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1.  Efficacy and tolerability of 1- and 3-month leuprorelin acetate depot formulations (Eligard®/Depo-Eligard®) for advanced prostate cancer in daily practice: a Belgian prospective non-interventional study 
Archives of Medical Science : AMS  2014;10(3):477-483.
The 1-, 3- and 6- month biodegradable polymer matrix depot formulations of leuprorelin acetate (Eligard®/Depo-Eligard®, Astellas Pharma Inc/BV) were shown to reduce testosterone and prostate-specific antigen levels and to be well tolerated in patients with advanced prostate cancer in several clinical trials. This study aimed at evaluating the efficacy, safety and tolerability of the 1- and 3-month leuprorelin acetate depot formulations in daily clinical practice.
Material and methods
A prospective, open-label, non-interventional, phase IV study (MANTA) was conducted in 243 Belgian prostate cancer patients who had been prescribed the 1-month (7.5 mg) or 3-month (22.5 mg) leuprorelin acetate depot formulation. Patients were followed for at least 3 months.
Median serum prostate-specific antigen levels were reduced by 95% from 12.0 ng/ml at baseline to 0.60 ng/ml after a median follow-up time of 132 days, while median testosterone levels were reduced by 94% from 360 ng/dl to 20 ng/dl. Partial or complete treatment response was observed in 83% of patients at the final visit (according to the physician's assessment). Ninety-two patients (37.86%) experienced treatment-emergent adverse events, with injection site-related reactions, hot flushes and tumor flare being the most common ones. Overall safety and tolerability of the leuprorelin acetate depot formulation were rated as good or excellent by 90% of physicians.
These data are consistent with efficacy and tolerability results from clinical trials. They confirm that the 1- and 3-month leuprorelin acetate depot formulations are well tolerated and reliably lower serum prostate-specific antigen and testosterone levels in routine clinical practice.
PMCID: PMC4107255  PMID: 25097577
leuprolide; physician's practice patterns; prospective studies; prostatic neoplasms; treatment outcome
2.  Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium 
BMC Urology  2012;12:8.
In Belgium, bladder cancer is the fifth most common cancer in males (5.2%) and the sixth most frequent cause of death from cancer in males (3.8%). Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of bladder cancer. This suggests that selenium may also be suitable for chemoprevention of recurrence.
The SELEBLAT study opened in September 2009 and is still recruiting all patients with non-invasive transitional cell carcinoma of the bladder on TURB operation in 15 Belgian hospitals. Recruitment progress can be monitored live at Patients are randomly assigned to selenium yeast (200 μg/day) supplementation for 3 years or matching placebo, in addition to standard care. The objective is to determine the effect of selenium on the recurrence of bladder cancer. Randomization is stratified by treatment centre. A computerized algorithm randomly assigns the patients to a treatment arm. All study personnel and participants are blinded to treatment assignment for the duration of the study.
The SELEnium and BLAdder cancer Trial (SELEBLAT) is a phase III randomized, placebo-controlled, academic, double-blind superior trial.
This is the first report on a selenium randomized trial in bladder cancer patients.
Trial registration identifier: NCT00729287
PMCID: PMC3352119  PMID: 22436453
Selenium; Bladder cancer; Transitional Cell Carcinoma; Chemoprevention; Randomized clinical trial; Urology
3.  Comparison of the haemostatic properties of conventional monopolar and bipolar transurethral resection of the prostate in patients on oral anticoagulants 
The aim of study is comparing the haemostatic properties of conventional monopolar resection (TURP) and bipolar transurethral resection in saline (TURIS) of the prostate in patients under chronic oral anticoagulants.
Material and methods
Out of a cohort group of 550 endoscopic resections for bladder outlet obstruction, 176 patients on chronic oral anticoagulant therapy required endoscopic resection either by monopolar TURP or bipolar TURIS technology. Changes in haemoglobin, blood transfusion, and clot retention were compared between both groups.
