- Email: [email protected]
MP42-07 IMPACT OF SURGICAL APPROACH ON ERECTILE FUNCTION RECOVERY FOLLOWING BILATERAL NERVE SPARING-RADICAL PROSTATECTOMY: RESULTS FROM A RANDOMIZED CONTROLLED TRIAL OF TADALAFIL VERSUS PLACEBO (REACTT)
THE JOURNAL OF UROLOGYâ
e510
infection-related hospitalization within 30 days post-biopsy, and validated these events with claims data for a subset of patients. We then compared the frequency of infection-related hospitalizations before (n¼ 5,028 biopsies) and after (n¼ 4,087 biopsies) implementation of the QI intervention. RESULTS: Overall, the proportion of patients with infectionrelated hospitalizations after prostate biopsy decreased by 53% from before to after implementation of the QI intervention (1.19% pre vs. 0.56% post, p¼0.002). Among post-implementation biopsies, rates of hospitalization were similar for patients receiving culture-directed (0.47%) versus augmented (0.57%) prophylaxis. At a practice-level, the relative change in hospitalization rates varied from a 3.0% increase to a 7.4% decrease (Figure). Fourteen practices had no postimplementation hospitalizations. In the validation sample of 228 men, we noted perfect concordance between the registry and claims data for identification of hospitalizations. CONCLUSIONS: A statewide intervention aimed at addressing FQ resistance reduced post-prostate biopsy, infection-related hospitalizations in Michigan by 53%. Additional data are needed to clarify the relative benefit of the culture-directed versus augmented pathways.
Vol. 193, No. 4S, Supplement, Sunday, May 17, 2015
definitive treatment (DT) were then estimated for the study period. AS was defined as a patient who had a repeat biopsy following diagnosis before any DT was instituted. Rates of expectant therapies were compared over time using the Cochrane-Armitage test for trend. The probability of discontinuing AS over time was estimated using cumulative incidence function. RESULTS: Among the 44 292 patients included in this study, 21.0%, 9.4% and 69.6% were respectively managed by AS, WW and DT during the study period. Rates of expectant therapy increased from 26.4% in 2002 to 36.0% in 2010. More specifically, the rates of AS increased from 14.7% in 2002 to 23.5% in 2010 (p <0.001). Among patients deemed to be on AS, 58.3% of them underwent a confirmatory biopsy within the first year, while 82.9% were rebiopsied within 2 years of the initial diagnosis. Overall, 61.9% of the patients initially managed by AS eventually received DT. The majority of these patients were treated within 6 months of the confirmatory biopsy (77.8%) and 60.7% received DT within the first year following diagnosis. The cumulative probability of discontinuing AS at 1-, 2-, 3-, 4- and 5-year was respectively 39.6%, 49.3%, 55.4%, 60.4% and 64.2%. CONCLUSIONS: Given an any-risk PCa population-based cohort, the use of expectant therapy and more specifically AS was frequently applied. Moreover, the rates seemed to increase over time. However, 61.9% of these patients eventually moved on to receive DT. Due to the limitations of the administrative data, rates of AS according to specific risk-groups and reasons for the discontinuation of AS were unavailable at this time. Source of Funding: Prostate Cancer Canada
MP42-07 IMPACT OF SURGICAL APPROACH ON ERECTILE FUNCTION RECOVERY FOLLOWING BILATERAL NERVE SPARING-RADICAL PROSTATECTOMY: RESULTS FROM A RANDOMIZED CONTROLLED TRIAL OF TADALAFIL VERSUS PLACEBO (REACTT) Martin Schostak*, Magdeburg, Germany; Markus Graefen, Hamburg, Germany; Christian Kriegel, Leipzig, Germany; Uwe Michl, Hamburg, Germany; Antonio Martin Morales, Malaga, Spain; Peter J. Pommerville, Vancouver, Canada; Martina Manning, € ttner, Carsten Henneges, Bad Homburg, Germany; Hartwig Bu Jens-Uwe Stolzenburg, Leipzig, Germany Source of Funding: Blue Cross Blue Shield of Michigan
