Alpha emitter radium-223 and survival in metastatic prostate cancer.

BACKGROUND: Radium-223 dichloride (radium-223), an alpha emitter, selectively targets bone metastases with alpha particles. We assessed the efficacy and safety of radium-223 as compared with placebo, in addition to the best standard of care, in men with castration-resistant prostate cancer and bone metastases. METHODS: In our phase 3, randomized, double-blind, placebo-controlled study, we randomly assigned 921 patients who had received, were not eligible to receive, or declined docetaxel, in a 2:1 ratio, to receive six injections of radium-223 (at a dose of 50 kBq per kilogram of body weight intravenously) or matching placebo; one injection was administered every 4 weeks. In addition, all patients received the best standard of care. The primary end point was overall survival. The main secondary efficacy end points included time to the first symptomatic skeletal event and various biochemical end points. A prespecified interim analysis, conducted when 314 deaths had occurred, assessed the effect of radium-223 versus placebo on survival. An updated analysis, when 528 deaths had occurred, was performed before crossover from placebo to radium-223. RESULTS: At the interim analysis, which involved 809 patients, radium-223, as compared with placebo, significantly improved overall survival (median, 14.0 months vs. 11.2 months; hazard ratio, 0.70; 95% confidence interval [CI], 0.55 to 0.88; two-sided P=0.002). The updated analysis involving 921 patients confirmed the radium-223 survival benefit (median, 14.9 months vs. 11.3 months; hazard ratio, 0.70; 95% CI, 0.58 to 0.83; P<0.001). Assessments of all main secondary efficacy end points also showed a benefit of radium-233 as compared with placebo. Radium-223 was associated with low myelosuppression rates and fewer adverse events. CONCLUSIONS: In this study, which was terminated for efficacy at the prespecified interim analysis, radium-223 improved overall survival. (Funded by Algeta and Bayer HealthCare Pharmaceuticals; ALSYMPCA ClinicalTrials.gov number, NCT00699751.).

Early postoperative pelvic-floor biofeedback improves erectile function in men undergoing radical prostatectomy: a prospective, randomized, controlled trial.

Erectile dysfunction (ED) and urinary incontinence are common complications following radical prostatectomy (RP). Although pelvic-floor biofeedback training (PFBT) may improve urinary continence following RP, its effects on the recovery of potency are unknown. Fifty-two patients selected for RP were prospectively randomized for a treatment group (n=26) receiving PFBT once a week for 3 months and home exercises or a control group (n=26), in which patients received verbal instructions to contract the pelvic floor. Erectile function (EF) was evaluated with the International Index of Erectile Function-5 (IIEF-5) before surgery and 1, 3, 6 and 12 months postoperatively. Patients were considered potent when they had a total IIEF-5 score>20. Continence status was assessed and defined as the use of no pads. Groups were comparable in terms of age, body mass index, diabetes, pathological tumor stage and neurovascular bundle preservation. A significant reduction in IIEF-5 scores was observed after surgery in both groups. In the treatment group, 8 (47.1%) patients recovered potency 12 months postoperatively, as opposed to 2 (12.5%) in the control group (P=0.032). The absolute risk reduction was 34.6% (95% confidence interval (CI): 3.8-64%) and the number needed to treat was 3 (95% CI: 1.5-17.2). A strong association between recovery of potency and urinary continence was observed, with continent patients having a 5.4 higher chance of being potent (P=0.04). Early PFBT appears to have a significant impact on the recovery of EF after RP. Urinary continence status was a good indicator of EF recovery, with continent patients having a higher chance of being potent.

KTP laser nerve sparing radical prostatectomy: comparison of ultrasonic and cold scissor dissection on cavernous nerve function.

