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P077 Comparative analysis in a consecutive series of 160 brachytherapies and 153 prostatectomies
A B S T R A C T S / E U R O P E A N U R O L O G Y S U P P L E M E N T S 12 (2013) 123–180
in striving for adequate visualization of the oncologic process, which may allow to evaluate the effectiveness of the treatment of prostate cancer by alternative focal methods. Material & Methods: 124 patients (pts), who have been previously (in a period of 7 days to 9 years) VIFU-therapy for prostate cancer, since September 2011 held the HS. The study was conducted again at 1, 3, 6 and 12 months. HS performed using diagnostic system Histoscanning. For the detection of recurrence of the disease was used Stuttgart criterion, or prostate biopsy under ultrasound guidance with further morphological verification. Results: Prostate biopsy was made in the first year after surgery in 37 pts, at a later date – 45. Biopsy in the first year after surgery in 38% (14 pts) histological material comprised mainly of fibrosis, in 56% – of necrotic tissue (21 pts) and in 22% – of prostate adenocarcinoma (8 pts). Advantageously occurred combination of this findings with hyperplasia, lymphoid infiltrate and between itselves. Result of HS (on laterality and location of the lesion) coincided with the histological findings in 22% (8 pts), were falsepositive in 32% (12 pts prostate cancer was not detected, despite the suspicious tissue structure on the results of the HS), falsenegative results were not observed. When during a biopsy, these histological changes were presented in 72% (32 pts), 26% (12 pts) and 42% (19 pts), respectively. Mostly there has been a combination of them together, hyperplasia and lymphoid infiltration were less common. Result of HS (on laterality and location of the lesion) coincided with the histological findings in 36% (16 pts), were false-positive in 52% (23 pts) and false-negative results in 6% (3 pts). 42 pts biopsy was not performed, 12 of them relapsed set on the basis of the criterion of Stuttgart. In this group false positive result was in 21% (9 pts) and in 5% it was false negative (patient 2). Of the total number of pts in the study of the volume of suspicious tissue structures in 68 people has made – less than 0.2 cm3 , in 32 people – from 0.2 cm3 to 0.5 cm3 , in 24 people – more than 0.5 cm3 . The first group of pts relapse was diagnosed in 2 pts (3%). Second group – relapse was diagnosed in 15 pts (47%). A third group – 22 pts (88%). In assessing the false-positive and false-negative results in the first group sensitivity of HS was 100%, specificity of 3%, in the second group – 82% and 47%, in the third group – 100% and 88%, respectively. Conclusions: HS is a highly informative method capable of detecting prostate cancer foci of 0.2 cm3 with a high degree of sensitivity and specificity. At a volume less than 0.2 cm3 specificity of procedure is insignificant, although clinically malignant process such volumes are likely to be insignificant. Also, given the small size of the foci, is not ruled out aiming error when performing a biopsy, which finally do not denies the data obtained at the HS. Best informativeness of HS is marked with the identification of suspicious areas of more than 0.5 cm3 . The specificity of the method depends on the degree of sclerotic changes in the prostate tissue: the more they are expressed, that is the lower. Sclerotic process after HIFU ablation of the prostate becomes more pronounced with time. Therefore, the HS is more specific in the first year following the patient. Thus, the HS may result in improved outcomes in pts prostate cancer through early detection of recurrence of the disease and to enable timely treatment. P077 Comparative analysis in a consecutive series of 160 brachytherapies and 153 prostatectomies C. Baena Villamarin, J.M. Conde Sánchez, C.B. Congregado Ruiz, I. Osman García, E. Argüelles Salido, J.M. Pena Outeriño, R.A. Medina López. Hospital Universitario Virgen del Rocío, Urology, Sevilla, Spain Introduction & Objectives: The recent increase in the use of minimal invasive techniques to treat prostate cancer such as robotic
159
prostatectomy and brachytherapy (BT) has arisen the interest of both medical managers and surgeons. However, there are not enough comparative studies providing solid evidence in relation to such techniques. We present a comparative study and survival analysis of a consecutive series of 160 prostate BT and 153 robotic-assisted laparoscopic radical prostatectomies using the “Da Vinci” (DV) surgical system. Material & Methods: 313 patients with low-risk localized prostate cancer: 160 patients underwent low-dose I-125 RapidStrand BT at a prescribed dose of 145 Gy and 153 underwent robotic-assisted radical prostatectomy (Da Vinci). The patients who met the inclusion criteria for each technique have chosen the procedure on the basis of a validated Decision-Making-Tool.We analysed the following parameters: age, PSA level, stage, Gleason score, prostate volume at the time of diagnosis, IPSS (pre and post-treatment), flowmetry and global and disease-free survival. The oncologic follow-up of patients was carried out one month after the intervention, every three months during the first year and every six months subsequently. We carried out a descriptive and comparative analysis of oncologic follow-up and survival-related variables. Results: No differences have been found as regards the number of patients showing complications in each series (3% vs 6.5%). However, we observed differences as regards the severity of the complication (according to Clavien-Dindo classification) as 4 patients in the DV series required a new intervention. 