MP42-06 THE UPTAKE OF ACTIVE SURVEILLANCE IN PROSTATE CANCER: RESULTS OF A POPULATION BASED-STUDY Patrick O. Richard*, Shabbir Alibhai, David Urbach, Neil E. Fleshner, Narhari Timilshina, Laurence Klotz, Antonio Finelli, Toronto, Canada INTRODUCTION AND OBJECTIVES: Expectant management such as active surveillance (AS) and watchful waiting (WW) are recognized as possible treatment options in the care of prostate cancer (PCa), especially for low-risk disease. Although several singlecenter studies have reported the merit of expectant therapies, there seems to be a delayed uptake of these treatment options at a population-based level. The objectives of this study were to examine the trends in active surveillance and watchful waiting in a contemporary cohort and to examine the probability of discontinuing active surveillance over time. METHODS: This is a retrospective population-based cohort study, in which we used administrative hospital data, physician billing codes and cancer registry data to identify men, less than 75 years of age, diagnosed with any-risk localized adenocarcinoma of the prostate in Ontario, Canada between 2002 and 2010. Rates of AS, WW and
INTRODUCTION AND OBJECTIVES: Erectile function (EF) after nerve-sparing radical prostatectomy (nsRP) may be impacted by the type of surgical approach. We report pre-specified and exploratory analyses on the effect of different surgical approaches on recovery of EF obtained from the multicenter, randomized, double-blind, REACTT trial of tadalafil once a day (OaD) or on demand (pro re nata, PRN) versus placebo. METHODS: Patients (pts)68yrs with normal preoperative EF who underwent nsRP for localized prostate cancer were randomized postnsRP 1:1:1 to 9 month double-blind, double-dummy treatment (DBT) with tadalafil 5mg OaD, tadalafil 20mg PRN, or placebo, followed by 6-week drug-free washout and 3-month open-label OaD treatment. EF-recovery was defined as an International Index of Erectile Function (IIEF)-EF domain score 22, and normal orgasmic function was defined as IIEF Question 10 item score 4. Both parameters were analyzed after washout using logistic regression including terms for: treatment, country, visit, visit-by-treatment interaction, age group, nerve-sparing score, and surgical approach. Time to EF-recovery was analyzed post-hoc with a Cox proportional-hazards model including terms for: treatment, age-group, country, nerve-sparing score, surgical approach, and surgery-by-treatment interaction. RESULTS: Of 422 pts enrolled at 50 centers, 189 had open surgery, 115 robot-assisted laparoscopy (lap), 88 conventional lap, and 30 surgeries classified as “other” (endoscopic extraperitoneal nsRP). The odds of achieving EF-recovery at the end of drug-free washout were approximately twice as high for the robot-assisted laparoscopy group compared with the open surgery group (odds ratio: 2.42; 95%CI 1.24, 4.72; p¼0.029). Pts who underwent robot-assisted laparoscopy
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were significantly more likely to recover during DBT compared with pts who had open surgery (hazard ratio: 1.9; 95%CI 1.18, 3.18; p¼0.009). A favorable effect of conventional laparoscopy compared with open surgery could not be observed. CONCLUSIONS: Although the trial was not primarily designed for these analyses, the results may provide further insights into the impact of surgery on EF-recovery post-nsRP.
