A microdose clinical trial to evaluate [18F]Florastamin as a positron emission tomography imaging agent in patients with prostate cancer.

PURPOSE: To evaluate the biodistribution of [18F]Florastamin, a novel 18F-labelled positron emission tomography (PET) tracer for prostate-specific membrane antigen (PSMA) for the diagnosis of prostate cancer. METHODS: PET was performed for five healthy controls and 10 patients with prostate cancer at 0, 10, 30, 70, and 120 mins after injecting 370 MBq of [18F]Florastamin. The maximum standardised uptake value (SUVmax) was evaluated in the primary tumour. The mean SUVmax (SUVmean) was evaluated in normal organs. Furthermore, the residence time was evaluated by assessing radioactivity in each organ. The internal radiation dosimetry was calculated using the OLINDA/EXM software. RESULTS: The SUVmax in primary tumours increased with time. A favourable tumour to background ratio was also observed over time. Multiple lymph nodes and bone metastases were also evaluated and showed a similar pattern to SUVmax in the primary tumour. In one patient, a tiny lymph node metastasis was identified using [18F]Florastamin PET, which was not observed using other modalities, and was histologically confirmed. The highest absorbed dose was observed in the kidney (0.062 ± 0.015 mGy/MBq), followed by the bladder (0.032 ± 0.013 mGy/MBq), liver (0.022 ± 0.006 mGy/MBq), and salivary gland (0.018 ± 0.006 mGy/MBq). The effective dose with a 370 MBq injection of [18F]Florastamin was 1.81 mSv. No adverse events related to [18F]Florastamin were reported. CONCLUSION: We identified a novel PSMA-targeted PET ligand, [18F]Florastamin, for imaging prostate cancer. [18F]Florastamin showed a high SUVmax and relatively high tumour to background ratio in both primary tumour and metastatic lesions, which suggests its high sensitivity to detect tumours without any adverse events. TRIAL REGISTRATION: KCT0003924 registered at https://cris.nih.go.kr/ .

The Feasibility of 64Cu-PSMA I&T PET for Prostate Cancer.

Background: The goal of this research was to investigate the feasibility of 64Cu labeling in prostate-specific membrane antigen imaging and therapy (PSMA I&T) for PSMA positron emission tomography (PET) imaging and biodistribution evaluation. Materials and Methods: PSMA I&T was labeled with 64Cu, and stability in human and mouse sera was evaluated. Prostate cancer cell lines were used for specific uptake assays (22RV1 for PSMA-positive, PC-3 for -negative). Both PC-3 and 22RV1 cells were transplanted into the left and right thighs in a mouse for PET/computed tomography (CT) imaging. Biodistribution was performed using 22RV1 tumor models. Results: Labeling yield (decay corrected) of 64Cu-PSMA I&T was more than 95% compared to the free 64Cu peak. The serum stability of 64Cu-PSMA I&T was maintained at more than 90% until 60 h. Regarding the specific binding of 64Cu-PSMA I&T was 7.5-fold higher to 22RV1 cells than PC-3 cells (p < 0.001). On PET/CT imaging, more specific 64Cu-PSMA I&T uptake was observed to 22RV1 tumors than to PC-3 tumors. In the PSMA blocking study using 2-phosphonomethoxypropyl adenine (2-PMPA), the 64Cu-PSMA I&T signal significantly decreased in the 22RV1 tumor region. In the biodistribution study, the kidney uptake was the highest among all organs at 2 h (52.6 ± 20.8%ID/g) but sharply decreased at 24 and 48 h. Also, the liver showed similar uptake over time (range, 10-12%ID/g). On the contrary, 64Cu-PSMA I&T uptake of the tumors increased with time and peaked at 48 h (5.6 ± 0.1%ID/g). Conclusions: PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging through in vitro and in vivo studies. Furthermore, 64Cu-PSMA I&T might be considered as the candidate of future clinical trial.

An X-ray spectrum estimation method from transmission measurement combined with scatter correction.

