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708 LONG-TERM RESULTS WITH HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) IN 140 PATIENTS WITH LOCALIZED PROSTATE CANCER
P40 MINIMALLY INVASIVE AND OTHER TREATMENT STRATEGIES IN LOCALISED PROSTATE CANCER Friday, 23 March, 09.15-10.45, Room 11B
705
Salvage cryotherapy for recurrent prostate cancer. The UK experience Ismail M.1, Ahmed S.2, Davies J.1
Introduction & Objectives: In this study we report our experience in salvage cryotherapy for recurrent prostate cancer after radiation failure, evaluating the biochemical outcome, complications and management and quality of life. Material & Methods: Between May 2000 and November 2005,100 patients underwent salvage cryoablation of the prostate. The mean follow-up was 27.5 months (range 6-73 months). The mean age was 67 years (range 54-78 years).All patients had biopsy proven recurrent prostate cancer. Two cryotherapy systems were used, Cryocare n=45 and Seednet n=55. Biochemical recurrence free survival was defined as PSA level <0.5 ng/ml. Patients were stratified into 3 risk groups according to the following factors: PSA level, Gleason score and clinical stage. Results: There were no operative or cancer related mortalities. Sixty one patients received hormonal therapy prior to their cryosurgery. The 5 years actuarial biochemical recurrence free survival was 73% for the low risk group, 45% for the intermediate risk group and 11% for the high risk group. Six patients had redo cryosurgery. Complications included incontinence (13%). Erectile dysfunction (85.5%), lower urinary tract symptoms (16%), prolonged perineal pain (4%), urinary retention 2% and rectovesical fistula 1%. Conclusions: Salvage cryotherapy of the prostate is safe and effective treatment and offers additional hope of cure for patients with recurrent prostate cancer following radiotherapy.
707
High Intensity Focused Ultrasound (HIFU) for localized prostate cancer (T1-2, N0, M0): Intra-procedure determinants of biopsy proven failure using the Sonoblate® 500 system Calleary J.1, Leslie T.2, Iling R.1, Ahmed H.1, Kennedy J.2, Brewster S.2, Allen C.3, Freeman A.4, Emberton M.1
University College London Hospital, Urology, London, United Kingdom, 2Churchill Hospital Oxford, Urology, Oxford, United Kingdom, 3University College Hospital London, Radiology, London, United Kingdom, 4University College Hospital London, Pathology, London, United Kingdom 1
Introduction & Objectives: To date there is little HIFU literature that informs the ideal conduct of therapy. Early work suggests greater total intra-prostatic energy deposition (Iling 2006) and gland coverage (Chaussy 2001) are significant factors. We retrospectively review “biopsy failures” that occurred in our early experience to identify factors that predict failure. Identification of these factors should help in defining competencies, planning training, and shortening learning curves. Material & Methods: Twenty men were enrolled in a European multi-centred trial using visually directed HIFU (ie High energy deposition). Disease characterisation included PSA, TRUS and MRI at entry and six months. Protocol biopsy was performed at six months. Radiological failure is defined as significant residual tissue on imaging. Biochemical failure was said to have occurred if a PSA nadir > 0.2 ng/ml was detected at 3 months (Uchida 2006). Therapy conduct was reviewed by an experienced Sonoblate® HIFU practitioner not actively involved in the trial and then compared to the radiological and biochemical results. Results: Eight failed by histological criteria. Their tumour characteristics (T stage, grade, extent, burden) were identical to those with negative biopsy. Listed are the biochemical, radiological and therapy status of those who failed.
GS- 6/12 MRI; site enhancing, residual tissue Calcification Therapy failure site Therapy failure cause
1 2.48 < 0.05 0.12 R <10% 3+3 R Not graded None, Apical 0 Apex
2 6.72 0.57 0.61 L <10% 3+4 L 40% 3+4
3 3.45 0.51 0.51 B <10% 4+3 L acini 3+3
4 8.73 1.29 1.54 L <10% 3+3
None, R side & apex
Left
R ant
None, Min
1 Left post
2 none
1 none
NC
CAL
?
2 Apex R lat & base Not covered Apex NC, (NC) CAL
706
Cryotherapy for the prostate – an in vitro study of two new developments – IceRods™ and Multitemp™ 1601 Temperature Monitoring System Gowardhan B., Greene D.
