New targeted therapies for anaplastic thyroid cancer.

Anaplastic thyroid cancer (ATC) is often incurable because it doesn't respond to radioiodine, radiotherapy or chemotherapy, and new therapeutic approaches are needed. Peroxisome proliferator-activated receptor-gamma (PPARg) gene and protein are present in ATC cells, and PPARg ligands inhibit cell proliferation, induce apoptosis, and also down regulate the invasive potential of ATC cells. Also, inhibitors of the Aurora serine/threonine kinases have antineoplastic effect on ATC cells in vitro and on ATC xenografts. Tyrosine kinases inhibitors are actually under evaluation for the treatment of ATC, for example imanitib or sorafenib. Other studies have focused on evaluating antiangiogenic agents for treatment of ATC. These agents include: combretastatin A4 phosphate, aplidin, PTK787/ZK222584, and human VEGF monoclonal antibodies (bevacizumab, cetuximab). Small-molecule adenosine triphosphate (ATP) competitive inhibitors directed intracellularly at epidermal growth factor receptor (EGFR)'s tyrosine kinase, such as erlotinib, or gefitinib are also under evaluation. The development of drugs that have multiple therapeutic targets and the utilization of multiple cancer-targeting agents are both emerging strategies for ATC treatment. For example, a preclinical study evaluated the activity of a dual inhibitor of EGFR and vascular endothelial growth factor (VEGF), NVP-AEE788, alone and in combination with paclitaxel for the treatment of ATC. Even if new therapeutic approaches against ATC are under development, more research is needed to finally identify therapies able to control and to cure this disease. The possibility of testing the sensitivity of primary ATC cells from each subject to different drugs could increase the effectiveness of the treatment in the next future.

Choosing the nephrostomy size after percutaneous nephrolithotomy.

PURPOSE: To evaluate the effect of nephrostomy tube size on perioperative outcomes of percutaneous nephrolithtotmy (PCNL). METHODS: Forty-five well-matched patients with normal renal function were prospectively divided in two nonrandomized groups after uneventful PCNL (to receive either a 22-Fr, group 1 (n = 24 pts), or a 12-Fr nephrostomy tube, group 2 (n = 21 pts)). In all a balloon nephrostomy catheter with detachable funnel (Rüsch Teleflex, Germany) was used. A Visual Analogue Scale (VAS) for measuring the pain was administered 8 and 24 h after the procedure. Postoperative analgesics use (Ketoralac Tromethamine 30 mg), pre- and postoperative Hb, renal function and urinary leaks were registered. RESULTS: Groups were comparable as demographics and stone characteristics. VAS pain score was significantly higher in group 1 (4.25 vs. 3.2, P < 0.001) only 8 h postoperatively. No significant difference was found in the VAS pain score 24 h p.o. Similarly, analgesics use (1.6 vs. 1.1, P = 0.05), sHb (1.42 vs. 1.21, P = 0.055) and hospital stay (3.8 vs. 3.6, P = 0.63) were not significant between the two groups of patients. CONCLUSIONS: A small bore nephrostomy catheter may reduce pain in the immediate postoperative time. It does not affect blood loss and hospital stay so it can safely be used instead of a large size nephrostomy tube, after uneventful percutaneous procedures.

PCNL in Italy.