Source of Funding: Blue Cross Blue Shield of Michigan
MP42-09 SHOULD INCLUSION CRITERIA FOR ACTIVE SURVEILLANCE FOR LOW-RISK PROSTATE CANCER BE MORE STRINGENT? : FROM AN INTERIM ANALYSIS OF PRIAS-JAPAN Mikio Sugimoto*, Hiromi Hirama, Yoshiyuki Kakehi, Kagawa, Japan; PRIAS-JAPAN study group -, -, Japan
Source of Funding: Eli Lilly and Company
MP42-08 INSTITUTION OF A WEB-BASED PATIENT-REPORTED OUTCOMES (PRO) SYSTEM FOR RADICAL PROSTATECTOMY IN A STATEWIDE QUALITY IMPROVEMENT COLLABORATIVE Khurshid Ghani*, Tae-Kyung Kim, Ann Arbor, MI; Patrick Hurley, Southfield, MI; Jay Starr, Traverse City, MI; Susan Linsell, Ann Arbor, MI; James Peabody, Detroit, MI; James Montie, David Miller, Ann Arbor, MI; Michael Cher, Detroit, MI INTRODUCTION AND OBJECTIVES: In order to improve the quality of radical prostatectomy (RP), it is important to collect quantitative quality of life data directly from patients. We instituted a webbased patient-reported outcomes (PRO) system at five pilot practices in the Michigan Urological Surgery Improvement Collaborative (MUSIC). METHODS: MUSIC-PRO is a validated and quantitative 21question survey evaluating urinary function, sexual function, and quality of life. On behalf of the treating urologist, MUSIC’s coordinating center sends an automated email to the patient requesting online survey completion before surgery (baseline) and 3, 6, 12, and 24 months after surgery. Patients failing to complete the survey within 2 weeks receive an automated email reminder, and if necessary, a telephone call. Patients who opt out of the web-based system or lack email/internet access are given paper surveys for completion by mail or in the clinic. Outcome reports with trend analysis are available to the patient and urologist at the time of clinic visit. RESULTS: Pilot data were collected during the first six months of MUSIC-PRO from patients in 5 practices. Out of 183 patients scheduled for RP, 172 (94%) completed pre-operative surveys (Table). Out of 53 patients reaching the three-month time point after surgery, 51 (96%) completed the survey. Online survey completion without the need for telephone reminder was 44% and 76% for baseline and 3-month surveys, respectively. Telephone reminders were necessary for 17% and 4%, respectively. Overall, 26% of baseline surveys were paper-based, and this decreased to 8% for patients completing 3-month surveys. Electronic communication roadblocks include lack of physician directive, lack of email, and age of patient population. CONCLUSIONS: Initial patient engagement with a statewide PRO system for RP has demonstrated >90% survey response rate. However, not all patients respond via a web-based system, with at least a quarter requesting paper surveys at the start. After surgery, patients adapt to the electronic system more readily.
INTRODUCTION AND OBJECTIVES: To investigate clinical and pathological factors that can predict reclassification at 1-year repeated biopsy (re-Bx) based on the Japanese cohort which is a part of the Prostate Research International: Active Surveillance (PRIAS). METHODS: Inclusion criteria for the PRIAS study are as follow: clinical stage T1c/T2, PSA <10 ng/ml, PSA density (PSAD) <0.2 ng/ml per milliliter, one or two positive biopsy cores, and Gleason score (GS) <6 at initial diagnostic biopsy. Baseline clinical characteristics and PSADT at the time of re-Bx were analyzed in a multivariate logistic regression with respect to reclassification and ,eno cancer,f on the 1-year re-Bx. RESULTS: In total of 386 patients were enrolled into the PRIAS-JAPAN until the end of 2013. 216 patients underwent re-Bx at 1year. Of whom 73 men (33.8%) revealed reclassification while 74 men (34.3%) showed no cancer. Higher age, higher PSAD, higher positive cores rate and shorter PSADT were the significant predictors of reclassification. Positive core rate is the predictor common to reclassification, no cancer and high Gleason score in re-Bx.(Table) AS remaining rate at 1, 2 and 3-years was 87.1%, 65.9% and 61.3%, respectively.(Figure) CONCLUSIONS: An interim analysis on Japanese AS cohort participating in PRIAS revealed that positive core rate is strongly associated with reclassification at 1-year re-Bx. However, amendment of inclusion criteria of PRIAS using positive core rate may reduce concern about underestimation but may lead to decrease in number of patients who could benefit from AS. Pathological findings in re-biopsy at one-year after enrollment (multivariate analysis) Non-reclassification group vs. Reclassification group