Royal Surrey County Hospital, Urology, Guildford, United Kingdom, 2East Surrey Hospital, Urology, Reading, United Kingdom 1
Patient # PSA- pre PSA- nadir PSA- 6/12 GS- pre
R 20% 3+3
5 2.39 (0.6) 0.11 0.37 R 50% 3+4 R 20% 3+4
6 5.46 0.07 0.2 B 70% 3+3
7 9.59 0.05 0.14 B 10% 3+3
8 2.66 0.10 0.21 B 50% 3+3
R <10% 3+3 None, Min
R acini 3+3
B acini 3+3
None, Min
None, necrotic tissue
2 2 Apex & Left none edge CAL CAL
-
Calcification (CAL); 0 = none; 1 = present; 2 = Extensive Conclusions: Tumour characteristics appears not to be a risk factor for failure. Key factors in determining failure in our early experience were: patient selection and sub-optimal application of energy. Dense focal calcification was the most important patient selection factor (4/8 patients reviewed). Operator inexperience was characterised by inadequate targeting of apical tissue. This was significant in 2/8 and is now better targeted. Despite technically failing, 4/8 had residual disease, likely to be clinically insignificant, and have chosen to be monitored alone. In addition, this small series highlights the difficulty in using one single failure definition in this relatively new technology. Abbreviations: GS, Gleason Score; MRI, Magnetic Resonance Imaging; PSA, Prostate Specific Antigen; TRUS, Trans Rectal Ultrasound; R, right; L, left; B, both sides
Sunderland Royal Hospital, Urology, Sunderland, United Kingdom Introduction & Objectives: Prostate cancer is a common cancer with a high morbidity and mortality worldwide. Cryotherapy has been used in the treatment of localised, locally advanced and radiation failed prostate cancer for just over 20 years. A number of developments have aided the advancement of cryosurgery in particular TRUS, urethral warming catheters and temperature monitoring probes. We aimed to assess the characteristics of two new developments, IceRodsTM – 17 gauge cryoneedles with an advanced heat exchanger which produces a precise ice ball that is comparable in size to larger diameter cryoprobes and multi-sensor temperature monitoring system (TMS) 1601 probes in an in vitro model. Material & Methods: SeedNetTM cryoneedles are conventional needles with a single heat exchanger able of forming a single ice ball per needle; IceRodsTM are new cryoneedles with two heat exchangers per needle, able to form 2 ice balls per needle which fused to form a larger ice ball. TMS 1601 probes had either 4 or 8 temperature measuring points per probe. Two 4point probes and one 8-point probe were used per experiment. Phantom prostates with thermal properties similar to human prostate were used for all experiments. The experiment was done in 4 parts - first was to assess the impact of distance from the cryoneedle on temperature; the second was to assess the effect of multiple cryoneedles and distance on temperature; the third was to assess the temperature readings when a conventional clinical layout of IceRodTM cryoneedles was used and fourth was to assess the temperature readings when a conventional clinical layout of SeedNetTM cryoneedles was used. Results: Our data revealed that IceRodsTM had a superior ability to freeze tissue reaching lower temperatures as compared to conventional cryoneedles. Also, we noted that IceRods were capable of forming ice balls with a maximum diameter of over 6cms after freezing at 100% power for 10 minutes. The TMS probes were able to depict real time temperature gradients over either 4 or 8 points in a linear array, enabling a more thorough monitoring of the temperature changes during a treatment cycle. Conclusions: The clinical usefulness of these two developments lies in the reduction of cryoneedles per treatment with expected lower morbidity and the avoidance of a pull back technique for larger prostates which reduces the treatment time. A more thorough assessment of the temperatures reached during a treatment cycle ensures adequate treatment of all prostate tissue with expected improved oncological outcomes and finally a better assessment of the temperatures reached in the rectum which would reduce the incidence of rectal injury even further. We feel that the TMS 1601 system will allow clinicians interested in cryosurgery, to learn the technique safely in a shorter period of time. Clinical testing is highly recommended for these two developments.
