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PROSTATE CANCER CONTROL WITH TRANSRECTAL HIFU IN 124 PATIENTS: 7-YEARS' ACTUARIAL RESULTS
441 PROSTATE CANCER CONTROL WITH TRANSRECTAL HIFU IN 124 PATIENTS: 7-YEARS’ ACTUARIAL RESULTS
442 TEN YEARS APPLICATION OF HIGH-INTENSITY ULTRASOUND (HIFU) IN PROSTATE CANCER (PCA)
FOCUSED
Chaussy C., Thueroff S., Knauer K.
Gelet A.1, Chapelon J.Y.2, Murat F.J.1, Curiel L.2, Bouvier R.1, Rouviere O.1, Martin X.1
Krankenhaus München Harlaching, Department of Urology, Munich, Germany
1
INTRODUCTION & OBJECTIVES: Review of 673 cases of local HIFU treatment in localised PCa. 2 patient groups: (A) = “T1-2, low or intermediate risk”, (B) = “T 1-2 high risk” or “T3 = locally advanced” had a complete treatment. Regarding PSAi, Gleason score and tumour volume (=no. of positive biopsies), in group A all, in group B one of the inclusion criteria had to be fulfilled.
Hopital Edouard Herriot, Rhone, Lyons, France, 2Inserm U556, Rhone, Lyons, France
INTRODUCTION & OBJECTIVES: To evaluate the 7-year results after HIFU treatment for localised prostate cancer according to disease-related prognostic factors. MATERIAL & METHODS: Patients with no previous history of prostate cancer radical treatment, a clinical T1-2 prostate cancer, a baseline PSA < or = 15 ng/ml, a Gleason score < or = 7, a prostate volume < or = 40 cc, and a minimum 1-year follow-up were selected for this study among 1024 patients included in our HIFU database and treated between October 19923 and May 2002. All patients were treated with the Ablatherm® HIFU device (prototypes and first generation) under spinal or general anesthesia. Follow-up included: serial PSA measurements, control biopsies performed at 3 months post-HIFU and in case of rising PSA. Failure (disease free rate) was defined as any positive biopsy occurrence or 3 consecutive rises in the PSA equals or exceeds 1 ng/ml. Clinical progression was defined as the date of any adjuvant therapy (external beam radiation therapy or hormonal deprivation) introduction. Kaplan-Meier product limit methods and Log-rank test were used in analyzing data. RESULTS: 190 patients met the selection criteria with a mean follow-up of 40.4 months (12136). Median nadir PSA achieved within 4 months was 0.48 ± 0.88 ng/ml (median 0.16 ng/ml). Eleven patients died of a prostate unrelated event and 2 developend bone metastatic disease. The actuarial 7-year disease free rate (ADFR) combining pathological and biochemical outcomes was 61% with no significant changes according to clinical stage (T1/T2) or Gleason score. Clinical progression was observed in 28 patients (15%) and treated by external beam radiation therapy, hormonal deprivation or both in 13, 10 and 5 patients, respectively. The overall 7-year survival rate free of adjuvant therapy (SRFAT) was 76%. Both, the ADFR and the SRFAT were inversely related tot the initial PSA level with 83% and 95%, 54% and 74%, 59% and 67% for patients with a PSA less than 4 ng/ml, between 4.1 and 10 ng/ml and greater than 10.1 ng/ml, respectively (log rank test, p<0.05). CONCLUSIONS: This minimally invasive treatment was related to a high clinical control of the localised prostate cancer. HIFU appeared as a possible therapeutic option for patients not candidate for radical prostatectomy whose life expectancy was not suitable for a watchful waiting attitude.