PURPOSE: Conventional x-ray spectrum estimation methods from transmission measurement often lead to inaccurate results when extensive x-ray scatter is present in the measured projection. This study aims to apply the weighted L1-norm scatter correction algorithm in spectrum estimation for reducing residual differences between the estimated and true spectrum. METHOD: The scatter correction algorithm is based on a simple radiographic scattering model where the intensity of scattered x-ray is directly estimated from a transmission measurement. Then, the scatter-corrected measurement is used for the spectrum estimation method that consists of deciding the weights of predefined spectra and representing the spectrum as a linear combination of the predefined spectra with the weights. The performances of the estimation method combined with scatter correction are evaluated on both simulated and experimental data. RESULTS: The results show that the estimated spectra using the scatter-corrected projection nearly match the true spectra. The normalized-root-mean-square-error and the mean energy difference between the estimated spectra and corresponding true spectra are reduced from 5.8% and 1.33 keV without the scatter correction to 3.2% and 0.73 keV with the scatter correction for both simulation and experimental data, respectively. CONCLUSIONS: The proposed method is more accurate for the acquisition of x-ray spectrum than the estimation method without scatter correction and the spectrum can be successfully estimated even the materials of the filters and their thicknesses are unknown. The proposed method has the potential to be used in several diagnostic x-ray imaging applications.

Targeted alpha immunotherapy of CD20-positive B-cell lymphoma model: dosimetry estimate of 225Ac-DOTA-rituximab using 64Cu-DOTA-rituximab.

OBJECTIVE: The aim of this study was to evaluate the radiation dosimetry of alpha-emitter 225Ac-DOTA-rituximab using Monte Carlo simulation of 64Cu-DOTA-rituximab. METHODS: CD20 expression was evaluated in lymphoma cell lines (Jurkat and Raji). DOTA-rituximab was conjugated and then chelated by 64Cu. Tumor xenograft models were established in BALB/c-nu mice. Animal PET/CT imaging was obtained after tail vein injection with and without a pre-dose of 2 mg of cold rituximab. Specific binding of tumors was evaluated by an organ distribution assay and autoradiography. CD20 expression in tumor tissues was evaluated by immunohistochemistry. The residence time was calculated using 64Cu-DOTA-rituximab PET/CT acquisition data using OLINDA/EXM software. 225Ac-DOTA-rituximab tumor dosimetry was performed using Monte Carlo simulation with 64Cu-DOTA-rituximab PET/CT images. RESULTS: Specific binding of Raji cells (CD20 positive) was 90 times that of Jurkat cells (CD20 negative) (p < 0.0001). Immunoreactivity was more than 75%. PET/CT imaging with 64Cu-DOTA-rituximab was specifically observed in tumors. The radioactivity of the tumor was much higher than that of other organs, and tumor uptake was related to CD20 expression. The predicted human dose for the administration of 64Cu-DOTA-rituximab was measured as the effective dose (1.07E-02 mSv/MBq). In the tumor region, equivalent doses of 225Ac-DOTA-rituximab (14 SvRBE5/MBq) were much higher (74-fold) than those of 64Cu-DOTA-rituximab (0.19 SvRBE5/MBq) (p < 0.01). CONCLUSION: Tumor dosimetry of 225Ac-DOTA-rituximab can be estimated via the Monte Carlo simulation of 64Cu-DOTA-rituximab. 225Ac-DOTA-rituximab can be employed for lymphoma as targeted alpha therapy.

Differential diagnosis of complex cystic renal mass using multiphase computerized tomography.

PURPOSE: We evaluated the additional usefulness of multiphase computerized tomography for improving the differential diagnosis of cystic renal masses by the Bosniak classification. MATERIALS AND METHODS: We reviewed the records of 104 patients with Bosniak class II (29 or 27.8%), III (38 or 36.5%) and IV (37 or 35.7%) cystic renal masses managed surgically between 1997 and 2007. On preoperative multiphase computerized tomography enhancement differences in HU between the precontrast and corticomedullary phases were measured at the highest enhancement area to correlate with pathological findings. RESULTS: Renal cell carcinoma was diagnosed in 56 patients (53.8%). Of the tumors 35 (62.5%) showed clear cell histology. According to Bosniak class 3 (11.5%), 21 (55.2%) and 32 (86.4%) class II to IV lesions, respectively, were diagnosed as renal cell carcinoma. For renal cell carcinoma and benign cysts mean HU at the precontrast phase was similar (31.5 and 32.4 HU, respectively), while renal cell carcinoma showed a significantly higher measurement at the corticomedullary phase (112.9 vs 59.8 HU, p <0.0001). To differentiate renal cell carcinoma a corticomedullary phase minus precontrast phase value of greater than 42 HU was predictive with 97.1% sensitivity and 85.7% specificity (area under the ROC curve 0.966). In a multiple regression model the corticomedullary phase minus precontrast phase value and the Bosniak classification independently determined malignant pathological findings (corticomedullary phase minus precontrast phase greater than 42 HU HR 31.541, 95% CI 8.320-119.563 and Bosniak class HR 5.545, 95% CI 2.153-14.279, each p <0.0001). CONCLUSIONS: In cases of complex cystic renal masses diagnostic accuracy can be improved to differentiate renal cell carcinoma by combining Bosniak class and enhancement differences measured on multiphase computerized tomography between precontrast and maximal enhancement phases. This would help determine the need for and the method of surgical treatment.

