Moderate hypofractionated helical tomotherapy for prostate cancer in a cohort of older patients: a mono-institutional report of toxicity and clinical outcomes.

PURPOSE OR OBJECTIVE: To evaluate toxicity and outcomes of moderately hypofractionated helical tomotherapy for the curative treatment of a cohort of patients aged ≥ 75 years with localized prostate cancer (PC). MATERIALS AND METHODS: From January 2013 to February 2017, 95 patients with median age 77 years (range 75-88) were treated for PC. 39% were low risk, 33% intermediate risk (IR), 28% high risk (HR). Median iPSA was 9.42 ng/ml (1.6-107). Androgen deprivation was prescribed according to NCCN recommendations. All patients received 70 Gy in 28 fractions to the prostate; 61.6 Gy were delivered to the seminal vesicles for IR; whole pelvis irradiation with a total dose of 50.4 Gy was added in the HR group. Toxicity evaluation was based on CTCAE V4.0 criteria, biochemical failure was defined following Phoenix criteria. Quality of Life was assessed with the EPIC-26 index. Overall survival and biochemical failure-free survival were analysed with Kaplan-Meier method. RESULTS: With a median follow-up of 36 months (range 24-73), acute and late toxicity were acceptable. No correlation between toxicity patterns and clinical or dosimetric parameter was registered. EPIC-26 showed a negligible difference in urinary and bowel function post-treatment that did not reach statistical significance. The 2- and 3-years OS were 93% and 87% with cancer specific survival of 97.9% and 96.2%. CONCLUSION: Moderate hypofractionated RT reported excellent outcomes in our cohort of older patients. Shorter schedules may be proposed regardless of chronological age facilitating the treatment compliance in the older population.

Predictors of oncological outcomes in T1G3 patients treated with BCG who undergo radical cystectomy.

PURPOSE: To evaluate the oncological impact of postponing radical cystectomy (RC) to allow further conservative therapies prior to progression in a large multicentre retrospective cohort of T1-HG/G3 patients initially treated with BCG. METHODS: According to the time of RC, the population was divided into 3 groups: patients who did not progress to muscle-invasive disease, patients who progressed before radical cystectomy and patients who experienced progression at the time of radical cystectomy. Clinical and pathological outcomes were compared across the three groups. RESULTS: Of 2451 patients, 509 (20.8%) underwent RC. Patients with tumors > 3 cm or with CIS had earlier cystectomies (HR = 1.79, p = 0.001 and HR = 1.53, p = 0.02, respectively). Patients with tumors > 3 cm, multiple tumors or CIS had earlier T3/T4 or N + cystectomies. In patients who progressed, the timing of cystectomy did not affect the risk of T3/T4 or N + disease at RC. Patients with T3/T4 or N + disease at RC had a shorter disease-specific survival (HR = 4.38, p < 0.001), as did patients with CIS at cystectomy (HR = 2.39, p < 0.001). Patients who progressed prior to cystectomy had a shorter disease-specific survival than patients for whom progression was only detected at cystectomy (HR = 0.58, p = 0.024) CONCLUSIONS: Patients treated with RC before experiencing progression to muscle-invasive disease harbor better oncological and survival outcomes compared to those who progressed before RC and to those upstaged at surgery. Tumor size and concomitant CIS at diagnosis are the main predictors of surgical treatment while tumor size, CIS and tumor multiplicity are associated with extravesical disease at surgery.

Recurrence, progression and cancer-specific mortality according to stage at re-TUR in T1G3 bladder cancer patients treated with BCG: not as bad as previously thought.

