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PD43-11 ADJUVANT MAXIMUM ANDROGEN BLOCKAGE COMPARED WITH BICALUTAMIDE 150MG IN PATIENTS WITH LOCALIZED HIGH-RISK PROSTATE CANCER AFTER RADICAL PROSTATECTOMY
THE JOURNAL OF UROLOGYâ
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9.9413.7. Rates of CCI low, intermediate and high were 12.5% (124/994), 21.7% (216/994) and 11.2% (111/994), respectively. The mean SAS was 7.021.19, 31.8% (316/994) and 68.2% (678/994) had a SAS of 6 and >6, respectively. Mean SAS in patients with none, low, intermediate, or high complication burden was 7.181.13, 6.861.2, 6.911.35, and 6.621.18, respectively (p<0.0001). Of those with a SAS 6 43.4% (137/316), 13.3% (42/316), 25.9% (82/ 316), and 17.4% (55/316) had none, low, intermediate or high complication burden, respectively. In the univariate analysis SAS 6 was associated with intermediate (odds ratio OR 1.81, 95% confidence interval CI 1.29-2.54 p<0.001) and high (OR 2.91, 95% CI 1.91-4.43 p<0.0001) complication burden. In the multivariate analysis SAS 6 was an independent predictor of intermediate (OR 1.79, 95% CI 1.26-2.56 p<0.001) and high (OR 2.31, 95% CI 1.49-3.58 p<0.0001) complication burden, respectively. CONCLUSIONS: The SAS is easily calculated from intraoperative available data. Immediatly after surgery patients whith increased risk for a high 30-day complication burden are identified as these are predicted by a SAS 6. The surgeon and the anaesthesiologist should avoid low SAS values during the procedure. Source of Funding: none
PD43-10 HYPOGONADISM INDEPENDENTLY PREDICTS PATHOLOGICAL GLEASON PATTERN 5 AT THE TIME OF RADICAL PROSTATECTOMY Marco Moschini*, Paolo Dell’Oglio, Nicola Fossati, Giorgio Gandaglia, Alessandro Larcher, Armando Stabile, Giuseppe Saitta, Eugenio Ventimiglia, Milan, Italy; Guido Barbagli, Arezzo, Italy; Shahrokh François Shariat, Vienna, Austria; Renaud Bollens, Brussels, Belgium; Francesco Montorsi, Alberto Briganti, Milan, Italy INTRODUCTION AND OBJECTIVES: Pathological Gleason score is a powerful predictor of oncological outcomes in patients diagnosed with prostate cancer (PCa) and treated with radical prostatectomy (RP). Particularly, the presence of hypogonadism has been associated with higher rates of biochemical recurrence and more advanced pathological stage. Our study aimed at evaluating the ability of preoperative sex hormones to predict the presence of pathological Gleason pattern 5 in RP specimen, which may explain the unfavorable outcomes of hypogonadal men diagnosed with PCa. METHODS: A cohort of 1,071 consecutive Caucasian patients who underwent RP at a single institution was analyzed with pre-operative serum hormones values available. None of the patients had taken any hormonal neoadjuvant treatment or other hormonal preparations during the previous 12 months. Serum testosterone (TT), 17b-estradiol (E2) and sex hormone-binding globulin (SHBG) were measured the day before surgery (8-10 AM) in all cases. Hypogonadism was defined as defined as TT<3 ng/ml. Multivariable logistic regression models tested the impact of preoperative circulating sex steroids and presence of both pathological Gleason pattern 5 pattern and pathological Gleason score 8-10 at final pathology. Separated models were created for each single hormone, as well as for the presence of hypogonadism. Covariates consisted of age and D Amico risk groups RESULTS: Overall, 118 patients (11.0%) harbored a pathological Gleason pattern 5 at RP specimen, 27 (22.9%) as primary and 96 (81.3%) as secondary pattern, of which 5 (4.2%) harbored Gleason 5+5. At univariable analyses, no differences were recorded between patients with or without GS pattern 5, regarding TT, E2, age and PSA. Conversely, SHBG (41.8 vs. 37.5 mmol/dL) and the rate of hypogonadism (32.0% vs. 21.4%) were higher in patients harboring Gleason pattern 5 (all p<0.007). At multivariable analyses, TT and E2 were not associated with either pathological Gleason pattern 5 (all p>0.4), while SHBG levels (OR: 1.02, p¼0.03) were able to predict the presence of pathological Gleason pattern 5. After adjusting for age, D Amico risk groups and SHBG, the presence of hypogonadism (OR 1.79, p¼0.025)