Age at diagnosis is an independent predictor of small renal cell carcinoma recurrence-free survival.

PURPOSE: Controversy exists as to the influence of age at diagnosis on prognosis in patients with renal cell carcinoma. We investigated the relationship between age at diagnosis and disease recurrence after surgery in patients with small renal cell carcinoma. MATERIALS AND METHODS: Of the 1,196 patients who underwent curative surgery for renal cell carcinoma between 1989 and 2005 at our institution 490 with renal cell carcinoma 4 cm or less were included in our study. Patients were stratified into 3 subgroups according to age at diagnosis, including 40 years or less in 93, 41 to 60 years in 253 and greater than 60 years in 144. Clinical and pathological variables at diagnosis were compared and survival analysis was performed. RESULTS: A total of 17 patients (3.5%) experienced disease recurrence and 9 (1.8%) died of metastatic renal cell carcinoma during followup. Higher Fuhrman nuclear grade was associated with older age at diagnosis (p = 0.001). Histological subtypes were associated with age categories (p = 0.016). The overall recurrence-free survival rate was 97.2% and 92.4% at 5 and 10 years, respectively. The 10-year recurrence-free survival rate was 100% for patients 40 years old or younger, 95.7% for those 41 to 60 years old and 79.0% for those older than 60 years (p = 0.002). Multivariate analysis revealed that age at diagnosis and Fuhrman grade independently predicted recurrence-free survival (p = 0.027 and <0.001, respectively). CONCLUSIONS: Age at diagnosis was an independent predictor of recurrence-free survival after curative surgical treatment in patients with small renal cell carcinoma. Our results suggest that older patients with small renal cell carcinoma should be more closely followed after surgery than younger patients.

Performance evaluation of a Compton SPECT imager for determining the position and distribution of 225Ac in targeted alpha therapy: A Monte Carlo simulation based phantom study.

In this study, the performance of a Compton Single Photon Emission Computed Tomography (SPECT) imager when in vivo monitoring the position and distribution of 225Ac radionuclide in targeted alpha therapy (TAT) was evaluated. When 225Ac radionuclide, which emits various γ-rays (218 and 440 keV), is used in TAT, both the photoelectric and Compton scattering events can be used for image reconstruction. Moreover, all information pertaining to the various γ-rays of the 225Ac radionuclide can be individually or simultaneously utilized in the reconstructed image. Three types of simulation phantoms and a quantitative evaluation method were used to compare the performance of the Compton SPECT imager to that of conventional SPECT imaging, which uses only photoelectric events, and the results demonstrated that the Compton SPECT imager exhibited a higher performance as the effective count for the image reconstruction was higher. To verify the accuracy of the position and distribution of the 225Ac radionuclide that had been inserted into the phantom, reconstructed images of the various γ-rays were combined with cross-sectional images of the human phantom and all combined images were found to match the predetermined simulation conditions. In conclusion, the simulation results demonstrated the feasibility of the in vivo monitoring of the position and distribution of 225Ac radionuclide using the γ-rays in TAT.

Primary Tumor Characteristics Are Important Prognostic Factors for Sorafenib-Treated Patients with Metastatic Renal Cell Carcinoma: A Retrospective Multicenter Study.

We aimed to identify prognostic factors associated with progression-free survival (PFS) and overall survival (OS) in metastatic renal cell carcinoma (mRCC) patients treated with sorafenib. We investigated 177 patients, including 116 who received sorafenib as first-line therapy, using the Cox regression model. During a median follow-up period of 19.2 months, the PFS and OS were 6.4 and 32.6 months among all patients and 7.4 months and undetermined for first-line sorafenib-treated patients, respectively. Clinical T3-4 stage (hazard ratio [HR] 2.56) and a primary tumor size >7 cm (HR 0.34) were significant prognostic factors for PFS among all patients, as were tumor size >7 cm (HR 0.12), collecting system invasion (HR 5.67), and tumor necrosis (HR 4.11) for OS (p < 0.05). In first-line sorafenib-treated patients, ≥4 metastatic lesions (HR 28.57), clinical T3-4 stage (HR 4.34), collecting system invasion (univariate analysis HR 2.11; multivariate analysis HR 0.07), lymphovascular invasion (HR 13.35), and tumor necrosis (HR 6.69) were significant prognosticators of PFS, as were bone metastasis (HR 5.49) and clinical T3-4 stages (HR 4.1) for OS (p < 0.05). Our study thus identified a number of primary tumor-related characteristics as important prognostic factors in sorafenib-treated mRCC patients.

