Search

Background: A new edition of the TNM was recently released that includes modifications for the staging system of kidney cancers. Specifically, T2 cancers were subclassified into T2a and T2b ( 10 cm), tumors with renal vein involvement or perinephric fat involvement were classified as T3a cancers, and those with adrenal involvement were classified as T4 cancers. Objective: Our aim was to validate the recently released edition of the TNM staging system for primary tumor classification in kidney cancer. Design, setting, and participants: Our multicenter retrospective study consisted of 5339 patients treated in 16 academic Italian centers. Intervention: Patients underwent either radical or partial nephrectomy. Measurements: Univariable and multivariable Cox regression models addressed cancer-specific survival (CSS) after surgery. Results and limitations: In the study, 1897 patients (35.5%) were classified as pT1a, 1453 (27%) as pT1b, 437 (8%) as pT2a, 153 (3%) as pT2b, 1059 (20%) as pT3a, 117 (2%) as pT3b, 26 (0.5%) as pT3c, and 197 (4%) as pT4. At a median follow-up of 42 mo, 786 (15%) had died of disease. In univariable analysis, patients with pT2b and pT3a tumors had similar CSS, as did patients with pT3c and pT4 tumors. Moreover, both pT3a and pT3b stages included patients with heterogeneous outcomes. In multivariable analysis, the novel classification of the primary tumor was a powerful independent predictor of CSS (p for trend < 0.0001). However, the substratification of pT1 tumors did not retain an independent predictive role. The major limitations of the study are retrospective design, lack of central pathologic review, and the small number of patients included in some substages. Conclusions: The recently released seventh edition of the primary tumor staging system for kidney tumors is a powerful predictor of CSS. However, some of the substages identified by the classification have overlapping prognoses, and other substages include patients with heterogeneous outcomes. The few modifications included in this edition may have not resolved the most critical issues in the previous version. (C) 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Study Type - Therapy (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Few studies supported the expanded indications for nephron-sparing surgery (NSS) in selected patients with 4.1 cm renal tumours in the size range (T1b). However, all these comparative studies included both imperative and elective partial nephrectomy and patient selection for analysis was based on pathological stage (pT1) and not on clinical stage (cT1). Patients with clinically organ-confined RCC (cT1) who are candidates for elective PN have a limited risk of clinical understaging. NSS is not associated with an increased risk of recurrence and cancer-specific mortality both in cT1a and cT1b tumours OBJECTIVE: • To compare the oncological outcomes of patients who underwent elective partial nephrectomy (PN) or radical nephrectomy (RN) for clinically organ-confined renal masses ≤7 cm in size (cT1). PATIENTS AND METHODS: • The records of 3480 patients with cT1N0M0 disease were extracted from a multi-institutional database and analyzed retrospectively. RESULTS: • In patients who underwent PN, the risk of clinical understaging was 3.2% in cT1a cases and 10.6% in cT1b cases. • With regard to the cT1a patients, the 5- and 10-year cancer-specific survival (CSS) estimates were 94.7% and 90.4%, respectively, after RN and 96.1% and 94.9%, respectively, after PN (log-rank test: P = 0.01). • With regard to cT1b patients, the 5-year CSS probabilities were 92.6% after RN and 90% after PN, respectively (log-rank test: P = 0.89). • Surgical treatment failed to be an independent predictor of CSS on multivariable analysis, both for cT1a and cT1b patients. • Interestingly, PN was oncologically equivalent to RN also in patients with pT3a tumours (log-rank test: P = 0.91). CONCLUSIONS: • Elective PN is not associated with an increased risk of recurrence and cancer-specific mortality in both cT1a and cT1b tumours. • Data from the present study strongly support the use of partial nephrectomy in patients with clinically T1 tumours, according to the current recommendations of the international guidelines.

Study Type - Outcomes (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? About 80% of RCCs have clear cell histology, and consistent data are available about the clinical and histological characteristics of this histological subtype. Conversely, less attention has been dedicated to the study of non-clear cell renal tumours Specifically, published data show that chromophobe RCC (ChRCC) have often favourable pathological stages and better nuclear grades as well as a lower risk of metastasizing compared with clear cell RCC (ccRCC). Patients with ChRCC were shown to have significantly higher cancer-specific survival (CSS) probabilities compared with ccRCC. However, an independent prognostic role of RCC histotype was not confirmed in some large multicenter series and only a few studies have focused on the oncological outcomes of ChRCC. The present study is one of the few to evaluate cancer-related outcomes of ChRCC and represents to our knowledge the largest series of ChRCCs. Consequently, the present findings may assist in elucidating the natural history of surgically treated ChRCC. The present study confirms that ChRCCs have good prognosis and a low tendency to progress and metastasize. Only 1.3% of patients presented with distant metastases at diagnosis, and the 5- and 10-year CSS were 93% and 88.9%, respectively. However, although ChRCCs are generally characterised by an excellent prognosis, we observed that patients with locally advanced or metastatic cancers as well as those with sarcomatoid differentiation have a poor outcome. The study also investigated prognostic factors for recurrence-free survival (RFS) and CSS for this RCC histotype. The definition of outcome predictors can be useful for patient counselling, planning of follow-up strategies, and patient selection for clinical trials. In the present study, gender, clinical T stage, pathological T stage, and presence of sarcomatoid differentiation were significantly associated with RFS and CSS at multivariable analysis. We also identified N/M stage as an independent predictor of CSS. Notably, as Fuhrman grade was not an independent predictor of cancer-related outcomes, the present study confirms that this histological variable is not a reliable prognostic factor for ChRCC. OBJECTIVES: To investigate cancer-related outcomes of chromophobe renal cell carcinoma (ChRCC) in a large multicentre dataset. To determine prognostic factors for recurrence-free survival (RFS) and cancer-specific survival (CSS) for this RCC histological type. PATIENTS AND METHODS: In all, 291 patients with ChRCC were identified from a multi-institutional retrospective database including 5463 patients who were surgically treated for RCC at 16 Italian academic centres between 1995 and 2007. Univariable and multivariable Cox regression models were used to identify prognostic factors predictive of RFS and CSS after surgery for ChRCC. RESULTS: At a median follow-up of 44 months, 25 patients (8.6%) had disease recurrence and 18 patients (6.2%) died from disease. The 5-year RFS and CSS rates were 89.3% and 93%, respectively. Gender (P= 0.014), clinical T stage (P= 0.017), pathological T stage (P= 0.003), and sarcomatoid differentiation (P= 0.032) were independent predictors of RFS at multivariable analysis. For CSS, there was an independent prognostic role for gender (P= 0.032) and T stage (P= 0.019) among the clinical variables and for T stage (P= 0.016), N/M stage (P= 0.023), and sarcomatoid differentiation (P= 0.015) among the pathological variables. CONCLUSIONS: Patients with ChRCC have a low risk of tumour progression, metastasis, and cancer-specific death. Patient gender, clinical and pathological tumour stage, and sarcomatoid differentiation are significant predictors of RFS and CSS for ChRCC.