No cancer group vs. Cancer group
GS<7 vs. GS>6
Age
1.91 (1.02-3.57)/0.044
1.42 (0.79-2.56)/ 0.245
1.39 (0.702.77)/0.345
PSAD
2.15 (1.14-4.05)/0.019
1.57 (0.86-2.86)/ 0.145
1.97 (0.974.00)/0.062
Positive core rate (%)
1.88 (1.34-2.66)/0.000
1.69 (1.18-2.37)/ 0.004
1.49 (1.022.18)/0.041
Clinical T stage
2.51 (0.94-6.68)/0.065
0.91 (0.35-2.38)/ 0.850
3.24 (1.238.57)/0.018
PSADT
1.49 (1.02-2.18)/0.040
0.84 (0.59-1.21)/ 0.351
1.36 (0.902.06)/0.143
odds ratio (95% confidence interval) /p-value, PSAD: PSA density, PSADT: PSA doubling time
e510
infection-related hospitalization within 30 days post-biopsy, and validated these events with claims data for a subset of patients. We then compared the frequency of infection-related hospitalizations before (n¼ 5,028 biopsies) and after (n¼ 4,087 biopsies) implementation of the QI intervention. RESULTS: Overall, the proportion of patients with infectionrelated hospitalizations after prostate biopsy decreased by 53% from before to after implementation of the QI intervention (1.19% pre vs. 0.56% post, p¼0.002). Among post-implementation biopsies, rates of hospitalization were similar for patients receiving culture-directed (0.47%) versus augmented (0.57%) prophylaxis. At a practice-level, the relative change in hospitalization rates varied from a 3.0% increase to a 7.4% decrease (Figure). Fourteen practices had no postimplementation hospitalizations. In the validation sample of 228 men, we noted perfect concordance between the registry and claims data for identification of hospitalizations. CONCLUSIONS: A statewide intervention aimed at addressing FQ resistance reduced post-prostate biopsy, infection-related hospitalizations in Michigan by 53%. Additional data are needed to clarify the relative benefit of the culture-directed versus augmented pathways.
Vol. 193, No. 4S, Supplement, Sunday, May 17, 2015
definitive treatment (DT) were then estimated for the study period. AS was defined as a patient who had a repeat biopsy following diagnosis before any DT was instituted. Rates of expectant therapies were compared over time using the Cochrane-Armitage test for trend. The probability of discontinuing AS over time was estimated using cumulative incidence function. RESULTS: Among the 44 292 patients included in this study, 21.0%, 9.4% and 69.6% were respectively managed by AS, WW and DT during the study period. Rates of expectant therapy increased from 26.4% in 2002 to 36.0% in 2010. More specifically, the rates of AS increased from 14.7% in 2002 to 23.5% in 2010 (p <0.001). Among patients deemed to be on AS, 58.3% of them underwent a confirmatory biopsy within the first year, while 82.9% were rebiopsied within 2 years of the initial diagnosis. Overall, 61.9% of the patients initially managed by AS eventually received DT. The majority of these patients were treated within 6 months of the confirmatory biopsy (77.8%) and 60.7% received DT within the first year following diagnosis. The cumulative probability of discontinuing AS at 1-, 2-, 3-, 4- and 5-year was respectively 39.6%, 49.3%, 55.4%, 60.4% and 64.2%. CONCLUSIONS: Given an any-risk PCa population-based cohort, the use of expectant therapy and more specifically AS was frequently applied. Moreover, the rates seemed to increase over time. However, 61.9% of these patients eventually moved on to receive DT. Due to the limitations of the administrative data, rates of AS according to specific risk-groups and reasons for the discontinuation of AS were unavailable at this time. Source of Funding: Prostate Cancer Canada
MP42-07 IMPACT OF SURGICAL APPROACH ON ERECTILE FUNCTION RECOVERY FOLLOWING BILATERAL NERVE SPARING-RADICAL PROSTATECTOMY: RESULTS FROM A RANDOMIZED CONTROLLED TRIAL OF TADALAFIL VERSUS PLACEBO (REACTT) Martin Schostak*, Magdeburg, Germany; Markus Graefen, Hamburg, Germany; Christian Kriegel, Leipzig, Germany; Uwe Michl, Hamburg, Germany; Antonio Martin Morales, Malaga, Spain; Peter J. Pommerville, Vancouver, Canada; Martina Manning, € ttner, Carsten Henneges, Bad Homburg, Germany; Hartwig Bu Jens-Uwe Stolzenburg, Leipzig, Germany Source of Funding: Blue Cross Blue Shield of Michigan