INTRODUCTION: The first Italian meeting on percutaneous nephrolithotomy (PCNL) was held in Milan in 1984. Since then PCNO has been practised in many centres but is diffusion has not been fast. MATERIAL AND METHODS: A Medline search using as keywords: PCNL, Percutaneous nephrolithotomy, Percutaneous surgery, was performed, time limits 1983 to 2008 to look for contribution of Italian authors in indexed journals. The proceeding and abstract book of the SIU (Societia Italiana di Urologia) from 1984 were consulted to ascertain the number of communications presented to the italian national congress. The number of PCNL performed and hospital stay in Italy are official data from the Ministero della Salute website www.ministerosalute.it. RESULTS AND DISCUSSION: The number of papers published by Italian authors on indexed journals, although of good quality, has been poor in the past but is rising in recent years. Also from the proceedings of the Italian Urological Association an increase in the interest for PCNL is testify by the growing number of communications presented to the national congress. Of the 2555 PCNL performed in 2005 in Italy, 2513 were inpatient procedures with a mean hospital stay of 8, 11 days. Even if the number of procedures/year is increasing still there is a wide difference among different Italian regions and PCNL can be considered an underutilized procedure. CONCLUSIONS: It is mandatory to increase the number of educational courses on PCNL to increase the number of urologists performing this technique and in order to minimize hospital stay and to reduce the number of repeated extracorporeal lithotripsy for large burden stones and, most of all, the number of open procedures still performed.

Four-year outcome of a prospective randomised trial comparing bipolar plasmakinetic and monopolar transurethral resection of the prostate.

BACKGROUND: No data have been published on the midterm efficacy of bipolar transurethral resection of the prostate (TURP). OBJECTIVE: To evaluate 4-yr results from a prospective randomised trial comparing bipolar TURP with standard monopolar TURP. DESIGN, SETTING, AND PARTICIPANTS: Seventy patients with symptomatic benign prostatic hyperplasia were enrolled in this prospective randomised controlled trial in a tertiary-care institution. Inclusion criteria were age > 50 yr, good performance status, urinary retention, International Prostate Symptom Score (IPSS) > or = 18, and maximal flow rate (Q(max)) < or = 15 ml/s. Exclusion criteria were prostate volume < 30 cm(3), documented or suspected prostate cancer, neurogenic bladder, bladder stone or diverticula, urethral stricture, and maximal bladder capacity > 500 ml. INTERVENTION: Patients underwent standard or bipolar plasmakinetic TURP performed by the same surgeon using the same surgical technique. MEASUREMENTS: Treatment efficacy was evaluated at 1, 2, 3, and 4 yr by comparing urinary flow rates, IPSS, and estimated postvoid residual (PVR) urine volume. Midterm complications were also recorded. RESULTS AND LIMITATIONS: The number of dropouts was not statistically significantly different in the two groups (p=0.2). The significant improvements in both groups were maintained at 4 yr for the IPSS, quality of life score, Q(max), and PVR versus baseline values. The main outcome variables at 4 yr for bipolar and monopolar TURP were mean IPSS 6.9 and 6.4 (p=0.58); mean Q(max) 19.8 ml/s and 21.2 ml/s (p=0.44), and mean PVR volume 42 ml and 45 ml (p=0.3). Overall, 2 of 32 (6.2%) and 3 of 31 (9.6%) patients required reoperation because of late complications (p=0.15). The major study limitation was the small sample size. CONCLUSIONS: This study represents the secondary, midterm analysis of a previously published trial. Our 4-yr data confirm our initial positive findings for the efficacy and safety of bipolar plasmakinetic TURP. Larger well-designed studies are needed to corroborate these findings.

Effect of tamsulosin in preventing ureteral stent-related morbidity: a prospective study.

PURPOSE: We conducted a randomized study to evaluate the effect of tamsulosin in improving symptoms and quality of life (QoL) in patients with indwelling double-pigtail ureteral stents, using both generic and specific questionnaires. MATERIALS AND METHODS: We prospectively enrolled 75 patients (29 men, 46 women; mean age, 42.3 years), who underwent ureteral stent positioning and were assigned to one of two study groups. In group A (n = 38), patients were discharged with a prescription for tamsulosin, 0.4 mg once daily. In group B (n = 37), patients received no alpha(1)-blocker (control group). RESULTS: One week after stent placement (visit week 1 [W1]), analysis of the ureteral stent symptoms questionnaire showed a significant worsening of urinary symptoms (13.1 v 26.4, P = 0.008) and pain (4.1 v 21.6, P = 0.002) in patients not receiving tamsulosin. There was also a significant difference in the mean visual analog score (VAS) of health scale between the two groups (P < 0.001) compared with the result obtained at the W4 evaluation (visit). The proportion of patients reporting level 2 or 3 for the pain/discomfort domain in the QoL questionnaire from W4 to W1 varied between the two groups in a highly statistically significant manner (P = 0.006). CONCLUSIONS: Our findings indicate that administration of tamsulosin has a positive effect on stent-related urinary symptoms and QoL. Further clinical research in this area is warranted to better define the role of alpha(1)-blockers in current clinical practice.