PURPOSE: Energy sources used during nerve sparing radical prostatectomy are known to compromise cavernous nerve function. Lasers offer the potential for accurate dissection while minimizing collateral injury to delicate neural structures. We evaluated cavernous nerve function following KTP laser dissection and compared outcomes to those of ultrasonic shears and cold scissor dissection. MATERIALS AND METHODS: Laparoscopic unilateral neurovascular bundle mobilization was performed in 36 survival dogs using a KTP laser, ultrasonic shears and an athermal technique with cold scissors and clips in 12 each. Peak intracavernous pressure upon cavernous nerve stimulation, expressed as a percent of mean arterial pressure, was measured acutely and at 1 month. Thermal spread from the KTP laser and ultrasonic shears was assessed histologically ex vivo in harvested peritoneum. RESULTS: Median peak intracavernous pressure as a percent of mean arterial pressure was similar immediately and 1 month after laser and athermal dissection, and significantly decreased after dissection with ultrasonic shears. Acute peak intracavernous pressure as a percent of mean arterial pressure was 53%, 96% and 98% for ultrasonic shears, laser and the athermal technique, respectively (laser vs athermal p = 0.51, ultrasonic shears vs laser p <0.001 and ultrasonic shears vs athermal p <0.001). Chronic peak intracavernous pressure as a percent of mean arterial pressure was 56%, 98% and 100% for ultrasonic shears, laser and the athermal technique, respectively (laser vs athermal p = 0.38, ultrasonic shears vs laser p = 0.016 and ultrasonic shears vs athermal p = 0.013). The median depth of acute laser injury was 600 microm compared to 1.2 mm for ultrasonic shear dissection and 450 microm crush injury due to the athermal technique. Thermography revealed less collateral thermal spread from the laser than from the ultrasonic shears (median greater than 60C thermal spread 1.07 vs 6.42 mm, p <0.01). CONCLUSIONS: The KTP laser was comparable to the athermal technique and superior to the ultrasonic shears for preserving cavernous nerve function.

[Testicular toxoplasmosis: a rare case of a testicular mass]. / Toxoplasmosis testicular: un caso raro de masa testicular.

Toxoplasma gondii is an intracellular protozoan infecting birds and mammals. Acute infection is asymptomatic in immune competent people. For immune deficient patients (acquired immune deficiency syndrome, lymphoma patients or those under steroids to prevent organ transplantation rejection) infection may be lethal. We describe an uncommon case of testicular toxoplasmosis in patient under steroids after organ transplantation with no positive serum test for HIV and/or systemic toxoplasmosis.

Orthotopic ileal neobladder: the influence of reservoir volume and configuration on urinary continence and emptying properties.

OBJECTIVE: To evaluate the influence of the volume and configuration of the neobladder on urinary continence and reservoir emptying in orthotopic urinary reservoirs using intestinal segments for bladder replacement after radical cystectomy. PATIENTS AND METHODS: Fifty-nine patients who had had a radical cystectomy and urinary reconstruction with an orthotopic ileal neobladder were followed for > or = 1 year; 27 (group 1) had the ileal neobladder created with a shorter intestinal segment (40 cm) in an elongated shape ('J'), and 32 (group 2) had their reservoir made more spherical with a longer ileal loop (60-65 cm). The rates of urinary continence, enuresis, neobladder capacity and postvoid residual urine were evaluated first at 3-6 months and again 1 year after surgery in both groups. RESULTS: At 3-6 months after surgery urinary incontinence and enuresis were more common in group 1, but at 1 year had the same frequency in both groups, at respectively 11% and 44% in group 1, and 13% and 47% in group 2 (P > 0.05). The neobladder capacity and postvoid residual urine were significantly higher in group 2, at > 600 mL and > 100 mL, respectively, in 14% and 14% of the patients in group 1 and 57% and 52% of those in group 2 (P < 0.05). Urinary retention requiring intermittent catheterization did not occur in group 1 but did in 19% of group 2. CONCLUSION: The orthotopic spherical ileal neobladder with a large initial volume is apparently not associated with better continence rates and is prone to developing progressive enlargement, which can lead to neobladder atony and progressive emptying failure, increasing the chance of complete urinary retention.