PURPOSE: The goals of transurethral resection of a bladder tumor (TUR) are to completely resect the lesions and to make a correct diagnosis to adequately stage and treat the patient. Persistent disease after TUR is not uncommon and is why re-TUR is recommended in T1G3 patients. When there is T1 tumor in the re-TUR specimen, very high risks of progression (82%) have been reported. We analyze the risks of recurrence, progression to muscle-invasive disease and cancer-specific mortality (CSM) according to tumor stage at re-TUR in T1G3 patients treated with BCG. METHODS: In our retrospective cohort of 2451 T1G3 patients, 934 patients (38.1%) underwent re-TUR. 667 patients had residual disease (71.4%): Ta in 378 (40.5%), T1 in 289 (30.9%) patients. Times to recurrence, progression and CSM in the three groups were estimated using cumulative incidence functions and compared using the Cox regression model. RESULTS: During a median follow-up of 5.2 years, 512 patients recurred. The recurrence rate was significantly higher in patients with a T1 at re-TUR (P < 0.001). Progression rates differed according to the pathology at re-TUR, 25.3% in T1, 14.6% in Ta and 14.2% in case of no residual tumor (P < 0.001). Similar trends were seen in both patients with and without muscle in the original TUR specimen. CONCLUSIONS: Patients with T1G3 tumors and no residual disease or Ta at re-TUR have better recurrence, progression and CSM rates than previously reported, with a CSM rate of 13.1 and a 25.3% progression rate in re-TUR T1 disease.

The clinical use of statistical permutation test methodology: a tool for identifying predictive variables of outcome.

OBJECTIVES: To identify the predictive variables affecting the outcome after radical surgery for bladder cancer by a newer statistical methodology, i.e. nonparametric combination (NPC). METHODS: A multicenter study enrolled 1,312 patients who had undergone radical cystectomy for bladder cancer in 11 Italian oncological centers from January 1982 to December 2002. A statistical analysis of their medical history and diagnostic, pathological and postoperative variables was performed using a NPC test. The patients were included in a comprehensive database with medical history and clinical and pathological data. Five-year survival was used as the dependent variable, and p values were corrected for multiplicity using a closed testing procedure. The newer nonparametric approach was used to evaluate the prognostic importance of the variables. All of the analyses were performed using routines developed in MATLAB© and the significance level was set at α = 0.05. RESULTS: A significant prognostic predictive value (p < 0.01) for tumor clinical staging, hydronephrosis, tumor pathological staging, grading, presence of concomitant carcinoma in situ, regional lymph node involvement, corpora cavernosa invasion, microvascular invasion, lymphatic invasion and prostatic stroma involvement was found. CONCLUSIONS: The NPC test could handle any type of variable (categorical and quantitative) and take into account the multivariate relation among variables. This newer methodology offers a significant contribution in biomedical studies with several endpoints and is recommended in presence of non-normal data and missing values, as well as solving high-dimensional data and problems relating to small sample sizes.

Risk factors for residual disease at re-TUR in a large cohort of T1G3 patients.

INTRODUCTION AND OBJECTIVES: The goals of transurethral resection of a bladder tumor (TUR) are to completely resect the lesions and to make a correct diagnosis in order to adequately stage the patient. It is well known that the presence of detrusor muscle in the specimen is a prerequisite to minimize the risk of under staging. Persistent disease after resection of bladder tumors is not uncommon and is the reason why the European Guidelines recommended a re-TUR for all T1 tumors. It was recently published that when there is muscle in the specimen, re-TUR does not influence progression or cancer specific survival. We present here the patient and tumor factors that may influence the presence of residual disease at re-TUR. MATERIAL AND METHODS: In our retrospective cohort of 2451 primary T1G3 patients initially treated with BCG, pathology results for 934 patients (38.1%) who underwent re-TUR are available. 74% had multifocal tumors, 20% of tumors were more than 3 cm in diameter and 26% had concomitant CIS. In this subgroup of patients who underwent re-TUR, there was no residual disease in 267 patients (29%) and residual disease in 667 patients (71%): Ta in 378 (40%) and T1 in 289 (31%) patients. Age, gender, tumor status (primary/recurrent), previous intravesical therapy, tumor size, tumor multi-focality, presence of concomitant CIS, and muscle in the specimen were analyzed in order to evaluate risk factors of residual disease at re-TUR, both in univariate analyses and multivariate logistic regressions. RESULTS: The following were not risk factors for residual disease: age, gender, tumor status and previous intravesical chemotherapy. The following were univariate risk factors for presence of residual disease: no muscle in TUR, multiple tumors, tumors > 3 cm, and presence of concomitant CIS. Due to the correlation between tumor multi-focality and tumor size, the multivariate model retained either the number of tumors or the tumor diameter (but not both), p < 0.001. The presence of muscle in the specimen was no longer significant, while the presence of CIS only remained significant in the model with tumor size, p < 0.001. CONCLUSIONS: The most significant factors for a higher risk of residual disease at re-TUR in T1G3 patients are multifocal tumors and tumors more than 3 cm. Patients with concomitant CIS and those without muscle in the specimen also have a higher risk of residual disease.

