Trends in urologic oncology clinical practice and medical education under COVID-19 pandemic: An international survey of senior clinical and academic urologists.

OBJECTIVE: Ad-hoc guidelines for managing the COVID-19 pandemic are published worldwide. We investigated international applications of such policies in the urologic-oncology community. METHODS: A 20-item survey was e-mailed via SurveyMonkey to 100 international senior urologic-oncology surgeons. Leaders' policies regarding clinical/surgical management and medical education were surveyed probing demographics, affiliations, urologic-oncologic areas of interest, and current transportation restrictions. Data on COVID-19 burden were retrieved from the ECDC. Statistical analyses employed non-parametric tests (SPSS v.25.0, IBM). RESULTS: Of 100 leaders from 17 countries, 63 responded to our survey, with 58 (92%) reporting university and/or cancer-center affiliations. Policies on new-patient visits remained mostly unchanged, while follow-up visits for low-risk diseases were mostly postponed, for example, 83.3% for small renal mass (SRM). Radical prostatectomy was delayed in 76.2% of cases, while maintaining scheduled timing for radical cystectomy (71.7%). Delays were longer in Europe than in the Americas for kidney cancer (SRM follow-up, P = 0.014), prostate cancer (new visits, P = 0.003), and intravesical therapy for intermediate-risk bladder cancer (P = 0.043). In Europe, COVID-19 burden correlated with policy adaptation, for example, nephrectomy delays for T2 disease (r = 0.5, P =0.005). Regarding education policies, trainees' medical education was mainly unchanged, whereas senior urologists' planned attendance at professional meetings dropped from 6 (IQR 1-11) to 2 (IQR 0-5) (P < 0.0001). CONCLUSION: Under COVID-19, senior urologic-oncology surgeons worldwide apply risk-stratified approaches to timing of clinical and surgical schedules. Policies regarding trainee education were not significantly affected. We suggest establishment of an international consortium to create a directive for coping with such future challenges to global healthcare.

Fundamental Concepts Regarding Testosterone Deficiency and Treatment: International Expert Consensus Resolutions.

To address widespread concerns regarding the medical condition of testosterone (T) deficiency (TD) (male hypogonadism) and its treatment with T therapy, an international expert consensus conference was convened in Prague, Czech Republic, on October 1, 2015. Experts included a broad range of medical specialties including urology, endocrinology, diabetology, internal medicine, and basic science research. A representative from the European Medicines Agency participated in a nonvoting capacity. Nine resolutions were debated, with unanimous approval: (1) TD is a well-established, clinically significant medical condition that negatively affects male sexuality, reproduction, general health, and quality of life; (2) symptoms and signs of TD occur as a result of low levels of T and may benefit from treatment regardless of whether there is an identified underlying etiology; (3) TD is a global public health concern; (4) T therapy for men with TD is effective, rational, and evidence based; (5) there is no T concentration threshold that reliably distinguishes those who will respond to treatment from those who will not; (6) there is no scientific basis for any age-specific recommendations against the use of T therapy in men; (7) the evidence does not support increased risks of cardiovascular events with T therapy; (8) the evidence does not support increased risk of prostate cancer with T therapy; and (9) the evidence supports a major research initiative to explore possible benefits of T therapy for cardiometabolic disease, including diabetes. These resolutions may be considered points of agreement by a broad range of experts based on the best available scientific evidence.

Increased body mass index as a risk factor in localized prostate cancer treated by radical prostatectomy.