[Prevalence of viral hepatitis B markers in a sample of students at the School of Medicine and Surgery, University of Brescia]. / Prevalenza dei markers dell'epatite virale B in un campione di studenti della Facoltà di Medicina e Chirurgia dell'Università di Brescia.

Seroepidemiologic study on hepatitis B virus markers in a group of students in Medicine at the University of Brescia. The prevalence of hepatitis B virus (HBV) markers was studied in a group of 633 students in Medicine at the University of Brescia. HBsAg was detected in 16 (2.5%) students; anti-HBs and anti-HBc in 73 (11.5%); anti-HBs alone in 4 (0.6%); anti-HBc alone in 9 (1.4%). On the whole 102 (16.1%) students were reactive for one HBV marker at least. Significant differences in frequency of HBV markers were found according to age and to personal and familiar history of viral hepatitis; the prevalence of the markers was not associated with sex, year in school, hospital clinical training, blood transfusions and presence of health-care workers in the family. In this seroepidemiologic study the risk of contracting hepatitis B appears not higher in medical students than in other university students and in general population of the same age, sex and residence area. The results of the investigation suggest that medical students are appropriate candidates for hepatitis B vaccine at the beginning of their post-graduate medical profession.

Left ventricular dysfunction versus paravalvular leak in patients with mitral disc prostheses.

UNLABELLED: Left ventricular dysfunction and prosthesis malfunction are the main causes of hemodynamic deterioration following prosthetic mitral valve replacement. The aim of this study is to reassess the usefulness of a combined echo-phonocardiographic technique to differentiate these different situations in order to select medical or surgical treatment in patients with a mitral disc prosthesis. Two patient groups were studied. The first group consists of five patients with paravalvular leak (PL), surgically or pathologically verified. Second group: nine patients with left ventricular failure (LVF) and normal functioning prosthesis. The diastolic diameter of the left ventricle (LV) was significantly increased in the LVF group compared with the PL group. A protodiastolic hump was present in four cases of PL. The variability of the interval between A2 and the mitral valve opening (delta A2-MVO) was less than 30 msec in the LVF group and greater than 30 msec in the PL group. The interval between A2 and maximal LV posterior wall (A2-PW) exceeded 60 msec in the PL group and was shorter than 60 msec in the LVF group. IN CONCLUSION: the echo-phonocardiographic technique, especially when by using two newly proposed parameters, seems to be very useful to discriminate between PL and LVF.

[Comparative evaluation of phonocardiogram and echocardiogram in mitral valve prolapse diagnosis (author's transl)]. / Valutazione comparative del fonocardiogramma e dell'ecocardiogramma nella diagnostica del prolasso mitralico.

In order to determine the correlation between echocardiography (ECHO) and phonocardiography (PHONO) in the evaluation of the Mitral Prolapse Syndrome (PM), 87 subjects with echo or phono criteria of PM were studied using both techniques. The phonocardiographic criteria used for PM diagnosis were the presence of a telesystolic click and/or a telesystolic murmur. The echocardiographic criteria were a telesystolic or holosystolic posterior movement of a mitral leaflet continuously seen through systole or of both mitral leaflets seen in part of systole. In the 63 patients with ECHO indicative of PM, the PHONO was positive in 55 cases (87%). Methoxamin administration, in 5 cases whose basal PHONO was normal, allowed the observation of 3 telesystolic murmurs and 2 clicks. The drug also diminished the number of clicks and increased tfhe telesystolic murmurs. In 79 subjects with PHONO indicative of PM, the ECHO was positive in 57 cases (72%): this technique was of particular value in patients with olosystolic murmur; valuable also to evaluate the diastolic diameter of the left ventricle and the left atrium and other signs having a possible use for a more accurate physiopatologic definition of the PM syndrome.