terms of quality-of-life impact and disruption to daily life. Many patients expressed concerns regarding the lack of treatment options, the possibility of side effects, and how their diagnosis and treatment would affect relationships, daily lives, and ability to complete certain tasks. Both data sources yielded valuable and rich information on the patient experience and perceptions of hematologic cancers, in particular for acute myeloid leukemia, and its treatments. Further understanding of these insights could aid discussions between clinicians, patients, and their caregivers regarding treatment decisions, highlight outcomes of importance to patients in clinical studies, and ultimately, inform patient-focused drug development and evaluation.

Clinical and Economic Impact of a Potential Switch from 13-Valent to 10-Valent Pneumococcal Conjugate Infant Vaccination in Canada.

INTRODUCTION: Pneumococcal conjugate vaccines (PCVs) have been available in Canada since 2001, with 13-valent PCV (PCV13) added to the infant routine immunization program throughout all Canadian provinces by 2011. The use of PCVs has dramatically reduced the burden of pneumococcal disease in Canada. As a result, decision-makers may consider switching from a more costly, higher-valent vaccine to a lower-cost, lower-valent vaccine in an attempt to allocate funds for other vaccine programs. We assessed the health and economic impact of switching the infant vaccination program from PCV13 to 10-valent PCV (PCV10) in the context of the Canadian health care system. METHODS: We performed a review of Canadian databases supplemented with published and unpublished data to obtain the historical incidence of pneumococcal disease and direct and indirect medical costs. Observed invasive pneumococcal disease (IPD) trends from surveillance data were used as a basis to forecast the future number of cases of IPD, pneumococcal pneumonia, and acute otitis media given a PCV13- or PCV10-based program. Costs and outcomes over 10 years were then estimated and presented in 2017 Canadian dollars discounted at 3% per year. RESULTS: Switching from PCV13 to PCV10 would result in an additional 762,531 cases of pneumococcal disease over 10 years. Although PCV13 has a higher acquisition cost, switching to PCV10 would increase overall costs by over $500 million. Forecasted overall disease incidence was estimated substantially higher with PCV10 than with PCV13 primarily because of the potential reemergence of serotypes 3 and 19A. PCV13 was also cost saving compared with PCV10, even within a 5-year time horizon. Probabilistic sensitivity analysis showed that a PCV13-based program remained cost saving in all simulations. CONCLUSION: Although switching to a PCV10-based infant vaccination program in Canada might result in lower acquisition costs, it would also result in higher public health cost and burden because of serotype reemergence. FUNDING: Pfizer Inc.

Tumor size is a determinant of the rate of stage T1 renal cell cancer synchronous metastasis.

PURPOSE: A recent multi-institutional analysis of 995 patients treated for renal cell cancer questioned the relationship between tumor size and the synchronous metastasis rate. We revisited the hypothesis that metastatic potential is unrelated to tumor size. MATERIALS AND METHODS: We tested the relationship between tumor size and synchronous metastasis in 22,204 patients with T1a and T1b renal cell cancer diagnosed and/or treated with nephrectomy for clear cell, papillary or chromophobe histological subtypes in 1 of 9 Surveillance, Epidemiology and End Results registries between 1988 and 2004. RESULTS: In the study population the synchronous metastasis rate was 9.6%, including 5.6% vs 14.2% for T1a vs T1b. Stratification by 1 cm tumor size intervals revealed that the rate increased with increasing tumor size, that is 4.8% at 1.0 cm or less, 4.2% at 1.1 to 2.0 cm, 4.9% at 2.1 to 3.0 cm, 7.1% at 3.1 to 4.0 cm, 12.1% at 4.1 to 5.0 cm, 13.3% at 5.1 to 6.0 cm and 18.4% 6.1 to 7.0 cm (chi-square trend p <0.001). Cubic spline analysis showed that tumor size was virtually linearly related to the synchronous metastasis rate. Stratification by histological subtype in patients treated with nephrectomy revealed that clear cell renal cell cancer was most frequently associated with synchronous metastasis. Finally, tumor size was an independent predictor of synchronous metastasis in multivariate regression models adjusted for age, gender, histological subtype and year of diagnosis quartiles. CONCLUSIONS: Our study confirms that tumor size is an important determinant of the likelihood of synchronous metastasis in patients with T1a and T1b renal cell cancer. The synchronous metastasis rate directly increases with increasing tumor size. Even patients with small renal masses are at risk for synchronous metastasis and patients with clear cell renal cell cancer are at highest risk.

