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MP62-03 HIGH-INTENSITY FOCUSSED ULTRASOUND IN THE TREATMENT OF LOCALISED PROSTATE CANCER: FOCAL SALVAGE TRANSITION RATES
THE JOURNAL OF UROLOGYâ
e718
Vol. 191, No. 4S, Supplement, Monday, May 19, 2014
MP62-03 HIGH-INTENSITY FOCUSSED ULTRASOUND IN THE TREATMENT OF LOCALISED PROSTATE CANCER: FOCAL SALVAGE TRANSITION RATES Stephanie Guillaumier*, Louise Dickinson, Clare Allen, Alex Kirkham, Alex Freeman, Mark Emberton, Hashim Ahmed, London, United Kingdom INTRODUCTION AND OBJECTIVES: Focal therapy has shown encouraging low rates of genitourinary side-effects in the treatment of localised prostate cancer. As biochemical failure is difficult to define discussion has centred on rates of transition to whole-gland local therapy and need for systemic therapy. We report on our registry experience of over 1,000 men treated with transrectal HIFU. METHODS: Our independent academic HIFU registry incorporates a total of 830 patients with low, intermediate and high risk, stage T2a-T3aN0M0 prostate adenocarcinoma treated between 2004 and 2012 in a primary setting. Of these, 509 had focal HIFU treatment (Sonablate 500); 313 had whole-gland treatment. We defined our composite failure as need for whole-gland therapy and/or systemic therapy. RESULTS: Of 509 men undergoing focal HIFU therapy, 84 required redo-HIFU (17%). None of the patients in this group went on to have radical prostatectomy. 1% (5/509) had salvage radiotherapy and <0.5% (1/509) had salvage chemotherapy due to lung metastases following a renal primary. 1% (5/509) were subsequently treated with androgen deprivation therapy alone. In the same period, 313 patients had whole-gland HIFU treatment. Of these, 40% (124/313) had redo-HIFU and 5% (15/313) had androgen deprivation for treatment failure. 6% (18/313) underwent salvage radiotherapy and <1% (2/313) were further treated with salvage radical prostatectomy. <0.5% (1/313) had salvage chemotherapy and <0.5% (1/313) had cryotherapy. CONCLUSIONS: Focal therapy demonstrates reassuringly low short to medium term rates of transition to whole-gland local therapy or systemic therapy in 11%. Longer follow-up will determine rates of metastases and mortality. Re-do
Radical
Total
HIFU
Prostatectomy
ERBT
Hormones
Chemotherapy
Cryotherapy
Focal
509
84
0
5
5
1
0
Whole
313
124
2
18
15
1
1
gland
Source of Funding: Sonacare Inc.
MP62-04 DOES AGE REPRESENT A LIMITATION FOR HIFU TREATMENT? AGE STRATIFIED OUTCOMES FROM A MULTICENTRE STUDY OF 2762 PATIENTS ANALYSED FROM THE @-REGISTRY Sebastien Crouzet*, Lyon, France; Roman Ganzer, Regensburg, € rth, Germany; Stefan Thueroff, Munich, Germany; Andreas Blana, Fu Germany; Christian Chaussy, Regensburg, Germany; Albert Gelet, Lyon, France INTRODUCTION AND OBJECTIVES: High intensity focused ultrasound (HIFU) performed by Ablathermâ has been used as primary treatment of localized prostate cancer. In the last years, HIFU has been recognized as a therapeutic option in patients over 70 years old with 10 years life expectancy. The objective of this study is to report the biochemical and biopsy outcomes, stratified by age, in patients who have undergone HIFU. METHODS: A total of 2762 consecutive patients with T1-T2 prostate cancer treated by HIFU Ablathermâ (EDAP-TMS, Lyon, France), in three European HIFU centers since 1993 were included. Treatment results, and post treatment morbidity have been registered in the online Ablathermâ HIFU database, @-Registry. This is a secured on-line database collecting relevant de-identified clinical and technical