MATERIAL & METHODS: 309 patients (A), and 364 patients (B), treated for biopsy proven PCa by transrectal HIFU in a monocentric prospective cohort study, using Ablatherm® HIFU device (EDAP, France). Analysis of database. RESULTS:
A
grouping criteria
grouping results
PSA ng/ml median
%
Patient groups
B
309
number of patients
364
<3
T
all
0
N/M
0
<4
Gleason score (1 – 5)
all
<4
number of + biopsies
>3
< 21
PSA i
>20
100
treated prostatic vol in %
100
0
% Gleason 4 or 5
60
2
number of positive biopsies
3
73
age (median)
74
20
prostate volume (cc)
18
64
potent before therapy
50
7,8
PSA initially
14
0,0
...Nadir
0,0
12,5
time to Nadir (weeks)
11,4
0,1
…velocity (ng/year)
0,15 / 0,78
77
…stability (ASTRO)
73,2 / 23,1
0,0
… at last PSA test
0,7
75
negative biopsies
51
1 / < 3 mm
If residual Tumour: No/Vol
2 / 6mm
2,3
additional Pca therapy
15 / 28
1,6
severe complications
2,7
18
Endo OR after HIFU
22
9,3
HIFU reTX rate
21
63 / 315
FU (weeks med / max)
44 / 365
42
potent after HIFU
21
CONCLUSIONS: HIFU by Ablatherm®, a one session endourological robotic operation, proved high local and biochemical efficacy in localised, non surgical cases and locally advanced PCa. A good balance between high local efficacy and low therapy induced morbidity was demonstrated using this technology since 10 years.
443
444
SALVAGE HIFU FOR RADIORECURRENT PROSTATE CANCER: FACTORS INFLUENCING THE OUTCOME
HIGH-INTENSITY FOCUSED ULTRASOUND (HIFU) IN PROSTATE CANCER
Murat F.J.1, Chapelon J.Y.2, Poissonnier L.1, Bouvier R.1, Curiel L.2, Martin X.1, Gelet A.1
Zizzi V., Callea A., Piccinni R., Cafarelli A., Sblendorio D., Berardi B., Tempesta A., Gala F., Traficante A.
Hopital Edouard Herriot, Rhone, Lyons, France, 2Inserm U 556, Rhone, Lyons, France 1
INTRODUCTION & OBJECTIVES: To evaluate the efficacy of a salvage therapy with transrectal High Intensity Focused Ultrasound (HIFU) for local relapse after external beam radiation therapy (EBRT). MATERIAL & METHODS: All patients were treated with the Ablatherm®HIFU device (EDAP SA, France) under general or spinal anaesthesia. Specific shot parameters were adapted during the study period in order to avoid any rectal damage. Patient follow-up included control biopsies and serial PSA measurements. Progression was defined as the date of salvage androgen deprivation (SAD) introduction. RESULTS: 118 patients, mean age 68.9 ± 6.01 years, were included in this study. Overall mean PSA level was 7.87 ± 8.52 ng/ml. All patients had positive prostate biopsies with a pre-HIFU Gleason score ≤ 6 in 38 patients (32%), 7 in 28 patients (24%) and ≥ 8 in the remaining 52 patients (44%). Mean follow-up was 16.4 months. After HIFU treatment 84% of the patients had negative control biopsies and 62% demonstrated a nadir PSA level < 0.5 ng/ml within 4 months following HIFU. The survival free rates without SAD were 58%, 44%, and 14% for patients with pre-HIFU Gleason score ≤ 6, equal to 7, and ≥ 8, respectively (log rank test, p < 0.05). Progression free rate significantly decreased with the increase of the preHIFU initial risk level (D’Amico et al, JAMA 1998) with 78%, 49.5% and 14% for low (18pts), intermediate (37pts), and high (63pts) risk groups, respectively (log rank test, p<0.005). Adverse events related to HIFU included recto-urethral fistula in 3%, grade II or III incontinence in 28%, and bladder neck strictures in 10%. With the modified shot parameters we found no more rectal injury. CONCLUSIONS: HIFU appeared as a promising treatment option with a curative intent for patients with local recurrence after EBRT. The HIFU provided a high local control of the tumour. The disease control was highly correlated with the initial risk level.