BACKGROUND: The association between obesity and aggressive forms of prostate cancer is controversial. We compared preoperative body mass index (BMI) and prostate-specific antigen (PSA) levels as predictive risk factors for increased prostate weight and disease aggressiveness. MATERIALS AND METHODS: This retrospective review of 464 patients with localized prostate cancer who underwent radical prostatectomy between March 1999 and October 2006 examined relationships among clinicopathological variables (BMI, preoperative serum PSA, biopsy and pathologic Gleason score [GS], and whole prostate weight) using linear and multinomial logistic regression analysis. We used multivariate regression modeling adjusting for age, year of surgery, PSA or BMI, pathologic stage, and GS. RESULTS: Median age of patients (51% cT1c, 69% pT2) was 61 years (41-76), mean BMI 26.50kg/m(2) (standard deviation = 4.82), mean PSA 6.8ng/ml (0.67-27.2), median prostate weight 51g (12-200), median biopsy GS 6 (3-9), and median pathologic GS 7 (4-10). GS was upgraded in 227 patients (49%) from median GS 6 to 7 (P<0.00001). Mean prostate weight was 47±13.7g for BMI<25kg/m(2) (n = 170), 47±15g for BMI 25 to 30kg/m(2) (n = 224), and 59±26g for BMI>30kg/m(2) (n = 69) (P<0.00184). Mean prostate weight was significantly higher for BMI>30 than BMI<25 (47±13g vs. 59±25g, P<0.00015). Mean PSA was significantly higher for BMI>30 than for all other patients combined (8.56 [95% CI: 6.94-10.18] vs. 8.34 [7.23-9.45]; P = 0.001). PSA was positively associated with high biopsy GS for BMI≥25 (P = 0.048) and BMI≥30 (P = 0.009) but not for BMI≤25 (P = 0.151). BMI≥30 was associated with higher pT stage (odd ratio = 1.279 [1.5-1.56]; P = 0.015). In multivariate analyses, higher BMI was associated with higher prostate weight (P = 0.036) and pT stage (P = 0.008), and higher PSA with higher biopsy GS (P = 0.002). Neither BMI nor PSA was associated with GS upgrading. CONCLUSIONS: Higher BMI was associated with higher prostate weight and PSA, as well as with higher pT stage and pathologic GS in men undergoing radical prostatectomy, providing further evidence that obese men are more likely to have aggressive cancer. BMI thus constitutes an additional risk factor besides PSA.

Testosterone Therapy in Men With Prostate Cancer.

CONTEXT: The use of testosterone therapy in men with prostate cancer was previously contraindicated, although recent data challenge this axiom. Over the past 2 decades, there has been a dramatic paradigm shift in beliefs, attitude, and treatment of testosterone deficiency in men with prostate cancer. OBJECTIVE: To summarize and analyze current literature regarding the effect of testosterone replacement in men with prostate cancer. EVIDENCE ACQUISITION: We conducted a Medline search to identify all publications related to testosterone therapy in both treated and untreated prostate cancer. EVIDENCE SYNTHESIS: The historical notion that increasing testosterone was responsible for prostate cancer growth was based on elegant yet limited studies from the 1940s and anecdotal case reports. Current evidence reveals that high endogenous androgen levels do not increase the risk of a prostate cancer diagnosis. Similarly, testosterone therapy in men with testosterone deficiency does not appear to increase prostate cancer risk or the likelihood of a more aggressive disease at prostate cancer diagnosis. Androgen receptor saturation (the saturation model) appears to account for this phenomenon. Men who received testosterone therapy after treatment for localized prostate cancer do not appear to suffer higher rates of recurrence or worse outcomes; although studies to date are limited. Early reports of men on active surveillance/watchful waiting treated with testosterone have not identified adverse progression events. CONCLUSIONS: An improved understanding of the negative effects of testosterone deficiency on health and health-related quality of life-and the ability of testosterone therapy to mitigate these effects-has triggered a re-evaluation of the role testosterone plays in prostate cancer. An important paradigm shift has occurred within the field, in which testosterone therapy may now be regarded as a viable option for selected men with prostate cancer suffering from testosterone deficiency. PATIENT SUMMARY: In this article, we review and summarize the existing literature surrounding the use of testosterone therapy in men with prostate cancer. Historically, testosterone was contraindicated in men with a history of prostate cancer. We show that this contraindication is unfounded and, with careful monitoring, its use is safe in that regard.

Localising prostate cancer: comparison of endorectal magnetic resonance (MR) imaging and 3D-MR spectroscopic imaging with transrectal ultrasound-guided biopsy.

