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PD56-02 AVOIDANCE OF ANDROGEN DEPRIVATION THERAPY IN RADIORECURRENT PROSTATE CANCER AS A CLINICALLY MEANINGFUL ENDPOINT FOR SALVAGE CRYOABLATION
THE JOURNAL OF UROLOGYâ
Vol. 197, No. 4S, Supplement, Monday, May 15, 2017
Prostate Cancer: Localized: Ablative Therapy II Podium 56 Monday, May 15, 2017
1:00 PM-3:00 PM
PD56-01 LONG-TERM OUTCOMES OF SALVAGE CRYOABLATION FOR RECURRENT PROSTATE CANCER FOLLOWING RADIATION THERAPY: A COMBINED ANALYSIS OF TWO CENTERS Michael Metcalfe*, Houston, TX; Khurram Siddiqui, Malcolm Dewar, London, Canada; John Ward, Houston, TX; Joseph Chin, London, Canada; Louis Pisters, Houston, TX INTRODUCTION AND OBJECTIVES: There is a paucity of longterm data following local recurrences from radiation refractory prostate cancer (RRPCa). We analyzed the long-term survival outcomes of salvage cryoablation (Cryo) for RRPCa cancer across two centers. METHODS: Patients undergoing salvage Cryo for biopsy proven, localized RRPCa from 1990 to 2004 were prospectively accrued. Preoperative characteristics, perioperative morbidity and postoperative data were reviewed from a prospectively maintained database. The primary outcome was overall survival (OS). Secondary outcomes were metastasis-free survival (MFS) and disease specific survival (DSS). RESULTS: 268 patients were identified with a median follow up of 115 months (55.25-151 IQR). Median age is 70 yrs. (65.8-73 IQR). Median PSA nadir was 2 (1-4.25 IQR) and median pre-salvage PSA was 6 (3.5-10.4 IQR). 20% (54/268) had Gleason score <7 at time of recurrence, 10% (28/268) had a Gleason score of 7, and 69% (184/268) had Gleason score >7. Out of 268 patients, 15 (5.6%) underwent repeat cryotherapy and neoadjuvant hormones were used in 29% of patients (77/268). Of the 268 patients, 123 (45%) experienced some form of morbidity. 101 (38%) had mild-moderate incontinence (0-1 pad/day), 43 (16%) had severe incontinence (2 pad/day), 43 (16%) experienced pelvic/perineal pain, 4 (1.5%) had rectourethral fistula, 68 (25%) had urinary retention, 38 (14%) had gross hematuria, and 28 (10.4%) had a bladder neck contracture, 12 (4.4) had urethral stricture disease. There were 176 Clavien 1-2, and 48 Clavien 3 events in the cohort. 4 (1.4%) patients were SP tube dependent and 3 (1.1%) patients went on to cystoprostatectomy.48% (130/268) of patients died by study follow up, 22% (59/268) died of RRPCa, and 31% (84/268) developed metastasis. Median OS was 163 mo., DSS 210 mo. and MFS was 199 mo. There was a significantly worse OS (p¼0.027) and MFS (p¼0.0114) for patients with a pre-cryotherapy PSA > 10 than those with a PSA <5, and those with PSA 5-10 e Figure 1. CONCLUSIONS: Cryo for RRPCa provides long term MFS, DSS and OS with an acceptable degree of morbidity and is a viable treatment option of localized RRPCa following radiation therapy. PreCryo PSA appears to serve as a prognostic tool for patient selection, and further prospective trials are required for validation.
