The purpose of these clinical studies was to validate a Tissue Change Monitoring (TCM) algorithm in vivo. TCM is a quantitative tool for the real-time assessment of HIFU dose. TCM provides ...quantitative analysis of the backscatter pulse echo signals (pre and immediately post HIFU) for each individual ablative site, using ultrasonic tissue characterization as a surrogate for monitoring tissue temperature. Real-time analysis generates an energy difference parameter (ΔE in dB) that is proportional to tissue temperature.
Post in vitro studies, two clinical studies were conducted to validate the TCM algorithm on the Sonablate® device. Studies enrolled histologically confirmed, organ confined prostate cancer patients. The first clinical study was conducted in two phases for whole gland ablation. First eight patients' data were used to measure the algorithm performance followed by 89 additional patients for long term outcome. The second clinical study enrolled five patients; four patients with focal cancer had hemi-ablation only and one had whole gland ablation. Four 3 Fr. needles containing three thermocouples each were placed transperineally in the prostate to record tissue temperatures in the focal zone, posterior to the focal zone and on the lateral gland where no HIFU was applied. Tissue temperatures from the focal zone were correlated to the ΔE parameter.
In the first clinical study, the average TCM rate was 86%. Pre and 6 months post HIFU, median PSA was 7.64 and 0.025 ng/ml respectively and 97% patients had negative biopsy. For the second clinical study, the measured prostate tissue temperatures (Average, Max, and Min) in the ablation zones were 84°, 114° and 60 °C and the corresponding ΔE (dB/10) parameters were 1.05, 2.6 and 0.4 resulting in 83% of temperatures in the range of 75°-100 °C and 17% in the 60°-74 °C range. Outside the focal zone, the average temperature was 50 °C and in the lateral lobe where no HIFU was applied, peak temperature was 40.7 °C.
The TCM algorithm is able to estimate tissue changes reliably during the HIFU procedure for prostate tissue ablation in real-time and can be used as a guide for HIFU dose delivery and tissue ablation control.
: Erectile dysfunction (ED) is common among patients on dialysis therapy. In the present study, we attempted administration of sildenafil to Japanese patients undergoing dialysis. In order to ...diagnose ED before prescribing sildenafil, we assessed the hemodialysis patients who desired sildenafil by using the five items version of the International Index of Erectile Function (IIEF‐5). In addition, the characteristics of the quality of life in Japanese hemodialysis patients who desired sildenafil were assessed using the kidney disease quality of life (KDQOL). To all 37 male subjects (mean age of 53.8 ± 10.4 years) attending the Outpatient Hemodialysis Unit at Atsugi Clinic (Atsugi City, Japan), it was explained by their primary doctor that the treatment of ED with sildenafil was possible. As a result, 10 patients (27.0%) desired the treatment. For eight patients, ED was diagnosed by IIEF‐5 prior to prescription of sildenafil. The mean IIEF‐5 scores were 6.13 ± 4.67 points. Sildenafil was prescribed to five patients (three diabetic, two non‐diabetic) and sexual function was improved in three cases. The main adverse effect was found to be ventricular arrhythmia in one case. As for KDQOL, the group desiring sildenafil showed significantly high values in Dialysis Staff Encouragement and Patient Satisfaction. Among the other nine dialysis patients (five diabetic, four non‐diabetic; mean age of 58.1 ± 8.9 years) who visited the ED department of Ishida Hospital (Asahikawa City, Japan), sildenafil was effective for all non‐diabetic patients (100%) and for only one diabetic patient (20%). Among all 14 patients at Atsugi Clinic and Ishida Hospital, sildenafil efficacy rates were 83.3% for non‐diabetic patients and 37.5% for diabetic patients. Non‐diabetic patients without the side‐effects were all responders for the sildenafil treatment. The patients who relied on the dialysis staff and were more satisfied with the general treatment in the dialysis institute desired the administration of sildenafil under the present circumstances wherein the dialysis population had few experiences of sildenafil treatment. Diabetic status is thought to be a negative factor for the response of sildenafil treatment in dialysis patients.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