A population based assessment of perioperative mortality after cystectomy for bladder cancer.

PURPOSE: Large variability exists in the rates of perioperative mortality after cystectomy. Contemporary estimates range from 0.7% to 5.6%. We tested several predictors of perioperative mortality and devised a model for individual perioperative mortality prediction. MATERIALS AND METHODS: We relied on life tables to quantify 30, 60 and 90-day mortality rates according to age, gender, stage (localized vs regional), grade, type of surgery (partial vs radical cystectomy), year of cystectomy and histological bladder cancer subtype. We fitted univariable and multivariable logistic regression models using 5,510 patients diagnosed with bladder cancer and treated with partial or radical cystectomy within 4 SEER (Surveillance, Epidemiology, and End Results) registries between 1984 and 2004. We then externally validated the model on 5,471 similar patients from 5 other SEER registries. RESULTS: At 30, 60 and 90 days the perioperative mortality rates were 1.1%, 2.4% and 3.9%, respectively. Age, stage and histological subtype represented statistically significant and independent predictors of 90-day mortality. The combined use of these 3 variables and of tumor grade resulted in the most accurate model (70.1%) for prediction of individual probability of 90-day mortality after cystectomy. CONCLUSIONS: The accuracy of our model could potentially be improved with the consideration of additional parameters such as surgical and hospital volume or comorbidity. While better models are being developed and tested we suggest the use of the current model in individual decision making and in informed consent considerations because it provides accurate predictions in 7 of 10 patients.

Nephrectomy improves survival in patients with invasion of adjacent viscera and absence of nodal metastases (stage T4N0 renal cell carcinoma).

OBJECTIVE: To examine the cancer-specific mortality (CSM) of patients with T4N0-2M0 renal cell carcinoma (RCC) treated with either nephrectomy (RN) or no surgery (NS). PATIENTS AND METHODS: Of 43 143 patients with RCC identified in the Surveillance, Epidemiology and End Results database, 310 had tumours involving adjacent organs with no evidence of distant metastases (T4NanyM0) and had RN (246, 79.4%) or NS (64, 20.6%). Kaplan-Meier analyses, Cox regression and competing-risks regression models were used to compare the effect of RN vs NS on CSS. RESULTS: In patients with T4N0 disease the median survival benefit associated with RN vs NS was 42 months (48 vs 6 months, P < 0.001). Conversely, the median survival in patients T4N1-2 was no different between RN and NS (9.3 vs 9.1 months, P = 0.9). Multivariable analyses in T4N0 cases indicated a substantial survival disadvantage for patients having NS vs RN (hazard ratio 4.8, P < 0.001). Conversely, in patients with N1-2 stages, the CSS was virtually the same for NS and RN (hazard ratio 0.9, P = 0.9). Competing-risks regression models confirmed the benefit of RC in patients with T4N0 and the lack of benefit in those with T4N1-2 disease, after controlling for other-cause mortality. CONCLUSION: Our data suggest a survival benefit in patients with T4N0 RCC treated with RC. By contrast, RN seems to have no effect on survival in patients with evidence of nodal metastases.

A population-based comparison of survival after nephrectomy vs nonsurgical management for small renal masses.

OBJECTIVE: To examine population-based rates of cancer-specific and other-cause mortality after either non-surgical management (NSM) or nephrectomy, in patients with small renal masses, as several reports from selected institutions support the applicability of surveillance in patients with small renal masses, but there are no population-based studies confirming the general applicability of this therapy. PATIENTS AND METHODS: Of 43 143 patients with renal cell carcinoma identified in the 1988-2004 Surveillance, Epidemiology and End Results database, 10 291 had localized small renal masses (

External validation of the updated partin tables in a cohort of French and Italian men.