Di Venere Hospital, Department of Urology, Bari, Italy INTRODUCTION & OBJECTIVES: HIFU is a minimally invasive treatment based on thermal ablation of tissues which are warmed up to 85°C in the focal area. Clinical studies have shown such treatment modality to be safe and effective in the management of both localised (Tl-2) and locally advanced (T3) prostate cancer (as well as of local recurrences after radical prostatectomy). MATERIAL & METHODS: From May 2002 to September 2005, 108 patients with prostate cancer, aged 44 to 86 years (mean 74.2) underwent 123 HIFU treatments; 15 patients needed a second treatment as the first was incomplete (4 patients) or because of recurrence (11 patients). Indications for HIFU treatment included patient’s choice or not eligible to radical prostatectomy because age (> 75 years) or high anaesthesiological risk. Mean PSA was 27.7 ng/ml (range 0, 1-143) and mean Gleason sum 6.1 (range 3-9). The prognosis subgroups were defined as lowrisk in 16 patients (clinical stage T1-T2a, PSA < or = 10 ng/mL, and Gleason score lower than 7), intermediate-risk in 14 patients (clinical stage T2b or PSA 10 - 20 ng/mL, or Gleason score of 7), and high-risk in 78 patients (clinical stage > or = T2c, or PSA > 20 ng/mL, or Gleason score higher than 7). Preoperative assessment included renal, bladder and transrectal prostatic ultrasounds, uroflowmetry, as well as I-PSS, QoL and IIEF-5 questionnaires. CT scan and bone scan were performed only in patients with PSA >10ng/ml. All patients received spinal anaesthesia. After placing a suprapubic catheter, and performing a debulking TURP, HIFU treatment was carried out with a transrectal probe (ABLATHERM, EDAP TECHNOMED). RESULTS: Follow-up included PSA determination after 6 and 12 weeks and then every 3 months, transrectal prostatic biopsy after 6 months, I-PSS, and QoL and IIEF-5 questionnaires every 3 months. At a mean follow-up of 22.5 months, biochemical success rate (PSA constantly <0.5 ng/ml) was obtained in 76.6% of low and intermediate risk patients and in 41.6% of high risk patients; post-treatment biopsies (6 months after treatment) revealed no residual tumour in 95.6% of low or intermediate risk patients and in 67.3% of high risk patients. Complications included: asymptomatic urinary tract infections (38.3%), prostatitis (6.8%), epididymorchitis and emorrhoidal pain (4.1%), and haematuria (8.2%), strictures of urethra (9.5%), bladder neck sclerosis (5.4%) and rectourethral fistula (0.9%). Light stress incontinence occurred in 4.1% of the patients and erectile dysfunction in 67.8%. CONCLUSIONS: Radical prostatectomy remains the “gold standard” for localised prostate cancer. However, HIFU seems to be a promising alternative and less invasive treatment modality with an encouraging success rate, at least in the short-term. Long-term success rate and outcome of complications, particularly strictures, remain to be defined to determine to exact role of this treatment option in managing prostate cancer.
Eur Urol Suppl 2006;5(2):133
442 TEN YEARS APPLICATION OF HIGH-INTENSITY ULTRASOUND (HIFU) IN PROSTATE CANCER (PCA)
FOCUSED
Chaussy C., Thueroff S., Knauer K.
Gelet A.1, Chapelon J.Y.2, Murat F.J.1, Curiel L.2, Bouvier R.1, Rouviere O.1, Martin X.1
Krankenhaus München Harlaching, Department of Urology, Munich, Germany
1
INTRODUCTION & OBJECTIVES: Review of 673 cases of local HIFU treatment in localised PCa. 2 patient groups: (A) = “T1-2, low or intermediate risk”, (B) = “T 1-2 high risk” or “T3 = locally advanced” had a complete treatment. Regarding PSAi, Gleason score and tumour volume (=no. of positive biopsies), in group A all, in group B one of the inclusion criteria had to be fulfilled.
