P. Van Cangh

Postoperative Radiotherapy After Radical Prostatectomy: A Randomised Controlled Trial (EORTC Trial 22911)

Summary Background Local failure after prostatectomy can arise in patients with cancer extending beyond the capsule. We dida randomised controlled trial to compare radical prostatectomy followed by immediate external irradiation withprostatectomy alone for patients with positive surgical margin or pT3 prostate cancer. Methods After undergoing radical retropubic prostatectomy, 503 patients were randomly assigned to a wait-and-seepolicy, and 502 to immediate postoperative radiotherapy (60 Gy conventional irradiation delivered over 6 weeks).Eligible patients had pN0M0 tumours and one or more pathological risk factors: capsule perforation, positivesurgical margins, invasion of seminal vesicles. Our revised primary endpoint was biochemical progression-freesurvival. Analysis was by intention to treat. Findings The median age was 65 years (IQR 61–69). After a median follow-up of 5 years, biochemical progression-free survival was significantly improved in the irradiated group (74·0%, 98% CI 68·7–79·3

Efficacy and Safety of a New Prolonged Release Formulation of Alfuzosin 10 mg Once Daily versus Alfuzosin 2.5 mg Thrice Daily and Placebo in Patients with Symptomatic Benign Prostatic Hyperplasia

Objectives: To assess the efficacy and safety of a new prolonged release formulation of the uroselective α1–blocker alfuzosin for a once–daily dosing regimen in patients with lower urinary tract symptoms (LUTS) suggestive of symptomatic benign prostatic hyperplasia (BPH). Methods: After a 1–month run–in period, 447 patients were randomly allocated in a double–blind placebo–controlled study to receive alfuzosin 10 mg once daily (n = 143), alfuzosin 2.5 mg thrice daily (n = 150) or placebo (n = 154) for 3 months. At inclusion, 46% of the randomised population had concomitant cardiovascular disease and 30% received an antihypertensive treatment. Uroflowmetry was performed close to trough plasma concentration of alfuzosin once daily to demonstrate the 24–hour coverage with this formulation. Results: Both alfuzosin formulations significantly improved urinary symptoms versus placebo assessed using the International Prostate Symptom Score (alfuzosin 10 mg once daily: –6.9; alfuzosin 2.5 mg thrice daily: –6.4; placebo: –4.9, p = 0.005). Peak flow rate increased significantly with alfuzosin 10 mg once daily (+2.3 ml/s, p = 0.03 vs. placebo) and with alfuzosin 2.5 mg thrice daily (+3.2ml/s, p<0.0001 vs. placebo) compared to placebo (+1.4 ml/s). Overall both formulations of alfuzosin were well tolerated in comparison with placebo. In addition, vasodilatory adverse events appeared to be less frequent with the once daily than the thrice daily formulation (6.3 vs. 9.4%, respectively). No first–day effect was reported with alfuzosin once daily and the effect on blood pressure did not differ from those observed in placebo, both in normotensive and hypertensive patients. No specific sexual dysfunction including ejaculation disorder was reported in the alfuzosin 10 mg once–daily group. Conclusion: The new once–daily formulation of alfuzosin administered at a dose of 10 mg daily is an effective 24–hour treatment of LUTS associated with BPH. Alfuzosin is as effective as the immediate formulation and shows a better cardiovascular safety. The better safety profile enables the same dose to be used in all patients, providing the patients with the benefits of a once–daily administration.

The Role of Antibiotics in the Treatment of Chronic Prostatitis: A Consensus Statement

Practical guidelines for the diagnosis and treatment of chronic prostatitis are presented. Chronic prostatitis is classified as chronic bacterial prostatitis (culture-positive) and chronic inflammatory prostatitis (culture-negative). If chronic bacterial prostatitis is suspected, based on relevant symptoms or recurrent UTIs, underlying urological conditions should be excluded by the following tests: rectal examination, midstream urine culture and residual urine. The diagnosis should be confirmed by the Meares and Stamey technique. Antibiotic therapy is recommended for acute exacerbations of chronic prostatitis, chronic bacterial prostatitis and chronic inflammatory prostatitis, if there is clinical, bacteriological or supporting immunological evidence of prostate infection. Unless a patient presents with fever, antibiotic treatment should not be initiated immediately except in cases of acute prostatitis or acute episodes in a patient with chronic bacterial prostatitis. The work-up, with the appropriate investigations should be done first, within a reasonable time period which, preferably, should not be longer than 1 week. During this period, nonspecific treatment, such as appropriate analgesia to relieve symptoms, should be given. The minimum duration of antibiotic treatment should be 2–4 weeks. If there is no improvement in symptoms, treatment should be stopped and reconsidered. However, if there is improvement, it should be continued for at least a further 2–4 weeks to achieve clinical cure and, hopefully, eradication of the causative pathogen. Antibiotic treatment should not be given for 6–8 weeks without an appraisal of its effectiveness. Currently used antibiotics are reviewed. Of these, the fluoroquinolones ofloxacin and ciprofloxacin are recommended because of their favourable antibacterial spectrum and pharmacokinetic profile. A number of clinical trials are recommended and a standard study design is proposed to help resolve some outstanding issues.

Pudendal cortical somatosensory evoked potentials.

To determine normal reference latencies pudendal cortical somatosensory evoked potentials were evaluated in 20 healthy volunteers. The dorsal nerve of the penis or clitoris was stimulated electrically and the cortical response was recorded from the CZ-2 point (2 cm. behind the central vertex). Reproducible responses were obtained and reference values were established.