Long-term results with high intensity focused ultrasound (HIFU) in 140 patients with localized prostate cancer
708
Blana A.1, Thüroff S.2, Murat F.J.3, Walter B.1, Chaussy C.2, Gelet A.3 University of Regensburg, Urology, Regensburg, Germany, 2Städtisches Krankenhaus Harlaching, Urology, Munich, Germany, 3Edouard Herriot Hospital, Urology, Lyon, France 1
Introduction & Objectives: To evaluate the long-term efficacy and safety of HIFU treatment for patients with localized prostate cancer. Material & Methods: Between October 1997 and August 2001, patients with T1-T2 NxM0 prostate cancer with a PSA < 15ng/ml and a Gleason score (Gs) ≤ 7 treated with prototype or first generation Ablatherm HIFU devices were included in this multicenter analysis. All patients were unsuitable for radical prostatectomy or unwilling to go for the operation. 23 received a short (≤ 3 months) hormone therapy to downsize the prostatic volume. All patients or relatives were contacted to update the records between May and August 2006. Biochemical failure was considered as PSA nadir + 2 ng/ml. Treatment failure was defined as: PSA nadir + 2 ng/ml or positive biopsy or rescue treatment introduction. Results: 140 patients, mean age 69.1 ± 6.6, were included. Low (PSA < 10ng/ml, Gs ≤ 6) and intermediate (PSA 10-15ng/ml, Gs = 7) risk patients represented 72 and 68 patients, respectively. Mean PSA was 7.0 ± 3.5ng/ml. Mean prostatic volume was 25.9 ± 11.2 cc. Mean follow-up was 6.4 ± 1.1 years. Control prostate biopsies (3 months after HIFU) were negative in 86.4%. Median PSA nadir (achieved within 21.3 weeks) was 0.16 ng/mL with a PSA nadir ≤ 0.5 ng/mL in 68.4% of the cases. 21 patients (15 %) received a rescue therapy during follow-up. The 8-year actuarial overall and cancerspecific survival rates were 83 % and 98%, respectively. 1 patient died 72 months after the HIFU treatment of a metastatic disease. The actuarial biochemical failure-free survival rates at 5 and 6 years were 73 % and 69 % respectively. The actuarial salvage treatment-free survival rates at 5 and 8 years were 86 % and 79 %, respectively. The actuarial disease-free survival rates at 5 and 6 years were 63 % and 59 %, respectively with a significant difference at 5 years between low and intermediate risk patients (68% versus 58%, p <0.02). Conclusions: HIFU is an effective way to treat patients with localized prostate cancer who are no candidates for surgery. HIFU offers an excellent long-term prostate cancerspecific survival without requiring adjuvant therapy in 79% of the cases at 8 years.
Eur Urol Suppl 2007;6(2):199
705
Salvage cryotherapy for recurrent prostate cancer. The UK experience Ismail M.1, Ahmed S.2, Davies J.1
Introduction & Objectives: In this study we report our experience in salvage cryotherapy for recurrent prostate cancer after radiation failure, evaluating the biochemical outcome, complications and management and quality of life. Material & Methods: Between May 2000 and November 2005,100 patients underwent salvage cryoablation of the prostate. The mean follow-up was 27.5 months (range 6-73 months). The mean age was 67 years (range 54-78 years).All patients had biopsy proven recurrent prostate cancer. Two cryotherapy systems were used, Cryocare n=45 and Seednet n=55. Biochemical recurrence free survival was defined as PSA level <0.5 ng/ml. Patients were stratified into 3 risk groups according to the following factors: PSA level, Gleason score and clinical stage. Results: There were no operative or cancer related mortalities. Sixty one patients received hormonal therapy prior to their cryosurgery. The 5 years actuarial biochemical recurrence free survival was 73% for the low risk group, 45% for the intermediate risk group and 11% for the high risk group. Six patients had redo cryosurgery. Complications included incontinence (13%). Erectile dysfunction (85.5%), lower urinary tract symptoms (16%), prolonged perineal pain (4%), urinary retention 2% and rectovesical fistula 1%. Conclusions: Salvage cryotherapy of the prostate is safe and effective treatment and offers additional hope of cure for patients with recurrent prostate cancer following radiotherapy.