Hopital Edouard Herriot, Rhone, Lyons, France, 2Inserm U556, Rhone, Lyons, France
INTRODUCTION & OBJECTIVES: To evaluate the 7-year results after HIFU treatment for localised prostate cancer according to disease-related prognostic factors. MATERIAL & METHODS: Patients with no previous history of prostate cancer radical treatment, a clinical T1-2 prostate cancer, a baseline PSA < or = 15 ng/ml, a Gleason score < or = 7, a prostate volume < or = 40 cc, and a minimum 1-year follow-up were selected for this study among 1024 patients included in our HIFU database and treated between October 19923 and May 2002. All patients were treated with the Ablatherm® HIFU device (prototypes and first generation) under spinal or general anesthesia. Follow-up included: serial PSA measurements, control biopsies performed at 3 months post-HIFU and in case of rising PSA. Failure (disease free rate) was defined as any positive biopsy occurrence or 3 consecutive rises in the PSA equals or exceeds 1 ng/ml. Clinical progression was defined as the date of any adjuvant therapy (external beam radiation therapy or hormonal deprivation) introduction. Kaplan-Meier product limit methods and Log-rank test were used in analyzing data. RESULTS: 190 patients met the selection criteria with a mean follow-up of 40.4 months (12136). Median nadir PSA achieved within 4 months was 0.48 ± 0.88 ng/ml (median 0.16 ng/ml). Eleven patients died of a prostate unrelated event and 2 developend bone metastatic disease. The actuarial 7-year disease free rate (ADFR) combining pathological and biochemical outcomes was 61% with no significant changes according to clinical stage (T1/T2) or Gleason score. Clinical progression was observed in 28 patients (15%) and treated by external beam radiation therapy, hormonal deprivation or both in 13, 10 and 5 patients, respectively. The overall 7-year survival rate free of adjuvant therapy (SRFAT) was 76%. Both, the ADFR and the SRFAT were inversely related tot the initial PSA level with 83% and 95%, 54% and 74%, 59% and 67% for patients with a PSA less than 4 ng/ml, between 4.1 and 10 ng/ml and greater than 10.1 ng/ml, respectively (log rank test, p<0.05). CONCLUSIONS: This minimally invasive treatment was related to a high clinical control of the localised prostate cancer. HIFU appeared as a possible therapeutic option for patients not candidate for radical prostatectomy whose life expectancy was not suitable for a watchful waiting attitude.
MATERIAL & METHODS: 309 patients (A), and 364 patients (B), treated for biopsy proven PCa by transrectal HIFU in a monocentric prospective cohort study, using Ablatherm® HIFU device (EDAP, France). Analysis of database. RESULTS:
A
grouping criteria
grouping results
PSA ng/ml median
%
Patient groups
B
309
number of patients
364
<3
T
all
0
N/M
0
<4
Gleason score (1 – 5)
all
<4
number of + biopsies
>3
< 21
PSA i
>20
100
treated prostatic vol in %
100
0
% Gleason 4 or 5
60
2
number of positive biopsies
3
73
age (median)
74
20
prostate volume (cc)
18
64
potent before therapy
50
7,8
PSA initially
14
0,0
...Nadir
0,0
12,5
time to Nadir (weeks)
11,4
0,1
…velocity (ng/year)
0,15 / 0,78
77
…stability (ASTRO)
73,2 / 23,1
0,0
… at last PSA test
0,7
75
negative biopsies
51
1 / < 3 mm
If residual Tumour: No/Vol
2 / 6mm
2,3
additional Pca therapy
15 / 28
1,6
severe complications
2,7
18
Endo OR after HIFU
22
9,3
HIFU reTX rate
21
63 / 315
FU (weeks med / max)
44 / 365
42
potent after HIFU
21
CONCLUSIONS: HIFU by Ablatherm®, a one session endourological robotic operation, proved high local and biochemical efficacy in localised, non surgical cases and locally advanced PCa. A good balance between high local efficacy and low therapy induced morbidity was demonstrated using this technology since 10 years.
443
444
SALVAGE HIFU FOR RADIORECURRENT PROSTATE CANCER: FACTORS INFLUENCING THE OUTCOME
HIGH-INTENSITY FOCUSED ULTRASOUND (HIFU) IN PROSTATE CANCER
Murat F.J.1, Chapelon J.Y.2, Poissonnier L.1, Bouvier R.1, Curiel L.2, Martin X.1, Gelet A.1
Zizzi V., Callea A., Piccinni R., Cafarelli A., Sblendorio D., Berardi B., Tempesta A., Gala F., Traficante A.
