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UP-2.160: Treating Unilateral Localised Prostate Cancer with Hemi-Ablation High Intensity Focused Ultrasound (HIFU): Results of a NCRN-Approved Phase II Focal Therapy Clinical Trial
UNMODERATED POSTER SESSIONS
low risk T1c-T2 Nx M0 prostate cancer. Three months NHT was employed in 35 patients. Twelve received simple NHT (SNHT) and in 23 bicalutamide was added (CNHT). Transrectal ultrasound was employed to evaluate prostate volume prior and following (mean time 87 days) NHT. The global downsizing prostate volume and reduction in each prostate diameters are evaluated. Results: Mean prostate volume pre and post NHT was 53 cc and 34 cc respectively (35% reduction). The mean percentage decreasing prostate volume for SNHT and CNHT was 30% and 39% for each group (p⫽0.05). The mean percentage diameter reduction was 17% for ante-posterior, 14% for transversal and 10% for longitudinal. Conclusions: The NHT downsizing effect is 30%. Adding bicalutamide a 9% additional can be obtained. UP-2.160 Treating Unilateral Localised Prostate Cancer with Hemi-Ablation High Intensity Focused Ultrasound (HIFU): Results of a NCRN-Approved Phase II Focal Therapy Clinical Trial Sahu M1, Ahmed H1, Kumaar S1, Arumainayagam N1, Rogers K1, Scott R1, Kirkham A2, Allen C2, Freeman A3, Emberton M1 1 Division of Surgery and Interventional Sciences, 2Department of Radiology, 3Department of Histopathology, University College London Hospital, London, UK Introduction and Objectives: Focal therapy is a new therapeutic strategy proposing only to treat areas on cancer, thereby limiting and avoiding the damage to neighbouring vital structures. Up to onethird of men have unilateral cancer and are therefore potential candidates for focal therapy with minimally-invasive therapies such as HIFU. We report our interim results assessing feasibility, safety, patient acceptability and early cancer control in men treated with Hemi-ablation HIFU (Sonablate® 500) for unilateral prostate cancer. Materials and Methods: Twenty men with low-moderate risk cancer (Gleasonⱕ7,PSA ’15,ⱕT2bN0M0) were treated. Unilaterality was verified with multi-sequence MRI (T2-weighted, dynamic contrast-enhancement, diffusion weighting) and prostate mapping with 5mm spaced transperineal templateguided biopsies All had transrectal HIFU under general/spinal anaesthetic incorporating the entire positive hemiprostate upto the midline. Suprapubic catheters
S282
were inserted with discharge within 23 hours. Follow-up involved dynamic-contrast MRI at 2 weeks to assess the degree of necrosis, with suprapubic catheter removal within two weeks. Follow-up was with PSA and validated questionnaires (IIEF-15, IPSS, FACT-P, ICS Incontinence) at 1, 3, 6, 9 and 12 months. At 6 months a multi-sequence MRI prior to TRUS biopsies of the treated side was performed to verify the absence of disease. The primary objective was to assess erectile function and incontinence. Secondary objectives were to evaluate PSA kinetics and early cancer control post HIFU. Eighteen and 16 men have completed 6 months and 12 months follow up, respectively. Results: Restoration of erectile function occurred in 70% and 95% of men by 2 weeks and 3 months respectively. One has Grade 1 SUI requiring 1 pad a day. Mean PSA reduction was 77% and 80% at 3 and 12 months. Two had residual cancer on the 6 month TRUS biopsy. Both had 1mm of Gleason 3⫹3 disease. One opted for re-treatment with focal-HIFU and is cancer-free, whilst, the other has chosen active surveillance. Conclusion: Hemi-HIFU is safe, acceptable and feasible. At 3 months, 95% were free of significant genito-urinary side effects; in 87.5% there was no evidence of disease at 6 months. Complete follow-up of all men treated is awaited and will guide the development of a phase III RCT. UP-2.161 Focal High Intensity Focused Ultrasound (HIFU) Therapy in the Treatment of Localised Prostate Cancer: Early Results of a Phase II Trial Sahu M1, Ahmed H1, Kumaar S1, Arumainayagam N1, Rogers K1, Scott R1, Kirkham A2, Allen C2, Freeman A3, Emberton M1 1 Division of Surgery And Interventional Sciences, 2Department of Radiology, 3Department of Histopathology, University College London, London, UK Introduction and Objective: The choice for men with localised prostate cancer lies between active surveillance and whole gland therapy of surgery or radiotherapy. The concept of Focal therapy as a treatment modality with minimally invasive therapies such as HIFU have emerged due to the development of minimally-invasive therapies that can target and ablate just areas of cancer, thereby limiting wholegland treatment associated morbidities We report our early results of a NCRI Phase II trial assessing feasibility, safety,