Long-Term Safety and Efficacy of a Once-Daily Formulation of Alfuzosin 10 mg in Patients with Symptomatic Benign Prostatic Hyperplasia: Open-Label Extension Study

OBJECTIVES To evaluate the long-term safety and efficacy of a new, once-daily (o.d.) prolonged-release formulation of the clinically uroselective alpha1-blocker, alfuzosin, in patients with symptomatic benign prostatic hyperplasia (BPH). METHODS This is a 9-month open-label extension of a 3-month double-blind, placebo-controlled evaluation of alfuzosin 10 mg o.d. and standard alfuzosin 2.5 mg, three times daily (t.i.d.), administered without dose titration in both cases. A total of 311 patients continued in the extension phase and all received alfuzosin 10 mg o.d. Efficacy was evaluated in all patients enrolled in the extension phase (n = 311). Safety was assessed in all patients exposed to alfuzosin, whether in the double-blind or extension phase (n = 360). RESULTS Mean international prostate symptom score (IPSS) improved significantly, from 17.1 to 9.3 (P < 0.0001), and mean peak flow rate (PFR) (assessed at through plasma levels) increased significantly, from 9.1 to 11.3 ml/s (P < 0.0001), between baseline (i.e. beginning of the double-blind phase) and the endpoint of the extension phase. Quality of life (QOL) index also improved significantly, from 3.3 to 2.1 (P < 0.0001). Alfuzosin was well tolerated, with only 16 of 360 patients (4.4%) reporting adverse events potentially related to alpha-blockade (mainly dizziness). Ejaculation disorders were infrequent (0.6%) and did not show a relationship to treatment. The incidence of asymptomatic orthostatic hypotension was low (2.8%), and no age effect was identified. CONCLUSIONS Alfuzosin 10 mg o.d. provides effective relief from BPH, and clinical benefits are maintained up to 12 months. This study also demonstrates the satisfactory long-term safety of this formulation, and its safe use even in at-risk populations.

Early diagnosis and treatment of localized prostate cancer

This paper reviews the principal issues relating to the early diagnosis and treatment of localized prostate cancer. The chapter is divided into three sections. These are (1) Optimizing Early Detection of Prostate Cancer, (2) Which Is the Appropriate Patient for Watchful Waiting, and How Can He Be Identified?, and (3) The Best Patient for Potentially Curative Treatment: How Can We Lower Prostate Cancer mortality? With the advent of prostate specific antigen (PSA) testing and screening programmes, localized disease is now detected at an earlier stage in younger men. This presents an opportunity to reduce prostate cancer related mortality by early aggressive treatment; however, it has also led to a degree of overdiagnosis. An improved understanding of prognostic factors relating to tumour histology and patient characteristics is needed, so that we can better identify those patients with a poor prognosis and tailor treatment to individual patients. Optimizing Early Detection of Prostate Cancer

Posterior urethral valves in adult males.

Abstract We report on 2 cases of posterior urethral valves in young adult males referred for urinary and sexual symptoms.

REVERSIBLE RENAL ARTERY STENOSIS IN RENAL TRANSPLANTATION

Spontaneous regression of an arterial stenosis in a renal transplant recipient is documented. Implications of this observation and possible pathogenic mechanisms are discussed.

Indinavir Calculi: Diagnosis with Magnetic Resonance Urography

Indinavir sulfate is a protease inhibitor of the human immunodeficiency virus (HIV) type 1, that is widely used to treat patients with HIV infection. Indinavir therapy is associated with a significant incidence of crystalluria and urolithiasis [1]. These calculi are not opaque and consist of monohydrate indinavir crystals. Computed tomographic findings of ureteral calculi in patients with HIV receiving indinavir sulfate have recently been reported [2, 3]. Diagnosis is difficult with unenhanced computed tomography, and images after intravenous injection of an iodinated contrast agent may need to be performed to identify the cause of obstruction. We report a case of bilateral ureteral calculi demonstrated by magnetic resonance (MR) urography in an HIV-infected patient treated with indinavir sulfate.

L’imagerie par resonance magnetique (IRM) de la moelle osseuse permet la mesure objective et le suivi sous traitement des metastases osseuses du cancer prostatique

Objectifs Evaluer la performance de l’IRM de la moelle osseuse (IRMmo) (1) pour la mesure des metastases osseuses (MetOs) du cancer prostatique (CP) en utilisant les criteres de quantification des metastases parenchymateuses decrits dans la litterature (RECIST = Response Evaluation Criteria in Solid Tumors), et (2) pour apprecier la reponse therapeutique de ces metastases. Materiels et methodes Etude IRMmo pelvi-rachidienne chez des patients presentant des MetOs de CP avant (n = 38) et apres (n = 20) traitement systemique, en plus de l’imagerie habituelle (TDM abdo-mino-pelvienne [TDM-AP], scintigraphie osseuse et radiographies). Evaluation de la reponse au traitement sur les examens IRMmo selon les criteres RECIST et comparaison a l’evaluation de la reponse par suivi TDM-AP des metastases des tissus mous et par suivi du taux de PSA. Resultats Onze patients (28,9 %) presentent des metastases des tissus mous (ganglionnaires ou hepatiques) mesurables par TDM-AP. Vingt-cinq (65,7 %) patients presentent des MetOs mesurables selon les criteres RECIST. L’evaluation de la reponse tumorale (reponse partielle ou complete, progression ou stabilite lesionnelle) en IRMmo est concordante avec la reponse determinee par suivi TDM-AP des lesions des tissus mous et avec la reponse biologique (PSA) dans la plupart des cas. Conclusion L’IRMmo permet une quantification precise des MetOs de CP, et l’evaluation de leur reponse au traitement.