(Objective) To evaluate the efficacy and invasiveness of focal therapy with transrectal high-intensity focused ultrasound (HIFU) for localized prostate cancer based on spatial location of significant ...cancer with magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided biopsy. (Methods) Patients with low- and intermediate-risk significant prostate cancer who were followed-up at least 1 year, were prospectively recruited. The spatial localization of the significant cancer was determined by MRI-TRUS fusion image-guided transperineal prostate biopsy. Focal therapy targeting the regions of significant cancer was performed by transrectal HIFU using a Sonablate® 500 (SonaCare Medical, Indianapolis, IN, USA). Serum prostate-specific antigen (PSA) kinetics, multi-parametric MRI, and MRI-TRUS fusion image-guided prostate biopsy were analyzed to determine the treatment efficacy. Questionnaires and uroflowmetry were performed to evaluate the invasiveness. (Results) Ten men with median age of 67 years (range, 48-79), median PSA level of 7.07 ng/ml (range, 4.67-15.99), median prostate volume of 25 ml (range, 19-36) were treated. Median operative time was 29.5 minutes (range, 14-85). Catheterization was performed within 24 hours after the treatment in all patients. The median PSA concentration significantly decreased to 1.35 ng/ml (p<0.0001) at 3 months after the treatment. Contrast-enhanced T1-weighted MRI showed the disappearance of blood flow in all targeted regions of the prostate. MRI-TRUS fusion image-guided prostate biopsy detected the significant cancer out of the treated region in 1 patient. In urinary function, residual urine was significantly increased at 3 months after the treatment (p=0.007), but improved to the preoperative level (p=0.411). There was no significant deterioration in IPSS, IPSS QOL, OABSS, and the urinary function domain of EPIC between before and 3, 6, 9, and 12 months after the treatment. In sexual function, there was no significant difference in IIEF-5 and the sexual domain of EPIC between before and 3, 6, 9, and 12 months after the treatment. In quality of life, there was no significant difference in EPIC and SF-36 between before and 3, 6, 9, and 12 months after the treatment. The proportion of men with erections sufficient for penetration and ejaculation remained unchanged at 100% (5 of 5 patients). No serious adverse events were recorded. (Conclusions) The focal therapy with HIFU has the potential to provide accurate treatment with low morbidity in patients with localized prostate cancer. Further large studies are required to investigate the effects of the focal therapy with HIFU for analysis of oncological and functional outcomes in patients with localized prostate cancer.
Abstract Background Metastin, the final peptide of the KiSS-1 gene, has been proposed to suppress cell motility. Objective This study investigated whether renal cell carcinoma (RCC) tissue expresses ...metastin or its receptor, and clarified whether metastin can suppress migration and/or invasion and/or proliferation of RCC cells in vitro. Design, Setting, and Participants Twenty-five RCC samples were submitted. Fresh RCC tissues were prepared for real-time RT-PCR, and formalin-fixed and paraffin-embedded tissues blocks were examined by immunohistochemistry. RCC cell lines Caki-1 and ACHN were supplied for cell migration, invasion, and proliferation assays. Measurements Real-time RT-PCR was performed by using Taq Man gene expression system. ENVISION system was used in immunohistochemistry. Wound-healing assay and matrigel assays were used to identify migration and invasion abilities of RCC cell lines. Cell Counting Kit-8 was applied to measure the cell proliferation. Cell morphology was examined under a META system. Statistical analysis was performed with SPSS® 15.0J. Results and Limitations In twenty-five RCC samples, the mRNA level of metastin receptor was identified to be significantly higher than non-neoplastic renal cortex by real-time RT-PCR ( p = 0.011). Immunohistochemical study also detected metastin receptor protein in all RCC tumors. In vitro, this study showed that metastin inhibited migration and invasion of Caki-1 and ACHN cells. In contrast, it had no effects on cell proliferation. Metastin (10 μmol/l) induced excessive formation of focal adhesions and stress fibers in Caki-1 and ACHN cells; this phenomenon was inhibited by pretreating pharmacological Rho-kinase inhibitor (Y-27632) to those cells. Conclusion This is the first report regarding overexpression of the metastin receptor hOT7T175 in human RCC. We demonstrate that metastin can inhibit migration and invasion of the RCC cell line, which is regulated by a Rho-kinase inhibitor. Metastin and its receptor are therefore probable targets for suppressing RCC.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Transurethral endoscopic surgery is a minimally invasive treatment for urological diseases. For the past 60 years, transurethral resection of the prostate (TUR-P) has been the gold standard treatment ...for patients with benign prostatic hyperplasia (BPH), because of effectiveness, low risk of complication, and economical saving. Recently, various minimally invasive treatments have been developed in transurethral endoscopic surgery. But, a long follow-up are necessary for evaluation of these novel treatments. We reviewed the literature of transurethral endoscopic surgery of BPH, superficial bladder cancer, urinary calculus and vesicoureteral reflex.
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