PURPOSE: To test the discrimination and calibration properties of the newly developed 2007 Partin Tables in two European cohorts with localized prostate cancer. METHODS: Data on clinical and pathologic characteristics were obtained for 1,064 men treated with radical prostatectomy at the Creteil University Health Center in France (n = 839) and at the Milan University Vita-Salute in Italy (n = 225). Overall discrimination was assessed with receiver operating characteristic curve analysis, which quantified the accuracy of stage predictions for each center. Calibration plots graphically explored the relationship between predicted and observed rates of extracapsular extension (ECE), seminal vesicle invasion (SVI) and lymph node invasion (LNI). RESULTS: The rates of ECE, SVI, and LNI were 28%, 14%, and 2% in the Creteil cohort vs. 11%, 5%, and 5% in the Milan cohort. In the Creteil cohort, the accuracy of ECE, SVI, and LNI prediction was 61%, 71%, and 82% vs. 66%, 92% and 75% for the Milan cohort. Important departures were recorded between Partin Tables' predicted and observed rates of ECE, SVI, and LNI within both cohorts. CONCLUSIONS: The 2007 Partin Tables demonstrated worse performance in European men than they originally did in North American men. This indicates that predictive models need to be externally validated before their implementation into clinical practice.

Cytoreductive partial nephrectomy does not undermine cancer control in metastatic renal cell carcinoma: a population-based study.

OBJECTIVES: We examined the population-based rates of cancer-specific survival in patients with metastatic renal cell carcinoma (MRCC) treated with either partial (PN) or radical cytoreductive nephrectomy (RN). METHODS: Patients diagnosed with MRCC and treated with either PN or RN were identified within nine SEER cancer registries. Matched and unmatched Kaplan-Meier survival analyses, as well as multivariable Cox regression models compared the effect of RN (n = 1997, 97.8%) vs. PN (n = 46, 2.2%) on cancer-specific survival (CSS). Covariates consisted of age, gender, community type (rural vs urban), race, Surveillance, Epidemiology, and End Results (SEER) registry, tumor size and year of diagnosis. RESULTS: In multivariable unmatched Cox regression analyses, no statistically significantly difference was found in CSS between the two groups (hazard ratio [HR] 1.40, P = .16). Similarly, no difference in CSS was found in the matched analyses (HR 1.35, log rank P = .34). CONCLUSION: Cytoreductive PN does not appear to undermine survival in patients with MRCC.

Assessment of biochemical recurrence rate in patients with pathologically confirmed insignificant prostate cancer.

OBJECTIVES: To examine the rate of biochemical recurrence (BCR) in patients with pathologically confirmed insignificant prostate cancer (PIPCa). METHODS: A total of 1358 patients underwent open retropubic radical prostatectomy at the University Medical Center Eppendorf in Hamburg, Germany, and their specimens were whole-mounted, step-sectioned, and subjected to computer-based three-dimensional reconstruction. We identified patients who fulfilled the Epstein criteria for definition of PIPCa (tumor volume

External validation of the updated Partin tables in a cohort of North American men.

PURPOSE: The Partin tables were updated in 2007. However, to our knowledge their accuracy and performance characteristics have not been confirmed in an external validation cohort. MATERIALS AND METHODS: We examined the discrimination and calibration properties of the 2007 Partin tables in 1,838 men treated with radical prostatectomy between 2001 and 2005 at Cleveland Clinic Foundation. The ROC derived AUC and the Brier score were used to quantify the discriminant properties of the predictions of the 2007 Partin tables for extraprostatic extension, seminal vesical invasion and lymph node invasion. Loess based calibration plots were used to examine the relationship between the predicted and observed rates of extraprostatic extension, seminal vesical invasion and lymph node invasion. RESULTS: The rates of extraprostatic extension, seminal vesical invasion and lymph node invasion were 26.9%, 5.5% and 1.8%. The accuracy of extraprostatic extension, seminal vesical invasion and lymph node invasion prediction was 71%, 80% and 75% according to the AUC method, and 0.176, 0.051 and 0.037 according to the Brier score, respectively. Extraprostatic extension predictions between 0% and 25%, and lymph node invasion predictions between 0% and 5% correlated well with observed extraprostatic extension and lymph node invasion rates, respectively. Conversely a suboptimal correlation was recorded between predicted and observed seminal vesical invasion rates as well as between predicted and observed rates of extraprostatic extension and lymph node invasion for predicted extraprostatic extension and lymph node invasion values above 25% and 5%, respectively. CONCLUSIONS: In this examined validation cohort the overall accuracy (AUC) of the Partin tables was comparable to results reported in the original 2007 development cohort. However, performance characteristics indicate that predictions within specific probability ranges should be interpreted with caution.