Modified supine versus prone position in percutaneous nephrolithotomy for renal stones treatable with a single percutaneous access: a prospective randomized trial.

OBJECTIVES: To compare operative time, safety, and effectiveness of percutaneous nephrolithotomy in the supine versus prone position in a prospective randomized trial. MATERIAL AND METHODS: From October 2005 to June 2007, 75 patients (33 men, 42 women; mean age, 39.3 yr) were prospectively enrolled and randomly divided into group A (39 patients, supine position) and group B (36 patients, prone position). Inclusion criteria were diagnosis of single or multiple renal stones (pelvic-caliceal) treatable with a single percutaneous access, stone diameter >2.5cm, body mass index (BMI) <30kg/m(2), and no contraindications to perform the operation in the prone position. Exclusion criteria were stones in more than one calyx, complete staghorn stones, and coexisting renal anomalies. RESULTS: The two groups were comparable in age, BMI, male-to-female ratio, and stone size. No significant difference was ascertained between the two groups in terms of stone-free rate (group A, 88.7% vs. group B, 91.6%, p=0.12), mean blood loss (group A, Delta hemoglobin -2.3g/dl vs. group B, -2.2g/dl, p=0.23), and mean hospital stay (group A, 4.3 d vs. group B, 4.1 d, p=0.18). The only significant difference reported was mean operative time (group A, 43min vs. group B, 68min, p<0.001). No blood transfusions were needed and no organ injuries were reported. CONCLUSIONS: In this carefully selected patient population with uncomplicated renal stones, the supine position was similar to the prone position for percutaneous stone removal.

Clinicopathologic features of prostate adenocarcinoma incidentally discovered at the time of radical cystectomy: an evidence-based analysis.

OBJECTIVES: To review all relevant features of incidentally discovered prostate cancer (PCa) in patients undergoing radical cystectomy for bladder cancer: incidence, pathologic characteristics, clinical significance, and implications for its management. METHODS: A structured literature review through a MEDLINE search was performed. RESULTS: The frequency of incidentally discovered PCa in cystoprostatectomy specimens is extremely variable because of several factors, particularly the pathology sampling. The relationship among clinically, incidentally, and autopsy-detected cancer is uncertain. The definition of clinically significant cancer varies among published reports and remains inadequate for clinical application. High-grade prostatic intraepithelial neoplasia is a marker for concurrent PCa and the risk depends more on the volume than on its absolute presence. Outcome of patients with unsuspected PCa after cystoprostatectomy relies mostly on the bladder tumor. CONCLUSIONS: Incidental PCa in patients with bladder cancer is highly variable and with an unclear clinical significance. For those who are candidates for prostate-sparing surgery, it seems reasonable to include a routine prostate biopsy in the standard preoperative work-up irrespective of prostate-specific antigen values. In the absence of sufficient data to make firm recommendations, when PCa is incidentally discovered, PCa surveillance should be part of the follow-up scheme after radical cystectomy.

A new transportable shock-wave lithotripsy machine for managing urinary stones: a single-centre experience with a dual-focus lithotripter.