Prospective, randomized, crossover comparison of sublingual apomorphine (3 mg) with oral sildenafil (50 mg) for male erectile dysfunction.

PURPOSE: We established the efficacy and safety of sublingual apomorphine compared with oral sildenafil in comparable groups of patients with erectile dysfunction (ED). MATERIALS AND METHODS: This prospective, randomized, crossover study included 77 heterosexual men with ED of various etiologies and severities. A total of 62 men were randomized but only 34 were evaluable for efficacy and tolerability. The study started with a run-in period of 2 to 4 weeks. The first 4 weeks of treatment were followed by a washout period of 4 weeks, after which patients changed to the alternate treatment for an additional 4-week period. The sequence of the 2 treatments was established by a randomization list in blocks in closed packets. The primary efficacy end point was the percent of attempts resulting in erection firm enough for intercourse. Additional variables were the percent of attempts resulting in intercourse and improvement in ED, as evaluated by the erectile function domain score of the International Index of Erectile Function questionnaire. RESULTS: Sildenafil was significantly more effective than apomorphine in regard to the percent of attempts resulting in erection firm enough for intercourse (85% vs 44%, p <0.0001) and actually resulting in intercourse (81% vs 43%, p <0.0001) as well as erectile function evaluated by the erectile function domain score of the International Index of Erectile Function (p <0.001). The incidence of adverse events was not significantly different for the 2 drugs. Although the number of patients was small, this study had strong statistical power due to the striking difference in results. CONCLUSIONS: Sildenafil was significantly more effective than apomorphine for ED. No statistical difference in adverse events was noted.

Intravesical mitoxantrone in superficial bladder tumours (Ta-T1).

36 patients with histologically proven grade G1-G2, Ta-T1 transitional cell carcinoma of the bladder were introduced, after transurethral resection (TUR), into a study of intravesical chemoprophylaxis with mitoxantrone (20 mg diluted in 50 ml). After a mean follow-up of 23 months, 16 (50%) patients showed a superficial recurrence with a mean recurrence rate of 0.56 per year. In 19 patients with recurring tumours the mean recurrence rate decreased from 1.65 to 0.58 per year. 9 patients (25.7%) suffered from a chemical cystitis that in 2 cases (5.7%) required treatment interruption.

The role of epipodophyllotoxin derivatives in bladder cancer.

Past and present experiences with podophyllin derivatives in bladder cancer are described. A preliminary study of teniposide was conducted in 1975 at the Institute of Urology, University of Palermo, in patients with advanced or superficial bladder cancer. In 18 patients with advanced bladder cancer, teniposide was administered intravenously (IV), followed in seven patients by peptichemio or doxorubicin. One complete response (CR) and four partial responses (PRs) were achieved. In 24 patients with superficial tumors, teniposide at a dose of 50 mg dissolved in 30 mL normal saline was administered intravesically as ablative therapy or as prophylaxis following transurethral resection (TUR). Of 12 patients in the ablative therapy group, two CRs and two PRs were achieved. Only 2 patients of 12 in the prophylaxis group relapsed within 6 months. In five cases, teniposide was administered in combination with peptichemio. In recent years, the Urological Group of the European Organization for the Research and Treatment of Cancer (EORTC) has performed a phase II study in which teniposide was used in combination with cisplatin given IV in the treatment of advanced bladder cancer. The EORTC group has also performed a randomized study to compare intravesical teniposide versus thiotepa versus no treatment other than initial resection. A brief report on both studies is given. In December 1987, a study was initiated to evaluate intravesical etoposide use in the prophylaxis of recurrences of superficial transitional cell carcinoma of the bladder. Intravesical etoposide (200 mg dissolved in 50 mL saline solution) was administered at weekly intervals for the first month after TUR and then monthly for 11 months. Of 38 evaluable patients, 20 had recurrences at a mean follow-up of 14 months. No systemic toxicity was noted.