Efficacy and Safety of Sorafenib Therapy on Metastatic Renal Cell Carcinoma in Korean Patients: Results from a Retrospective Multicenter Study.

OBJECTIVE: To evaluate the efficacy and safety of sorafenib for Korean patients with metastatic renal cell carcinoma (mRCC). METHODS: A total of 177 mRCC patients using sorafenib as first- (N = 116), second- (N = 43), and third-line (N = 18) therapies were enrolled from 11 Korean centers between 2006 and 2012. The patient characteristics, therapy duration, tumor response, disease control rate, and tolerability were assessed at baseline and at routine follow-ups, and the progression-free survival (PFS) and overall survival (OS) times and rates were analyzed. RESULTS: Among all patients, 18 (10.2%) stopped sorafenib treatment for a median of 1.7 weeks, including 15 (8.5%) who discontinued the drug, while 40 (22.6%) and 12 (6.8%) patients required dose reductions and drug interruptions, respectively. Severe adverse events (AEs) or poor compliance was observed in 64 (36.2%) patients, with 118 (7.4%) ≥grade 3 AEs. During the treatment, one myocardial infarction was observed. The number of ≥grade 3 AEs in the first-line sorafenib group was 71 (6.8% of the total 1048 AEs). During a median follow-up of 17.2 months, the radiologically confirmed best objective response rate, disease control rate, median PFS, and median OS were 22.0%, 53.0%, 6.4 months (95% confidence interval [CI], 5.2-8.9), and 32.6 months (95% CI, 27.3-63.8) for the total 177 sorafenib-treated patients, respectively, and 23.2%, 56.0%, 7.4 months (95% CI, 5.5-10.5), and not reached yet (95% CI, 1.0-31.1) for the first-line sorafenib group, respectively. CONCLUSIONS: Sorafenib produced tolerable safety, with a ≥grade 3 AE rate of 7.4% and an acceptable disease control rate (53.0%) in Korean mRCC patients.

Palliative care of malignant ureteral obstruction with polytetrafluoroethylene membrane-covered self-expandable metallic stents: initial experience.

PURPOSE: We assessed the efficacy and safety of insertion of a polytetrafluoroethylene membrane-covered self-expandable metallic stent (UVENTA stent) for palliation of malignant ureteral obstruction on the basis of our early results. MATERIALS AND METHODS: Eighteen patients underwent UVENTA stent insertion for extrinsic malignant ureteral obstructions of 20 ureters. The UVENTA stents were deployed retrogradely under cystoscopy and fluoroscopy. Candidates for the procedure had preexisting double-J stents that were nonfunctional or caused excessive bladder irritation. We recorded the success and patency rate in addition to any complications associated with the procedure. RESULTS: The mean length of obstruction was 10.6 cm (range, 2 to 20 cm). Two ureters were obstructed in the upper ureter, 9 in the lower ureter, and 9 in multiple levels of ureter. Simultaneous balloon dilation was performed in 12 ureters. UVENTA stents were successfully inserted in all patients. No obstruction of the UVENTA stents occurred during the mean follow-up period of 7.3 months (patency rate 100%), but de novo ureteral obstruction developed in 4 ureters. There were no instances of stone formation, hyperplastic reaction, encrustation, or migration. Abnormally elevated serum creatinine decreased to normal levels and hydronephrosis gradually resolved during the 4 weeks after UVENTA insertion. No significant complications developed except for transient and self-limiting hematuria and mild lower abdominal pain. CONCLUSIONS: UVENTA stents may relieve malignant ureteral obstruction safely and easily. Long-term follow-up is necessary to assess the role of this stent in the treatment of malignant ureteral obstruction.

Ureteral injury in gynecologic surgery: a 5-year review in a community hospital.

