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PROSPECTIVE PROTOCOL BASED ACTIVE SURVEILLANCE FOR EARLY PROSTATE CANCER: SHORT-TERM RESULTS OF 500 PATIENTS IN THE PRIAS STUDY
THE JOURNAL OF UROLOGY®
606
RESULTS: Laparoscopic modified inguinal lymphadenectomy was successfully completed on both sides. The procedure took 120 minutes per leg. We demonstrate the limits of dissection as well as useful anatomic landmarks used in the procedure. The patient did well without complication. On pathologic review, we obtained 9 and 10 nodes, respectively. CONCLUSIONS: A endoscopic approach to modified inguinal lymphadenectomy is a versatile technique which can be performed in a stepwise manner for a variety of disease conditions. In our experience, oncologic efficacy is maintained. We have demonstrated our technique as well as discuss useful anatomic landmarks. This technique may potentially lead to reduced complications. At our institution, we have performed this surgery in 5 patients (10 legs) without any wound complications. Source of Funding: None
V1681 ROBOT ASSISTED PARTIAL CYSTECTOMY: A NOVEL TECHNIQUE USING SIMULTANEOUS CYSTOSCOPIC AND LAPAROSCOPIC MONITORING WITH STAPLE CONTROL OF TUMOR Alok Shrivastava*, Louis S Krane, Mani Menon, James O Peabody, Detroit, MI INTRODUCTION AND OBJECTIVES: We describe a novel technique of robot assisted partial cystectomy with simultaneous endoscopic and laparoscopic monitoring using the Tile-ProTM. Endovascular stapler was used to prevent potential tumor spillage. METHODS: 78 year old female with recurrent transitional cell carcinoma on the dome of the bladder underwent robotic assisted partial cystectomy with a 6-port approach. Cystoscopy was performed simultaneously in order to delineate the tumor by direct vision and transillumination and this was monitored with side by side video imaging using the Tile-ProTM feature of daVinciTM Surgical System. After identification of the tumor and required tumor margin the endovascular stapler was used to cut across the bladder and to isolate the tumor in an attempt to prevent intra-abdominal tumor spillage. The resected partial cystectomy specimen was then placed in an specimen bag. The staple line on the bladder was then resected and sent for frozen section to assess the completeness of resection. The bladder was then closed in two layers. The patient then underwent an extended pelvic lymph node dissection and bilateral salpingo-oophorectomy. RESULTS: The post-operative bladder volume was 250 ml, length of hospitalization was 1 day and the catheter was removed in one weeks. Final tumor pathological stage was T3a. The surgical margin was free of tumor. CONCLUSIONS: This novel approach to partial cystectomy has the potential advantage of identifying the location of the tumor by simultaneous monitoring both laparoscopically and cystoscopically. Use of the endovascular stapler prevents spillage and stapler line resection confirms the completeness of resection without requiring the extraction of the specimen prior to bladder reconstruction.
Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009
Prostate Cancer: Localized (V) Moderated Poster 55 Tuesday, April 28, 2009
3:30 pm - 5:30 pm
1682 CLINICAL RESULTS OF LONG TERM FOLLOW-UP OF A LARGE ACTIVE SURVEILLANCE COHORT Laurence H Klotz*, Robert Nam, Adam Lam, Alex Mamedov, Andrew Loblaw, Toronto, ON, Canada INTRODUCTION AND OBJECTIVES: In 1995, a prospective phase 2 trial of active surveillance was initiated at our centre. This approach was offered to men with favorable risk prostate cancer as an alternative to radical intervention. Patients were closely followed with serial PSA and periodic biopsy, and intervention was offered based on PSA kinetics or grade progression. Our initial results were reported in 2002 on 231 patients. This report is our 2nd analysis of this group, which now constitutes 453 men. METHODS: This is a prospective, single arm cohort study. Patients with favorable clinical parameters (screen diagnosed patients with Gleason <=6, PSA <=10) were managed with active surveillance. Initially a subset of men > 70 were included with Gleason 3+4 or PSA 10-15. In 2000, the study was restricted to favorable risk disease. Definitive intervention was offered to those patients with a PSA doubling time of < 3 years, Gleason score progression (to 4+3 or greater), or unequivocal clinical progression. PSA doubling time was calculated using the General Linear Mixed Model. RESULTS: Since November 1995, 453 patients have been entered on the program. Median age is 70 (range 45-86). The median followup is 7.2 years (range 1-13 yrs). Overall survival is 83%, and prostate cancer survival is 99%. 