Source of Funding: None
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PD56-02 AVOIDANCE OF ANDROGEN DEPRIVATION THERAPY IN RADIORECURRENT PROSTATE CANCER AS A CLINICALLY MEANINGFUL ENDPOINT FOR SALVAGE CRYOABLATION Kevin Ginsburg*, Detroit, MI; Ahmed ElShafei, Changhong Yu, J. Stephen Jones, Cleveland, OH; Michael Cher, Detroit, MI INTRODUCTION AND OBJECTIVES: Success of salvage cryoablation (SCAP) for radiorecurrent prostate cancer is typically measured by the ability to control serum PSA. However, slight elevations in PSA are typically asymptomatic and likely unimportant especially considering that most SCAP patients have a limited life expectancy based on comorbidities and advancing age. We propose that a more clinically meaningful endpoint would be the ability of SCAP to avoid the need for androgen deprivation therapy (ADT). Using the Cryo On-Line Database (COLD) registry, we investigated the ability of SCAP to delay or avoid ADT in local recurrence after radiation therapy. METHODS: The COLD registry is comprised of retrospectively and prospectively collected data on patients undergoing primary and SCAP. Patients with local recurrence after curative radiation to the prostate were identified. Kaplan-Meier analysis was used to calculate ADT-free survival. RESULTS: 998 patients were identified in the COLD database that had undergone SCAP. Median follow up was 19 months. 171 (17.1%) had been started on ADT post-SCAP. Overall, the calculated 5-year ADT-free survival was 71.7% (Figure 1). When stratified by D0 Amico risk group, 301 high-risk patients (74.5%), 263 intermediaterisk (88.0%) and 261 low-risk (89.1%) were free of ADT post-SCAP. This correlates with a 5-year ADT-free survival of 61.2%, 74.3%, and 82.7%, respectively (Figure 2). Preoperative ADT use or full vs. partial gland SCAP did not have an effect on ADT use postoperatively. Of 213 patients with recurrence based on serum PSA elevations (Phoenix definition), ADT was avoided in 118 (55%). CONCLUSIONS: For the patient with local recurrence after radiation, SCAP is an option that provides a high chance of avoiding ADT. The potential to avoid ADT and its associated side effects should be a part of counseling sessions between the patient, family, and urologist when discussing treatment options for locally radiorecurrent prostate cancer. Avoidance of ADT is more clinically relevant endpoint than biochemical recurrence.
THE JOURNAL OF UROLOGYâ
e1116
Vol. 197, No. 4S, Supplement, Monday, May 15, 2017
CONCLUSIONS: In a large, mixed cohort of patients undergoing primary whole gland cryoablation for prostate cancer, the incidence of urethral fistula was very low at 1.2%. The strongest association was present in men with post-procedural urinary retention. Further study regarding instrumentation of the lower tract for retention following cryotherapy in the early post-operative setting is warranted. Source of Funding: none
PD56-04 SALVAGE PROSTATE CRYOABLATION IN OLDER MEN J. Kellogg Parsons, San Diego, CA; Ashley Ross, Baltimore, MD; Ahmed El Shafei, Asmaa Hatem, Cleveland, OH; Britney Cotta*, San Diego, CA; Kae Jack Tay, Thomas Polascik, Durham, NC; Robert Given, Norfolk, VA; Vladimir Mouraviev, Celebration, FL; J Stephen Jones, Cleveland, OH
Source of Funding: Healthtronics
PD56-03 PREDICTORS OF RECTO-URETHRAL FISTULA AFTER PRIMARY, WHOLE GLAND CRYOABLATION OF PROSTATE CANCER: RESULTS FROM THE CRYO-ON-LINE DATABASE (COLD) REGISTRY. Ariel Schulman*, Kae Jack Tay, Ghalib Jibara, Efrat Tsivian, Durham, NC; Ahmed Elshafei, Cleveland, OH; Thomas Polascik, Durham, NC; J. Stephen Jones, Cleveland, OH INTRODUCTION AND OBJECTIVES: While recto-urethral fistula is a rare complication following salvage cryoablation for radiorecurrent prostate cancer, less is known about the development of recto-urethral fistula after primary whole gland cryoablation. We define the incidence and risk factors for recto-urethral fistula in a multicenter, centralized registry. METHODS: The Cryo-On-Line Data (COLD) Registry was queried for men undergoing primary whole gland cryotherapy between 1990 and 2014 who developed a recto-urethral fistula. Patient factors and disease parameters were correlated with the recto-urethral fistula using chi-squared tests for categorical variables and t-test for continuous variables. Variables with p<0.25 were entered into a binary logistic regression with stepwise backward elimination to determine the factors associated with formation of urethral fistula. RESULTS: We identified 4,102 men who underwent primary whole gland cryotherapy between 1990 and 2014. Median age was 71 years (IQR:66-76). Median PSA was 6.5 (IQR: 4.8-9.8). Available Gleason Score included 8-10:500 pts, 7:1,194 pts and 6:1,601 while pretreatment clinical stage included T1:1539, T2:1,503 T3:328 and T4:20. 1,508 pts received neoadjuvant androgen deprivation. 805 cases were performed at academic centers and 3297 were performed in the private setting. Post-operative recto-urethral fistula was identified in 50 (1.2%) men. On univariate analysis, pre-operative Gleason score, pre-operative incontinence and post-operative urinary retention were statistically significant predictors for development of recto-urethral fistula. On multivariate analysis, postoperative urinary retention (OR 7.26, 95%CI 4.06-13.03, p<0.001) pre-operative Gleason score of 7 (OR 1.92, 95%CI 1.08-3.43, p¼0.027) and pre-operative incontinence (OR 2.95, 95% CI 1.127.76, p¼0.028) predicted urethral fistula.