PURPOSE: We reviewed the cases of ureteral injury during gynecologic surgeries in a community hospital and attempted to find possible options for alleviating these distressing situations. MATERIALS AND METHODS: A total of 2,927 patients underwent gynecologic surgeries in the last 5 years at our hospital. We retrospectively analyzed the cases, particularly the possible risk factors and management according to the time of detection of the injury. Thirty-five cases (1.2%) were identified with ureteral injury in a total of 2,927 gynecologic surgeries. Risk factors included endometriosis, pelvic inflammatory disease, previous pelvic surgery, history of pelvic radiation, and congenital anomalies. Among 2,927 patients, 522 had predisposing factors for ureteral injuries. RESULTS: The incidence of ureteral injury in laparoscopic cases was 1.1%, similar to the cases of laparotomy (1.2%). The rate of ureteral injury was significantly higher in the group with risk factors (2.7%) than in the group without risk factors (0.9%; p=0.002). Prophylactic ureteral stenting was performed in 101 of 522 patients with risk factors according to the gynecologic surgeon's preference. The injury rate (1.0%) in the stenting group was lower than that in the non-stenting group (3.1%; p=0.324). Management of ureteral injuries was successful in all cases. Of the patients with postoperatively diagnosed injuries, two patients were managed with secondary procedures, such as retrograde balloon dilatation or ureteroneocystostomy. CONCLUSIONS: The incidence of ureteral injury was significantly higher in cases having risk factors than in cases without risk factors. Surgeons should be cautious to avoid ureteral injury during gynecologic surgery, especially in patients with risk factors.

Comparison of 2002 TNM nodal status with lymph node density in node-positive patients after radical cystectomy for bladder cancer: analysis by the number of lymph nodes removed.

OBJECTIVE: Because 2002 TNM pathologic nodal (pN) status was established in patients from whom a relatively small number of lymph nodes had been removed, it is necessary to validate this staging system in current clinical practice, in which the removal of more lymph nodes is recommended during radical cystectomy and pelvic lymphadenectomy. We assessed the ability of lymph node density (LND) and 2002 TNM pathologic nodal (pN) status to predict disease-specific survival (DSS) in node-positive patients after radical cystectomy for bladder cancer, and investigated whether these factors were affected by the number of lymph nodes removed during pelvic lymphadenectomy. MATERIALS AND METHODS: We retrospectively evaluated outcomes in 130 patients with nodal metastases after radical cystectomy performed between 1989 and 2006. Patients were divided into 2 subgroups based on the median number of lymph nodes removed, those with <15 and those with ≥ 15 lymph nodes removed. The effect of several variables on DSS was assessed. RESULTS: The overall 5-year DSS rate was 38.5%. Multivariate analysis showed that in the entire cohort, LND (HR = 2.28, 1.04-5.03, P = 0.041) and the use of adjuvant chemotherapy (HR = 2.68, 1.42-5.06, P = 0.002) were significant predictors of DSS. In patients with <15 lymph nodes removed, pN status (HR = 5.19, 1.24-21.75, P = 0.024) and use of adjuvant chemotherapy (HR = 6.23, 2.32-16.73, P < 0.001) were independent predictors of DSS. In patients with ≥ 15 lymph nodes removed, however, only LND (HR = 4.08, 1.10-15.10, P = 0.036) was a predictor of DSS. CONCLUSIONS: LND was an independent predictor of DSS in node-positive patients. However, when small numbers of lymph nodes were removed, TNM pN status was a better predictor than LND. These findings suggest that abilities of TNM pN status and LND in node-positive patients to predict DSS could be affected by the total number of lymph nodes removed.

The long-term effect of alfuzosin in patients with lower urinary tract symptoms suggestive of benign prostate hyperplasia: evaluation of voiding and storage function with respect to bladder outlet obstruction grade and contractility.