OBJECTIVE: To assess the efficacy and safety of a transportable extracorporeal shock wave lithotripsy (ESWL) machine, the Modulith SLX-F2(TM) (Storz Medical Italia, Rome, Italy), in the management of solitary urinary calculi. PATIENTS AND METHODS: The study included 233 patients (mean age 51 years; 172 male, 61 female) with symptomatic solitary renal (group A, 170, mean diameter 15.5 mm) or ureteric stones (group B, 63, mean diameter 9.5 mm) treated in a tertiary care institution. Exclusion criteria for the analysis were: pelvi-ureteric junction obstruction, multiple stones, stone diameter >2 cm, stones in a lower calyx with unfavourable anatomy, active infection, or impacted ureteric stones. Selected patients had ureteric stenting before treatment, and all patients were treated with no anaesthesia. Hospitalization, complications and subsequent auxiliary procedures were evaluated. Patients were assessed after a single ESWL session and after 3 months by a plain abdominal film and renal ultrasonography. Stone-free status was defined as no evidence of calculi, and clinical success as the presence of stone fragments of <4 mm. An efficiency quotient (EQ) was calculated for the ESWL treatment. Pain was assessed using a visual analogue scale. RESULTS: The mean number of shocks used was 3779 and the mean (range) treatment time was 35 (5-55) min. The overall clinical success rate after one ESWL session was 83.7% and 82.5% for renal and ureteric stones, respectively, and the overall 3-month stone-free rate was 77% and 74.6%, respectively; the overall EQ was 0.64. When risk factors for persistent calculi were analysed simultaneously in a logistic regression model, only stones of >1 cm were statistically significant (P < 0.05). Most patients reported that pain during ESWL was mild to moderate and easily tolerated. Only minor complications occurred, with an overall complication rate of 3.8%. CONCLUSIONS: This transportable lithotripter is a safe and effective device for managing solitary stones throughout the urinary tract. Its main advantage is represented by the dual-focus system. Moreover, it shares with other contemporary machines several important features such as outpatient setting, no need for anaesthesia, easy patient positioning, and the capability of ancillary procedures.

Docetaxel, vinorelbine, and zoledronic acid as first-line treatment in patients with hormone refractory prostate cancer: a phase II study.

OBJECTIVES: Combining antineoplastic agents is the key to improving the treatment options for men with hormone refractory prostate cancer (HRPC). The current study investigated the combination of docetaxel, vinorelbine, and zoledronic acid as a first-line treatment for HRPC. METHODS: Patients were treated repeatedly with docetaxel (25 mg/mq) and vinorelbine (10 mg/mq) intravenously for three consecutive weeks followed by a 1-wk rest until disease progression or side effects. Zoledronic acid was administered every 4 wk. Changes in prostate-specific antigen (PSA) levels and objective responses were evaluated after two and three cycles, respectively. Toxicity and pain evaluation, based on pain intensity reduction and analgesic drug reduction, were assessed every cycle. RESULTS: Forty men with HRPC (median age: 65 yr) were treated. Among 38 evaluable patients, complete and major PSA responses were observed in seven (18%) and 12 (32%), respectively; a partial objective response was observed in six of 15 (40%) patients with measurable disease. Neutropenia (25%) was the most important grade 3 haematologic toxicity observed. Only three patients (7.5%) reported grade 4 neutropenia. Nineteen patients (47.5%) achieved a reduction of pain intensity and analgesic drug use after two cycles. Median progression-free survival was 7 mo (95% CI: 2-10 mo), with a median overall survival of 17 mo (95% CI: 6-22 mo). CONCLUSIONS: The combination of docetaxel, vinorelbine, and zoledronic acid is associated with improvement in biochemical, objective, and pain responses and is well tolerated as a first-line treatment for HRPC.

Quality of life in women with multiple sclerosis and overactive bladder syndrome.

The aim of this study was to evaluate the impact of symptoms of overactive bladder syndrome (OAB) on the quality of life (QoL) in female patients with or without multiple sclerosis (MS) and their correlation with findings from urodynamics (UDS). We enrolled 107 female patients with clinically definite MS and urinary symptoms of OAB. One-hundred female patients with similar OAB symptoms were used as a control group. Data on OAB symptoms, onset and progression, and results of any previous investigation were obtained, and any urinary complications were documented. A complete UDS investigation was performed. Health status assessment was obtained using the Kings Health Questionnaire. Results showed that urinary symptoms had a greater impact on the QoL in patients with MS. Nevertheless, the perception of the severity of these symptoms was minor in the MS group compared to the control group. No significant correlations were found between the dysfunctions as detected by UDS and the OAB symptoms in both groups. Recurrent urinary tract infections represented the main complication in the study population. In conclusion, OAB symptoms have a major impact on the QoL in patients with MS, even if their perception of QoL impairment remains limited. Optimal management in these subjects should include a complete UDS assessment.