INTRODUCTION AND OBJECTIVES: Outcomes of salvage prostate cryosurgery in older men remain undefined. We evaluated oncological and functional outcomes after salvage full gland prostate cryoablation in men over age 75 years. METHODS: We identified 923 men who underwent salvage full gland prostate cryoablation for recurrent prostate cancer after primary radiotherapy, including 240 (26%) > 75 years at time of surgery. Primary outcomes were progression-free survival (PFS) using Phoenix criteria and post-treatment biopsy status. Secondary outcomes included post-treatment urinary incontinence, erectile dysfunction (ED), rectal fistulae, and urinary retention. RESULTS: Mean follow-up was 26 months (SD30). Compared to men 75 years, men > 75 years were more likely to have pre-treatment Gleason sum 7 disease (71% vs.63%, p¼0.03) and less likely to have undergone neoadjvuant androgen deprivation therapy (29% vs. 37%, p¼0.02) (Table 1). In Kaplan Meir analyses, there were no significant differences in 5-year PFS between groups: 61% versus 57% for men > 75 and 75 years, respectively (p¼0.43) (Figure 1). Post-treatment biopsy was positive in 34% versus 29% of men >75 years and 75 years, respectively (p¼0.5). Older men were more likely to have post-treatment urinary retention (23% versus 15%, p¼0.003). There were no significant differences in recto-urethral fistulae (3% versus 2%, p¼0.62), urinary incontinence (32% versus 30%, p¼0.48), or new onset ED (54% versus 49%, p¼0.63) between groups (Table 1). CONCLUSIONS: Salvage whole gland cryoablation of the prostate in men > 75 years is associated with robust progression-free survival and functional outcomes comparable to younger men. Prostate cryoablation should be considered in older men with recurrent disease after primary radiotherapy.
Vol. 197, No. 4S, Supplement, Monday, May 15, 2017
Prostate Cancer: Localized: Ablative Therapy II Podium 56 Monday, May 15, 2017
1:00 PM-3:00 PM
PD56-01 LONG-TERM OUTCOMES OF SALVAGE CRYOABLATION FOR RECURRENT PROSTATE CANCER FOLLOWING RADIATION THERAPY: A COMBINED ANALYSIS OF TWO CENTERS Michael Metcalfe*, Houston, TX; Khurram Siddiqui, Malcolm Dewar, London, Canada; John Ward, Houston, TX; Joseph Chin, London, Canada; Louis Pisters, Houston, TX INTRODUCTION AND OBJECTIVES: There is a paucity of longterm data following local recurrences from radiation refractory prostate cancer (RRPCa). We analyzed the long-term survival outcomes of salvage cryoablation (Cryo) for RRPCa cancer across two centers. METHODS: Patients undergoing salvage Cryo for biopsy proven, localized RRPCa from 1990 to 2004 were prospectively accrued. Preoperative characteristics, perioperative morbidity and postoperative data were reviewed from a prospectively maintained database. The primary outcome was overall survival (OS). Secondary outcomes were metastasis-free survival (MFS) and disease specific survival (DSS). RESULTS: 268 patients were identified with a median follow up of 115 months (55.25-151 IQR). Median age is 70 yrs. (65.8-73 IQR). Median PSA nadir was 2 (1-4.25 IQR) and median pre-salvage PSA was 6 (3.5-10.4 IQR). 20% (54/268) had Gleason score <7 at time of recurrence, 10% (28/268) had a Gleason score of 7, and 69% (184/268) had Gleason score >7. Out of 268 patients, 15 (5.6%) underwent repeat cryotherapy and neoadjuvant hormones were used in 29% of patients (77/268). Of the 268 patients, 123 (45%) experienced some form of morbidity. 101 (38%) had mild-moderate incontinence (0-1 pad/day), 43 (16%) had severe incontinence (2 pad/day), 43 (16%) experienced pelvic/perineal pain, 4 (1.5%) had rectourethral fistula, 68 (25%) had urinary retention, 38 (14%) had gross hematuria, and 28 (10.4%) had a bladder neck contracture, 12 (4.4) had urethral stricture disease. There were 176 Clavien 1-2, and 48 Clavien 3 events in the cohort. 4 (1.4%) patients were SP tube dependent and 3 (1.1%) patients went on to cystoprostatectomy.48% (130/268) of patients died by study follow up, 22% (59/268) died of RRPCa, and 31% (84/268) developed metastasis. Median OS was 163 mo., DSS 210 mo. and MFS was 199 mo. There was a significantly worse OS (p¼0.027) and MFS (p¼0.0114) for patients with a pre-cryotherapy PSA > 10 than those with a PSA <5, and those with PSA 5-10 e Figure 1. CONCLUSIONS: Cryo for RRPCa provides long term MFS, DSS and OS with an acceptable degree of morbidity and is a viable treatment option of localized RRPCa following radiation therapy. PreCryo PSA appears to serve as a prognostic tool for patient selection, and further prospective trials are required for validation.