BACKGROUND: Magnetic resonance imaging (MRI) and MR spectroscopic imaging (MRSI) have been gaining acceptance as tools in the evaluation of prostate cancer. We compared the accuracy of transrectal ultrasound (TRUS)-guided biopsy and dynamic contrast-enhanced MRI combined with three-dimensional (3D) MRSI in locating prostate tumours and determined the influence of prostate weight on MRI accuracy. PATIENTS AND METHODS: Between March 1999 and October 2006, 507 patients with localised prostate cancer underwent radical prostatectomy (RP) at the Jules Bordet Institute. Of these, 220 had undergone endorectal MRI (1.5 T Siemens Quantum Symphony) and 3D-MRSI prior to RP. We retrospectively reviewed data on tumour location and compared the results obtained by MRI and by TRUS-guided biopsy with those obtained on histopathology of the RP specimen. RESULTS: Patient data were as follows: median age 62.4 years (45-74); median PSA 6.36 ng/ml (0.5-22.6); 73.6% of patients had non-palpable disease (T1c); median biopsy Gleason score 6 (3-9); median RP specimen weight 50 g (12-172); median pathological Gleason score 7 (4-10); 68.64% of patients had organ-confined (pT2) disease. Tumour localisation was correlated with RP data in a significantly higher percentage of patients when using MRI rather than TRUS-guided biopsy (47.4 vs. 36.6%, p < 0.0001). MRI was marginally superior to TRUS-guided biopsy in detecting malignancy at the prostate apex (48.3 vs. 41.9%, p = 0.0687) and somewhat better at the prostate base (46 vs. 39.1%, p = 0.0413). It was highly significantly better at mid-gland (52 vs. 41.1%, p = 0.0015) and in the transition zone (40.1 vs. 24.3%, p < 0.0001). MRI had higher sensitivity in larger (≥50 g) than smaller (<50 g) prostates (50.3 vs. 42.2%, p = 0.0017). CONCLUSIONS: MRI was superior to TRUS-guided biopsy in locating prostate tumours except at the gland apex. MRI was more accurate in larger (≥50 g) than smaller prostates.

Testosterone measurement in patients with prostate cancer.

CONTEXT: Serum testosterone measurement has no widely accepted place in the management of patients with prostate cancer (PCa). However, several potential clinical applications of serum testosterone determination can be envisaged. OBJECTIVE: To review the role of testosterone and the androgen axis in the natural history of PCa and evaluate the evidence for the clinical application of serum testosterone measurement in patient screening, diagnosis, and management. EVIDENCE ACQUISITION: A Medline search retrieved original research and review articles relating to the androgen axis in PCa and the use of testosterone measurement for (1) assessing PCa risk in the general population, (2) adding to the specificity of prostate-specific antigen (PSA) testing, (3) determining tumour aggressiveness, (4) assessing the efficacy of androgen-deprivation therapy (ADT), and (5) optimising the scheduling of intermittent ADT. Relevant data were reviewed during a roundtable discussion, and consensus recommendations were agreed. EVIDENCE SYNTHESIS: A body of data implicates the androgen axis in PCa throughout its natural history. Based on current evidence, serum testosterone measurement cannot be recommended for determining PCa risk, increasing specificity of PSA testing, or assessing tumour aggressiveness. In contrast, for patients receiving ADT, there is a clear rationale for serum testosterone monitoring to ensure that castration levels are achieved. Practical recommendations for testosterone measurement during ADT are outlined. If PSA is rising while on ADT, castration levels of serum testosterone must be demonstrated before hormonal independence can be assumed. Serum testosterone levels might be considered an additional trigger for therapy reinitiation in intermittent ADT schedules. Finally, future prospective studies should further evaluate the potential relevance of testosterone measurement as an independent assessment of prognosis and treatment decision in different disease stages. CONCLUSIONS: As a therapeutic target, serum testosterone levels should be monitored to verify response to ADT and confirm suspected castration independence.