Vol. 195, No. 4S, Supplement, Monday, May 9, 2016
was independently associated with the presence of pathological Gleason pattern 5 CONCLUSIONS: Hypogonadism status and preoperative SHBG levels were independent predictor of pathological GS 5 pattern at final pathology. Our results may explain the increased risk of hypogonadal men to harbor unfavorable pathological and long term outcomes in men diagnosed with PCa and treated with RP Source of Funding: none
PD43-11 ADJUVANT MAXIMUM ANDROGEN BLOCKAGE COMPARED WITH BICALUTAMIDE 150MG IN PATIENTS WITH LOCALIZED HIGH-RISK PROSTATE CANCER AFTER RADICAL PROSTATECTOMY kun chang*, Xiao-jian Qin, Ding-wei Ye, Shanghai, China, People’s Republic of INTRODUCTION AND OBJECTIVES: The role of adjuvant hormonal therapy and optimized regimens for high-risk localized prostate cancer (PCa) after radical prostatectomy (RP) remains controversial. METHODS: The clinical trial CU1005 prospectively evaluated two regimens of maximum androgen blockage (MAB) or bicalutamide 150 mg daily as immediate adjuvant therapy for high-risk localized prostate cancer. Overall, 209 consecutive patients were recruited in this study, 107 of whom received 9 months of adjuvant maximum androgen blockage MAB, while 102 received 9 months of adjuvant bicalutamide 150 mg. The primary endpoints were biochemical recurrence (BCR). RESULTS: The median post-operative follow-up time was 27.0 months. Of the 209 patients, 59 patients developed biochemical recurrence BCR. There was no difference between the two groups with respect to clinical characteristics, including age, pretreatment prostatespecific antigen PSA, Gleason score, surgical margin status, or pathological stages.(Table 1) The maximum androgen blockage MAB group experienced longer biochemical recurrence-free survival (P ¼ 0.004) compared with the bicalutamide 150 mg group.(Figure 1) Side effects in the two groups were similar and could be moderately tolerated in all patients.(Table 2) CONCLUSIONS: Immediate, 9-month maximum androgen blockage MAB should be considered as an alternative to bicalutamide 150 mg as adjuvant treatment for high-risk localized prostate cancer patients after radical prostatectomy.
Vol. 195, No. 4S, Supplement, Monday, May 9, 2016
THE JOURNAL OF UROLOGYâ
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operative urinary continence recovery (UCR) and urinary bother symptoms in a prospective non-randomized study. METHODS: We focused on 81 consecutive prostate cancer patients treated with RSP (n¼41) vs. VIP (n¼40), between July and December 2014, in one institution. Kaplan-Meier curves were used to estimate UCR rate after RSP vs. VIP. Univariable and multivariable regression analyses tested the relationship between surgical technique (RSP vs. VIP) and two endpoints: 1) UCR rate, defined as the use of <¼1 pad/day; 2) post-operative urinary bother symptoms measured using the quality of life question in the International Prostate Symptom Score questionnaire (no bother, score 0-2; bother, score >¼3). RESULTS: Median age at surgery was 64.0 years. Patients treated with RSP were younger than their VIP counterparts (median: 62.0 vs. 66.5, p¼0.03). At 1-, 2-, and 4-week after surgery, UCR rate was respectively 42%, 78%, and 95% for RSP patients vs. 20%, 50%, and 61% for VIP patients (p<0.001) (Figure). For the same treatment groups, the percentage of patients without urinary bother symptoms was respectively 90.9% vs. 64.3% (p¼0.02) at 2-week, and 96.9% vs. 74.2% (p¼0.01) at 4-week. These results were confirmed on multivariable analyses (odds ratio for RSP vs. VIP 2.19 for UCR [p¼0.007] and 6.60 for urinary bother [p¼0.03]). The non-randomized nature of the study is a limitation. CONCLUSIONS: The use of RSP technique might significantly improve the rate of post-operative urinary continence recovery. This in turn can translate into a higher post-operative quality of life and/or patient satisfaction. Results from an ongoing randomized trial at our center may allow further validation of these findings.