Prostate cancer (PCa) is a common malignancy in men associated with an increase in the incidence rate. Radical prostatectomy (RP) or external beam radiotherapy (EBRT) represents the most employed treatments for the local control of disease. However, 10-50% of patients who experienced a recurrence of disease after primary treatments can benefit from salvage or palliative therapies. To date, prostate specific antigen (PSA) is usually used in clinical practice to monitor the status of disease and to early detect the recurrence of PCa. Nevertheless, PSA cannot discriminate the presence of local vs. distant metastatic disease. Circulating tumor cells are considered as a sign of disease widespread, but their correlation with metastatic PCa and local recurrence of disease is still indeterminate. Digital rectal exploration and transrectal ultrasonography are considered the first clinical and diagnostic approach to identify the local recurrence of PCa, but are associated with a low detection rate and low diagnostic accuracies. Conversely, magnetic resonance imaging (MRI) has gained a great importance in this setting of disease, being able to determine the presence of local recurrence with high sensitivity, also in the presence of low serum PSA levels. Lastly, the introduction of positron emission tomography/computed tomography (PET/CT) with radiolabeled choline agents let to improve the management of patients with early recurrence of disease, although its accuracy is linked to the PSA and PSA dynamic values. New radiopharmaceutical agents, like 68Ga-PSMA or 18F-FACBC and others could improve the diagnostic accuracy of PET/CT, but the data is still preliminary. In the present review we will discuss both clinical and diagnostic instrumentations, actually available in clinical practice, able to early identify the presence of recurrent PCa and to differentiate between local and distant relapse of tumor.

Objective: Diet interventions may reduce the risk of urinary stone formation and its recurrence, but there is no conclusive consensus in the literature regarding the effectiveness of dietary interventions and recommendations about specific diets for patients with urinary calculi. The aim of this study was to review the studies reporting the effects of different dietary interventions for the modification of urinary risk factors in patients with urinary stone disease. Materials and Methods: A systematic search of the Pubmed database literature up to July 1, 2014 for studies on dietary treatment of urinary risk factors for urinary stone formation was conducted according to a methodology developed a priori. Studies were screened by titles and abstracts for eligibility. Data were extracted using a standardized form and the quality of evidence was assessed. Results: Evidence from the selected studies were used to form evidencebased guideline statements. In the absence of sufficient evidence, additional statements were developed as expert opinions. Conclusions: General measures: Each patient with nephrolithiasis should undertake appropriate evaluation according to the knowledge of the calculus composition. Regardless of the underlying cause of the stone disease, a mainstay of conservative management is the forced increase in fluid intake to achieve a daily urine output of 2 liters. Hypercalciuria: Dietary calcium restriction is not recommended for stone formers with nephrolithiasis. Diets with a calcium content ≥ 1 g/day (and low protein-low sodium) could be protective against the risk of stone formation in hypercalciuric stone forming adults. Moderate dietary salt restriction is useful in limiting urinary calcium excretion and thus may be helpful for primary and secondary prevention of nephrolithiasis. A low-normal protein intake decrease calciuria and could be useful in stone prevention and preservation of bone mass. Omega-3 fatty acids and bran of different origin decreases calciuria, but their impact on the urinary stone risk profile is uncertain. Sports beverage do not affect the urinary stone risk profile. Hyperoxaluria: A diet low in oxalate and/or a calcium intake normal to high (800-1200 mg/day for adults) reduce the urinary excretion of oxalate, conversely a diet rich in oxalates and/or a diet low in calcium increase urinary oxalate. A restriction in protein intake may reduce the urinary excretion of oxalate although a vegetarian diet may lead to an increase in urinary oxalate. Adding bran to a diet low in oxalate cancels its effect of reducing urinary oxalate. Conversely, the addition of supplements of fruit and vegetables to a mixed diet does not involve an increased excretion of oxalate in the urine. The intake of pyridoxine reduces the excretion of oxalate. Hyperuricosuria: In patients with renal calcium stones the decrease of the urinary excretion of uric acid after restriction of dietary protein and purine is suggested although not clearly demonstrated. Hypocitraturia: The administration of alkaline-citrates salts is recommended for the medical treatment of renal stone-formers with hypocitraturia, although compliance to this treatment is limited by gastrointestinal side effects and costs. Increased intake of fruit and vegetables (excluding those with high oxalate content) increases citrate excretion and involves a significant protection against the risk of stone formation. Citrus (lemons, oranges, grapefruit, and lime) and non citrus fruits (melon) are natural sources of dietary citrate, and several studies have shown the potential of these fruits and/or their juices in raising urine citrate levels. Children: There are enought basis to advice an adequate fluid intake also in children. Moderate dietary salt restriction and implementation of potassium intake are useful in limiting urinary calcium excretion whereas dietary calcium restriction is not recommended for children with nephrolithiasis. It seems reasonable to advice a balanced consumption of fruit and vegetables and a low consumption of chocolate and cola according to general nutritional guidelines, although no studies have assessed in pediatric stone formers the effect of fruit and vegetables supplementation on urinary citrate and the effects of chocolate and cola restriction on urinary oxalate in pediatric stone formers. Despite the low level of scientific evidence, a low-protein (< 20 g/day) low-salt (< 2 g/day) diet with high hydration (> 3 liters/day) is strongly advised in children with cystinuria. Elderly: In older patients dietary counseling for renal stone prevention has to consider some particular aspects of aging. A restriction of sodium intake in association with a higher intake of potassium, magnesium and citrate is advisable in order to reduce urinary risk factors for stone formation but also to prevent the loss of bone mass and the incidence of hypertension, although more hemodynamic sensitivity to sodium intake and decreased renal function of the elderly have to be considered. A diet rich in calcium (1200 mg/day) is useful to maintain skeletal wellness and to prevent kidney stones although an higher supplementation could involve an increase of risk for both the formation of kidney stones and cardiovascular diseases. A lower content of animal protein in association to an higher intake of plant products decrease the acid load and the excretion of uric acid has no particular contraindications in the elderly patients, although overall nutritional status has to be preserved.