Estudio ciego multicéntrico a largo plazo del extracto de Escherichia coli (OM-89) en pacientes mujeres con infecciones recurrentes del tracto urinario / A long-term multicenter, double blind study of an Escherichia coli extract (OM-89) in female patients with recurrent urinary tract infections

Objetivo: Investigar el efecto preventivo a largo plazo del inmunoterápico OM-89 en comparación con placebo en la infección del tracto urinario (ITU) recurrente en una gran cohorte de mujeres. Métodos: Fueron seleccionadas en este estudio doble ciego multicéntrico, mujeres adultas 3 con cuadro clínico de ITU aguda y análisis de orina (mayo que 10 bacterias/mL). Las pacientes recibieron el inmunoterápico OM-89 ó 1 cápsula al día durante 90 días, 3 meses sin tratamiento, luego los primeros 10 días de los meses 7, 8 y 9, realizándose seguimiento durante 12 meses. Los criterios de eficacia primarios fueron los índices de ITU durante los 12 meses, la distribución de las ITU y la proporción de pacientes con ITU. Resultados: Se trató a un total de 453 pacientes, 231 en el grupo activo y 222 en el grupo placebo. La tasa promedio de ITU luego del inicio del tratamiento fue significativamente menor en el grupo activo que en el grupo placebo (0,84 versus 1,28; p menor que 0,003), correspondiente a una reducción de 34 por ciento en las ITU en las pacientes tratadas con OM-89. En el grupo activo, 93 pacientes (40,3 por ciento) tuvieron 185 ITU luego del inicio del estudio, en comparación con 276 ITU en 122 pacientes (55,0 por ciento) en el grupo placebo (p = 0,001). El perfil de seguridad de OM-89 fue bueno. Conclusiones: OM-89 redujo significativamente la incidencia de ITU durante los 12 meses del periodo del estudio incluyendo 3 meses de tratamiento y tres cursos de refuerzo de 10 días. Estos resultados confirman que OM-89 es un componente valioso en el tratamiento de la ITU recurrente.

Phase 3, randomized, controlled trial of atrasentan in patients with nonmetastatic, hormone-refractory prostate cancer.

BACKGROUND: Atrasentan is a potent, oral, selective endothelin-A (ET(A)) receptor antagonist that has clinical activity in patients with hormone-refractory prostate cancer (HRPC). In this article, the authors report the results from a phase 3, randomized, double-blind, placebo-controlled trial of atrasentan in patients with nonmetastatic HRPC. METHODS: Of 941 patients who had adequate androgen suppression and no radiographic evidence of metastases but rising prostate-specific antigen (PSA) levels, 467 patients were randomized to receive atrasentan at a dose of 10 mg, and 474 patients were randomized to receive placebo daily. The primary endpoint was the time to disease progression (TTP), which was defined as the onset of metastases. Secondary endpoints were the time to PSA progression, change in bone alkaline phosphatase (BALP) levels, PSA doubling time, and overall survival. RESULTS: There was a 93-day delay in the median TTP with atrasentan, but the difference from placebo in TTP was not statistically significant (P= .288). Large geographic differences in the median TTP were noted: in the US: The difference was 81 days longer with placebo; whereas, in non-US sites, the difference was 180 days longer with atrasentan. Atrasentan lengthened the PSA doubling time (P= .031) and slowed the increase in BALP (P< .001). The median survival was 1477 days with atrasentan and 1403 days with placebo. The most common adverse events associated with atrasentan were peripheral edema, nasal congestion, and headache, consistent with the vasodilatory properties of ET(A) receptor antagonists. CONCLUSIONS: Although the primary endpoint was not achieved, large regional differences in TTP were noted, suggesting that trial conduct may have influenced the results. The biologic activity was consistent with findings from other clinical trials of atrasentan in HRPC.