Carcinoma of the prostate. Guidelines for treatment: the role of antiandrogens.

Our preliminary experience shows that flutamide is effective in patients with stage C or D prostate cancer. Local and distant response rates are comparable to those obtained with "classic" hormone therapy. Libido and sexual potency generally are unaffected. Palliation of symptoms, which is frequent, is usually accompanied by improved performance status and quality of life. Side effects are slight or moderate, but elevated transaminase levels in patients with borderline liver insufficiency are possible.

Combined renal and pyelic fusion with crossed ectopia of single ureter.

A case of a forty-five-year-old woman with fused kidneys and intercommunicating pelves drained by a single ureter crossing the midline is reported. A review of the literature is presented.

Results of conservative treatment (transurethral resection plus adjuvant intravesical chemotherapy) in patients with primary T1, G3 transitional cell carcinoma of the bladder.

OBJECTIVES: To evaluate a selected population of 50 consecutive patients with primary T1, G3 bladder transitional cell carcinoma in the absence of carcinoma in situ (Tis) treated with a bladder-sparing approach. METHODS: Between January 1983 and December 1992, all patients were treated by transurethral resection (TUR) plus adjuvant intravesical chemotherapy over 1 year. In most cases, doxorubicin, epirubicin, and mitomycin were used alone or in combination. RESULTS: At a mean follow-up period of 52 months (range, 18 to 126), 16 of 50 patients (32%) showed a recurrent superficial tumor. The recurrent lesion was of Stage T1 in 11 (22%) cases, but was a T1, G3 tumor only in 5 cases (10%). In 2 additional patients (4%) a Tis developed during the observation period after TUR. The mean interval between TUR and first recurrence was 14.6 months (range, 3 to 38). At a mean time of 17 months after the initial TUR, 3 patients (6%) underwent a radical cystectomy due to a progression in T category and 3 additional patients (6%) developed distant metastases at a mean time of 23 months after TUR. In brief, 84% of the patients are alive and tumor-free. Five patients (10%) died of bladder cancer with a mean follow-up of 52 months. CONCLUSIONS: If no concomitant Tis exist, a conservative approach is a legitimate option as an initial treatment of patients with primary T1, G3 bladder tumors.

Antiandrogens alone or in combination for treatment of prostate cancer: the European experience.

In Europe, antiandrogens have been used for many years to treat prostate cancer, either as monotherapy or as part of a "combination therapy" with either surgical or chemical castration. However, considerable debate still exists regarding the relative benefits of combination therapy versus antiandrogen monotherapy or castration alone. This article reviews the European experience with antiandrogen therapy, including the personal experiences of the authors.

Urinary NMP22 for the detection of recurrence after transurethral resection of transitional cell carcinoma of the bladder: experience on 137 patients.

OBJECTIVES: To evaluate the nuclear matrix protein 22 (NMP22) test in the management of patients after transurethral resection (TUR) of recurrent transitional cell carcinoma of the bladder. METHODS: The NMP22 test was performed in 137 patients: in 42 patients, a bladder recurrence was detected by cystoscopy and histologically confirmed; 95 patients were recurrence-free at cytology and cystoscopy performed at least 3 months after TUR. RESULTS: In patients with tumoral recurrence, the mean NMP22 value was 54.8 U/mL. The false-negative rate was 28.5%. In recurrence-free patients, the mean NMP22 value was 22.8 U/mL. The specificity of the NMP22 test was 61%. Higher NMP22 mean values (29.6 versus 15.8 U/mL) were found in patients who underwent intravesical chemotherapy or immunotherapy. CONCLUSIONS: Despite its good sensitivity, the NMP22 test cannot be adopted as a routine tool in the surveillance after TUR of patients with superficial bladder cancer because of its low specificity.