707
High Intensity Focused Ultrasound (HIFU) for localized prostate cancer (T1-2, N0, M0): Intra-procedure determinants of biopsy proven failure using the Sonoblate® 500 system Calleary J.1, Leslie T.2, Iling R.1, Ahmed H.1, Kennedy J.2, Brewster S.2, Allen C.3, Freeman A.4, Emberton M.1
University College London Hospital, Urology, London, United Kingdom, 2Churchill Hospital Oxford, Urology, Oxford, United Kingdom, 3University College Hospital London, Radiology, London, United Kingdom, 4University College Hospital London, Pathology, London, United Kingdom 1
Introduction & Objectives: To date there is little HIFU literature that informs the ideal conduct of therapy. Early work suggests greater total intra-prostatic energy deposition (Iling 2006) and gland coverage (Chaussy 2001) are significant factors. We retrospectively review “biopsy failures” that occurred in our early experience to identify factors that predict failure. Identification of these factors should help in defining competencies, planning training, and shortening learning curves. Material & Methods: Twenty men were enrolled in a European multi-centred trial using visually directed HIFU (ie High energy deposition). Disease characterisation included PSA, TRUS and MRI at entry and six months. Protocol biopsy was performed at six months. Radiological failure is defined as significant residual tissue on imaging. Biochemical failure was said to have occurred if a PSA nadir > 0.2 ng/ml was detected at 3 months (Uchida 2006). Therapy conduct was reviewed by an experienced Sonoblate® HIFU practitioner not actively involved in the trial and then compared to the radiological and biochemical results. Results: Eight failed by histological criteria. Their tumour characteristics (T stage, grade, extent, burden) were identical to those with negative biopsy. Listed are the biochemical, radiological and therapy status of those who failed.
GS- 6/12 MRI; site enhancing, residual tissue Calcification Therapy failure site Therapy failure cause
1 2.48 < 0.05 0.12 R <10% 3+3 R Not graded None, Apical 0 Apex
2 6.72 0.57 0.61 L <10% 3+4 L 40% 3+4
3 3.45 0.51 0.51 B <10% 4+3 L acini 3+3
4 8.73 1.29 1.54 L <10% 3+3
None, R side & apex
Left
R ant
None, Min
1 Left post
2 none
1 none
NC
CAL
?
2 Apex R lat & base Not covered Apex NC, (NC) CAL
706
Cryotherapy for the prostate – an in vitro study of two new developments – IceRods™ and Multitemp™ 1601 Temperature Monitoring System Gowardhan B., Greene D.
Royal Surrey County Hospital, Urology, Guildford, United Kingdom, 2East Surrey Hospital, Urology, Reading, United Kingdom 1
Patient # PSA- pre PSA- nadir PSA- 6/12 GS- pre
R 20% 3+3
5 2.39 (0.6) 0.11 0.37 R 50% 3+4 R 20% 3+4
6 5.46 0.07 0.2 B 70% 3+3
7 9.59 0.05 0.14 B 10% 3+3
8 2.66 0.10 0.21 B 50% 3+3
R <10% 3+3 None, Min
R acini 3+3
B acini 3+3
None, Min
None, necrotic tissue
2 2 Apex & Left none edge CAL CAL
-
Calcification (CAL); 0 = none; 1 = present; 2 = Extensive Conclusions: Tumour characteristics appears not to be a risk factor for failure. Key factors in determining failure in our early experience were: patient selection and sub-optimal application of energy. Dense focal calcification was the most important patient selection factor (4/8 patients reviewed). Operator inexperience was characterised by inadequate targeting of apical tissue. This was significant in 2/8 and is now better targeted. Despite technically failing, 4/8 had residual disease, likely to be clinically insignificant, and have chosen to be monitored alone. In addition, this small series highlights the difficulty in using one single failure definition in this relatively new technology. Abbreviations: GS, Gleason Score; MRI, Magnetic Resonance Imaging; PSA, Prostate Specific Antigen; TRUS, Trans Rectal Ultrasound; R, right; L, left; B, both sides
Sunderland Royal Hospital, Urology, Sunderland, United Kingdom Introduction & Objectives: Prostate cancer is a common cancer with a high morbidity and mortality worldwide. Cryotherapy has been used in the treatment of localised, locally advanced and radiation failed prostate cancer for just over 20 years. A number of developments have aided the advancement of cryosurgery in particular TRUS, urethral warming catheters and temperature monitoring probes. We aimed to assess the characteristics of two new developments, IceRodsTM – 17 gauge cryoneedles with an advanced heat exchanger which produces a precise ice ball that is comparable in size to larger diameter cryoprobes and multi-sensor temperature monitoring system (TMS) 1601 probes in an in vitro model. Material & Methods: SeedNetTM cryoneedles are conventional needles with a single heat exchanger able of forming a single