The natural history of urolithiasis includes the risk of recurrence and of the development of chronic kidney and/or bone disease, which is why a thorough clinical and metabolic evaluation of these patients is of the utmost importance at disease onset. This paper is aimed at identifying the type of urolithiasis, the related risk factors, and the corresponding treatment options. The diagnostic and therapeutic approach described here includes 1) accurate history taking to detect secondary nephrolithiasis and screen for the main risk factors for kidney and bone disease; 2) metabolic evaluation graded according to different complexity levels based on the severity of the disease and the presence of risk factors; 3) carrying out appropriate imaging procedures. The resulting information allows to plan treatment based either on general rules of lifestyle and diet, or on selected medical intervention, if necessary. This report, which is based on current guidelines, was produced by the Gruppo Italiano di Studio Multidisciplinare per la Calcolosi Renale. It is addressed to all professionals involved in the management of patients suffering from nephrolithiasis, first of all general practitioners, who often become involved immediately at the onset of the disease.

Aims: To compare the pathological stage and surgical margin status in patients undergoing either immediate radical prostatectomy or 12 and 24 weeks of neoadjuvant hormonal treatment (NHT) in a prospective, randomised study. Methods: Whole mount sections of 393 radical prostatectomy specimens were evaluated: 128 patients had immediate surgery, 143 were treated for 12 weeks and 122 for 24 weeks with complete androgen blockade. Results: Histopathology revealed organ confined tumours in 40.4% of patients with clinical stage B disease in the immediate surgery group, whereas 12 and 24 weeks of NHT increased the number of organ confined tumours to 54.6% and 64.8%, respectively. Among patients with clinical stage C tumours, pathological staging found organ confined disease in 10.4%, 31.4%, and 61.2% in the immediate surgery, 12 weeks of NHT, and 24 weeks of NHT groups, respectively. Preoperative NHT caused a significant decrease in positive margins both in patients with clinical stage B and C disease. The extent of margin involvement was not influenced by preoperative treatment. Conclusions: Neoadjuvant androgenic suppression is effective in reducing both the pathological stage and the positive margin rate in patients with stage B and C prostatic cancer undergoing radical surgery. Some beneficial effects are evident in those patients treated for 24 weeks, and it is reasonable to assume that the optimal duration of NHT is longer than three months.

OBJECTIVE: To compare the perioperative, pathological and functional outcomes in two contemporary, large series of patients in different institutions and who underwent open partial nephrectomy (OPN) or robot-assisted PN (RAPN) for suspected renal tumours. PATIENTS AND METHODS: This was a retrospective, multicentre, international, matched-pair analysis comparing patients who underwent RAPN or OPN for suspected renal cell carcinoma. Data on patients who underwent OPN were extracted by an Italian observational registry collecting data from 19 different centres. Data on patients who received RAPN were extracted from a multicentre, international database collecting cases treated in four high-volume referral centres of robotic surgery. The matching was in a 1:1 ratio for the surgical approach and included 200 patients in each arm. RESULTS: The mean warm ischaemia time was shorter in the OPN group than in the RAPN group, at a mean (SD) of 15.4 (5.9) vs 19.2 (7.3) min (P < 0.001). Conversely, the median (interquartile range) estimated blood loss was 150 (100-300) mL in the OPN group and 100 (50-150) mL in the RAPN group (P < 0.001). There were no differences in operating time (P = 0.18) and the intraoperative complication rate (P = 0.31) between the approaches. Postoperative complications were recorded in 43 (21.5%) patients who underwent OPN and in 28 (14%) who received RAPN (P = 0.02). Moreover, major complications (grade 3-4) were reported in nine (4.5%) patients after OPN and in nine (4.5%) after RAPN. Positive margins were detected in nine (5.5%) patients after OPN and in nine (5.7%) after RAPN (P = 0.98). The mean (SD) 3-month estimated glomerular filtration rate declined by 16.6 (18.1) mL/min from the preoperative value in the OPN group and by 16.4 (22.9) mL/min in the RAPN group (P = 0.28). CONCLUSION: RAPN can achieve equivalent perioperative, early oncological and functional outcomes as OPN. Moreover, RAPN is a less invasive approach, offering a lower risk of bleeding and postoperative complications than OPN

An observational study was planned by the QuABIOS group, to survey the hormonal treatment administered to prostate cancer patients in Italy within a time window of 12 months. We report here a prospective quality of life (QOL) evaluation over time and by hormonal treatment modalities.Patients with diagnosis of prostate cancer and treated with hormonal therapy were eligible for this study. The EORTC QLQ-C30 v.3 questionnaire was administered at enrolment, after 6 months and after 12 months from enrolment.587 patients were enrolled by 33 urological centers. When 1518 visits were considered together independently of time, antiandrogen monotherapy was associated with a significantly better QOL than LHRH-analogue containing treatment modalities in almost all functional scales; cyproterone acetate demonstrated a better physical function and general health status than bicalutamide. When QOL was analyzed in a prospective 12-month window, a worsening of physical function and general health status was observed, notwithstanding, antiandrogens remained significantly associated to a better QOL than LHRH-analogue therapies also over time: a favourable physical function and general health status appeared again to be related to cyproterone acetate than bicalutamide.Androgen deprivation therapy is associated with decline in QOL, particularly in the domains of physical function, energy, and general health status. This survey demonstrated that antiandrogens had a better QOL profile than LHRH-analogue containing therapies;furthermore, a more favourable tolerability for cyproterone acetate as compared to bicalutamide is suggested.