MP42-06 THE UPTAKE OF ACTIVE SURVEILLANCE IN PROSTATE CANCER: RESULTS OF A POPULATION BASED-STUDY Patrick O. Richard*, Shabbir Alibhai, David Urbach, Neil E. Fleshner, Narhari Timilshina, Laurence Klotz, Antonio Finelli, Toronto, Canada INTRODUCTION AND OBJECTIVES: Expectant management such as active surveillance (AS) and watchful waiting (WW) are recognized as possible treatment options in the care of prostate cancer (PCa), especially for low-risk disease. Although several singlecenter studies have reported the merit of expectant therapies, there seems to be a delayed uptake of these treatment options at a population-based level. The objectives of this study were to examine the trends in active surveillance and watchful waiting in a contemporary cohort and to examine the probability of discontinuing active surveillance over time. METHODS: This is a retrospective population-based cohort study, in which we used administrative hospital data, physician billing codes and cancer registry data to identify men, less than 75 years of age, diagnosed with any-risk localized adenocarcinoma of the prostate in Ontario, Canada between 2002 and 2010. Rates of AS, WW and
INTRODUCTION AND OBJECTIVES: Erectile function (EF) after nerve-sparing radical prostatectomy (nsRP) may be impacted by the type of surgical approach. We report pre-specified and exploratory analyses on the effect of different surgical approaches on recovery of EF obtained from the multicenter, randomized, double-blind, REACTT trial of tadalafil once a day (OaD) or on demand (pro re nata, PRN) versus placebo. METHODS: Patients (pts)68yrs with normal preoperative EF who underwent nsRP for localized prostate cancer were randomized postnsRP 1:1:1 to 9 month double-blind, double-dummy treatment (DBT) with tadalafil 5mg OaD, tadalafil 20mg PRN, or placebo, followed by 6-week drug-free washout and 3-month open-label OaD treatment. EF-recovery was defined as an International Index of Erectile Function (IIEF)-EF domain score 22, and normal orgasmic function was defined as IIEF Question 10 item score 4. Both parameters were analyzed after washout using logistic regression including terms for: treatment, country, visit, visit-by-treatment interaction, age group, nerve-sparing score, and surgical approach. Time to EF-recovery was analyzed post-hoc with a Cox proportional-hazards model including terms for: treatment, age-group, country, nerve-sparing score, surgical approach, and surgery-by-treatment interaction. RESULTS: Of 422 pts enrolled at 50 centers, 189 had open surgery, 115 robot-assisted laparoscopy (lap), 88 conventional lap, and 30 surgeries classified as “other” (endoscopic extraperitoneal nsRP). The odds of achieving EF-recovery at the end of drug-free washout were approximately twice as high for the robot-assisted laparoscopy group compared with the open surgery group (odds ratio: 2.42; 95%CI 1.24, 4.72; p¼0.029). Pts who underwent robot-assisted laparoscopy
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were significantly more likely to recover during DBT compared with pts who had open surgery (hazard ratio: 1.9; 95%CI 1.18, 3.18; p¼0.009). A favorable effect of conventional laparoscopy compared with open surgery could not be observed. CONCLUSIONS: Although the trial was not primarily designed for these analyses, the results may provide further insights into the impact of surgery on EF-recovery post-nsRP.
Source of Funding: Blue Cross Blue Shield of Michigan
MP42-09 SHOULD INCLUSION CRITERIA FOR ACTIVE SURVEILLANCE FOR LOW-RISK PROSTATE CANCER BE MORE STRINGENT? : FROM AN INTERIM ANALYSIS OF PRIAS-JAPAN Mikio Sugimoto*, Hiromi Hirama, Yoshiyuki Kakehi, Kagawa, Japan; PRIAS-JAPAN study group -, -, Japan
Source of Funding: Eli Lilly and Company