Source of Funding: none
PD43-12 URINARY CONTINENCE OUTCOMES AFTER RETZIUS-SPARING ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROSPECTIVE, NON-RANDOMIZED, IDEAL STAGE 2B (EXPLORATION) STUDY. Firas Abdollah*, Royal Oak, MI; Deepansh Dalela, Akshay Sood, Jesse Sammon, Madhu Ashni-Prasad, Wooju Jeong, James Peabody, Mani Menon, Detroit, MI INTRODUCTION AND OBJECTIVES: Data regarding the outcomes of Retzius-Sparing robot-assisted radical Prostatectomy (RSP) are scarce in literature. This is especially true for data originating from North American patients. Our objective was to test the impact of surgical technique (RSP vs. Vattikuti Institute Prostatectomy [VIP]) on post-
Source of Funding: None
e996
9.9413.7. Rates of CCI low, intermediate and high were 12.5% (124/994), 21.7% (216/994) and 11.2% (111/994), respectively. The mean SAS was 7.021.19, 31.8% (316/994) and 68.2% (678/994) had a SAS of 6 and >6, respectively. Mean SAS in patients with none, low, intermediate, or high complication burden was 7.181.13, 6.861.2, 6.911.35, and 6.621.18, respectively (p<0.0001). Of those with a SAS 6 43.4% (137/316), 13.3% (42/316), 25.9% (82/ 316), and 17.4% (55/316) had none, low, intermediate or high complication burden, respectively. In the univariate analysis SAS 6 was associated with intermediate (odds ratio OR 1.81, 95% confidence interval CI 1.29-2.54 p<0.001) and high (OR 2.91, 95% CI 1.91-4.43 p<0.0001) complication burden. In the multivariate analysis SAS 6 was an independent predictor of intermediate (OR 1.79, 95% CI 1.26-2.56 p<0.001) and high (OR 2.31, 95% CI 1.49-3.58 p<0.0001) complication burden, respectively. CONCLUSIONS: The SAS is easily calculated from intraoperative available data. Immediatly after surgery patients whith increased risk for a high 30-day complication burden are identified as these are predicted by a SAS 6. The surgeon and the anaesthesiologist should avoid low SAS values during the procedure. Source of Funding: none
PD43-10 HYPOGONADISM INDEPENDENTLY PREDICTS PATHOLOGICAL GLEASON PATTERN 5 AT THE TIME OF RADICAL PROSTATECTOMY Marco Moschini*, Paolo Dell’Oglio, Nicola Fossati, Giorgio Gandaglia, Alessandro Larcher, Armando Stabile, Giuseppe Saitta, Eugenio Ventimiglia, Milan, Italy; Guido Barbagli, Arezzo, Italy; Shahrokh François Shariat, Vienna, Austria; Renaud Bollens, Brussels, Belgium; Francesco Montorsi, Alberto Briganti, Milan, Italy INTRODUCTION AND OBJECTIVES: Pathological Gleason score is a powerful predictor of oncological outcomes in patients diagnosed with prostate cancer (PCa) and treated with radical prostatectomy (RP). Particularly, the presence of hypogonadism has been associated with higher rates of biochemical recurrence and more advanced pathological stage. Our study aimed at evaluating the ability of preoperative sex hormones to predict the presence of pathological Gleason pattern 5 in RP specimen, which may explain the unfavorable outcomes of hypogonadal men diagnosed with PCa. METHODS: A cohort of 1,071 consecutive Caucasian patients who underwent RP at a single institution was analyzed with pre-operative serum hormones values available. None of the patients had taken any hormonal neoadjuvant treatment or other hormonal preparations during the previous 12 months. Serum testosterone (TT), 17b-estradiol (E2) and sex hormone-binding globulin (SHBG) were measured the day before surgery (8-10 AM) in all cases. Hypogonadism was defined as defined as TT<3 ng/ml. Multivariable logistic regression models tested the impact of preoperative circulating sex steroids and presence of both pathological Gleason pattern 5 pattern and pathological Gleason score 8-10 at final pathology. Separated models were created for each single hormone, as well as for the presence of hypogonadism. Covariates consisted of age and D Amico risk groups RESULTS: Overall, 118 patients (11.0%) harbored a pathological Gleason pattern 5 at RP specimen, 27 (22.9%) as primary and 96 (81.3%) as secondary pattern, of which 5 (4.2%) harbored Gleason 5+5. At univariable analyses, no differences were recorded between patients with or without GS pattern 5, regarding TT, E2, age and PSA. Conversely, SHBG (41.8 vs. 37.5 mmol/dL) and the rate of hypogonadism (32.0% vs. 21.4%) were higher in patients harboring Gleason pattern 5 (all p<0.007). At multivariable analyses, TT and E2 were not associated with either pathological Gleason pattern 5 (all p>0.4), while SHBG levels (OR: 1.02, p¼0.03) were able to predict the presence of pathological Gleason pattern 5. After adjusting for age, D Amico risk groups and SHBG, the presence of hypogonadism (OR 1.79, p¼0.025)
Vol. 195, No. 4S, Supplement, Monday, May 9, 2016