information for patients treated by HIFU. Patients were stratified by age into two groups: below 70 years (n¼1359) and above 70 years (n¼1403) and stratified according to D’Amico’s 2003 risk group definitions. Kaplan-Meier analysis was performed to determine biochemical survival with failure defined according to the 2006 Phoenix definition (nadir+2). Biopsy data were also analyzed. RESULTS: In the group above 70 years, the median PSA and the mean Gleason score were higher than in the group below 70 years: 8.0ng/ml vs 7.2ng/ml (p<0.001) and 5.81.2 vs 6.21.2 (p<0.001). No significant difference was observed between the two groups for clinical stage (p¼0.232) and previous androgen deprivation (25% vs 25%), (p¼0.728). The mean follow-up was 5.0 4 years (median 4.5). The PSA nadir was similar in the two groups: 0.793.3 (median 0.10) vs 0.812.4 (median 0.10) (p¼0.851). The negative biopsy rates (<70 yrs / >70yrs) were 74.6% and 72.9% (p¼0.619). The actuarial biochemical disease free survival at 5 years (<70 yrs / >70yrs) was 84% and 78% (p<0.001). At 10 years the overall survival rates (<70 yrs / >70yrs) was significantly different: 85% /74% (p<0.0001), but the cancer specific survival and the metastasis free survival rates (<70 yrs / >70yrs) were not significantly different: 98%/98% (p¼0.975) and 94%/94% (p¼0.784). CONCLUSIONS: HIFU presents positive oncological and functional outcome in patients both below and above 70 years. HIFU treatment might be therefore a valuable therapeutic option for prostate cancer control regardless of age. Source of Funding: none
MP62-05 MAGNETIC RESONANCE IMAGING (MRI)-GUIDED TRANSURETHRAL ULTRASOUND ABLATION OF PROSTATE CANCER: PRELIMINARY OUTCOMES OF A PHASE I CLINICAL TRIAL Michele Billia*, London, Canada; Mathieu Burtnyk, Toronto, Canada; Timur Kuru, Heidelberg, Germany; Sascha Pahernik, heidelberg, Germany; Matthias Roethke, Heidelberg, Germany; Heinz-Peter Schlemmer, heidelberg, Germany; Cesare Romagnoli, Joseph Chin, London, Canada INTRODUCTION AND OBJECTIVES: MRI-guided transurethral ultrasound ablation (TULSA) is a new minimally-invasive technology for treatment of localized prostate cancer (PCa), aiming to provide good local disease control with a low side-effect profile. This modality consists of a transurethral device emitting planar ultrasound and generating a continuous and precise volume of thermal coagulation shaped to conform to the prostate, using real-time MRI monitoring and active temperature feedback control. A prospective, multi-center phase I clinical trial was initiated in March 2013 with the aim to determine safety and feasibility of MRIguided TULSA, and to assess initial efficacy for localized PCa treatment. METHODS: Patients with low-risk PCa: cT1c-T2a, N0, M0; PSA10ng/ml; GS6 are enrolled. Under general anesthesia, suprapubic catheter (SPC) is inserted and left in for 2 weeks. The TULSA device (PAD-105, Profound Medical Inc.) is inserted manually over a Nitinol guidewire and positioned precisely in the prostatic urethra with MRI guidance (3-Tesla unit). Treatment planning is performed under MRI prostate visualization, with therapeutic intent of conservative whole-gland ablation. Treatment is delivered under continuous MR thermometry feedback control, and patients recover with an outpatient protocol. Primary study endpoints are safety and feasibility, with follow-up to 12 months. Complete clinical monitoring is 5 years, including serial PSA, TRUS biopsy and QoL questionnaires (IPSS, IIEF, bowel domain of UCLA-PCI-SF). RESULTS: To-date, 17 patients have been treated with no intraoperative complications. Median treatment time was 29 (24 e 61) min and prostate volume 45 (34 e 95) cc. Spatial control of thermal ablation was within 1.5 mm and contrast-enhanced MRI confirmed the resulting non-perfused volume. Clavien II complications included