High surgical volume is associated with a lower rate of secondary therapy after radical prostatectomy for localized prostate cancer.

OBJECTIVE: To assess the relationship between surgical volume (SV), defined as the number of radical prostatectomies (RPs) within a calendar year, and the time to secondary therapy (ST) after RP, as this might represent an important determinant of cancer control. PATIENTS AND METHODS: The study included 7937 men treated with RP by 130 urologists between 1989 and 2000. Radiotherapy or any form of hormonal manipulation represented ST. Univariable and multivariable Cox regression analyses was used to evaluate the time to ST after RP. RESULTS: SV was an independent (P = 0.02) predictor of ST-free survival after RP, and the multivariable rate of ST sharply decreased with increasing SV. CONCLUSIONS: The use of ST is inversely proportional to SV of up to 24 RPs per year. A higher annual SV might be indicative of less restrictive use of RP in high-risk patients who eventually require combined treatments.

Mortality at 120 days after prostatic biopsy: a population-based study of 22,175 men.

Trans-rectal ultrasound guided biopsy of the prostate represents the diagnostic standard for prostate cancer, but its mortality rate has never been examined. We performed a population-based study of 120-day mortality after prostate biopsy in 22,175 patients, who underwent prostate biopsy between 1989 and 2000. The control group consisted of 1,778 men aged 65-85 years (median 69.5), who did not undergo a biopsy. Univariable and multivariable logistic regression analyses were performed in 11,087 of 22,175 (50%) men subjected to prostate biopsy, to identify predictors of 120-day mortality. Variables were age at biopsy, baseline Charlson comorbidity index and cumulative number of biopsy procedures. We externally validated the model's predictors in the remaining 50% of men. Overall 120-day mortality after biopsy was 1.3% versus 0.3% (p < 0.001) in the control group. Of men aged < or = 60 years, 0.2% died within 120 days versus 2.5% aged 76-80. Zero Charlson comorbidity score yielded 0.7% mortality versus 2.2%, if 3-4. First ever biopsy procedures carried a higher mortality risk than subsequent procedures (1.4 vs. 0.8 vs. 0.6%). In the multivariable model, first ever biopsy, increasing age and comorbidity predicted higher mortality. Overall, the model's variables were 79% accurate in predicting the probability of 120-day mortality after biopsy. In conclusion, our data suggest that prostate biopsy might predispose to higher mortality rate. The certainty of this association remains to be proven.

The effect of comorbidity and socioeconomic status on sexual and urinary function and on general health-related quality of life in men treated with radical prostatectomy for localized prostate cancer.

INTRODUCTION: Different treatments for localized prostate cancer (PCa) may be associated with similar overall survival but may demonstrate important differences in health-related quality of life (HRQOL). Therefore, valid interpretation of cancer control outcomes requires adjustment for HRQOL. AIM: To assess the effect of comorbidity and socioeconomic status (SES) on sexual and urinary function as well as general HRQOL in men treated with radical prostatectomy (RP) for PCa. METHODS: We sent a self-addressed mail survey, composed of the research and development short form 36-item health survey, the PCa-specific University of California at Los Angeles (UCLA) Prostate Cancer Index (PCI), as well as a battery of items addressing SES and lifetime prevalence of comorbidity, to 4,546 men treated with RP in Quebec between 1988 and 1996. MAIN OUTCOME MEASURES: The association between comorbidity, SES, and HRQOL was tested and quantified using univariable and multivariable linear regression models. RESULTS: Survey responses from 2,415 participants demonstrated that comorbidity and SES are strongly related to sexual, urinary, and general HRQOL in univariable and multivariable analyses. In multivariable models, the presence of comorbid conditions was associated with significantly worse HRQOL, as evidenced by lower scale scores by as much as 17/100 points in general domains, and by as much as 10/100 points in PCa-specific domains. Favorable SES characteristics were related to higher general (up to 9/100 points) and higher PCa-specific (up to 8/100 points) HRQOL scale scores. CONCLUSIONS: Comorbidity and SES are strongly associated with sexual, urinary and general HRQOL.

Body mass index and its association with genitourinary disorders in men undergoing prostate cancer screening.