patient acceptability and early cancer control in men treated with HIFU (Sonablate 500) focal-ablation for unilateral or bilateral low volume prostate cancer. Materials and Methods: Seventeen men with low-moderate risk disease (mean PSA 7.6ug/L, range 4.7-15.2ug/L) and unilateral or low-volume bilateral disease (ⱕT2bN0M0) identified on multi-sequence MRI (T2W, dynamic contrast-enhancement and diffusion weighting) and prostate mapping using 5mm spaced transperineal biopsies were treated. Eligibility criteria included gland size ⱕ45 cc and areas of cancer enabling focal-HIFU ablation such that approximately upto 50% of prostatic tissue was destroyed with preservation of atleast one neurovascular bundle. All had transrectal Sonablate HIFU as a daycase with suprapubic catheterisation. DCE-MRI was performed within 2 weeks to assess the degree of necrosis. Follow-up with PSA and validated questionnaires was at 1, 3, 6, 9 and 12 months, with multi-sequence MRI prior to transrectal biopsies at 6 months of the treated areas to verify absence of disease. Primary objective was to evaluate impotence and incontinence. Secondary objectives included biochemical and biopsy outcomes. Nine and seven men have completed follow-up of 6 and 12 months respectively. Results: No incontinence was reported. At 3 months 78% had erections sufficient for intercourse. One patient died at 3 months from an unrelated cause. Median PSA reduction was 65% at 3 months. Mean PSA was 2.8ug/L (range 0.3-11.8ug/L) and 1.2ug/L (range 0.3-3.4ug/L) at 12 months. 2 men had residual cancer on their 6 month protocol biopsy and were retreated with focal HIFU. Their post retreatment protocol biopsy is awaited. Conclusionz: Focal-ablation is technically feasible; is safe and acceptable from a patient perspective. The morbidity profile is low and erectile function is restored in most men. UP-2.162 Health-Related Quality of Life After HIFU Therapy for Organ-Confined Prostate Cancer Satoh M1, Kuwahara M1, Nakano O1, Kudoh T1, Horinouchi T2, Takeda M1, Ohkawa M1, Namiki S3, Arai Y3 1 Department of Urology, 2Department of Anesthesiology, Sen-en General Hospital, Tagajo, Japan; 3Department of Urology, Tohoku University Graduate School of Medicine, Sendai, Japan Introduction: High-intensity focused ultrasound (HIFU) on health related quality
UROLOGY 74 (Supplment 4A), October 2009
low risk T1c-T2 Nx M0 prostate cancer. Three months NHT was employed in 35 patients. Twelve received simple NHT (SNHT) and in 23 bicalutamide was added (CNHT). Transrectal ultrasound was employed to evaluate prostate volume prior and following (mean time 87 days) NHT. The global downsizing prostate volume and reduction in each prostate diameters are evaluated. Results: Mean prostate volume pre and post NHT was 53 cc and 34 cc respectively (35% reduction). The mean percentage decreasing prostate volume for SNHT and CNHT was 30% and 39% for each group (p⫽0.05). The mean percentage diameter reduction was 17% for ante-posterior, 14% for transversal and 10% for longitudinal. Conclusions: The NHT downsizing effect is 30%. Adding bicalutamide a 9% additional can be obtained. UP-2.160 Treating Unilateral Localised Prostate Cancer with Hemi-Ablation High Intensity Focused Ultrasound (HIFU): Results of a NCRN-Approved Phase II Focal Therapy Clinical Trial Sahu M1, Ahmed H1, Kumaar S1, Arumainayagam N1, Rogers K1, Scott R1, Kirkham A2, Allen C2, Freeman A3, Emberton M1 1 Division of Surgery and Interventional Sciences, 2Department of Radiology, 3Department of Histopathology, University College London Hospital, London, UK Introduction and Objectives: Focal therapy is a new therapeutic strategy proposing only to treat areas on cancer, thereby limiting and avoiding the damage to neighbouring vital structures. Up to onethird of men have unilateral cancer and are therefore potential candidates for focal therapy with minimally-invasive therapies such as HIFU. We report our interim results assessing feasibility, safety, patient acceptability and early cancer control in men treated with Hemi-ablation HIFU (Sonablate® 500) for unilateral prostate cancer. Materials and Methods: Twenty men with low-moderate risk cancer (Gleasonⱕ7,PSA ’15,ⱕT2bN0M0) were treated. Unilaterality was verified with multi-sequence MRI (T2-weighted, dynamic contrast-enhancement, diffusion weighting) and prostate mapping with 5mm spaced transperineal templateguided biopsies All had transrectal HIFU under general/spinal anaesthetic incorporating the entire positive hemiprostate upto the midline. Suprapubic catheters
