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COMBINED ANESTHESIA WITH PERIANAL-INTRARECTAL LIDOCAINE-PRILOCAINE CREAM AND PERIPROSTATIC NERVE BLOCK DURING TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY: A RANDOMIZED CONTROLLED TRIAL
THE JOURNAL OF UROLOGY®
Vol. 181, No. 4, Supplement, Wednesday, April 29, 2009
voided spontaneously through 3 month follow-up. At cystoscopy 2 weeks and 3 months later, urothelium appeared normal and little change was seen on TRUS. Improvement in IPSS and Qmax was modest, suggesting use of higher energy doses in ongoing trials. Sexual function was preserved in all 4 active men. _____Canine prostate 48 hours after Litx™ treatment_____
705
Prostate Cancer: Detection & Screening (III) Moderated Poster 66 Wednesday, April 29, 2009
10:30 am - 12:30 pm
1950 COMBINED ANESTHESIA WITH PERIANAL-INTRARECTAL LIDOCAINE-PRILOCAINE CREAM AND PERIPROSTATIC NERVE BLOCK DURING TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY: A RANDOMIZED CONTROLLED TRIAL
CONCLUSIONS: Canine and human studies indicate potential for a safe, effective, painless treatment of BPH using light-activated drug therapy in an office setting Source of Funding: Light Sciences Oncology
1949 MAGNETIC RESONANCE IMAGING-GUIDED FOCUSED ULTRASOUND FOR THERMAL ABLATION IN THE PROSTATE: A FEASIBILITY STUDY IN A CANINE MODEL Zohar A Dotan*, E Fridman, Y Inbar, D Kopelman, A Hananel, D Castel, H Ziso, B Raanan Berger, Jacob Ramon, Ramat Gan, Israel INTRODUCTION AND OBJECTIVES: Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS), is a novel technique that was developed to enable precise, image-guided targeting and destruction of tumors by thermocoagulation. The system, ExAblate for Prostate, is a focused ultrasound delivery system embedded within the MRI table of a conventional diagnostic MRI scanner. The device delivers ultrasound energy by a phased array transducer that converge it to selectively destroy the targeted tissue. Temperature maps generated by the MRI scanner are used to verify location and thermal rise, which are used to predict the thermal destruction in a real time closed loop feedback. To assess the safety, feasibility, and precision of this technology in the prostate, we have used the ExAblate for Prostate system to create thermal lesions in the prostate of dogs. METHODS: METHODS: Twenty dogs were anesthetized and positioned in the ExAblate for Prostate system. The dogs’ prostates were evaluated by the MRI for size and consistency. Local ablations were performed by the ExAblate for Prostate. The animals were then sacrificed. Prostates and the anterior rectal wall were removed for pathological study. The lesions were assessed macroscopically and histologically. The size, location and shape of accumulated thermal dose were compared with the post treatment contrast enhanced MRI scans and pathological specimen. Among the last 6 dogs, the transrectal balloon’s cooling temperature was decreased to 15ºC. RESULTS: RESULTS: High-energy sonications led to precise coagulation necrosis of the prostate specified targets as shown by the thermal maps during ablation, post-therapy MRI, macroscopic, and histological analysis. The thermal lesions were sharply demarcated from the surrounding surrounding preserved prostatic tissue. Limited superficial hematomas were detected at the anterior rectal wall’s mucosa and serosa due to mechanical trauma by the rectal probe in 12 (54%) of the animals. No evidence of thermal injury occurred when the cooling temperature was of 15ºC. CONCLUSIONS: MRI-guided focused ultrasound proved to be a precise and an effective means to destroy anatomically predefined prostate tissues by thermocoagulation with minimal associated edema or damage to adjacent structures, with the correct treatment parameters. Source of Funding: None
Gianluca Giannarini*, Pisa, Italy; Riccardo Autorino, Naples, Italy; Francesca Valent, Udine, Italy; Andrea Mogorovich, Francesca Manassero, Maurizio De Maria, Girolamo Morelli, Pisa, Italy; Fabio Barbone, Udine, Italy; Giuseppe Di Lorenzo, Naples, Italy; Cesare Selli, Pisa, Italy INTRODUCTION AND OBJECTIVES: Albeit periprostatic nerve block (PPNB) is currently considered the gold standard for pain control during TRUS-guided prostate biopsy (PBx), it does not alleviate proberelated anorectal discomfort and may even add pain due to transcapsular infiltration of local anesthetic. In this study we tested the efficacy and safety of combined anesthesia with perianal-intrarectal lidocaineprilocaine (PILP) cream, aimed at anorectal discomfort relief, and PPNB during TRUS-guided PBx. METHODS: A total of 280 patients were