Mean postoperative change in haemoglobin level was –1.21 ±0.92 mg/dl in the TURP group compared to –1.29 ±0.99 mg/dl in the TURIS group (p = 0.603). The need for blood transfusions and the mean numbers of units transfused did not significantly differ between the 2 groups. Clot retention appeared in 12 patients (15%) in the TURP group compared to 13 patients (13%) in the TURIS group (p = 0.828).
Despite promising experimental results of better haemostasis and deeper coagulation depth, bipolar technology does not permit one to reduce the amount of blood loss when compared to patients treated by conventional monopolar technology in this study group of patients on oral anticoagulation therapy. Patients on oral anticoagulants suffer more incidents of clot retention, which sometimes results in re-hospitalisation.
PMCID: PMC3258800  PMID: 22291832
prostate; bipolar; transurethral resection of prostate
4.  Bipolar versus monopolar technique for palliative transurethral prostate resection 
The aim was to evaluate the postoperative morbidity and outcome of palliative endoscopic resections for relief of infravesical obstruction in prostate cancer patients with hormone deprivation therapy, and to investigate the added value of bipolar technology over conventional monopolar resections.
Material and methods
A retrospective study was performed on 70 patients with prostate cancer under hormone deprivation therapy undergoing 75 endoscopic procedures, by either monopolar or bipolar technology, between August 2005 and March 2009 at a single institution. The analysis used outpatient, inpatient, and operative records, and observations of electrolyte changes in the serum, postoperative morbidity, and the overall results of palliative endoscopic resections. Preoperative cancer stages and grades were compared with the pathological findings after surgery. Postoperative outcome and complications of conventional monopolar and bipolar technology were compared.
Over a period of 44 months, 34 conventional monopolar resections were performed in 32 patients and 41 bipolar resections in 38 patients. Patients’ profiles regarding age, initial cancer stage and grade, resection weight, resection speed, catheterization time, and hospital stay were similar in both groups. No statistically significant difference was observed in sodium drop (p = 0.802), clot retention (p = 0.565), or urinary retention (p = 0.292). The overall success rate in relieving obstruction leading to spontaneous voiding was 77%. While 38% of the patients had a high grade tumour at diagnosis, 79% were found to be high grade after the endoscopic resection (p < 0.0001).
Palliative endoscopic transurethral resection is an acceptable and safe adjunctive surgical treatment for voiding disorders in prostate cancer patients. Bipolar technology offers no substantial benefit over conventional monopolar technology.
PMCID: PMC3298349  PMID: 22419939
prostate; prostate cancer; transurethral resection
5.  Normative Ethics Does Not Need a Foundation: It Needs More Science 
Acta Biotheoretica  2010;59(1):29-51.
The impact of science on ethics forms since long the subject of intense debate. Although there is a growing consensus that science can describe morality and explain its evolutionary origins, there is less consensus about the ability of science to provide input to the normative domain of ethics. Whereas defenders of a scientific normative ethics appeal to naturalism, its critics either see the naturalistic fallacy committed or argue that the relevance of science to normative ethics remains undemonstrated. In this paper, we argue that current scientific normative ethicists commit no fallacy, that criticisms of scientific ethics contradict each other, and that scientific insights are relevant to normative inquiries by informing ethics about the options open to the ethical debate. Moreover, when conceiving normative ethics as being a nonfoundational ethics, science can be used to evaluate every possible norm. This stands in contrast to foundational ethics in which some norms remain beyond scientific inquiry. Finally, we state that a difference in conception of normative ethics underlies the disagreement between proponents and opponents of a scientific ethics. Our argument is based on and preceded by a reconsideration of the notions naturalistic fallacy and foundational ethics. This argument differs from previous work in scientific ethics: whereas before the philosophical project of naturalizing the normative has been stressed, here we focus on concrete consequences of biological findings for normative decisions or on the day-to-day normative relevance of these scientific insights.
PMCID: PMC3068523  PMID: 20407803
Science and ethics; Naturalistic ethics; Normative ethics; Naturalistic fallacy

Results 1-5 (5)