INTRODUCTION: Elevated body mass index (BMI) may predispose to several pelvic pathologies. AIMS: We tested the association between BMI and five end points, namely, (i) erectile dysfunction (ED); (ii) lower urinary tract symptoms (LUTS); (iii) chronic prostatitis-associated pain (CPP); and ejaculatory dysfunction that is subdivided between (iv) pain/discomfort on ejaculation; and (v) subjectively decreased ejaculate volume. METHODS: Age, height, and weight were prospectively recorded in a cohort of 590 consecutive healthy men undergoing prostate cancer screening. Continuously coded and categorized BMI (World Health Organization classification) were studied. MAIN OUTCOME MEASURES: Age-adjusted analyses relied on logistic and linear regression models, according to data type. RESULTS: The average age was 54.1 years (range 30-83). Of all, 296 were overweight (50.2%, BMI 25-29.9 kg/m(2)) and 85 were obese (14.4%, BMI > or = 30 kg/m(2)). After age adjustment, elevated continuously coded BMI (P < 0.001) and elevated categorized BMI (P = 0.01) were associated with worse erectile function. Conversely, after age adjustment, elevated continuously coded BMI (P = 0.02) and elevated categorized BMI (P = 0.05) were associated with a lower rate of subjectively decreased ejaculate volume. Finally, after age adjustment, elevated categorically coded BMI was related to lower rates of CPP (P < 0.001) and to a lower rate of pain/discomfort on ejaculation (P = 0.03). CONCLUSIONS: In men undergoing prostate cancer screening, the effect of BMI on the five end points is not invariably detrimental. Elevated BMI may predispose to ED, but may also decrease the rate of pain/discomfort on ejaculation and may lower the reported rate of subjectively decreased ejaculate volume. Finally, it appeared to have no effect on LUTS.

Early detection of prostate cancer with ultrasound-guided systematic needle biopsy.

INTRODUCTION: Prostate biopsy strategies have greatly evolved over the past 2 decades. METHODS: We performed a literature review which addressed the initial and repeat biopsy schemes, pathologic risk factors for a positive repeat biopsy, and the ideal timing as well as the number of repeat biopsy sessions. RESULTS: Extended biopsy schemes (11-13 cores) should be used at initial and repeat biopsy. In the era of extended biopsy schemes, high-grade prostatic intraepithelial neoplasia no longer represents an independent predictor of prostate cancer on repeat biopsy. Conversely, the risk is appreciably increased with atypical small acinar proliferation, and its presence warrants a repeat biopsy, which may be performed as soon as the pathologic findings of the previous biopsy become available. Second and subsequent repeat biopsies carry a low detection yield. In most instances, the decision regarding the indications and the timing of a third or subsequent biopsy may be made after a 6 to 12 months interval following the repeat biopsy. CONCLUSION: Biopsy strategies and pathologic predictors of an increased risk of prostate cancer have appreciably changed over the past 2 decades.

A prospective randomized trial of 1-day versus 3-day antibiotic prophylaxis for transrectal ultrasound guided prostate biopsy.

PURPOSE: To compare the incidence of infection between a 1 day and a 3 day antibiotic prophylaxis regimen for transrectal ultrasound (TRUS) guided prostate biopsy in a prospective, randomized open-label trial. MATERIALS AND METHODS: TRUS examination was performed in the left lateral decubitus position using a Brüel and Kjaer 7 MHz rectal probe. Biopsies were carried out with an 18 gauge Tru-cut needle fired by the hand-held Biopsy gun. An average of eight core biopsies (range 6 to 12) was taken. From May 15, 2000 to May 16, 2001, 363 patients were enrolled in this study. Patients were randomized to receive either 1 day or 3 days of fluroquinolone antibiotic prophylaxis, consisting of either ciprofloxacin or levofloxacin orally. Antibiotics were begun at least 1 hour prior to biopsy. Seven days later, telephone follow-up was obtained. RESULTS: Two (0.55%) of the 363 patients, one in each group, had an episode of sepsis. No urinary tract infection was reported. Traumatic complications were only minor and no significant difference was observed between both groups: hematospermia (p> 0.4), hematuria (p>0.1) and rectorragia (p>0.2) being reported most frequently. CONCLUSION: There is no clinically nor statistically significant difference between a 1 day and 3 day antibiotic prophylaxis regimen for patients undergoing TRUS guided biopsies.