8% of the patients undergoing BT presented with biochemical progression vs 15% in the case of patients undergoing DV. Conclusions: IPSS and flowmetry worsen remarkably in the BT series. Fatigue, duration and hospital stay are lesser in the BT group. Complications and severity of complications are less common in the BT group. Less progressions are observed in the BT group (8%) than in the DV group (15%) without consequences as regards PFS or GS. P078 Health related quality of life and coping in patients on active surveillance: Two-year follow-up M.F. Alvisi 1 , L. Bellardita 1 , T. Rancati 1 , S. Villa 1 , C. Marenghi 1 , N. Bedini 2 , S. Villa 2 , D. Biasoni 3 , N. Nicolai 3 , R. Salvioni 3 , T. Magnani 1 , R. Valdagni 4 . 1 Fondazione IRCCS Istituto Nazionale Tumori, Prostate Cancer Program, Milan, Italy; 2 Fondazione IRCCS Istituto Nazionale Tumori, Radiation Oncology 1, Milan, Italy; 3 Fondazione IRCCS Istituto Nazionale Tumori, Urology, Milan, Italy; 4 Fondazione IRCCS Istituto Nazionale Tumori, Prostate Cancer Program, Radiation Oncology 1, Milan, Italy Introduction & Objectives: Active Surveillance (AS) is receiving increasing consensus as a viable alternative to radical treatment for low risk prostate cancer (PCa). Recent studies highlighted that men on AS reported high levels of health-related QoL (HRQoL) and adjustment to cancer. Nonetheless, longer term follow-up is needed as the possibility of decrease in the levels of QoL was highlighted. The aim of this study was to investigate the changes in HRQoL and adjustment to cancer over the first two years on AS. Material & Methods: Between Nov 2007 and Jan 2013, 208 patients were included in PRIAS-QoL study and completed questionnaires at enrolment in the AS protocol (T0). Evaluations after 10 months (T1) from diagnostic biopsy, 12 months (after the first re-biopsy – T2) and 24 months (T3) were completed by 156, 109 and 62 patients, respectively. Validated self-report questionnaires assessing QoL were administered, including: a) Functional Assessment of Cancer Therapy – Prostate Version (FACT-P), measuring HRQoL in terms of: physical wellbeing (PWB), social wellbeing (SWB), emotional wellbeing (EWB), functional wellbeing (FWB), and wellbeing related to prostate cancer symptoms (PCS); b) Mini Mental Adjustment to Cancer (Mini-MAC), evaluating the
in striving for adequate visualization of the oncologic process, which may allow to evaluate the effectiveness of the treatment of prostate cancer by alternative focal methods. Material & Methods: 124 patients (pts), who have been previously (in a period of 7 days to 9 years) VIFU-therapy for prostate cancer, since September 2011 held the HS. The study was conducted again at 1, 3, 6 and 12 months. HS performed using diagnostic system Histoscanning. For the detection of recurrence of the disease was used Stuttgart criterion, or prostate biopsy under ultrasound guidance with further morphological verification. Results: Prostate biopsy was made in the first year after surgery in 37 pts, at a later date – 45. Biopsy in the first year after surgery in 38% (14 pts) histological material comprised mainly of fibrosis, in 56% – of necrotic tissue (21 pts) and in 22% – of prostate adenocarcinoma (8 pts). Advantageously occurred combination of this findings with hyperplasia, lymphoid infiltrate and between itselves. Result of HS (on laterality and location of the lesion) coincided with the histological findings in 22% (8 pts), were falsepositive in 32% (12 pts prostate cancer was not detected, despite the suspicious tissue structure on the results of the HS), falsenegative results were not observed. When during a biopsy, these histological changes were presented in 72% (32 pts), 26% (12 pts) and 42% (19 pts), respectively. Mostly there has been a combination of them together, hyperplasia and lymphoid infiltration were less common. Result of HS (on laterality and location of the lesion) coincided with the histological findings in 36% (16 pts), were false-positive in 52% (23 pts) and false-negative results in 6% (3 pts). 42 pts biopsy was not performed, 12 of them relapsed set on the basis of the criterion of Stuttgart. In this group false positive result was in 21% (9 pts) and in 5% it was false negative (patient 2). Of the total number of pts in the study of the volume of suspicious tissue structures in 68 people has made – less than 0.2 cm3 , in 32 people – from 0.2 cm3 to 0.5 cm3 , in 24 people – more than 0.5 cm3 . The first group of pts relapse was diagnosed in 2 pts (3%). Second group – relapse was diagnosed in 15 pts (47%). A third group – 22 pts (88%). In assessing the false-positive and false-negative results in the first group sensitivity of HS was 100%, specificity of 3%, in the second group – 82% and 47%, in the third group – 100% and 88%, respectively. Conclusions: HS is a highly informative