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MP-3.08: Quality of Life After HIFU Treatment for Localized Prostate Cancer
MODERATED POSTER SESSIONS
sess the incidence and the clinical impact of the LN metastases. Materials and Methods: Between 1996 and 2008, a total of 111 patients underwent PLND and radical prostatectomy for localized or locally advanced prostate cancer. Among all, there were 61 cases, defined as HR PC after the receipt of the final pathological report. These were cases with poor pathological characteristics: initial PSA ⬎ 15 ng/ml, Gleason sum ⬎ 7, capsular invasion, seminal vesicle involvement, positive surgical margins, and/or positive LN. In all these cases, extended PLND, up to the aorta bifurcation, was performed. In recent years (20062008), PLND was facilitated by preoperative intraprostatic injection of Tc-99mnanocolloid and intraoperative detection of the sentinel lymph nodes by gamma probe. All LN harvested were cleaned from the fatty tissue and thus processed for histological and immunohistochemical examination. Results: A total of 752 pelvic LN (mean, 12 per case; range, 7-38) were collected and examined. LN metastases were found in 27 cases (44.3%). Most of the LN metastases were localized outside the obturator fossa. The metastatic LN were distributed as follows: obturator (32%); external iliac (28%); internal iliac (27%); common iliac (13%); and presacral LN (0%). The LN status showed to have a significant impact on disease-free survival, both in univariate, and in multivariate analysis. The KaplanMeier estimates of the disease-free, the overall and the cancer–specific survival at the 10th year after surgery were 65.1%, 78.7% and 88.0% for LN negative disease, and 12.2%, 46.8% and 46.8% for LN positive disease, respectively. Patients with low volume metastatic disease had significantly longer cancer-specific survival compared to those with LN metastases in more than one LN (p ⫽ 0.04, log-rank test). Conclusions: PLND has a significant impact on proper staging, prognosis and oncological outcome of prostate cancer. Our results confirm the necessity to perform an extended PLND in high-risk prostate cancer. MP-3.07 Clinical Experience with HIFU in Patients with Low-Risk Primary Prostate Cancer Suarez G1, Garcia C2, Estrella R3, Ryan M4, Meseke J4 1 International HIFU Society, South Miami, FL, USA; 2Hospital San Javier Marina, Puerto Vallarta, Mexico; 3Hospital Union Medica, Santiago, Dominican Republic; 4U.S. HIFU, LLC, Deland, FL, USA
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Introduction and Objectives: High intensity focused ultrasound (HIFU) using the Sonablate® 500 (Focus Surgery, Indianapolis, IN) has been used as primary treatment for patients with localized, lowto-moderate risk prostate cancer. This research reports PSA values and adverse events at 6 months post HIFU. Materials and Methods: A retrospective data analysis was performed on a total of 36 patients treated with HIFU between January 2006 and September 2007 in Puerto Vallarta, Santa Domingo, and Costa Rica. Inclusion criteria mimicked the current U.S. FDA trial for HIFU treatment of primary, organ confined prostate cancer. The median age and pre-treatment PSA level were 61 years (range 46-76) and 4.8 ng/ml (range 0.9 to 8.4). All patients had histologic grade 6 Gleason score. Mean prostate volume was 25.6 cc. No patients received prior neoadjuvent hormonal therapy. Data for all patients were evaluated for a period of 6.0 months post-treatment. The primary endpoint was defined as having achieved PSA of ⱕ 1.0 ng/mL at 6 months. Results: PSA response at 6 months was evaluable for twenty-seven patients (mean ⫽ 0.48 ng/mL). HIFU resulted in 92.5% (25/27) of patients achieving a PSA of 1.0 ng/mL or less by 6 months. Thirtysix patients were evaluable for adverse events. Seven (19%) patients developed a urethral stricture, 2 (6%) patients experienced bladder neck contractures. Rectal fistula was not observed in any patient (0/36). Conclusion: HIFU therapy appears to be a safe and efficacious minimally invasive therapy for patients with primary low risk, localized prostate cancer. Further research is needed to define long-term biochemical success rates and control of adverse events. Based on patient selection using the ongoing U.S. FDA clinical trials inclusion criteria, results show favorable outcomes with PSA nadir as a prognostic indicator.