Hopital Edouard Herriot, Rhone, Lyons, France, 2Inserm U 556, Rhone, Lyons, France 1
INTRODUCTION & OBJECTIVES: To evaluate the efficacy of a salvage therapy with transrectal High Intensity Focused Ultrasound (HIFU) for local relapse after external beam radiation therapy (EBRT). MATERIAL & METHODS: All patients were treated with the Ablatherm®HIFU device (EDAP SA, France) under general or spinal anaesthesia. Specific shot parameters were adapted during the study period in order to avoid any rectal damage. Patient follow-up included control biopsies and serial PSA measurements. Progression was defined as the date of salvage androgen deprivation (SAD) introduction. RESULTS: 118 patients, mean age 68.9 ± 6.01 years, were included in this study. Overall mean PSA level was 7.87 ± 8.52 ng/ml. All patients had positive prostate biopsies with a pre-HIFU Gleason score ≤ 6 in 38 patients (32%), 7 in 28 patients (24%) and ≥ 8 in the remaining 52 patients (44%). Mean follow-up was 16.4 months. After HIFU treatment 84% of the patients had negative control biopsies and 62% demonstrated a nadir PSA level < 0.5 ng/ml within 4 months following HIFU. The survival free rates without SAD were 58%, 44%, and 14% for patients with pre-HIFU Gleason score ≤ 6, equal to 7, and ≥ 8, respectively (log rank test, p < 0.05). Progression free rate significantly decreased with the increase of the preHIFU initial risk level (D’Amico et al, JAMA 1998) with 78%, 49.5% and 14% for low (18pts), intermediate (37pts), and high (63pts) risk groups, respectively (log rank test, p<0.005). Adverse events related to HIFU included recto-urethral fistula in 3%, grade II or III incontinence in 28%, and bladder neck strictures in 10%. With the modified shot parameters we found no more rectal injury. CONCLUSIONS: HIFU appeared as a promising treatment option with a curative intent for patients with local recurrence after EBRT. The HIFU provided a high local control of the tumour. The disease control was highly correlated with the initial risk level.
Di Venere Hospital, Department of Urology, Bari, Italy INTRODUCTION & OBJECTIVES: HIFU is a minimally invasive treatment based on thermal ablation of tissues which are warmed up to 85°C in the focal area. Clinical studies have shown such treatment modality to be safe and effective in the management of both localised (Tl-2) and locally advanced (T3) prostate cancer (as well as of local recurrences after radical prostatectomy). MATERIAL & METHODS: From May 2002 to September 2005, 108 patients with prostate cancer, aged 44 to 86 years (mean 74.2) underwent 123 HIFU treatments; 15 patients needed a second treatment as the first was incomplete (4 patients) or because of recurrence (11 patients). Indications for HIFU treatment included patient’s choice or not eligible to radical prostatectomy because age (> 75 years) or high anaesthesiological risk. Mean PSA was 27.7 ng/ml (range 0, 1-143) and mean Gleason sum 6.1 (range 3-9). The prognosis subgroups were defined as lowrisk in 16 patients (clinical stage T1-T2a, PSA < or = 10 ng/mL, and Gleason score lower than 7), intermediate-risk in 14 patients (clinical stage T2b or PSA 10 - 20 ng/mL, or Gleason score of 7), and high-risk in 78 patients (clinical stage > or = T2c, or PSA > 20 ng/mL, or Gleason score higher than 7). Preoperative assessment included renal, bladder and transrectal prostatic ultrasounds, uroflowmetry, as well as I-PSS, QoL and IIEF-5 questionnaires. CT scan and bone scan were performed only in patients with PSA >10ng/ml. All patients received spinal anaesthesia. After placing a suprapubic catheter, and performing a debulking TURP, HIFU treatment was carried out with a transrectal probe (ABLATHERM, EDAP TECHNOMED). RESULTS: Follow-up included PSA determination after 6 and 12 weeks and then every 3 months, transrectal prostatic biopsy after 6 months, I-PSS, and QoL and IIEF-5 questionnaires every 3 months. At a mean follow-up of 22.5 months, biochemical success rate (PSA constantly <0.5 ng/ml) was obtained in 76.6% of low and intermediate risk patients and in 41.6% of high risk patients; post-treatment biopsies (6 months after treatment) revealed no residual tumour in 95.6% of low or intermediate risk patients and in 67.3% of high risk patients. Complications included: asymptomatic urinary tract infections (38.3%), prostatitis (6.8%), epididymorchitis and emorrhoidal pain (4.1%), and haematuria (8.2%), strictures of urethra (9.5%), bladder neck sclerosis (5.4%) and rectourethral fistula (0.9%). Light stress incontinence occurred in 4.1% of the patients and erectile dysfunction in 67.8%. CONCLUSIONS: Radical prostatectomy remains the “gold standard” for localised prostate cancer. However, HIFU seems to be a promising alternative and less invasive treatment modality with an encouraging success rate, at least in the short-term. Long-term success rate and outcome of complications, particularly strictures, remain to be defined to determine to exact role of this treatment option in managing prostate cancer.
Eur Urol Suppl 2006;5(2):133