Idarubicin in the intravesical treatment of superficial transitional-cell carcinoma of the bladder (ta-t1) - a phase I-ii study.

Local recurrences of superficial transitional cell carcinoma of the bladder (TCCB) can be significantly reduced by intravesical treatment following transurethral resection (TUR) but they are not fully abolished. There is a need to gain experience with new agents. Anthracyclines, such as doxorubicin and epirubicin, have been clearly demonstrated to be active against superficial TCCB by intravesical route. Idarubicin is an anthracycline, much more lipophilic than doxorubicin, inhibiting tumour cell growth at lower concentrations. The aim of this study was to evaluate the tolerability and the ablative efficacy on a marker lesion of weekly intravesical instillations of idarubicin given at different doses and concentrations. Seventeen patients, affected by superficial TCCB, Ta-T1 G1-G2, after TUR of all tumours except one, that was used as a 'marker lesion', were treated intravesically with idarubicin weekly for two months. The drug, in the first 4 patients, was administered at the dose of 15 mg diluted in 30 mi of normal saline solution and maintained in the bladder for one hour. Because of severe chemical cystitis, the dose was reduced to 10 mg in 40 mi in the following 13 patients. The study was closed because of the severe local toxicity. In eight (47%) patients the treatment was interrupted for local toxicity between the first and sixth week and in 5 more patients pharmacological therapy was required because of severe chemical cystitis. No systemic toxicity was evident. Three patients achieved a complete response. Our experience shows that idarubicin is not indicated in the intravesical therapy of superficial TCCB because of severe chemical cystitis limiting the administration of doses able to explicate a relevant antitumoral action.

Endoprosthesis implantation in the treatment of recurrent urethral stricture: a multicenter study. Sicilian-Calabrian Urology Society.

PURPOSE: This study was conducted by nine urology departments in southern Italy to assess the efficacy of and tolerance to treatment of recurrent urethral stricture using a permanent prosthesis. PATIENTS AND METHODS: Since 1992, 99 prostheses have been implanted to treat inflammatory and iatrogenic (seven departments) or all types (two departments) of urethral strictures. The Urolume Wallstent was used in 94 cases. Three centers implanted more than one prosthesis when this was indicated. Local anesthesia was used by six centers, spinal anesthesia by two, and local or general by one. At three centers, urethrotomy was performed immediately prior to implantation; two centers used dilation to 30F, and two centers performed urethrotomy 24 or 36 hours before implantation. The median follow-up is 29.1 months (range 3-53 months). RESULTS: The results were good in 52%, fair in 34%, and poor in 14% of patients. The maximum flow rate increased >75% in 82% of patients. All departments reported complete reepithelialization of the urethra by 6 months. The short-term complications (7-28 days) were perineal discomfort (86%) and dribbling (14%). The long-term complications were painful erection (44%), mucous hyperplasia (44%), recurring stricture (29%), and incontinence (14%). All departments performed resection for hyperplasia in many cases. CONCLUSION: Permanent urethral endoprostheses can produce excellent results in patients with recurrent urethral strictures.

Current views on intravesical treatment and chemoprophylaxis of superficial bladder cancer. The present role of epirubicin and doxorubicin.