Study Type - Therapy (multi-centre cohort) Level of Evidence3b What's known on the subject? and What does the study add? In RCC about 5% of the patients presented multifocal disease. Prevalence of tumour multifocality was associated with a higher percentage of symptomatic RCC, higher pathological TNM stages, higher tumour grade and higher prevalence of tumour necrosis. Although in univariable analysis multifocal tumours had lower probability of CSS, tumour multifocality did not retain an independent predictive role in multivariable analysis. Patient age at surgery, gender, mode of presentation, pathological N stage and presence of metastases were independent predictors of CSS in multivariable analyses. OBJECTIVE: To evaluate the prevalence and the prognostic role of multifocality in a large multi-institutional series of patients who underwent radical or partial nephrectomy for renal cell carcinoma (RCC). METHODS: We retrospectively collected the data of 5378 patients who were surgically treated for RCC in 16 academic centres involved in the Surveillance and Treatment Update Renal Neoplasms (SATURN) project. Univariable and multivariable Cox regression models addressed time to cancer-specific survival (CSS) after surgery. RESULTS: Tumour multifocality was identified in 249 patients (5%). The median follow-up of the whole cohort was 42 months. At last follow-up, 786 (14.6%) were dead of cancer and 336 (6.2%) had experienced non-cancer-related death. The 5- and 10-year CSS estimates were 84.1% and 77.3%, respectively, in patients with monofocal RCC, compared with 71.1% and 63.6%, respectively, in patients with multifocal disease (P < 0.001). In univariable Cox regression analysis, tumour multifocality was significantly associated with CSS (hazard ratio [HR]= 1.83; P < 0.001). On multivariate Cox regression analysis adjusted for the effects of other covariates, tumour multifocality did not retain an independent predictive value (HR = 1.24; P= 0.291). CONCLUSIONS: In the present multi-institutional collaboration, about 5% of the patients presented multifocal RCC. The presence of multifocal cancer was associated with some unfavourable clinical and pathological features. Although in univariable analysis multifocal tumours had lower CSS probabilities, tumour multifocality did not retain an independent predictive role in multivariable analysis, once adjusted for the effect of the other clinical and pathological covariates.

The likelihood of finding organ-confined untreated prostate cancer (PCa) by pathological examination at the time of radical prostatectomy (RP) is only 50% in patients with clinically organ-confined disease. In addition, tumour is present at the resection margin in approximately 30% of clinical T2 (clinical stage B) cases. The issue of clinical "understaging" and of resection limit positivity have led to the development of novel management practices, including "neoadjuvant" hormonal therapy (NHT). The optimal duration of NHT is unknown. We undertook the present analysis to evaluate the effect of NHT on pathologic stage of PCa and resection limit status in patients with prostate cancer and treated with total androgen ablation either for three or six months before RP. Between January 1996 and February 1998, 259 men with prostate cancer underwent radical retropubic prostatectomy and bilateral pelvic node dissection in the 26 centres participating in the Italian randomised prospective PROSIT study. Whole mount sectioning of the complete RP specimens was adopted in each centre for accurately evaluating the pathologic stage and resection limit status. By February 1998, haematoxylin and eosin stained sections from 155 RP specimens had been received and evaluated by the reviewing pathologist (RM). 64 cases had not been treated with total androgen ablation (e.g. NHT) before RP was performed, whereas 58 and 33 had been treated for three and six months, respectively. 114 patients were clinical stage B whereas 41 were clinical stage C. After three months of total androgen ablation, pathological stage B was more prevalent among patients with clinical B tumours, compared with untreated patients (57% in treated patients vs. 36% in untreated). The percentage of cancers with negative margins was statistically significantly greater in patients treated with neoadjuvant therapy than those treated with immediate surgery alone (69% vs. 42%, respectively). After six months of NHT therapy the proportion of patients with pathological stage B (67% vs. 36%, respectively) and negative margins was greater than after 3 months (92% vs. 42%, respectively). For clinical C tumours, the prevalence of pathological stage B and negative margins in the patients treated for either 3 or 6 months was not as high as in the clinical B tumours, when compared with the untreated group (pathological stage B: 31% and 33% vs. 6% in the clinical C cases, respectively. Negative margins: 56% and 67% vs. 31%, respectively). The initial results of this study suggest that total androgen ablation before RP is beneficial in men with clinical stage B because of the significant pathological downstaging and decrease in the number of positive margins in the RP specimens. These two effects are more pronounced after six months of NHT than after three months of therapy. The same degree of beneficial effects are not observed in clinical C tumours.

Transurethral resection of the prostate (TURP) has been long debated as a possible cause of erectile dysfunction (ED). We investigated the role of common risk factors for ED in patients aged 60 to 70 undergoing TURP Factors related to the treatment were also considered.Ninety patients underwent TURP for benign prostate hyperplasia (BPH) from June 2002 to February 2003. Fourty-two of them, sexually active aged 60 to 70, were administered preoperatively and 3-month postoperatively the International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF-5) questionnaires. A complete assessment of risk factors for ED was performed in the preoperative setting (treated hypertension, diabetes, cigarette smoking, hypercolesterolemy, cardiovascular disease). IIEF score was related to age, comorbidities, operative time, resected tissue weight, retrograde ejaculation, IPSS score.Nine (21.4%) patients reported worsened IIEF-5 score after TURP, and 33 (78.6%) unchanged/improved score. Cardiovascular disease was present in 56% of patients with worsened IIEF-5 score and in 12% of patients with improved/unchanged IIEF-5 score; it was the only factor that correlated significantly in the regression model.In general, most patients report a stable sexual function after TURP. Patients with known cardiovascular disease undergoing TURP had an increased risk of sexual impairment after this procedure.

BACKGROUND The objective of the current study was to identify independent clinical and pathologic variables that were predictive of lymph node involvement in patients with squamous cell carcinoma of the penis in a multicenter series with the intent to select patients who were suitable to undergo immediate inguinal lymphadenectomy. METHODS Data were analyzed from 175 patients who underwent surgery for penile carcinoma in 11 urologic centers participating in the Gruppo Uro-Oncologico del Nord-Est (Northeast Uro-Oncological Group) Penile Cancer Data Base. Pathologically positive lymph nodes were defined as the presence of histologically confirmed lymph node metastasis in patients who underwent either immediate or delayed inguinal and/or pelvic lymphadenectomy. Patients who had clinically positive lymph nodes with cytologically positive fine-needle aspiration results and who had not undergone lymphadenectomy were censored. RESULTS Overall, lymph-node involvement was observed in 71 of 175 patients (40.6%) included in the analyses. After analyzing the whole group of patients, the following variables were identified as independent predictors of pathologic lymph node metastasis: clinical lymph node status, pathologic stage of the primary tumor, venous and lymphatic embolizations, and histologic grade. In the subgroup of patients with clinically negative lymph nodes, tumor thickness, histologic grade, lymphatic and venous embolizations, infiltration of both corpus spongiosum and urethra, and pathologic stage of the primary tumor (according to the 1997 TNM classification system) were predictive of lymph node involvement on univariate analysis. The generated logistic regression model showed that venous and/or lymphatic embolizations and infiltration of the corpus spongiosum and/or urethra were independent predictors of pathologic lymph node metastasis in patients with clinically negative lymph nodes. CONCLUSIONS Venous and/or lymphatic embolizations played relevant roles as predictors of pathologic lymph node involvement in patients with penile neoplasia and should be considered important parameters in determining which patients with clinically negative lymph nodes should undergo immediate lymphadenectomy. Cancer 2005. © 2005 American Cancer Society.