The forgotten stent: late complication in a patient with neobladder.

Encrustation constitutes a serious complication of ureteral stent use and can result in difficult stent removal. We report the case of a patient with a retained ureteral stent for 3 years following a radical cystectomy.

Gyrus bipolar versus standard monopolar transurethral resection of the prostate: a randomized prospective trial.

OBJECTIVES: To compare bipolar plasmakinetic (PK) with standard monopolar transurethral resection of the prostate (TURP). METHODS: A total of 70 patients were prospectively randomized into two groups: 35 patients underwent PK TURP with the Gyrus device, and 35 patients underwent standard monopolar TURP. We evaluated the time to catheter removal and hospital discharge, operating time, blood loss, postoperative irrigation, complications, urinary flow rates, symptom relief, and postvoid residual volumes. RESULTS: At baseline, the study groups were comparable in age, prostate volume, mean prostate-specific antigen value, International Prostate Symptom Score, quality-of-life score, flow rate, and postvoid residual volume. The mean catheterization time was 72 and 100 hours in the PK and standard groups, respectively. This difference was statistically significant (P <0.05), as was the difference in the time to hospital discharge. No difference was found in the mean resection time, amount of resected tissue, or variations in hemoglobin and sodium levels. The improvement in flow rate, postvoid residual volume, International Prostate Symptom Score, and quality-of-life score was comparable between the two groups at 12 months of follow-up. CONCLUSIONS: In our experience, PK TURP showed comparable perioperative results to those obtained with standard TURP, but with more favorable postoperative outcomes. The resection time and blood loss were similar between the two groups, but the need for continuous bladder irrigation after surgery and time to catheter removal and hospital discharge were significantly shorter in the PK group.

Medical expulsive treatment of distal-ureteral stones using tamsulosin: a single-center experience.

PURPOSE: To evaluate the efficacy of the addition of tamsulosin to our standard expulsive pharmacologic therapy for the treatment of distal-ureteral stones. PATIENTS AND METHODS: A series of 96 patients referred to our department for the management of symptomatic distal-ureteral calculi were randomly divided into group 1 (N = 46) who received diclofenac (100 mg/daily) plus aescin (80 mg/daily) and group 2 (N = 50) who received the same therapy plus tamsulosin (0.4 mg/daily) for a maximum of 2 weeks. There were no differences between the groups with respect to age, sex, or stone size. The primary endpoint was the expulsion rate. Expulsion time, need for analgesics, need for hospitalization, and drug side effects were the secondary endpoints. RESULTS: The expulsion rate was significantly higher in group 2 (90%) than in group 1 (58.7%; P = 0.01), and group 2 achieved stone passage in a shorter time (mean 4.4 v 7.5 days, respectively; P = 0.005). Lower analgesic use was found in group 2 (P = 0.003), as well as significantly fewer hospitalizations for recurrent colic (P = 0.01). Both groups experienced few side effects associated with expulsive therapy. CONCLUSIONS: A conservative approach should be considered as an option in the management of uncomplicated distal-ureteral stones. Even if the best pharmacologic expulsive regimen remains to be established, the use of the selective alpha-blocker tamsulosin is recommended in this setting.

Fate of abstracts presented at the World Congress of Endourology: are they followed by publication in peer-reviewed journals?