MP42-08 INSTITUTION OF A WEB-BASED PATIENT-REPORTED OUTCOMES (PRO) SYSTEM FOR RADICAL PROSTATECTOMY IN A STATEWIDE QUALITY IMPROVEMENT COLLABORATIVE Khurshid Ghani*, Tae-Kyung Kim, Ann Arbor, MI; Patrick Hurley, Southfield, MI; Jay Starr, Traverse City, MI; Susan Linsell, Ann Arbor, MI; James Peabody, Detroit, MI; James Montie, David Miller, Ann Arbor, MI; Michael Cher, Detroit, MI INTRODUCTION AND OBJECTIVES: In order to improve the quality of radical prostatectomy (RP), it is important to collect quantitative quality of life data directly from patients. We instituted a webbased patient-reported outcomes (PRO) system at five pilot practices in the Michigan Urological Surgery Improvement Collaborative (MUSIC). METHODS: MUSIC-PRO is a validated and quantitative 21question survey evaluating urinary function, sexual function, and quality of life. On behalf of the treating urologist, MUSIC’s coordinating center sends an automated email to the patient requesting online survey completion before surgery (baseline) and 3, 6, 12, and 24 months after surgery. Patients failing to complete the survey within 2 weeks receive an automated email reminder, and if necessary, a telephone call. Patients who opt out of the web-based system or lack email/internet access are given paper surveys for completion by mail or in the clinic. Outcome reports with trend analysis are available to the patient and urologist at the time of clinic visit. RESULTS: Pilot data were collected during the first six months of MUSIC-PRO from patients in 5 practices. Out of 183 patients scheduled for RP, 172 (94%) completed pre-operative surveys (Table). Out of 53 patients reaching the three-month time point after surgery, 51 (96%) completed the survey. Online survey completion without the need for telephone reminder was 44% and 76% for baseline and 3-month surveys, respectively. Telephone reminders were necessary for 17% and 4%, respectively. Overall, 26% of baseline surveys were paper-based, and this decreased to 8% for patients completing 3-month surveys. Electronic communication roadblocks include lack of physician directive, lack of email, and age of patient population. CONCLUSIONS: Initial patient engagement with a statewide PRO system for RP has demonstrated >90% survey response rate. However, not all patients respond via a web-based system, with at least a quarter requesting paper surveys at the start. After surgery, patients adapt to the electronic system more readily.
INTRODUCTION AND OBJECTIVES: To investigate clinical and pathological factors that can predict reclassification at 1-year repeated biopsy (re-Bx) based on the Japanese cohort which is a part of the Prostate Research International: Active Surveillance (PRIAS). METHODS: Inclusion criteria for the PRIAS study are as follow: clinical stage T1c/T2, PSA <10 ng/ml, PSA density (PSAD) <0.2 ng/ml per milliliter, one or two positive biopsy cores, and Gleason score (GS) <6 at initial diagnostic biopsy. Baseline clinical characteristics and PSADT at the time of re-Bx were analyzed in a multivariate logistic regression with respect to reclassification and ,eno cancer,f on the 1-year re-Bx. RESULTS: In total of 386 patients were enrolled into the PRIAS-JAPAN until the end of 2013. 216 patients underwent re-Bx at 1year. Of whom 73 men (33.8%) revealed reclassification while 74 men (34.3%) showed no cancer. Higher age, higher PSAD, higher positive cores rate and shorter PSADT were the significant predictors of reclassification. Positive core rate is the predictor common to reclassification, no cancer and high Gleason score in re-Bx.(Table) AS remaining rate at 1, 2 and 3-years was 87.1%, 65.9% and 61.3%, respectively.(Figure) CONCLUSIONS: An interim analysis on Japanese AS cohort participating in PRIAS revealed that positive core rate is strongly associated with reclassification at 1-year re-Bx. However, amendment of inclusion criteria of PRIAS using positive core rate may reduce concern about underestimation but may lead to decrease in number of patients who could benefit from AS. Pathological findings in re-biopsy at one-year after enrollment (multivariate analysis) Non-reclassification group vs. Reclassification group
No cancer group vs. Cancer group
GS<7 vs. GS>6
Age
1.91 (1.02-3.57)/0.044
1.42 (0.79-2.56)/ 0.245
1.39 (0.702.77)/0.345
PSAD
2.15 (1.14-4.05)/0.019
1.57 (0.86-2.86)/ 0.145
1.97 (0.974.00)/0.062
Positive core rate (%)
1.88 (1.34-2.66)/0.000
1.69 (1.18-2.37)/ 0.004
1.49 (1.022.18)/0.041
Clinical T stage
2.51 (0.94-6.68)/0.065
0.91 (0.35-2.38)/ 0.850
3.24 (1.238.57)/0.018
PSADT
1.49 (1.02-2.18)/0.040
0.84 (0.59-1.21)/ 0.351
1.36 (0.902.06)/0.143
odds ratio (95% confidence interval) /p-value, PSAD: PSA density, PSADT: PSA doubling time