Objectives. To compare the pathologic stage and surgical margin status in patients undergoing either immediate radical prostatectomy or surgery preceded by 3 or 6 months of neoadjuvant hormonal treatment (NHT) in a prospective, randomized study. Methods. Four hundred thirty-one men with prostate cancer were enrolled in the Italian randomized prospective PROSIT study. The whole-mount sectioning technique was used. By May 1999, the reviewing pathologist had evaluated 303 specimens. One hundred seven patients were untreated before radical prostatectomy was performed, and 114 and 82 patients had been treated for 3 and 6 months, respectively, with complete androgen blockade. Results. Pathologic organ-confined disease was found in 63.1% of patients with clinical Stage B disease treated with 6 months of NHT versus 61.0% after 3 months of NHT and 37.5% after immediate surgery. Among patients with clinical Stage C tumors, pathologic staging found organ-confined disease in 62.5%, 32.1%, and 11.1% of patients after 6 months of NHT, 3 months of NHT, and immediate surgery, respectively. Three months of NHT produced a significant increase in negative margins both in patients with clinical Stage B and C disease, but the addition of another 3 months of treatment did not significantly improve this result. A lower degree of benefit was observed in patients with clinical Stage C tumors. Conclusions. This study shows that complete androgen blockade before surgery is beneficial in men with clinical Stage B disease. The effects are more pronounced after 6 months of NHT than after 3 months.

The paper compares costs and Quality-Adjusted Life Years (QALYs) of different hormonal therapies (HTs) administered to 275 out of 471 patients with prostate cancer (PC) enrolled in the Quality of Life Antiandrogen Blockade Italian Observational Study (QuABIOS), who did not change HT during the study period.QALYs and costs related to monoHT witk cyproterone acetate (CYP) (42 patients); bicalutamide (BIC) (41 patients); LHRH-a (96 patients) and complete androgenic blockade (CAB) with: CYP (CYP CAB) (50 patients); BIC (BIC CAB) (46 patients) were compared via a cost-utility analysis (CUA) adopting the Italian National Healthcare Service (INHS) viewpoint.As no statistical significant difference among the mean QALYs gained with the different HTs was detected (p = 0.116), CUA was replaced by a cost minimization analysis (CMA). However, the lowest and the highest mean QALYs gained per patient were registered for BIC CAB (0.59; 95% CI: 0.50; 0.68) and for for CYP (0.75; 95% CI: 0.68; 0.82), respectively. CYP was the least costly HT, reaching the lowest and the highest savings when compared to LHRH-a (-Euros 974.99; 95% CI: -Euros 1066.86; -Euros 883.12; p0.0001) and to monoHT with BIC (-Euros 5887.81; 95% CI: -Euros 6143.99; -Euros 5631.64; p0.0001). A nonparametric bootstrap sensitivity analysis confirmed the robustness of the base case CMA.CYP is an interesting option for curbing the INHS drug expenditure for PC patients, with a trend towards increasing the mean number of QALYs gained.

We report the case of a 53-year-old man suffering from the contemporary onset of penile Mondor's disease and high-flow priapism 10 days after a transrectal prostate biopsy. We analyzed whether these pathological conditions were causally related to the biopsy, and the role of urologist regarding the onset of one or both the diseases. Critically evaluating the clinical picture and the procedure used for the biopsy, we were able to recognize a connection between the office procedure and the onset of the high-flow priapism, otherwise than for penile Mondor's disease. Our report is of value for urologists, making them aware of such possible complications, and for forensic experts that might have to deal with similar cases, as it demonstrates only a partial involvement of urologist in this clinical setting.

To compare the results of numerical chromosomal changes in chromophobe renal cell carcinoma obtained from whole tissue sections with those of tissue microarrays.Standard sections and tissue microarrays constructed from formalin-fixed and paraffin-embedded chromophobe renal cell carcinomas from 6 patients were subjected to interphase fluorescence in situ hybridization (FISH) using centromeric probes for chromosome 1, 2, 6, 10 and 17. Tissue microarrays were constructed with 3 cores per tumor and 2 cores of normal renal tissue controls.Whole sections of chromophobe renal cell carcinoma showed multiple chromosomal abnormalities in 3 out of 6 cases (case 1, 2, 5). In 2 cases all 5 chromosomes were lost in both whole and tissue microarray cores (cases 2 and 5), and for 1 case (case 1) losses of chromosomes 2, 10 and 17 were detected on both whole and tissue microarray cores. In another 2 cases there were 2 fluorescence signals for chromosomes 1 in the majority of malignant cells (cases 3 and 6), loss of chromosome 6 (case 3), loss of chromosome 2 (case 6) and a mosaic pattern with nuclei showing a mixture of signal losses and gains for the other chromosomes. The remaining tumor did not show abnormalities (case 4). When 2 core biopsies per tumor were examined, the level of substantial concordance of results ranged from 92% to 98%.In this study we have demonstrated that tissue microarrays are a valid substitute for whole tissue sections in large cohort studies of chromophobe renal cell carcinoma when FISH analysis is undertaken. Concordance of results was improved when the number of analyzed cores was increased from 2 to 3, at which point a concordance index ranging from substantial to almost perfect was observed.

Medullary nephrocalcinosis is a rare condition typically observed in metabolic conditions prone to renal calcium stones. Randall's plaques are very frequently observed in the common idiopathic calcium-oxalate nephrolithiasis. These plaques are apatite mineral structures, and we propose they also are an example of nephrocalcinosis. While these calcium deposits are generally considered to be the consequence of purely physico-chemical phenomena, we advance the hypothesis that they form because of a true ectopic biomineralization in the renal tissue. Henle's loop epithelial cells, or pericyte-like interstitial cells, or papillary stem-cells differentiating along a bone lineage could be involved.