was independently associated with the presence of pathological Gleason pattern 5 CONCLUSIONS: Hypogonadism status and preoperative SHBG levels were independent predictor of pathological GS 5 pattern at final pathology. Our results may explain the increased risk of hypogonadal men to harbor unfavorable pathological and long term outcomes in men diagnosed with PCa and treated with RP Source of Funding: none
PD43-11 ADJUVANT MAXIMUM ANDROGEN BLOCKAGE COMPARED WITH BICALUTAMIDE 150MG IN PATIENTS WITH LOCALIZED HIGH-RISK PROSTATE CANCER AFTER RADICAL PROSTATECTOMY kun chang*, Xiao-jian Qin, Ding-wei Ye, Shanghai, China, People’s Republic of INTRODUCTION AND OBJECTIVES: The role of adjuvant hormonal therapy and optimized regimens for high-risk localized prostate cancer (PCa) after radical prostatectomy (RP) remains controversial. METHODS: The clinical trial CU1005 prospectively evaluated two regimens of maximum androgen blockage (MAB) or bicalutamide 150 mg daily as immediate adjuvant therapy for high-risk localized prostate cancer. Overall, 209 consecutive patients were recruited in this study, 107 of whom received 9 months of adjuvant maximum androgen blockage MAB, while 102 received 9 months of adjuvant bicalutamide 150 mg. The primary endpoints were biochemical recurrence (BCR). RESULTS: The median post-operative follow-up time was 27.0 months. Of the 209 patients, 59 patients developed biochemical recurrence BCR. There was no difference between the two groups with respect to clinical characteristics, including age, pretreatment prostatespecific antigen PSA, Gleason score, surgical margin status, or pathological stages.(Table 1) The maximum androgen blockage MAB group experienced longer biochemical recurrence-free survival (P ¼ 0.004) compared with the bicalutamide 150 mg group.(Figure 1) Side effects in the two groups were similar and could be moderately tolerated in all patients.(Table 2) CONCLUSIONS: Immediate, 9-month maximum androgen blockage MAB should be considered as an alternative to bicalutamide 150 mg as adjuvant treatment for high-risk localized prostate cancer patients after radical prostatectomy.
Vol. 195, No. 4S, Supplement, Monday, May 9, 2016
THE JOURNAL OF UROLOGYâ
e997
operative urinary continence recovery (UCR) and urinary bother symptoms in a prospective non-randomized study. METHODS: We focused on 81 consecutive prostate cancer patients treated with RSP (n¼41) vs. VIP (n¼40), between July and December 2014, in one institution. Kaplan-Meier curves were used to estimate UCR rate after RSP vs. VIP. Univariable and multivariable regression analyses tested the relationship between surgical technique (RSP vs. VIP) and two endpoints: 1) UCR rate, defined as the use of <¼1 pad/day; 2) post-operative urinary bother symptoms measured using the quality of life question in the International Prostate Symptom Score questionnaire (no bother, score 0-2; bother, score >¼3). RESULTS: Median age at surgery was 64.0 years. Patients treated with RSP were younger than their VIP counterparts (median: 62.0 vs. 66.5, p¼0.03). At 1-, 2-, and 4-week after surgery, UCR rate was respectively 42%, 78%, and 95% for RSP patients vs. 20%, 50%, and 61% for VIP patients (p<0.001) (Figure). For the same treatment groups, the percentage of patients without urinary bother symptoms was respectively 90.9% vs. 64.3% (p¼0.02) at 2-week, and 96.9% vs. 74.2% (p¼0.01) at 4-week. These results were confirmed on multivariable analyses (odds ratio for RSP vs. VIP 2.19 for UCR [p¼0.007] and 6.60 for urinary bother [p¼0.03]). The non-randomized nature of the study is a limitation. CONCLUSIONS: The use of RSP technique might significantly improve the rate of post-operative urinary continence recovery. This in turn can translate into a higher post-operative quality of life and/or patient satisfaction. Results from an ongoing randomized trial at our center may allow further validation of these findings.
Source of Funding: none
PD43-12 URINARY CONTINENCE OUTCOMES AFTER RETZIUS-SPARING ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROSPECTIVE, NON-RANDOMIZED, IDEAL STAGE 2B (EXPLORATION) STUDY. Firas Abdollah*, Royal Oak, MI; Deepansh Dalela, Akshay Sood, Jesse Sammon, Madhu Ashni-Prasad, Wooju Jeong, James Peabody, Mani Menon, Detroit, MI INTRODUCTION AND OBJECTIVES: Data regarding the outcomes of Retzius-Sparing robot-assisted radical Prostatectomy (RSP) are scarce in literature. This is especially true for data originating from North American patients. Our objective was to test the impact of surgical technique (RSP vs. Vattikuti Institute Prostatectomy [VIP]) on post-
Source of Funding: None