PURPOSE: To estimate the acceptance rate of peer-reviewed journals, to describe the time course of subsequent full publication, and to identify those with characteristics associated with publication of the abstracts presented at the World Congress of Endourology (WCE). METHODS: All abstracts accepted for presentation at the 2001 and 2002 WCE meetings were identified from the published supplements to the Journal of Endourology. The subsequent publication rate for the corresponding studies was evaluated by scanning MEDLINE for the 5-year period after the meetings. RESULTS: Overall, 20.5% of the abstracts were followed by publication in peer-reviewed journals. Abstracts on transurethral, laparoscopic, and percutaneous procedures had the highest publication rates (25.5%, 25%, and 24.3%, respectively). Studies from North America had the highest publication rate (29.2%). The mean time to publication was 14.6 months. There was an 80% chance that an eventually published abstract was in print 2 years after presentation. The largest number of the reports were published in the Journal of Endourology (75 of 234; 32%), the official publication of the society that sponsors the WCE. CONCLUSIONS: Only one fifth of the abstracts presented at the WCE are ultimately published in peer-reviewed journals. Attendees should be aware of this limitation, and scientific committees should be encouraged to be more selective. Although presentation at major urological congresses constitutes an invaluable method for rapid scientific dissemination, abstracts contain data that usually are difficult to access and of questionable validity. In this respect, investigators are encouraged to publish their data.

Dynamic sentinel node biopsy in clinically node-negative penile cancer versus radical inguinal lymphadenectomy: a comparative study.

OBJECTIVES: To evaluate the reliability and morbidity of dynamic sentinel node biopsy compared with radical inguinal lymphadenectomy (RIL) in the treatment of selected patients with squamous cell penile carcinoma. METHODS: We retrospectively considered patients with clinically node-negative Stage pT2-pT3 penile cancer. From 1994 to 2000, 48 patients (group 1, mean age 63 years) underwent penectomy and, after 4 weeks, prophylactic bilateral RIL. From 2001 to 2004, 22 patients (group 2, mean age 67 years) underwent penectomy and dynamic sentinel node biopsy. After 4 weeks, bilateral RIL was performed. RESULTS: In group 1, nodal disease was found in 39.6% of the patients. Early complications occurred in 21 patients (47.5%), with the most common being seroma formation. Late complications occurred in 18 patients (37.5%), with the most common being leg edema. In group 2, preoperative lymphoscintigraphy revealed no sentinel nodes in 1 patient, unilateral sentinel nodes in 7, and bilateral nodes in 14. A total of 35 sentinel nodes were seen in 42 inguinal regions (mean 0.83), including 27 (77.2%) identified with the probe and blue dye and 8 (22.8%) located with the probe only. Metastases were noted in 8 (36.4%) of 22 patients, bilaterally in 4 of them. Early minor complications occurred in 3 patients (13.6%). The technique had an 89% negative predictive value and 90% sensitivity. CONCLUSIONS: The results of this study have shown that dynamic sentinel node biopsy is a minimally invasive technique that is easy to perform, with similar results to those of RIL, but lower morbidity. This procedure offers the possibility of less-extensive surgery for clinically node-negative penile carcinoma.

The use of tamsulosin in the medical treatment of ureteral calculi: where do we stand?

It has recently been demonstrated that specific adrenoceptors subtypes (alpha(1A)/alpha(1D)) are prevalent in the distal part of the ureter, a finding supporting the interesting results obtained by different groups with the use of tamsulosin in the treatment of distal ureteral calculi. We performed a prospective randomized study to evaluate the effects of the addition of tamsulosin on our standard pharmacological therapy for the treatment of selected ureteral stones. A total of 64 patients referred to our department for the management of symptomatic ureteral calculi were considered. Patients were randomly divided into two treatment groups: group A (n=32) who received diclofenac (100 mg/daily) plus aescin (80 mg/daily) and group B (n=32) who received the same therapy plus tamsulosin (0.4 mg/daily) for a maximum of 2 weeks. No significant differences were found between the groups for age, gender distribution and mean stone size measured in the single largest dimension at presentation. The stone expulsion rate was 60% (19/32 patients) for group A and 88% for (28/32) for group B with a mean expulsion time of 7.4+/-2.2 (range 3.5-12) and 4.8+/-2.7 days (range 1.8-10.5), respectively. Group B showed a significant advantage in terms of both expulsion rate (P=0.01) and expulsion time (P=0.005). Different analgesics from those used in the standard treatment regimen were required in ten patients in group A (31%) but only three patients in group B (9%). This difference was significant (P=0.003). Hospitalization for recurrent colic was needed in 21% of patients in group A (7/32) and in 9% in group B (3/32) (P=0.01). Only two patients in each group (6%) experienced minor side effects associated with the expulsive therapy. Our data confirm the efficacy of tamsulosin in the treatment of distal ureteral stones up to 1 cm. This selective alpha-blocker should therefore be included in the pharmacological regimen of patients when a conservative approach is considered in the treatment of ureteral lithiasis.