method capable of detecting prostate cancer foci of 0.2 cm3 with a high degree of sensitivity and specificity. At a volume less than 0.2 cm3 specificity of procedure is insignificant, although clinically malignant process such volumes are likely to be insignificant. Also, given the small size of the foci, is not ruled out aiming error when performing a biopsy, which finally do not denies the data obtained at the HS. Best informativeness of HS is marked with the identification of suspicious areas of more than 0.5 cm3 . The specificity of the method depends on the degree of sclerotic changes in the prostate tissue: the more they are expressed, that is the lower. Sclerotic process after HIFU ablation of the prostate becomes more pronounced with time. Therefore, the HS is more specific in the first year following the patient. Thus, the HS may result in improved outcomes in pts prostate cancer through early detection of recurrence of the disease and to enable timely treatment. P077 Comparative analysis in a consecutive series of 160 brachytherapies and 153 prostatectomies C. Baena Villamarin, J.M. Conde Sánchez, C.B. Congregado Ruiz, I. Osman García, E. Argüelles Salido, J.M. Pena Outeriño, R.A. Medina López. Hospital Universitario Virgen del Rocío, Urology, Sevilla, Spain Introduction & Objectives: The recent increase in the use of minimal invasive techniques to treat prostate cancer such as robotic
159
prostatectomy and brachytherapy (BT) has arisen the interest of both medical managers and surgeons. However, there are not enough comparative studies providing solid evidence in relation to such techniques. We present a comparative study and survival analysis of a consecutive series of 160 prostate BT and 153 robotic-assisted laparoscopic radical prostatectomies using the “Da Vinci” (DV) surgical system. Material & Methods: 313 patients with low-risk localized prostate cancer: 160 patients underwent low-dose I-125 RapidStrand BT at a prescribed dose of 145 Gy and 153 underwent robotic-assisted radical prostatectomy (Da Vinci). The patients who met the inclusion criteria for each technique have chosen the procedure on the basis of a validated Decision-Making-Tool.We analysed the following parameters: age, PSA level, stage, Gleason score, prostate volume at the time of diagnosis, IPSS (pre and post-treatment), flowmetry and global and disease-free survival. The oncologic follow-up of patients was carried out one month after the intervention, every three months during the first year and every six months subsequently. We carried out a descriptive and comparative analysis of oncologic follow-up and survival-related variables. Results: No differences have been found as regards the number of patients showing complications in each series (3% vs 6.5%). However, we observed differences as regards the severity of the complication (according to Clavien-Dindo classification) as 4 patients in the DV series required a new intervention. 8% of the patients undergoing BT presented with biochemical progression vs 15% in the case of patients undergoing DV. Conclusions: IPSS and flowmetry worsen remarkably in the BT series. Fatigue, duration and hospital stay are lesser in the BT group. Complications and severity of complications are less common in the BT group. Less progressions are observed in the BT group (8%) than in the DV group (15%) without consequences as regards PFS or GS. P078 Health related quality of life and coping in patients on active surveillance: Two-year follow-up M.F. Alvisi 1 , L. Bellardita 1 , T. Rancati 1 , S. Villa 1 , C. Marenghi 1 , N. Bedini 2 , S. Villa 2 , D. Biasoni 3 , N. Nicolai 3 , R. Salvioni 3 , T. Magnani 1 , R. Valdagni 4 . 1 Fondazione IRCCS Istituto Nazionale Tumori, Prostate Cancer Program, Milan, Italy; 2 Fondazione IRCCS Istituto Nazionale Tumori, Radiation Oncology 1, Milan, Italy; 3 Fondazione IRCCS Istituto Nazionale Tumori, Urology, Milan, Italy; 4 Fondazione IRCCS Istituto Nazionale Tumori, Prostate Cancer Program, Radiation Oncology 1, Milan, Italy Introduction & Objectives: Active Surveillance (AS) is receiving increasing consensus as a viable alternative to radical treatment for low risk prostate cancer (PCa). Recent studies highlighted that men on AS reported high levels of health-related QoL (HRQoL) and adjustment to cancer. Nonetheless, longer term follow-up is needed as the possibility of decrease in the levels of QoL was highlighted. The aim of this study was to investigate the changes in HRQoL and adjustment to cancer over the first two years on AS. Material & Methods: Between Nov 2007 and Jan 2013, 208 patients were included in PRIAS-QoL study and completed questionnaires at enrolment in the AS protocol (T0). Evaluations after 10 months (T1) from diagnostic biopsy, 12 months (after the first re-biopsy – T2) and 24 months (T3) were completed by 156, 109 and 62 patients, respectively. Validated self-report questionnaires assessing QoL were administered, including: a) Functional Assessment of Cancer Therapy – Prostate Version (FACT-P), measuring HRQoL in terms of: physical wellbeing (PWB), social wellbeing (SWB), emotional wellbeing (EWB), functional wellbeing (FWB), and wellbeing related to prostate cancer symptoms (PCS); b) Mini Mental Adjustment to Cancer (Mini-MAC), evaluating the