Tamsulosin modified release and oral controlled absorption system in the management of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

BACKGROUND: Tamsulosin MR has been on the market for the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) for many years. Recently, tamsulosin OCAS was introduced, which has improved pharmacokinetics. OBJECTIVE: To evaluate the efficacy and safety of tamsulosin. METHODS: Literature was identified through a PubMed search using the term 'tamsulosin' and by screening reference lists of review articles. RESULTS: Tamsulosin rapidly improves LUTS/BPH, with benefits maintained in the long-term. The overall tolerability of tamsulosin MR 0.4 mg is comparable to that of placebo. While the efficacy of tamsulosin OCAS and MR is comparable, tamsulosin OCAS is slightly better tolerated. CONCLUSION: Tamsulosin OCAS 0.4 mg has a favourable efficacy/safety profile and should be considered the treatment of choice for patients requiring optimal symptom control without increasing the risk of cardiovascular adverse events.

A phase 3 randomized controlled trial of the efficacy and safety of atrasentan in men with metastatic hormone-refractory prostate cancer.

BACKGROUND: The objective of this study was to evaluate the efficacy and safety of atrasentan (Xinlay), a selective endothelin-A receptor antagonist, in patients with metastatic hormone-refractory prostate cancer (HRPC). METHODS: This multinational, double-blind, placebo-controlled trial enrolled 809 men with metastatic HRPC. Patients were randomized 1:1 to receive either atrasentan 10 mg per day or placebo. The primary endpoint was time to disease progression (TTP), which was determined according to radiographic and clinical measures. Analyses of overall survival and changes in biomarkers also were performed. RESULTS: Atrasentan did not reduce the risk of disease progression relative to placebo (hazards ratio, 0.89; 95% confidence interval, 0.76-1.04; P = .136). Most patients progressed radiographically at the first 12-week bone scan without concomitant clinical progression. In exploratory analyses, increases from baseline to final bone alkaline phosphatase (BAP) and prostate-specific antigen (PSA) levels were significantly lower with atrasentan treatment (P < .05 for each). The median time to BAP progression (>/=50% increase from nadir) was twice as long with atrasentan treatment (505 days vs 254 days; P < .01). The delay in time to PSA progression did not reach statistical significance. Atrasentan generally was tolerated well, and the most common adverse events associated with treatment were headache, rhinitis, and peripheral edema, reflecting the vasodilatory and fluid-retention properties of endothelin-A receptor antagonism. CONCLUSIONS: Atrasentan did not delay disease progression in men with metastatic HRPC despite evidence of biologic effects on PSA and BAP as markers of disease burden.

Laparoscopic partial nephrectomy with "on-demand" clamping reduces warm ischemia time.

OBJECTIVES: To investigate the impact of "on-demand" clamping during laparoscopic partial nephrectomy on warm ischemia time. METHODS: We retrospectively reviewed 39 consecutive patients with renal tumors who had undergone transperitoneal laparoscopic partial nephrectomy from April 2002 to May 2006. Median tumor size was 2.3 cm. In all cases, the hilum was dissected early and extracorporeal clamping performed. The pedicle was clamped only in case of excessive bleeding, and it was released immediately after the closure of the renal defect with knot-tying sutures over Surgicel bolsters. RESULTS: Median operative time was 120 min. Renal clamping was required in 31 of 39 patients and in this subgroup the median warm ischemia time was 9 min. Median operative blood loss was 150 ml. Eight patients required blood transfusion and among these two were converted to open surgery. Positive surgical margin was observed in one case. Renal cell carcinoma was present in 22 (54.4%) specimens. No recurrence was observed after a median follow-up of 15 mo. CONCLUSIONS: This novel technique using extracorporeal clamping significantly decreases warm ischemia time, avoiding clamping of the pedicle in selected cases. Our study underlines the feasibility of performing laparoscopic partial nephrectomy with extracorporeal hilar clamping, allowing the shortest ischemia time ever published.

Laparoscopic live donor right nephrectomy: a new technique to maximize the length of the renal vein using a modified Endo GIA stapler.