randomized to PILP cream and PPNB (group 1), PILP cream alone (group 2), PPNB alone (group 3) or no anesthesia (group 4) before TRUS-guided PBx. All patients were administered either lidocaine-prilocaine cream or inert lubricant perianallyintrarectally in a single-blind fashion. Pain was evaluated with a 10-point visual analog scale (VAS) after perianal-intrarectal substance administration (VAS-a), prostate TRUS (VAS-b), PPNB (VAS-c) and prostate sampling with a 10-core template (VAS-d). VAS-a was an estimate of anorectal discomfort. Complications were assessed with questionnaire and telephone interview. Differences in patient characteristics and VAS scores were calculated with chi-square and Student-Newman-Keuls multiple range tests. To assess whether differences in VAS-b and VAS-d scores varied with age, prostate volume and VAS-a, stratified analyses using t-test and ANOVA were performed, taking median values of the 3 factors as cut-off. RESULTS: The 4 groups were comparable for age, prostate volume, pathology results and VAS-a. VAS-b was lower in groups 1, 2 vs 3, 4 (mean 1.5, 1.41 vs 5.37, 5.31; p<0.001), VAS-c was lower in group 1 vs 3 (mean 1.03 vs 3.74; p<0.001) and VAS-d was lower in group 1, 2, 3 vs 4 (mean 0.77, 1.27, 1.27 vs 4.33; p<0.001) and in group 1 vs 2, 3 (p<0.001). Stratified analyses showed that VAS-d was lower in group 1 vs 2, 3 for younger patients (a65 years), those with larger prostates (>49 cc) and with higher anorectal discomfort (VAS-a >2) (p=0.006, <0.001 and 0.003, respectively). Overall complication rate was similar in the 4 groups (p=0.87). CONCLUSIONS: Our findings suggest that the combination of PILP cream and PPNB provides a superior pain control than the 2 modalities alone in the sampling part of TRUS-guided PBx, with no increase in complication rate. The magnitude of this effect appears higher for younger men, those with larger prostates and with higher anorectal discomfort. Source of Funding: None
1951 INITIAL EXPERIENCE AND FEASIBILITY OF TARGETED TRANSRECTAL ULTRASOUND - MAGNETIC RESONANCE IMAGE FUSED GUIDED PROSTATE BIOPSIES. Juan M Proano*, Bradford Wood, Jochen Kruecker, Sheng Xu, Julia Locklin, Bethesda, MD; Neil Glossop, Toronto, ONCanada; Ismail Turkbey, Peter Choyke, Peter A Pinto, Bethesda, MD INTRODUCTION AND OBJECTIVES: Currently, sextant prostate biopsy only uses transrectal ultrasound (US) guidance. To biopsy tissue defined as suspicious on magnetic resonance imaging
Vol. 181, No. 4, Supplement, Wednesday, April 29, 2009
voided spontaneously through 3 month follow-up. At cystoscopy 2 weeks and 3 months later, urothelium appeared normal and little change was seen on TRUS. Improvement in IPSS and Qmax was modest, suggesting use of higher energy doses in ongoing trials. Sexual function was preserved in all 4 active men. _____Canine prostate 48 hours after Litx™ treatment_____
705
Prostate Cancer: Detection & Screening (III) Moderated Poster 66 Wednesday, April 29, 2009
10:30 am - 12:30 pm
1950 COMBINED ANESTHESIA WITH PERIANAL-INTRARECTAL LIDOCAINE-PRILOCAINE CREAM AND PERIPROSTATIC NERVE BLOCK DURING TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY: A RANDOMIZED CONTROLLED TRIAL
CONCLUSIONS: Canine and human studies indicate potential for a safe, effective, painless treatment of BPH using light-activated drug therapy in an office setting Source of Funding: Light Sciences Oncology
1949 MAGNETIC RESONANCE IMAGING-GUIDED FOCUSED ULTRASOUND FOR THERMAL ABLATION IN THE PROSTATE: A FEASIBILITY STUDY IN A CANINE MODEL Zohar A Dotan*, E Fridman, Y Inbar, D Kopelman, A Hananel, D Castel, H Ziso, B Raanan Berger, Jacob Ramon, Ramat Gan, Israel INTRODUCTION AND OBJECTIVES: Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS), is a novel technique that was developed to enable precise, image-guided targeting and destruction of tumors by thermocoagulation. The system, ExAblate for Prostate, is a focused ultrasound delivery system embedded within the MRI table of a conventional diagnostic MRI scanner. The device delivers ultrasound energy by a phased array transducer that converge it to selectively destroy the targeted tissue. Temperature maps generated by the MRI scanner are used to verify location and thermal rise, which are used to predict the thermal destruction in a real time closed loop feedback. To assess the safety, feasibility, and precision of this technology in the prostate, we have used the ExAblate for Prostate system to create thermal lesions in the prostate of dogs. METHODS: METHODS: Twenty dogs were anesthetized and positioned in the ExAblate for Prostate system. The dogs’ prostates were evaluated by the