Background: There is uncertainty in deferred active treatment (DAT) programmes, regarding patient selection, follow-up and monitoring, reclassification, and which outcome measures should be prioritised. Objective: To develop consensus statements for all domains of DAT. Design, setting, and participants: A protocol-driven, three phase study was undertaken by the European Association of Urology (EAU)-European Association of Nuclear Medicine (EANM)-European Society for Radiotherapy and Oncology (ESTRO)-European Association of Urology Section of Urological Research (ESUR)-International Society of Geriatric Oncology (SIOG) Prostate Cancer Guideline Panel in conjunction with partner organisations, including the following: (1) a systematic review to describe heterogeneity across all domains; (2) a two-round Delphi survey involving a large, international panel of stakeholders, including healthcare practitioners (HCPs) and patients; and (3) a consensus group meeting attended by stakeholder group representatives. Robust methods regarding what constituted the consensus were strictly followed. Results and limitations: A total of 109 HCPs and 16 patients completed both survey rounds. Of 129 statements in the survey, consensus was achieved in 66 (51%); the rest of the statements were discussed and voted on in the consensus meeting by 32 HCPs and three patients, where consensus was achieved in additional 27 statements (43%). Overall, 93 statements (72%) achieved consensus in the project. Some uncertainties remained regarding clinically important thresholds for disease extent on biopsy in low-risk disease, and the role of multiparametric magnetic resonance imaging in determining disease stage and aggressiveness as a criterion for inclusion and exclusion. Conclusions: Consensus statements and the findings are expected to guide and inform routine clinical practice and research, until higher levels of evidence emerge through prospective comparative studies and clinical trials. Patient summary: We undertook a project aimed at standardising the elements of practice in active surveillance programmes for early localised prostate cancer because currently there is great variation and uncertainty regarding how best to conduct them. The project involved large numbers of healthcare practitioners and patients using a survey and face-to-face meeting, in order to achieve agreement (ie, consensus) regarding best practice, which will provide guidance to clinicians and researchers. (C) 2019 Published by Elsevier B.V. on behalf of European Association of Urology.

Context While urinary incontinence (UI) commonly occurs after radical prostatectomy (RP), it is unclear what factors increase the risk of UI development. Objective To perform a systematic review of patient- and tumour-related prognostic factors for post-RP UI. The primary outcome was UI within 3 mo after RP. Secondary outcomes included UI at 3–12 mo and ≥12 mo after RP. Evidence acquisition Databases including Medline, EMBASE, and CENTRAL were searched between January 1990 and May 2020. All studies reporting patient- and tumour-related prognostic factors in univariable or multivariable analyses were included. Surgical factors were excluded. Risk of bias (RoB) and confounding assessments were performed using the Quality In Prognosis Studies (QUIPS) tool. Random-effects meta-analyses were performed for all prognostic factor, where possible. Evidence synthesis A total of 119 studies (5 randomised controlled trials, 24 prospective, 88 retrospective, and 2 case-control studies) with 131 379 patients were included. RoB was high for study participation and confounding; moderate to high for statistical analysis, study attrition, and prognostic factor measurement; and low for outcome measurements. Significant prognostic factors for postoperative UI within 3 mo after RP were age (odds ratio [OR] per yearly increase 1.04, 95% confidence interval [CI] 1.03–1.05), membranous urethral length (MUL; OR per 1-mm increase 0.81, 95% CI 0.74–0.88), prostate volume (PV; OR per 1-ml increase 1.005, 95% CI 1.000–1.011), and Charlson comorbidity index (CCI; OR 1.28, 95% CI 1.09–1.50). Conclusions Increasing age, shorter MUL, greater PV, and higher CCI are independent prognostic factors for UI within 3 mo after RP, with all except CCI remaining prognostic at 3–12 mo. Patient summary We reviewed the literature to identify patient and disease factors associated with urinary incontinence after surgery for prostate cancer. We found increasing age, larger prostate volume, shorter length of a section of the urethra (membranous urethra), and lower fitness were associated with worse urinary incontinence for the first 3 mo after surgery, with all except lower fitness remaining predictive at 3–12 mo.

Purpose: The excision of the renal tumor with a substantial margin of healthy parenchyma is considered the gold standard technique for partial nephrectomy. However, simple enucleation showed excellent results in some retrospective series. We compared the oncologic outcomes after standard partial nephrectomy and simple enucleation. Materials and Methods: We retrospectively analyzed 982 patients who underwent standard partial nephrectomy and 537 who had simple enucleation for localized renal cell carcinoma at 16 academic centers between 1997 and 2007. Local recurrence, cancer specific survival and progression-free survival were the main outcomes of this study. The Kaplan-Meier method was used to calculate survival functions and differences were assessed with the log rank statistic. Univariable and multivariable Cox regression models addressed progression-free survival and cancer specific survival. Results: Median followup of the patients undergoing traditional partial nephrectomy and simple enucleation was 51 +/- 37.8 and 54.4 +/- 36 months, respectively (p = 0.08). The 5 and 10-year progression-free survival estimates were 88.9 and 82% after standard partial nephrectomy, and 91.4% and 90.8% after simple enucleation (p = 0.09). The 5 and 10-year cancer specific survival estimates were 93.9% and 91.6% after standard partial nephrectomy, and 94.3% and 93.2% after simple enucleation (p = 0.94). On multivariable analysis the adopted nephron sparing surgery technique was not an independent predictor of progression-free survival (HR 0.8, p = 0.55) and cancer specific survival (HR 0.7, p = 0.53) when adjusted for the effect of the other covariates. Conclusions: To our knowledge this is the first multicenter, comparative study showing oncologic equivalence of standard partial nephrectomy and simple enucleation.

Background Docetaxel (D) or secondary hormonal therapy (SHT) each combined with androgen deprivation therapy (ADT) represent possible treatment options in males with metastasized hormone‐sensitive prostate cancer (mHSPC). Real‐world data comparing different protocols are lacking yet. Thus, our objective was to compare the efficacy and safety of abiraterone acetate (AA)+ADT versus D+ADT in mHSPC. Methods In a retrospective multicenter analysis including males with mHSPC treated with either of the aforementioned protocols, overall survival (OS), progression‐free survival 1 (PFS1), and progression‐free survival 2 (PFS2) were assessed for both cohorts. Median time to event was tested by Kaplan–Meier method and log‐rank test. The Cox‐proportional hazards model was used for univariate and multivariate regression analyses. Results Overall, 196 patients were included. The AA+ADT cohort had a longer PFS1 in the log‐rank testing (23 vs. 13 mos., p, Abiratreone acetate outperforms docetaxel in terms of PFS and PFS2, while the impact on OS as well as the rate of side effects is similar between both groups in real‐life utilization. Prospective randomized trials of available agents in mHSPC are required to generate high‐level evidence to facilitate sensible drug selection