S282
were inserted with discharge within 23 hours. Follow-up involved dynamic-contrast MRI at 2 weeks to assess the degree of necrosis, with suprapubic catheter removal within two weeks. Follow-up was with PSA and validated questionnaires (IIEF-15, IPSS, FACT-P, ICS Incontinence) at 1, 3, 6, 9 and 12 months. At 6 months a multi-sequence MRI prior to TRUS biopsies of the treated side was performed to verify the absence of disease. The primary objective was to assess erectile function and incontinence. Secondary objectives were to evaluate PSA kinetics and early cancer control post HIFU. Eighteen and 16 men have completed 6 months and 12 months follow up, respectively. Results: Restoration of erectile function occurred in 70% and 95% of men by 2 weeks and 3 months respectively. One has Grade 1 SUI requiring 1 pad a day. Mean PSA reduction was 77% and 80% at 3 and 12 months. Two had residual cancer on the 6 month TRUS biopsy. Both had 1mm of Gleason 3⫹3 disease. One opted for re-treatment with focal-HIFU and is cancer-free, whilst, the other has chosen active surveillance. Conclusion: Hemi-HIFU is safe, acceptable and feasible. At 3 months, 95% were free of significant genito-urinary side effects; in 87.5% there was no evidence of disease at 6 months. Complete follow-up of all men treated is awaited and will guide the development of a phase III RCT. UP-2.161 Focal High Intensity Focused Ultrasound (HIFU) Therapy in the Treatment of Localised Prostate Cancer: Early Results of a Phase II Trial Sahu M1, Ahmed H1, Kumaar S1, Arumainayagam N1, Rogers K1, Scott R1, Kirkham A2, Allen C2, Freeman A3, Emberton M1 1 Division of Surgery And Interventional Sciences, 2Department of Radiology, 3Department of Histopathology, University College London, London, UK Introduction and Objective: The choice for men with localised prostate cancer lies between active surveillance and whole gland therapy of surgery or radiotherapy. The concept of Focal therapy as a treatment modality with minimally invasive therapies such as HIFU have emerged due to the development of minimally-invasive therapies that can target and ablate just areas of cancer, thereby limiting wholegland treatment associated morbidities We report our early results of a NCRI Phase II trial assessing feasibility, safety,
patient acceptability and early cancer control in men treated with HIFU (Sonablate 500) focal-ablation for unilateral or bilateral low volume prostate cancer. Materials and Methods: Seventeen men with low-moderate risk disease (mean PSA 7.6ug/L, range 4.7-15.2ug/L) and unilateral or low-volume bilateral disease (ⱕT2bN0M0) identified on multi-sequence MRI (T2W, dynamic contrast-enhancement and diffusion weighting) and prostate mapping using 5mm spaced transperineal biopsies were treated. Eligibility criteria included gland size ⱕ45 cc and areas of cancer enabling focal-HIFU ablation such that approximately upto 50% of prostatic tissue was destroyed with preservation of atleast one neurovascular bundle. All had transrectal Sonablate HIFU as a daycase with suprapubic catheterisation. DCE-MRI was performed within 2 weeks to assess the degree of necrosis. Follow-up with PSA and validated questionnaires was at 1, 3, 6, 9 and 12 months, with multi-sequence MRI prior to transrectal biopsies at 6 months of the treated areas to verify absence of disease. Primary objective was to evaluate impotence and incontinence. Secondary objectives included biochemical and biopsy outcomes. Nine and seven men have completed follow-up of 6 and 12 months respectively. Results: No incontinence was reported. At 3 months 78% had erections sufficient for intercourse. One patient died at 3 months from an unrelated cause. Median PSA reduction was 65% at 3 months. Mean PSA was 2.8ug/L (range 0.3-11.8ug/L) and 1.2ug/L (range 0.3-3.4ug/L) at 12 months. 2 men had residual cancer on their 6 month protocol biopsy and were retreated with focal HIFU. Their post retreatment protocol biopsy is awaited. Conclusionz: Focal-ablation is technically feasible; is safe and acceptable from a patient perspective. The morbidity profile is low and erectile function is restored in most men. UP-2.162 Health-Related Quality of Life After HIFU Therapy for Organ-Confined Prostate Cancer Satoh M1, Kuwahara M1, Nakano O1, Kudoh T1, Horinouchi T2, Takeda M1, Ohkawa M1, Namiki S3, Arai Y3 1 Department of Urology, 2Department of Anesthesiology, Sen-en General Hospital, Tagajo, Japan; 3Department of Urology, Tohoku University Graduate School of Medicine, Sendai, Japan Introduction: High-intensity focused ultrasound (HIFU) on health related quality
UROLOGY 74 (Supplment 4A), October 2009