Since 1972, a large number of studies have shown that intravesical treatment with doxorubicin (adriamycin) is effective against carcinoma in situ and multiple papillary tumors. Furthermore, it significantly reduces the recurrence rate after transurethral resection. Its efficacy has been compared with that of Bacillus Calmette-Guerin (BCG), which is the only treatment accepted by the US Food and Drug Administration for therapy of carcinoma in situ (Tis). In more recent years, a few studies have been performed using intravesical epirubicin in the hope that different properties of the molecule might enhance the activity of the anthracyclines, but produce fewer and milder side-effects. After weekly instillations of epirubicin (50 mg in 50 ml of sterile water) a complete response is achieved in 47% of patients with a histologically proven papillary marker lesion. The prophylactic efficacy of even a single instillation of epirubicin within 6 hours after transurethral resection (TUR) was proved in a randomized study (30863) of the EORTC (European Organization for Research on Therapy of Cancer) Urological Group. A randomized Italian trial (Blinst 4) of chemoprophylaxis after TUR investigated the efficacy of different intravesical administration schedules of epirubicin (50 mg in 50 ml of sterile water). All treatment regimens were more effective than no treatment. The sequential intravesical combination of epirubicin and interferon-alpha-2b has shown, in our personal experience, encouraging clinical results and our laboratory data suggest the synergic activation of the local immune response.

Queyrat's erythroplasia of the prepuce: a case-report.

A case of Queyrat's erythroplasia of the prepuce is reported. The Authors emphasize the precancerous role of the lesion because of its high frequency of malignant transformation. Local excision appears to be the only adequate form of treatment.

[The Urologic Cooperative Group of the EORTC. Structure, scope, research, results]. / Il gruppo cooperativo urologico dell'EORTC. Struttura, scopi, ricerche, risultati.

The European Organization for Research and Treatment of Cancer (EORTC) was founded in 1962. The first urological group was French-speaking and concentrated particularly on testicular tumours. Shortly after, an English-speaking group started its activities in Yorkshire, with main emphasis on prostate cancer, and a "bladder cancer group" attracted many urologists from Belgium and other European countries. In 1976 all these groups were fused into a one new urological group of which M. Pavone-Macaluso from Palermo, Italy, secretary of the French-speaking group, was chosen as secretary and then chairman of the unified group, whereas Ph. Smith from Leeds, UK, chairman of the English-speaking group, was elected as chairman and later as secretary of the new group. The two "founding fathers" celebrated the 10th and 20th anniversaries of the foundation of the group respectively in Leeds in 1986 and in Palermo in 1996. Later chairman were L. Denis, Belgium; F. Schröder, The Netherlands; D. Newling, UK; F. Debruyne, The Netherlands and R. Hall, UK. A. van der Meijden, The Netherlands, will take over in 1997. The present secretary is A.V. Bono from Varese, Italy. The present structure of the group consists of a variety of working parties (disease-orientated groups), with special interest in a given pathology (such as prostate cancer, superficial or advanced bladder cancer, etc.) and of other committees (chemotherapy, quality of life, quality control). All the activities are coordinated by a Data Centre in Brussels, that is responsible for the statistical support. In its 20 years of activity the group has made many contributions of significance which have coincided with a number of changes in the urological oncology and have obtained international recognition. The paper analyses in detail the most significant of the group's achievements in the various fields of urological oncology.

[Conservative treatment of locally advanced bladder carcinoma: neoadjuvant chemotherapy, TUR and radiotherapy. Results in 40 patients]. / Trattamento conservativo del carcinoma vescicale localmente avanzato: chemioterapia neoadiuvante, TUR e radioterapia. Risultati su 40 pazienti.