Purpose: Reporting the perioperative and survival outcomes of vaginectomy with respect to a matched series of pelvic exenteration (PE) in women with isolated recurrent cervical cancer. Methods: The records of vaginal recurrent cervical cancer patients admitted at Fondazione Policlinico “Agostino Gemelli” IRCCS in Rome from January 2010 to June 2019 were retrospectively analyzed. A propensity-matched score analysis was performed by age, clinical stage, disease-free interval, and R0 resection. Postsurgical complications and survival rates were evaluated. Results: Fifteen women underwent vaginectomy, and 30 patients were submitted to PE. No statistical differences were observed between the two groups at baseline characteristics. The vaginectomy procedures were successfully performed in all women, and no case required conversion to PE. Moreover, a higher rate of major postoperative complications after PE with respect to vaginectomy (p = 0.027) was recorded. Among them, three women required reoperation within 30 postoperative days, and four experienced two or more complications. Twenty-five (55.6%) women experienced recurrence: 8 of 25 (32.0%) in the vaginectomy group, and 17 of 25 (68%) in the PE group, with a median progression-free survival of 20months and 13months, respectively (p = 0.169). In total, 5 of 15 (33.3%) died of disease in the vaginectomy group and 13/30 (43.3%) in the PE group, with a median overall survival of 39 and 18months for vaginectomy and PE, respectively (p = 0.161). Conclusions: The vaginectomy seems to allow for salvage treatment, such as radiotherapy and/or PE, but with a minimal impact on the quality of life in appropriately selected women with local recurrent cervical cancer.

Aims: The Pros-IT CNR project aims to monitor a sample of Italian males ≥18years of age who have been diagnosed in the participating centers with incident prostate cancer, by analyzing their clinical features, treatment protocols and outcome results in relation to quality of life. Methods: Pros-IT CNR is an observational, prospective, multicenter study. The National Research Council (CNR), Neuroscience Institute, Aging Branch (Padua) is the promoting center. Ninety-seven Italian centers located throughout Italy were involved. The field study began in September 1, 2014. Subjects eligible were diagnosed with biopsy-verified prostate cancer, naïve. A sample size of 1500 patients was contemplated. A baseline assessment including anamnestic data, clinical history, risk factors, the initial diagnosis, cancer staging information and quality of life (Italian UCLA Prostate Cancer Index; SF-12 Scale) was completed. Six months after the initial diagnosis, a second assessment evaluating the patient’s health status, the treatment carried out, and the quality of life will be made. A third assessment, evaluating the treatment follow-up and the quality of life, will be made 12months after the initial diagnosis. The 4th, 5th, 6th and 7th assessments, similar to the third, will be completed 24, 36, 48 and 60months after the initial diagnosis, respectively, and will include also a Food Frequency Questionnaire and the Physical Activity Scale for the Elderly. Discussion: The study will provide information on patients’ quality of life and its variations over time in relation to the treatments received for the prostate cancer.

Deferred active treatment (DAT) strategies, including active surveillance and active monitoring, are a recognised management option for men with localised low-risk prostate cancer. However, there is uncertainty due to heterogeneity of patient selection criteria, follow-up and monitoring characteristics, reclassification thresholds, and which outcome measures should be prioritised. This protocol describes a study led by the European Association of Urology (EAU) Prostate Cancer Guidelines Panel in conjunction with other guideline organisations and societies to develop consensus statements for all domains of deferred active treatment. The project is divided into 3 sequential phases: (1) Systematic review of studies reporting on DAT in order to summarise and define range of heterogeneity regarding all domains; (2) Two-round Delphi online survey involving a large, international panel of healthcare professionals (HCPs) and patients to initiate consensus; and (3) Consensus group meeting involving representatives from HCP and patient stakeholder groups to finalise the consensus process. The consensus statements are expected to be adopted by clinical practice guidelines in order to standardise and guide practice for clinicians and researchers until better evidence emerges. Patient summary: We describe a project aimed at standardising elements of practice in active surveillance/monitoring for early localised prostate cancer, because currently there is great variation and uncertainty regarding how best to conduct them. This will be achieved through a structured process of agreement (i.e. consensus) amongst a large, international panel of healthcare professionals and patients.

To perform a systematic review and meta-analysis of randomized clinical trials (RCTs) reporting the efficacy and safety of silodosin in the treatment of non-neurogenic male LUTS suggestive of benign prostatic enlargement. A systematic review searching multiple dataset for the term "silodosin". A meta-analysis was conducted using Review Manager software (Cochrane Collaboration, Oxford, UK). Our systematic search retrieved four studies summarizing the data of five RCTs. Silodosin was more effective than placebo with regard to mean change in all the parameters related to the IPSS and Q(max) (all p values < 0.0003). Adverse events (AE), abnormal ejaculation (AEj), and withdrawal due to AE were all more common with silodosin (all p values < 0.001). The prevalence of dizziness and adverse events other than AEj was similar with silodosin and placebo. Silodosin was more effective than tamsulosin 0.2 mg with regard to some IPSS-related parameters and Q(max) (p a parts per thousand currency sign 0.05). Silodosin and tamsulosin 0.4 mg were similarly effective in all the efficacy analyses. AEj was less common with tamsulosin 0.2 and 0.4 mg (p values < 0.00001); adverse events other than AEj were more common with tamsulosin 0.2 and 0.4 mg (p values a parts per thousand currency sign0.05). Silodosin was significantly more effective than placebo and tamsulosin 0.2 mg in improving symptoms and as effective as tamsulosin 0.4 mg. With regard to adverse events, AEj was more common with silodosin. All the adverse events other than AEj were significantly more common with tamsulosin 0.2 and 0.4 mg and as frequent with silodosin and placebo.

The rationale of posterior musculofascial plate reconstruction during radical prostatectomy is to shorten the time to reach urinary continence recovery and to reduce the risk of bleeding and anastomosis leakage. We describe our original technique incorporating the posterior muscolofascial reconstruction into urethrovesical anastomosis using robot-assisted radical prostatectomy (RARP). For this reconstructive step, we use a 30-cm V-Loc 90 3-0 barbed suture (V-20 tapered needle). Specifically, the free edge of the posterior layer of the Denonvilliers fascia is approximated to the posterior part of the sphincteric apparatus in a running fashion from left to right. The musculature of the urethral wall is incorporated in this first layer of the running suture. This suture is then continued back to the left in a second layer incorporating the anterior layer of the Denonvilliers fascia (or prostatovesical muscle), the bladder neck, and again the urethra, this time also with urethral mucosa. The urethrovesical anastomosis is completed using a second running barbed suture (15-cm V-Loc 90 3-0 barbed suture, V-20 tapered needle). No intraoperative complications were observed during this step of the procedure. Anastomotic leakages were observed only in 2% of cases. Only 12.5% showed urinary incontinence after catheter removal (1-2 pads). At mean follow-up of 9 months, the urinary continence recovery was 95%, and an anastomosis stricture necessitating an endoscopic incision developed in only three (1.5%) patients. Recent systematic reviews of the literature showed only a minimal advantage in favor of posterior musculofascial reconstruction in terms of urinary continence recovery within 1 month after radical prostatectomy. We support the use of this step of RARP because it is simple, reproducible, with a very limited increase in operative time, and with only a slight risk of potential harm to the patient. Moreover, it could improve hemostasis and provide greater support for a delicate anastomosis.