OBJECTIVES: To report the utilization of a modified Endo GIA vascular stapler to obtain the full length of the renal vein during transperitoneal laparoscopic live donor right nephrectomy. METHODS: We used a modified Endo GIA stapler, in which the triple staggered rows of staples were removed from the kidney donor side to obtain the full length of the right renal vein. This technique has currently been used in nine consecutive transperitoneal laparoscopic right donor nephrectomies. RESULTS: With this technique, the entire right renal vein length was harvested in all cases, without vascular complications. Mean renal warm ischemia time from clamping of the renal vessels to cold perfusion was 135s, and mean receptor postoperative glomerular filtration rate after 30 d was 67.3 ml/min. There were no graft losses. CONCLUSIONS: A novel technique for laparoscopic live donor right nephrectomy is described. It allows harvesting the full length of the right renal vein in a safe and feasible way without compromising warm ischemia time.

The interpretation of serum prostate specific antigen in men receiving 5alpha-reductase inhibitors: a review and clinical recommendations.

PURPOSE: We reviewed the effects of 5alpha-reductase inhibitors on prostate specific antigen and clarified the adjustments that should be made to compensate for these effects to ensure that the usefulness of prostate specific antigen for detecting prostate cancer is maintained. MATERIALS AND METHODS: We reviewed articles published in the scientific literature with relevance to the effects of 5alpha-reductase inhibitors on the usefulness of prostate specific antigen for detecting prostate cancer. RESULTS: A total serum prostate specific antigen of 4.0 ng/ml has traditionally been used as the threshold for triggering prostate biopsy. However, clinical trials of finasteride and dutasteride have shown that 5alpha-reductase inhibitors decrease serum prostate specific antigen in patients with and without prostate cancer. To compensate, the doubling rule has been applied in clinical trials and clinical practice. However, doubling serum prostate specific antigen may overestimate actual prostate specific antigen in some patients receiving 5alpha-reductase inhibitors for up to 6 to 9 months, accurately estimate prostate specific antigen from 1 to 3 years and underestimate it thereafter. An increase in prostate specific antigen of 0.3 ng/ml from nadir as a trigger for biopsy maintains 71% sensitivity for prostate cancer in men receiving dutasteride with 60% specificity, similar to the 4.0 ng/ml prostate specific antigen cutoff using placebo. CONCLUSIONS: We propose that a prostate specific antigen increase from nadir of 0.3 ng/ml or greater could represent an alternative to the doubling rule for monitoring prostate specific antigen in patients on 5alpha-reductase inhibitors. The prostate specific antigen increase from nadir appears to be a more accurate cancer indicator than a doubled value in some patients.

Evaluation of male sexual function in patients with Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) treated with a phytotherapeutic agent (Permixon), Tamsulosin or Finasteride.

OBJECTIVES: Sexual function is one of the aspects in the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) that has gained increasing attention. We compared the influence on men's sexuality of Permixon, a lipido-sterolic extract of Serenoa Repens, with Tamsulosin and Finasteride using a specific validated questionnaire exploring patient's sexual functions. METHODS: A database was created comprising patients from 3 main double-blind, randomized studies - Permixon vs. Finasteride, Permixon vs. Tamsulosin and Permixon 160 mg vs. 320 mg including a total of 2511 patients. Three hundred fifty four were on Tamsulosin, 545 on Finasteride and 1612 patients on Permixon. LUTS were assessed using the I-PSS questionnaire. Peak flow rates and prostate volume were recorded. The MSF-4 questionnaire, including 4 items that explore the patient's interest in sex, quality of erection, achievement of orgasm and ejaculation, was used across the studies. This questionnaire was demonstrated as highly reproducible and both psychometrically and clinically valid across different cultures. Correlation coefficients were given to assess the linear relationship between continuous variables. RESULTS: At 3 months, there were no statistically significant differences between the three treatment groups in terms of I-PSS or Qmax evolutions (all p values > 0.05). At 6 months, as compared to pretreatment data, there was a slight increase in sexual disorders in Tamsulosin (+0.3) and Finasteride (+0.8) treated patients while it slightly improved with Permixon therapy (-0.2). Ejaculation disorders were the most frequently reported side effects after Tamsulosin or Finasteride (both +0.2 on the specific MSF-4 question 4). There was no correlation between the evolution of the MSF-4 scores and the evolution in I-PSS neither in patients treated with Permixon, Finasteride or Tamsulosin. However, there was a slight correlation between the MSF-4 score at baseline and the I-PSS at baseline (r2 = 0.032). Although there was a correlation between the MSF-4 and age at baseline (r2 = 0.1452), there was no correlation between the evolution in MSF-4 during therapy and the age of the patients. CONCLUSION: The present study demonstrates that Permixon therapy has no negative impact on male sexual function. Both Finasteride and Tamsulosin had a slight impact on sexual function, especially on ejaculation, although these effects were rare and in line with previous reports about these two drugs.