PURPOSE: to assess the results of bladder preservation in infiltrating bladder cancer. The potential for neoadjuvant chemotherapy followed by extensive TUR and radiotherapy was investigated in 40 patients with T2-T4a G2-G3 bladder carcinoma. MATERIALS AND METHODS: from 1983 to 1995, 40 patients were submitted to bladder-sparing treatment consisting of neoadjuvant chemotherapy, extensive, TUR and radiotherapy. Most patients had T3G3 cancer. Cystectomy was not performed due to patient" choice in 29 cases (72.5%), for severe pulmonary or cardiovascular disease in disease in 9 patients (22.5) and age over 80 in 2 (5%) patients. A deep TUR-biopsy was performed before and after chemotherapy and an extensive TUR was repeated at the end of radiotherapy. In the first 30 patients chemotherapy consisted of 2-4 cycles of 70 mg/m2 cisplatin on fay 1, and 40 mg/m2 methotrexate on days 8 and 15. In the last 10 patients chemotherapy consisted of 3 cycles of CMV (100 mg/m2 cisplatin on day 2, 30 mg/m2 of vinblastine on days 1 and 8). Total dose of radiotherapy was 60-65 Gy. Recurrent superficial tumors were treated transurethrally. Radical cystectomy, when feasible, was considered for persistent or recurrent invasive disease. RESULTS: after chemotherapy, a clinical objective response was obtained in 27 patients (67.5%), 19 (47.5%) of whom showed a complete response. Thirteen (32.5%) patients showed no response and 5 (12.5%) progressed during chemotherapy. After extensive TUR of any residual mass and radiotherapy, a complete response was achieved in 6 patients who initially showed a partial response and in other 2 patients and stable disease after chemotherapy. Altogether, 27 patients (67.5%) presented had local recurrences, 3 patients underwent cystectomy. Fourteen patients (35%) are alive and 13 NED (65 months mean survival). Five patients died of unrelated disease. Twenty-one patients (52.5%) died of distant metastases (mean survival 28 months). Four patients presented distant metastases after vesical infiltrating recurrence and 4 patients had distant metastases in the absence of loco-regional recurrence. Twenty-two patients (55%) maintained an intact bladder. Patients with complete response to chemotherapy showed a low risk for developing recurrent infiltrating tumors and metastases. CONCLUSIONS: A complete tumor was maintained at 5 years in over 50% of the patients conservatively treated. Bladder salvage is feasible in selected patients.

[Antibiotic prophylaxis in prostate biopsy]. / La profilassi antibiotica nell'agobiopsia prostatica.

INTRODUCTION: Prostate biopsy is nowadays one of the most frequent diagnostic procedures in urology. The incidence of bacteraemia, bacteriuria and infective complications is higher after the transrectal procedure than after the transperineal one. A survey demonstrated that 98% of the urologists in USA use antibiotics to prevent infective complications. The transrectal prostate biopsy is the only diagnostic intervention procedure in urology for which an antibiotic prophylaxis is recommended, also for low-risk patients, by the guidelines of the European Association of Urology. If the perineal route is adopted, the antibiotic prophylaxis is recommended only in high-risk patients. MATERIALS AND METHODS: The patient should preferably receive an evacuative enema to achieve a rectal cleansing and to ameliorate the diagnostic accuracy of transrectal ultrasound. A survey in the US demonstrated that an evacuative enema with saline solution is adopted by more than 80% of urologists. Criteria for antibiotics choice. The majority of bacteraemias are transitory, asymptomatic and self-limiting. On the other side, bacteriuria can persist for several days. Antibiotics must achieve high drug concentrations not only in plasma and tissue but also in urine. Symptomatic infections are generally caused by E. Coli and less frequently by the Streptococcus faecalis. Nevertheless, other agents as Klebsiella and Chlostridium, although rare, might cause severe infections. Thus, prophylaxis needs antibiotics at large spectrum and a single agent may not be enough for high-risk patients. Risk determination and drug schedules. It is essential to point out the infective risk of the patient. The choice of the drug, the timing and schedule of antibiotic prophylaxis are still object of debate. Several randomized studies have been conducted with contradictory results. RESULTS: The antibiotic prophylaxis should be tailored according to patients? infective risk and to the procedure adopted. It is able to reduce infections rate after transrectal biopsy below 5%. The adoption of periprostatic anesthesia and the number of cores can influence the incidence of infective complications. Commonly, one-three days oral administration of fluoroquinolone is adopted. A single-dose prophylaxis can be also used with favorable results. Tolerability and route of administration should be taken into account, and also costs should be considered. CONCLUSIONS: Considering the low cost of antibiotics adopted as short-term prophylaxis and the high cost of the treatment of infective complications, it seems reasonable to provide antibiotics prophylaxis for all patients at high risk for infective complications and for all cases submitted to transrectal prostate biopsy.