Objectives The objective of this study was to validate the Italian version of the Urogenital Distress Inventory (UDI) in a sample of women with lower urinary tract symptoms (LUTS). Methods The linguistic validation of the questionnaire was performed through a multistep process: backward and forward translations coordinated by clinical investigators, followed by a pretest. The final version was administered to a larger sample of female patients, aged 18 years or older who had been having LUTS for at least 3 months, numbering 53 subjects. To evaluate test-retest reliability, patients were re-rated after 1 week. To test the questionnaire's capacity to discriminate women with or without LUTS (cases and controls, respectively), a sample of 53 healthy women was enrolled. A 72-h voiding diary was used as a gold standard and compared with the UDI. Results The correlation coefficient between ratings was ≥0.80, and the discriminant power between cases and controls was confirmed. The UDI showed good internal consistency for all domains, except irritative symptoms (total score's Cronbach alpha=0.86). Factor analytic structure revealed urinary incontinence to be opposite to the other urologic symptoms, with bed wetting being loaded separately. The average daily number of urgent micturitions was higher in patients who reported they "experience a strong feeling of urgency to empty bladder" in the UDI than those ones who did not ( p Conclusions The Italian version of the UDI is a valid and robust instrument, which can now be used reliably in daily practice and clinical research.

Background There is growing evidence that IGF-1 and binding proteins may be involved in prostate cancer promotion and progression. Patients and methods IGF-1 and binding proteins (IGFBP-1 and 3) serum levels were measured at baseline and after 3 and 6 months of treatment in a selected group of patients with prostate cancer who were randomly assigned to treatment with bicalutamide, bicalutamide plus anastrozole or bicalutamide plus tamoxifen in a comparative study investigating the role of pharmacological medication in the development of bicalutamide-induced gynecomastia. Results Bicalutamide monotherapy does not appear to alter the IGF-1/IGFBP system. In fact, the increase in IGF-1 levels induced by this treatment was paralleled by comparable increases in binding protein (IGFBP-3). No major changes from baseline up to month 6 either in IGF-1 or in IGFBP-1 and 3 were observed in the bicalutamide plus anastrozole arm. The addition of tamoxifen to bicalutamide produced a sharp decrease in IGF-1 levels (pConclusions The concurrent administration of tamoxifen and bicalutamide reduces the synthesis and bioavailability of IGF-1. Moreover, increased binding protein levels might exert antiproliferative and proapoptotic effects on prostate cancer cells, independently of the IGF-1/IGF receptor-mediated survival system. Both effects might have a synergistic inhibitory influence on prostate cancer growth.

OBJECTIVE To validate the Italian version of two questionnaires for lower urinary tract symptoms (LUTS), i.e. the long (LF) and the short form (SF) of the International Consultation on Incontinence Questionnaire (ICIQ). METHODS Two native Italian speakers and a native English speaker collaborated with clinical investigators through a multistep process to obtain a consensus version of the questionnaires. The resulting Italian versions were then pre-tested during a pilot study on 16 women for the LF and 10 for the SF. The final versions of the ICIQ-LF and ICIQ-SF were administered to two samples of consecutive female patients, aged ≥ 18 years, who had been having LUTS for ≥ 3 months, with respectively 82 and 50 women. Internal consistency and test-retest reliability were then assessed; to evaluate the latter, a subset of patients (25 for the ICIQ-LF and 42 for ICIQ-SF) was re-rated. To test the capacity of the questionnaires to discriminate women with or without LUTS (respectively cases and controls), a sample of healthy women was also enrolled and assessed. RESULTS Both scales showed good psychometric properties overall. The correlation coefficient between ratings was > 0.75 in both questionnaires, and the discriminant power between cases and controls was confirmed for both scales. The ICIQ-SF showed good internal consistency for the total score (Cronbach's α 0.90). The sections of the ICIQ-LF ‘impact of incontinence on everyday life’, ‘emotional aspects’, ‘urinary symptoms’ and the degree of bother seemed to be internally consistent (Cronbach's α > 0.70); there was a weak relationship for items related to ‘sexual matters’ (Cronbach's α 0.38). CONCLUSION The Italian version of both questionnaires is a valid and robust instrument which can now be used reliably both in daily practice and in clinical research.

Purpose To determine whether tamoxifen or anastrozole prevents gynecomastia and breast pain caused by bicalutamide (150 mg) without compromising efficacy, safety, or sexual functioning. Patients and Methods A double-blind, placebo-controlled trial was performed in patients with localized, locally advanced, or biochemically recurrent prostate cancer. Patients (N = 114) were randomly assigned to either bicalutamide (150 mg/d) plus placebo or in combination with tamoxifen (20 mg/d) or anastrozole (1 mg/d) for 48 weeks. Gynecomastia, breast pain, prostate-specific antigen (PSA), sexual functioning, and serum levels of hormones were assessed. Results Gynecomastia developed in 73% of patients in the bicalutamide group, 10% of patients in the bicalutamide-tamoxifen group, and 51% of patients in the bicalutamide-anastrozole group (P < .001); breast pain developed in 39%, 6%, and 27% of patients, respectively (P = .006). Baseline PSA level decreased by ≥ 50% in 97%, 97%, and 83% of patients in the bicalutamide, bicalutamide-tamoxifen, and bicalutamide-anastrozole groups, respectively (P = .07); and adverse events were reported in 37%, 35%, and 69% of patients, respectively (P = .004). There were no major differences among treatments in sexual functioning parameters from baseline to month 6. Elevated testosterone levels occurred in each group; however, free testosterone levels remained unchanged in the bicalutamide-tamoxifen group because of increased sex hormone–binding globulin levels. Conclusion Anastrozole did not significantly reduce the incidence of bicalutamide-induced gynecomastia and breast pain. In contrast, tamoxifen was effective, without increasing adverse events, at least in the short-term follow-up. These data support the need for a larger study to determine any effect on mortality.