e718
Vol. 191, No. 4S, Supplement, Monday, May 19, 2014
MP62-03 HIGH-INTENSITY FOCUSSED ULTRASOUND IN THE TREATMENT OF LOCALISED PROSTATE CANCER: FOCAL SALVAGE TRANSITION RATES Stephanie Guillaumier*, Louise Dickinson, Clare Allen, Alex Kirkham, Alex Freeman, Mark Emberton, Hashim Ahmed, London, United Kingdom INTRODUCTION AND OBJECTIVES: Focal therapy has shown encouraging low rates of genitourinary side-effects in the treatment of localised prostate cancer. As biochemical failure is difficult to define discussion has centred on rates of transition to whole-gland local therapy and need for systemic therapy. We report on our registry experience of over 1,000 men treated with transrectal HIFU. METHODS: Our independent academic HIFU registry incorporates a total of 830 patients with low, intermediate and high risk, stage T2a-T3aN0M0 prostate adenocarcinoma treated between 2004 and 2012 in a primary setting. Of these, 509 had focal HIFU treatment (Sonablate 500); 313 had whole-gland treatment. We defined our composite failure as need for whole-gland therapy and/or systemic therapy. RESULTS: Of 509 men undergoing focal HIFU therapy, 84 required redo-HIFU (17%). None of the patients in this group went on to have radical prostatectomy. 1% (5/509) had salvage radiotherapy and <0.5% (1/509) had salvage chemotherapy due to lung metastases following a renal primary. 1% (5/509) were subsequently treated with androgen deprivation therapy alone. In the same period, 313 patients had whole-gland HIFU treatment. Of these, 40% (124/313) had redo-HIFU and 5% (15/313) had androgen deprivation for treatment failure. 6% (18/313) underwent salvage radiotherapy and <1% (2/313) were further treated with salvage radical prostatectomy. <0.5% (1/313) had salvage chemotherapy and <0.5% (1/313) had cryotherapy. CONCLUSIONS: Focal therapy demonstrates reassuringly low short to medium term rates of transition to whole-gland local therapy or systemic therapy in 11%. Longer follow-up will determine rates of metastases and mortality. Re-do
Radical
Total
HIFU
Prostatectomy
ERBT
Hormones
Chemotherapy
Cryotherapy
Focal
509
84
0
5
5
1
0
Whole
313
124
2
18
15
1
1
gland
Source of Funding: Sonacare Inc.
MP62-04 DOES AGE REPRESENT A LIMITATION FOR HIFU TREATMENT? AGE STRATIFIED OUTCOMES FROM A MULTICENTRE STUDY OF 2762 PATIENTS ANALYSED FROM THE @-REGISTRY Sebastien Crouzet*, Lyon, France; Roman Ganzer, Regensburg, € rth, Germany; Stefan Thueroff, Munich, Germany; Andreas Blana, Fu Germany; Christian Chaussy, Regensburg, Germany; Albert Gelet, Lyon, France INTRODUCTION AND OBJECTIVES: High intensity focused ultrasound (HIFU) performed by Ablathermâ has been used as primary treatment of localized prostate cancer. In the last years, HIFU has been recognized as a therapeutic option in patients over 70 years old with 10 years life expectancy. The objective of this study is to report the biochemical and biopsy outcomes, stratified by age, in patients who have undergone HIFU. METHODS: A total of 2762 consecutive patients with T1-T2 prostate cancer treated by HIFU Ablathermâ (EDAP-TMS, Lyon, France), in three European HIFU centers since 1993 were included. Treatment results, and post treatment morbidity have been registered in the online Ablathermâ HIFU database, @-Registry. This is a secured on-line database collecting relevant de-identified clinical and technical