ice ball per needle; IceRodsTM are new cryoneedles with two heat exchangers per needle, able to form 2 ice balls per needle which fused to form a larger ice ball. TMS 1601 probes had either 4 or 8 temperature measuring points per probe. Two 4point probes and one 8-point probe were used per experiment. Phantom prostates with thermal properties similar to human prostate were used for all experiments. The experiment was done in 4 parts - first was to assess the impact of distance from the cryoneedle on temperature; the second was to assess the effect of multiple cryoneedles and distance on temperature; the third was to assess the temperature readings when a conventional clinical layout of IceRodTM cryoneedles was used and fourth was to assess the temperature readings when a conventional clinical layout of SeedNetTM cryoneedles was used. Results: Our data revealed that IceRodsTM had a superior ability to freeze tissue reaching lower temperatures as compared to conventional cryoneedles. Also, we noted that IceRods were capable of forming ice balls with a maximum diameter of over 6cms after freezing at 100% power for 10 minutes. The TMS probes were able to depict real time temperature gradients over either 4 or 8 points in a linear array, enabling a more thorough monitoring of the temperature changes during a treatment cycle. Conclusions: The clinical usefulness of these two developments lies in the reduction of cryoneedles per treatment with expected lower morbidity and the avoidance of a pull back technique for larger prostates which reduces the treatment time. A more thorough assessment of the temperatures reached during a treatment cycle ensures adequate treatment of all prostate tissue with expected improved oncological outcomes and finally a better assessment of the temperatures reached in the rectum which would reduce the incidence of rectal injury even further. We feel that the TMS 1601 system will allow clinicians interested in cryosurgery, to learn the technique safely in a shorter period of time. Clinical testing is highly recommended for these two developments.
Long-term results with high intensity focused ultrasound (HIFU) in 140 patients with localized prostate cancer
708
Blana A.1, Thüroff S.2, Murat F.J.3, Walter B.1, Chaussy C.2, Gelet A.3 University of Regensburg, Urology, Regensburg, Germany, 2Städtisches Krankenhaus Harlaching, Urology, Munich, Germany, 3Edouard Herriot Hospital, Urology, Lyon, France 1
Introduction & Objectives: To evaluate the long-term efficacy and safety of HIFU treatment for patients with localized prostate cancer. Material & Methods: Between October 1997 and August 2001, patients with T1-T2 NxM0 prostate cancer with a PSA < 15ng/ml and a Gleason score (Gs) ≤ 7 treated with prototype or first generation Ablatherm HIFU devices were included in this multicenter analysis. All patients were unsuitable for radical prostatectomy or unwilling to go for the operation. 23 received a short (≤ 3 months) hormone therapy to downsize the prostatic volume. All patients or relatives were contacted to update the records between May and August 2006. Biochemical failure was considered as PSA nadir + 2 ng/ml. Treatment failure was defined as: PSA nadir + 2 ng/ml or positive biopsy or rescue treatment introduction. Results: 140 patients, mean age 69.1 ± 6.6, were included. Low (PSA < 10ng/ml, Gs ≤ 6) and intermediate (PSA 10-15ng/ml, Gs = 7) risk patients represented 72 and 68 patients, respectively. Mean PSA was 7.0 ± 3.5ng/ml. Mean prostatic volume was 25.9 ± 11.2 cc. Mean follow-up was 6.4 ± 1.1 years. Control prostate biopsies (3 months after HIFU) were negative in 86.4%. Median PSA nadir (achieved within 21.3 weeks) was 0.16 ng/mL with a PSA nadir ≤ 0.5 ng/mL in 68.4% of the cases. 21 patients (15 %) received a rescue therapy during follow-up. The 8-year actuarial overall and cancerspecific survival rates were 83 % and 98%, respectively. 1 patient died 72 months after the HIFU treatment of a metastatic disease. The actuarial biochemical failure-free survival rates at 5 and 6 years were 73 % and 69 % respectively. The actuarial salvage treatment-free survival rates at 5 and 8 years were 86 % and 79 %, respectively. The actuarial disease-free survival rates at 5 and 6 years were 63 % and 59 %, respectively with a significant difference at 5 years between low and intermediate risk patients (68% versus 58%, p <0.02). Conclusions: HIFU is an effective way to treat patients with localized prostate cancer who are no candidates for surgery. HIFU offers an excellent long-term prostate cancerspecific survival without requiring adjuvant therapy in 79% of the cases at 8 years.
Eur Urol Suppl 2007;6(2):199