OBJECTIVES: To evaluate the efficacy of alfuzosin treatment on voiding and storage in patients with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) with respect to bladder outlet obstruction and contractility. METHODS: A 12-month, multicenter, observational, prospective study was conducted at four university hospitals in Korea. Patients were divided into four groups: group 1 (bladder outlet obstruction index (BOOI) ≥20, bladder contractility index (BCI) ≥100), group 2 (BOOI ≥20, BCI <100), group 3 (BOOI <20, BCI ≥100), and group 4 (BOOI <20, BCI <100), with respect to BOOI and BCI evaluated by pressure-flow study. Treatment efficacy was analyzed by validated symptom scores. RESULTS: Two-hundred thirty-two men with LUTS/BPH were enrolled, and 165 (41, 50, 30, and 44 in groups 1-4, respectively) were followed to the end of the study. After 12 months of alfuzosin treatment, all International Prostate Symptom Score (IPSS) parameters improved in all four groups. Mean improvement in IPSS subscore for voiding was 4.0 points in group 1, 5.5 points in group 2, 5.5 points in group 3, and 3.0 points in group 4. Change in IPSS subscore for storage was 2.5 points in group 1, 3.6 points in group 2, 2.9 points in group 3, and 1.8 points in group 4. There was no difference among four groups in improvements seen in storage or voiding IPSS subscore. International Continence Society male questionnaire scores significantly improved in all four groups with no between-group differences. CONCLUSIONS: Alfuzosin treatment in men with LUTS indicative of BPH effectively improved voiding and storage symptoms regardless of BOOI or BCI.

Voiding and sexual function after autonomic-nerve-preserving surgery for rectal cancer in disease-free male patients.

PURPOSE: We evaluated the effects of surgery for rectal cancer on postoperative voiding and sexual function over the course of time. MATERIALS AND METHODS: Data from 28 patients who underwent autonomic nerve preserving rectal cancer surgery were retrospectively analyzed. Operations were performed between October 2005 and July 2007 and all patients were followed-up for more than 3 years. Preoperatively, all patients underwent urodynamic studies including uroflowmetry, and filled out the International Prostate Symptom Score (IPSS). The evaluation of sexual function consisted of Erectile Function domain score in International Index of Erectile Function (IIEF-EFD) and Ejaculation domain score in Male Sexual Health Questionnaire (MSHQ-EjD). Data from uroflowmetry and questionnaires were examined. RESULTS: At 3 years postoperatively the prostate volume was similar to the preoperative value (p=0.727). There were no statistically significant postoperative changes in the average maximum flow rate (15.9 ml/s vs. 16.2 ml/s, p=0.637) and post-void residual urine volume (34.7 ml vs. 36.8 ml, p=0.809). No statistically significant differences were observed in the IPSS (13.2 vs. 12.2, p=0.374). However, although pelvic autonomic nerve preservation have been performed, a significant proportion of rectal cancer patients suffer from sexual dysfunction and the average of IIEF-EFD and MSHQ-EjD scores was decreased postoperatively until 3 years (25.1 vs. 16.1 and 28.3 vs. 14.2 respectively, p<0.001). CONCLUSIONS: Voiding function was not affected after autonomic nerve-preserving rectal cancer surgery, however sexual function was significantly aggravated. We recommend that the baseline genitourinary function should be evaluated before the treatment for male rectal cancer patients, and penile rehabilitation is necessary for their quality of life after treatment.

Effectiveness of local anaesthesia techniques in patients undergoing transrectal ultrasound-guided prostate biopsy: a prospective randomized study.

AIM: This study was designed to compare the effectiveness of intrarectal lidocaine gel versus periprostatic lidocaine injection during transrectal ultrasound (TRUS)-guided prostate biopsy. METHODS: Ninety men undergoing transrectal prostate biopsy from July through December 2004 were randomized into three groups of 30 patients each. Before the biopsy, patients in Group 1 received 20 mL of 2% lidocaine gel intrarectally; patients in Group 2 received 5 mL (2.5 mL per side) of 2% lidocaine solution injected near the junction of the seminal vesicle with the base of the prostate (along the neurovascular bundles), and patients in Group 3 (control group) received 5 mL (2.5 mL per side) of normal saline injected along the neurovascular bundles. Pain level after the biopsy was assessed using a 10-point linear visual analog scale (VAS). Results were statistically compared by the Wilcoxon Rank Sum test. RESULTS: Patients in Group 2 had significantly lower VAS scores than those in Group 3 (3.6 +/- 2.1 vs 5.8 +/- 1.9, P < 0.0001), but those in Group 1 did not (5.5 +/- 2.7 vs 5.8 +/- 1.9, P = 0.67). Gross hematuria, rectal bleeding, and hemospermia occurred in 36 (40.0%), 6 (7%) and 5 (6%) patients. One patient had temporary vasovagal syncope. No patient reported febrile urinary tract infection or urinary retention. CONCLUSIONS: Periprostatic injection of local anaesthetic is a safe technique that significantly reduces pain during prostate biopsy, whereas intrarectal lidocaine injection did not reduce pain. This safe, simple technique should be applied in men undergoing TRUS-guided prostate biopsy to limit patient discomfort.