Source of Funding: None
e1115
PD56-02 AVOIDANCE OF ANDROGEN DEPRIVATION THERAPY IN RADIORECURRENT PROSTATE CANCER AS A CLINICALLY MEANINGFUL ENDPOINT FOR SALVAGE CRYOABLATION Kevin Ginsburg*, Detroit, MI; Ahmed ElShafei, Changhong Yu, J. Stephen Jones, Cleveland, OH; Michael Cher, Detroit, MI INTRODUCTION AND OBJECTIVES: Success of salvage cryoablation (SCAP) for radiorecurrent prostate cancer is typically measured by the ability to control serum PSA. However, slight elevations in PSA are typically asymptomatic and likely unimportant especially considering that most SCAP patients have a limited life expectancy based on comorbidities and advancing age. We propose that a more clinically meaningful endpoint would be the ability of SCAP to avoid the need for androgen deprivation therapy (ADT). Using the Cryo On-Line Database (COLD) registry, we investigated the ability of SCAP to delay or avoid ADT in local recurrence after radiation therapy. METHODS: The COLD registry is comprised of retrospectively and prospectively collected data on patients undergoing primary and SCAP. Patients with local recurrence after curative radiation to the prostate were identified. Kaplan-Meier analysis was used to calculate ADT-free survival. RESULTS: 998 patients were identified in the COLD database that had undergone SCAP. Median follow up was 19 months. 171 (17.1%) had been started on ADT post-SCAP. Overall, the calculated 5-year ADT-free survival was 71.7% (Figure 1). When stratified by D0 Amico risk group, 301 high-risk patients (74.5%), 263 intermediaterisk (88.0%) and 261 low-risk (89.1%) were free of ADT post-SCAP. This correlates with a 5-year ADT-free survival of 61.2%, 74.3%, and 82.7%, respectively (Figure 2). Preoperative ADT use or full vs. partial gland SCAP did not have an effect on ADT use postoperatively. Of 213 patients with recurrence based on serum PSA elevations (Phoenix definition), ADT was avoided in 118 (55%). CONCLUSIONS: For the patient with local recurrence after radiation, SCAP is an option that provides a high chance of avoiding ADT. The potential to avoid ADT and its associated side effects should be a part of counseling sessions between the patient, family, and urologist when discussing treatment options for locally radiorecurrent prostate cancer. Avoidance of ADT is more clinically relevant endpoint than biochemical recurrence.