How to decrease pain during transrectal ultrasound guided prostate biopsy: a look at the literature.

PURPOSE: There is growing interest among urologists on the need for decreasing pain during transrectal ultrasound (TRUS) guided prostate biopsy. MATERIALS AND METHODS: We performed a systematic MEDLINE search of clinical trials of any kind of anesthesia, analgesia or sedation during TRUS guided prostate biopsy published since 2000. We critically analyzed the impact of pain and discomfort associated with the procedure, the described methods for evaluating it and the different techniques that have been described. RESULTS: There is strong evidence in the current literature that patient tolerance and comfort during TRUS guided prostate biopsy can be improved by anesthesia/analgesia. What remains is the need to urge all urologists to introduce it in clinical practice as a routine part of the procedure, whatever the biopsy scheme. CONCLUSIONS: Of the various options periprostatic anesthetic infiltration has been shown to be safe, easy to perform and highly effective. It should be considered the gold standard at the moment, even if the optimal technique remains to be established. Further studies addressing this issue are warranted.

Gynecomastia and breast pain induced by adjuvant therapy with bicalutamide after radical prostatectomy in patients with prostate cancer: the role of tamoxifen and radiotherapy.

PURPOSE: We investigated the role of tamoxifen and radiotherapy (RT) for the prevention and treatment of gynecomastia and breast pain during adjuvant bicalutamide monotherapy after radical prostatectomy (RP) in patients with prostate cancer. Also, we evaluated their effects on patient hormonal status, quality of life (QOL), sexual function and prostate specific antigen relapse-free survival. MATERIALS AND METHODS: This was a multicenter prospective trial. From January 2002 to February 2004, 102 patients who had undergone RP for localized or locally advanced prostate cancer were recruited and randomized into 3 groups, namely group 1-those receiving only 150 mg bicalutamide as adjuvant hormonal therapy, group 2-those receiving bicalutamide and 10 mg tamoxifen, and group 3-those receiving bicalutamide and RT. Patients in group 1 in whom gynecomastia or breast pain developed were subsequently randomized to receive tamoxifen or RT soon after symptoms started. Gynecomastia, breast pain, prostate specific antigen, QOL, sexual function and hormonal levels were assessed. Minimum followup was 12 months. RESULTS: Of group 1 patients 67% had gynecomastia compared with 8% in group 2 and 34% in group 3. Breast pain was more frequent in group 1 than in groups 2 and 3 (58% vs 7% and 30%, respectively). Differences were significant between groups 1 and 2 (OR 0.12 p <0.001), and groups 1 and 3 (OR 0.52 p < 0.01). In patients in group 1 who had gynecomastia or breast pain a significant decrease in symptoms was achieved in those receiving tamoxifen (p <0.05). Treatments were well tolerated in the 3 groups. No differences in QOL between groups 2 and 3 were found. At a median followup of 26 months we observed 12 biochemical relapses. CONCLUSIONS: Gynecomastia and breast pain induced by bicalutamide monotherapy after RP can be prevented and treated. Tamoxifen has been shown to be more effective and safe than RT in this setting. QOL and sexual function are not negatively influenced by these 2 treatment options.