tients after HIFU therapy and 25 patients after radical prostatectomy. Each patient was examined with the instrument twice: right before treatment and 1 year after treatment. Inquiry results before treatment were comparable in both groups. Results: Overall subjective quality of life reduced in both groups: after HIFU – 57.1% of patients, after prostatectomy – 84% (p⬍0.05). 8% after prostatectomy and 3.57% after HIFU were dissatisfied with the chosen therapy. Complaints on urination quality were stated by 10.71% of patients following HIFU (incontinence, bladder neck sclerosis) and 36% after radical prostatectomy (incontinence, urgency, infravesical obstruction) (p⫽0.04). Patients in both groups also stated the decrease of sexual function: total erectile dysfunction after HIFU – 32.14%, after prostatectomy (non nerve-sparing method) – 100% (p ⬍ 0.001). Considering subsequent erectile dysfunction correction, overall satisfaction with sexual function in 1st group was 71.43% and 20% in 2nd. Conclusion: Forecited data allow to consider HIFU-therapy as more preferable method form the position of quality of life. At the same time it is well known that radical prostatectomy is more reliable treatment method of localized prostate cancer with less risk of recurrence. Taking into consideration the fact that prostate cancer tends to progress slowly, nowadays the opinion of patient plays greater role. Not only radicalism of treatment is important, but also the impact of treatment on quality of life. This appears to be a serious argument for minimally invasive method - HIFU-therapy.
MP-3.08 Quality of Life After HIFU Treatment for Localized Prostate Cancer Shestiperov P, Alyaev Y, Amosov A, Chalyy M, Bezrukov E, Krupinov G Urology Clinic, Moscow Medical Academy, Moscow, Russia
Introduction and Objectives: The objective of this study was to study a cohort of morbidly obese individuals who underwent robotic radical prostatectomy with those of non-obese in our institute. Materials and Methods: Between September 2001 and September 2006, of the over 3181 robotic radical prostatectomy procedures done in a 5-year period, 125 (3%) of patients had a BMI of over 35. Preoperative, intraoperative, and postoperative variables were assessed and compared with 385 having a BMI of 25 and less.
Objectives: To assess the impact of HIFU therapy on patient quality of life, sexual function, urination quality and satisfaction with the chosen therapy. Methods: EORTC QLQ-C30 and QLQPR25 instruments were offered to 28 pa-
MP-3.09 Robotic Radical Prostatectomy in Morbidly Obese Patients Satyanarayana R, Krane L, Bhandari M, Menon M Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA
UROLOGY 72 (Supplement 5A), November 2008
sess the incidence and the clinical impact of the LN metastases. Materials and Methods: Between 1996 and 2008, a total of 111 patients underwent PLND and radical prostatectomy for localized or locally advanced prostate cancer. Among all, there were 61 cases, defined as HR PC after the receipt of the final pathological report. These were cases with poor pathological characteristics: initial PSA ⬎ 15 ng/ml, Gleason sum ⬎ 7, capsular invasion, seminal vesicle involvement, positive surgical margins, and/or positive LN. In all these cases, extended PLND, up to the aorta bifurcation, was performed. In recent years (20062008), PLND was facilitated by preoperative intraprostatic injection of Tc-99mnanocolloid and intraoperative detection of the sentinel lymph nodes by gamma probe. All LN harvested were cleaned from the fatty tissue and thus processed for histological and immunohistochemical examination. Results: A total of 752 pelvic LN (mean, 12 per case; range, 7-38) were collected and examined. LN metastases were found in 27 cases (44.3%). Most of the LN metastases were localized outside the obturator fossa. The metastatic LN were distributed as follows: obturator (32%); external iliac (28%); internal iliac (27%); common iliac (13%); and presacral LN (0%). The LN status showed to have a significant impact on disease-free survival, both in univariate, and in multivariate analysis. The KaplanMeier estimates of the disease-free, the overall and the cancer–specific survival at the 10th year after surgery were 65.1%, 78.7% and 88.0% for LN negative disease, and 12.2%, 46.8% and 46.8% for LN positive disease, respectively. Patients with low volume metastatic disease had significantly longer cancer-specific survival compared to those with LN metastases in more than one LN (p ⫽ 0.04, log-rank test). Conclusions: PLND has a significant impact on proper staging, prognosis and oncological outcome of prostate cancer. Our results confirm the necessity to perform an extended PLND in high-risk prostate cancer. MP-3.07 Clinical Experience with HIFU in Patients with Low-Risk Primary Prostate Cancer Suarez G1, Garcia C2, Estrella R3, Ryan M4, Meseke J4 1 International HIFU Society, South Miami, FL, USA; 2Hospital San Javier Marina, Puerto Vallarta, Mexico; 3Hospital Union Medica, Santiago, Dominican Republic; 4U.S. HIFU, LLC, Deland, FL, USA