THE JOURNAL OF UROLOGYâ
e1116
Vol. 197, No. 4S, Supplement, Monday, May 15, 2017
CONCLUSIONS: In a large, mixed cohort of patients undergoing primary whole gland cryoablation for prostate cancer, the incidence of urethral fistula was very low at 1.2%. The strongest association was present in men with post-procedural urinary retention. Further study regarding instrumentation of the lower tract for retention following cryotherapy in the early post-operative setting is warranted. Source of Funding: none
PD56-04 SALVAGE PROSTATE CRYOABLATION IN OLDER MEN J. Kellogg Parsons, San Diego, CA; Ashley Ross, Baltimore, MD; Ahmed El Shafei, Asmaa Hatem, Cleveland, OH; Britney Cotta*, San Diego, CA; Kae Jack Tay, Thomas Polascik, Durham, NC; Robert Given, Norfolk, VA; Vladimir Mouraviev, Celebration, FL; J Stephen Jones, Cleveland, OH
Source of Funding: Healthtronics
PD56-03 PREDICTORS OF RECTO-URETHRAL FISTULA AFTER PRIMARY, WHOLE GLAND CRYOABLATION OF PROSTATE CANCER: RESULTS FROM THE CRYO-ON-LINE DATABASE (COLD) REGISTRY. Ariel Schulman*, Kae Jack Tay, Ghalib Jibara, Efrat Tsivian, Durham, NC; Ahmed Elshafei, Cleveland, OH; Thomas Polascik, Durham, NC; J. Stephen Jones, Cleveland, OH INTRODUCTION AND OBJECTIVES: While recto-urethral fistula is a rare complication following salvage cryoablation for radiorecurrent prostate cancer, less is known about the development of recto-urethral fistula after primary whole gland cryoablation. We define the incidence and risk factors for recto-urethral fistula in a multicenter, centralized registry. METHODS: The Cryo-On-Line Data (COLD) Registry was queried for men undergoing primary whole gland cryotherapy between 1990 and 2014 who developed a recto-urethral fistula. Patient factors and disease parameters were correlated with the recto-urethral fistula using chi-squared tests for categorical variables and t-test for continuous variables. Variables with p<0.25 were entered into a binary logistic regression with stepwise backward elimination to determine the factors associated with formation of urethral fistula. RESULTS: We identified 4,102 men who underwent primary whole gland cryotherapy between 1990 and 2014. Median age was 71 years (IQR:66-76). Median PSA was 6.5 (IQR: 4.8-9.8). Available Gleason Score included 8-10:500 pts, 7:1,194 pts and 6:1,601 while pretreatment clinical stage included T1:1539, T2:1,503 T3:328 and T4:20. 1,508 pts received neoadjuvant androgen deprivation. 805 cases were performed at academic centers and 3297 were performed in the private setting. Post-operative recto-urethral fistula was identified in 50 (1.2%) men. On univariate analysis, pre-operative Gleason score, pre-operative incontinence and post-operative urinary retention were statistically significant predictors for development of recto-urethral fistula. On multivariate analysis, postoperative urinary retention (OR 7.26, 95%CI 4.06-13.03, p<0.001) pre-operative Gleason score of 7 (OR 1.92, 95%CI 1.08-3.43, p¼0.027) and pre-operative incontinence (OR 2.95, 95% CI 1.127.76, p¼0.028) predicted urethral fistula.
INTRODUCTION AND OBJECTIVES: Outcomes of salvage prostate cryosurgery in older men remain undefined. We evaluated oncological and functional outcomes after salvage full gland prostate cryoablation in men over age 75 years. METHODS: We identified 923 men who underwent salvage full gland prostate cryoablation for recurrent prostate cancer after primary radiotherapy, including 240 (26%) > 75 years at time of surgery. Primary outcomes were progression-free survival (PFS) using Phoenix criteria and post-treatment biopsy status. Secondary outcomes included post-treatment urinary incontinence, erectile dysfunction (ED), rectal fistulae, and urinary retention. RESULTS: Mean follow-up was 26 months (SD30). Compared to men 75 years, men > 75 years were more likely to have pre-treatment Gleason sum 7 disease (71% vs.63%, p¼0.03) and less likely to have undergone neoadjvuant androgen deprivation therapy (29% vs. 37%, p¼0.02) (Table 1). In Kaplan Meir analyses, there were no significant differences in 5-year PFS between groups: 61% versus 57% for men > 75 and 75 years, respectively (p¼0.43) (Figure 1). Post-treatment biopsy was positive in 34% versus 29% of men >75 years and 75 years, respectively (p¼0.5). Older men were more likely to have post-treatment urinary retention (23% versus 15%, p¼0.003). There were no significant differences in recto-urethral fistulae (3% versus 2%, p¼0.62), urinary incontinence (32% versus 30%, p¼0.48), or new onset ED (54% versus 49%, p¼0.63) between groups (Table 1). CONCLUSIONS: Salvage whole gland cryoablation of the prostate in men > 75 years is associated with robust progression-free survival and functional outcomes comparable to younger men. Prostate cryoablation should be considered in older men with recurrent disease after primary radiotherapy.