MRI for size and consistency. Local ablations were performed by the ExAblate for Prostate. The animals were then sacrificed. Prostates and the anterior rectal wall were removed for pathological study. The lesions were assessed macroscopically and histologically. The size, location and shape of accumulated thermal dose were compared with the post treatment contrast enhanced MRI scans and pathological specimen. Among the last 6 dogs, the transrectal balloon’s cooling temperature was decreased to 15ºC. RESULTS: RESULTS: High-energy sonications led to precise coagulation necrosis of the prostate specified targets as shown by the thermal maps during ablation, post-therapy MRI, macroscopic, and histological analysis. The thermal lesions were sharply demarcated from the surrounding surrounding preserved prostatic tissue. Limited superficial hematomas were detected at the anterior rectal wall’s mucosa and serosa due to mechanical trauma by the rectal probe in 12 (54%) of the animals. No evidence of thermal injury occurred when the cooling temperature was of 15ºC. CONCLUSIONS: MRI-guided focused ultrasound proved to be a precise and an effective means to destroy anatomically predefined prostate tissues by thermocoagulation with minimal associated edema or damage to adjacent structures, with the correct treatment parameters. Source of Funding: None
Gianluca Giannarini*, Pisa, Italy; Riccardo Autorino, Naples, Italy; Francesca Valent, Udine, Italy; Andrea Mogorovich, Francesca Manassero, Maurizio De Maria, Girolamo Morelli, Pisa, Italy; Fabio Barbone, Udine, Italy; Giuseppe Di Lorenzo, Naples, Italy; Cesare Selli, Pisa, Italy INTRODUCTION AND OBJECTIVES: Albeit periprostatic nerve block (PPNB) is currently considered the gold standard for pain control during TRUS-guided prostate biopsy (PBx), it does not alleviate proberelated anorectal discomfort and may even add pain due to transcapsular infiltration of local anesthetic. In this study we tested the efficacy and safety of combined anesthesia with perianal-intrarectal lidocaineprilocaine (PILP) cream, aimed at anorectal discomfort relief, and PPNB during TRUS-guided PBx. METHODS: A total of 280 patients were randomized to PILP cream and PPNB (group 1), PILP cream alone (group 2), PPNB alone (group 3) or no anesthesia (group 4) before TRUS-guided PBx. All patients were administered either lidocaine-prilocaine cream or inert lubricant perianallyintrarectally in a single-blind fashion. Pain was evaluated with a 10-point visual analog scale (VAS) after perianal-intrarectal substance administration (VAS-a), prostate TRUS (VAS-b), PPNB (VAS-c) and prostate sampling with a 10-core template (VAS-d). VAS-a was an estimate of anorectal discomfort. Complications were assessed with questionnaire and telephone interview. Differences in patient characteristics and VAS scores were calculated with chi-square and Student-Newman-Keuls multiple range tests. To assess whether differences in VAS-b and VAS-d scores varied with age, prostate volume and VAS-a, stratified analyses using t-test and ANOVA were performed, taking median values of the 3 factors as cut-off. RESULTS: The 4 groups were comparable for age, prostate volume, pathology results and VAS-a. VAS-b was lower in groups 1, 2 vs 3, 4 (mean 1.5, 1.41 vs 5.37, 5.31; p<0.001), VAS-c was lower in group 1 vs 3 (mean 1.03 vs 3.74; p<0.001) and VAS-d was lower in group 1, 2, 3 vs 4 (mean 0.77, 1.27, 1.27 vs 4.33; p<0.001) and in group 1 vs 2, 3 (p<0.001). Stratified analyses showed that VAS-d was lower in group 1 vs 2, 3 for younger patients (a65 years), those with larger prostates (>49 cc) and with higher anorectal discomfort (VAS-a >2) (p=0.006, <0.001 and 0.003, respectively). Overall complication rate was similar in the 4 groups (p=0.87). CONCLUSIONS: Our findings suggest that the combination of PILP cream and PPNB provides a superior pain control than the 2 modalities alone in the sampling part of TRUS-guided PBx, with no increase in complication rate. The magnitude of this effect appears higher for younger men, those with larger prostates and with higher anorectal discomfort. Source of Funding: None
1951 INITIAL EXPERIENCE AND FEASIBILITY OF TARGETED TRANSRECTAL ULTRASOUND - MAGNETIC RESONANCE IMAGE FUSED GUIDED PROSTATE BIOPSIES. Juan M Proano*, Bradford Wood, Jochen Kruecker, Sheng Xu, Julia Locklin, Bethesda, MD; Neil Glossop, Toronto, ONCanada; Ismail Turkbey, Peter Choyke, Peter A Pinto, Bethesda, MD INTRODUCTION AND OBJECTIVES: Currently, sextant prostate biopsy only uses transrectal ultrasound (US) guidance. To biopsy tissue defined as suspicious on magnetic resonance imaging