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Introduction and Objectives: High intensity focused ultrasound (HIFU) using the Sonablate® 500 (Focus Surgery, Indianapolis, IN) has been used as primary treatment for patients with localized, lowto-moderate risk prostate cancer. This research reports PSA values and adverse events at 6 months post HIFU. Materials and Methods: A retrospective data analysis was performed on a total of 36 patients treated with HIFU between January 2006 and September 2007 in Puerto Vallarta, Santa Domingo, and Costa Rica. Inclusion criteria mimicked the current U.S. FDA trial for HIFU treatment of primary, organ confined prostate cancer. The median age and pre-treatment PSA level were 61 years (range 46-76) and 4.8 ng/ml (range 0.9 to 8.4). All patients had histologic grade 6 Gleason score. Mean prostate volume was 25.6 cc. No patients received prior neoadjuvent hormonal therapy. Data for all patients were evaluated for a period of 6.0 months post-treatment. The primary endpoint was defined as having achieved PSA of ⱕ 1.0 ng/mL at 6 months. Results: PSA response at 6 months was evaluable for twenty-seven patients (mean ⫽ 0.48 ng/mL). HIFU resulted in 92.5% (25/27) of patients achieving a PSA of 1.0 ng/mL or less by 6 months. Thirtysix patients were evaluable for adverse events. Seven (19%) patients developed a urethral stricture, 2 (6%) patients experienced bladder neck contractures. Rectal fistula was not observed in any patient (0/36). Conclusion: HIFU therapy appears to be a safe and efficacious minimally invasive therapy for patients with primary low risk, localized prostate cancer. Further research is needed to define long-term biochemical success rates and control of adverse events. Based on patient selection using the ongoing U.S. FDA clinical trials inclusion criteria, results show favorable outcomes with PSA nadir as a prognostic indicator.
tients after HIFU therapy and 25 patients after radical prostatectomy. Each patient was examined with the instrument twice: right before treatment and 1 year after treatment. Inquiry results before treatment were comparable in both groups. Results: Overall subjective quality of life reduced in both groups: after HIFU – 57.1% of patients, after prostatectomy – 84% (p⬍0.05). 8% after prostatectomy and 3.57% after HIFU were dissatisfied with the chosen therapy. Complaints on urination quality were stated by 10.71% of patients following HIFU (incontinence, bladder neck sclerosis) and 36% after radical prostatectomy (incontinence, urgency, infravesical obstruction) (p⫽0.04). Patients in both groups also stated the decrease of sexual function: total erectile dysfunction after HIFU – 32.14%, after prostatectomy (non nerve-sparing method) – 100% (p ⬍ 0.001). Considering subsequent erectile dysfunction correction, overall satisfaction with sexual function in 1st group was 71.43% and 20% in 2nd. Conclusion: Forecited data allow to consider HIFU-therapy as more preferable method form the position of quality of life. At the same time it is well known that radical prostatectomy is more reliable treatment method of localized prostate cancer with less risk of recurrence. Taking into consideration the fact that prostate cancer tends to progress slowly, nowadays the opinion of patient plays greater role. Not only radicalism of treatment is important, but also the impact of treatment on quality of life. This appears to be a serious argument for minimally invasive method - HIFU-therapy.
MP-3.08 Quality of Life After HIFU Treatment for Localized Prostate Cancer Shestiperov P, Alyaev Y, Amosov A, Chalyy M, Bezrukov E, Krupinov G Urology Clinic, Moscow Medical Academy, Moscow, Russia
Introduction and Objectives: The objective of this study was to study a cohort of morbidly obese individuals who underwent robotic radical prostatectomy with those of non-obese in our institute. Materials and Methods: Between September 2001 and September 2006, of the over 3181 robotic radical prostatectomy procedures done in a 5-year period, 125 (3%) of patients had a BMI of over 35. Preoperative, intraoperative, and postoperative variables were assessed and compared with 385 having a BMI of 25 and less.
Objectives: To assess the impact of HIFU therapy on patient quality of life, sexual function, urination quality and satisfaction with the chosen therapy. Methods: EORTC QLQ-C30 and QLQPR25 instruments were offered to 28 pa-
MP-3.09 Robotic Radical Prostatectomy in Morbidly Obese Patients Satyanarayana R, Krane L, Bhandari M, Menon M Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA
UROLOGY 72 (Supplement 5A), November 2008