information for patients treated by HIFU. Patients were stratified by age into two groups: below 70 years (n¼1359) and above 70 years (n¼1403) and stratified according to D’Amico’s 2003 risk group definitions. Kaplan-Meier analysis was performed to determine biochemical survival with failure defined according to the 2006 Phoenix definition (nadir+2). Biopsy data were also analyzed. RESULTS: In the group above 70 years, the median PSA and the mean Gleason score were higher than in the group below 70 years: 8.0ng/ml vs 7.2ng/ml (p<0.001) and 5.81.2 vs 6.21.2 (p<0.001). No significant difference was observed between the two groups for clinical stage (p¼0.232) and previous androgen deprivation (25% vs 25%), (p¼0.728). The mean follow-up was 5.0 4 years (median 4.5). The PSA nadir was similar in the two groups: 0.793.3 (median 0.10) vs 0.812.4 (median 0.10) (p¼0.851). The negative biopsy rates (<70 yrs / >70yrs) were 74.6% and 72.9% (p¼0.619). The actuarial biochemical disease free survival at 5 years (<70 yrs / >70yrs) was 84% and 78% (p<0.001). At 10 years the overall survival rates (<70 yrs / >70yrs) was significantly different: 85% /74% (p<0.0001), but the cancer specific survival and the metastasis free survival rates (<70 yrs / >70yrs) were not significantly different: 98%/98% (p¼0.975) and 94%/94% (p¼0.784). CONCLUSIONS: HIFU presents positive oncological and functional outcome in patients both below and above 70 years. HIFU treatment might be therefore a valuable therapeutic option for prostate cancer control regardless of age. Source of Funding: none
MP62-05 MAGNETIC RESONANCE IMAGING (MRI)-GUIDED TRANSURETHRAL ULTRASOUND ABLATION OF PROSTATE CANCER: PRELIMINARY OUTCOMES OF A PHASE I CLINICAL TRIAL Michele Billia*, London, Canada; Mathieu Burtnyk, Toronto, Canada; Timur Kuru, Heidelberg, Germany; Sascha Pahernik, heidelberg, Germany; Matthias Roethke, Heidelberg, Germany; Heinz-Peter Schlemmer, heidelberg, Germany; Cesare Romagnoli, Joseph Chin, London, Canada INTRODUCTION AND OBJECTIVES: MRI-guided transurethral ultrasound ablation (TULSA) is a new minimally-invasive technology for treatment of localized prostate cancer (PCa), aiming to provide good local disease control with a low side-effect profile. This modality consists of a transurethral device emitting planar ultrasound and generating a continuous and precise volume of thermal coagulation shaped to conform to the prostate, using real-time MRI monitoring and active temperature feedback control. A prospective, multi-center phase I clinical trial was initiated in March 2013 with the aim to determine safety and feasibility of MRIguided TULSA, and to assess initial efficacy for localized PCa treatment. METHODS: Patients with low-risk PCa: cT1c-T2a, N0, M0; PSA10ng/ml; GS6 are enrolled. Under general anesthesia, suprapubic catheter (SPC) is inserted and left in for 2 weeks. The TULSA device (PAD-105, Profound Medical Inc.) is inserted manually over a Nitinol guidewire and positioned precisely in the prostatic urethra with MRI guidance (3-Tesla unit). Treatment planning is performed under MRI prostate visualization, with therapeutic intent of conservative whole-gland ablation. Treatment is delivered under continuous MR thermometry feedback control, and patients recover with an outpatient protocol. Primary study endpoints are safety and feasibility, with follow-up to 12 months. Complete clinical monitoring is 5 years, including serial PSA, TRUS biopsy and QoL questionnaires (IPSS, IIEF, bowel domain of UCLA-PCI-SF). RESULTS: To-date, 17 patients have been treated with no intraoperative complications. Median treatment time was 29 (24 e 61) min and prostate volume 45 (34 e 95) cc. Spatial control of thermal ablation was within 1.5 mm and contrast-enhanced MRI confirmed the resulting non-perfused volume. Clavien II complications included