A long-term, multicenter, double-blind study of an Escherichia coli extract (OM-89) in female patients with recurrent urinary tract infections.

OBJECTIVE: To investigate the long-term preventive effect of the immunotherapeutic OM-89 versus placebo in uncomplicated recurrent UTI in a large cohort of female patients only. METHODS: Adult female patients could enroll in this multicenter, double-blind study if they had acute UTI at the enrollment visit and positive results of urinalysis (> or =10(3)bacteria/ml). Patients received the immunotherapeutic OM-89 or a matching placebo; 1 capsule per day for 90 days, 3 months without treatment, then the first 10 days in Months 7, 8 and 9 and were followed up during 12 months. Primary efficacy criteria were UTI rates over 12 months, distribution of UTIs and proportion of patients with UTI. RESULTS: A total of 453 patients were treated, 231 in the active group and 222 in the placebo group. Mean rate of post-baseline UTIs was significantly lower in the active group than in the placebo group (0.84 vs. 1.28; p<0.003), corresponding to a 34% reduction of UTIs in patients treated with OM-89. In the active group, 93 patients (40.3%) had 185 post-baseline UTIs, compared to 276 UTIs in 122 patients (55.0%) in the placebo group (p=0.001). The safety profile of OM-89 was good and consistent with that reported in previous studies. CONCLUSIONS: OM-89 significantly reduced the incidence of UTI during the 12 months of the study including 3 months of treatment and three 10-day booster courses. These results confirm that OM-89 is a valuable component of the management of recurrent UTI.

Skeletal morbidity in men with prostate cancer: quality-of-life considerations throughout the continuum of care.

OBJECTIVE: With current treatments, men usually survive many years after being diagnosed with prostate cancer. However, without supportive care, the systemic effects of prostate cancer and therapies such as androgen deprivation therapy (ADT) can undermine skeletal integrity, resulting in skeletal complications that may erode quality of life (QOL). Prostate cancer patients are at risk for fractures from cancer treatment-induced bone loss. In addition, they are also at risk for pathologic fractures, severe bone pain, and other sequelae from bone metastases, which almost invariably occur during the progression of prostate cancer. This review investigates the incidence and pathophysiology of bone loss and skeletal morbidity in prostate cancer patients and reviews available treatment options for maintaining skeletal health throughout the continuum of care for these patients. METHODS: Studies were identified through MEDLINE searches, review of bibliographies of relevant articles, and review of abstracts from national meetings. RESULTS: Several supportive care options are available to prevent generalized and localized bone loss, including calcium and vitamin D supplements and bisphosphonates. Oral calcium and vitamin D supplementation alone, however, appears to be insufficient to prevent bone loss during ADT. Zoledronic acid administered every 3 months during ADT or every 3 to 4 weeks for patients with bone metastases can reverse bone loss and reduce skeletal morbidity, respectively, in patients with prostate cancer. CONCLUSIONS: Skeletal complications contribute to the erosion of QOL in prostate cancer patients. Palliative care can provide important benefits to these patients. Some agents, such as zoledronic acid, may provide skeletal health benefits throughout the course of prostate cancer progression. Further investigations of the QOL impact of these benefits are warranted.