5 of 453 patients have died of prostate cancer. 35% of patients have been reclassified as higher risk and offered definitive therapy. The commonest indication for treatment was a PSA DT < 3 years (14%) or Gleason upgrading (6%). Of 137 patients treated radically, the PSA failure rate was 52%. Patients with biochemical failure after radical therapy constitute 15% of the overall cohort. The ratio of non-prostate cancer to prostate cancer mortality was 16 CONCLUSIONS: A policy of watchful waiting with selective delayed intervention based on defined criteria of disease risk reclassification is associated with a low prostate cancer mortality. Patients with favorable risk parameters at baseline who subsequently demonstrate a PSA doubling time < 3 years or pathologic progression to Gleason 4+3 represent a high risk cohort, reflected in a 52% rate of biochemical progression after radical therapy. This strategy offers the benefit of an individualized approach based on reclassification of the risk of progression over time. It may decrease the burden of therapy in patients with indolent disease, while providing definitive therapy for those with more aggressive disease. Source of Funding: Prostate Cancer Research Foundation of Canada
Source of Funding: None
1683 PROSPECTIVE PROTOCOL BASED ACTIVE SURVEILLANCE FOR EARLY PROSTATE CANCER: SHORT-TERM RESULTS OF 500 PATIENTS IN THE PRIAS STUDY Roderick C n van den Bergh*, Rotterdam, Netherlands; Hanna Vasarainen, Helsinki, Finland; Tom Pickles, Vancouver, BCCanada; Riccardo Valdagni, Milan, Italy; Frederic Staerman, Reims, France; Antti Rannikko, Helsinki, Finland; Stijn Roemeling, Monique J Roobol, Fritz H Schröder, Chris H Bangma, Rotterdam, Netherlands INTRODUCTION AND OBJECTIVES: Active surveillance (AS) for early prostate cancer (PCa) may provide a partial solution to the overtreatment dilemma. AS programs, including the multicenter prospective observational PRIAS study, have been initiated to acquire prospective evidence for this strategy. To assess the effect of applying a
THE JOURNAL OF UROLOGY®
Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009
protocol for AS in men with small, localized, well-differentiated PCa, we present the short-term results of 500 PRIAS patients. METHODS: Men with T1c/T2 PCa, PSA =a10.0 ng/ml, PSAdensity <0.2 ng/ml/cc, Gleason score a3+3=6, and a2 positive biopsy cores, are eligible for inclusion in PRIAS. The follow-up protocol includes PSA measurements every 3 months, digital rectal examinations every 6 months, and standard re-biopsies at 1st, 4th and 7th year. We analysed baseline characteristics, PSA doubling time (PSA-DT) distributions, findings in re-biopsies regarding Gleason score and number of positive biopsies, the relation between rebiopsies and PSA-DT, clinical stage progression, treatment-free survival, compliance with the protocol, and reasons for treatment change. The interactive decision-tool www.priasproject.org was used for patient and data management. RESULTS: From the start of the PRIAS study in December 2006 to July 2008, a total of 500 European and North American men were included; 13 centres in 5 countries included q10 patients. At the time of this analysis, 151 men had a follow-up >1 year; 159 men received rebiopsies; median follow-up was 0.61 yr. Favorable (>10 yr or negative) and very unfavorable (0-3 yr) PSA-DTs were seen less frequently with longer follow-up. Compliance to re-biopsy after 1 year was 83%. The result of 35% of all re-biopsies was negative; 22% showed upgrading in Gleason score to >6 or >2 positive biopsy-cores. Of these men 66% also had an unfavorable PSA-DT (<10 yr). After 2 years the treatment-free survival was 74%, while this was 78% in a recent retrospective study of similar patients in whom no protocol was applied. Of patients changing to active therapy, 83% did so based on protocol. PC specific mortality will be analyzed when data on longer follow-up are available. CONCLUSIONS: AS is feasible in men with early PCa at diagnosis. However, it must be underlined that a large variation in shortterm clinical outcome occurs and that PSA-DT and re-biopsy findings are often contradictory. So far, the PRIAS study is the largest prospective AS study. It may provide further guidance in AS, helping to optimize future protocols. Updated results will be presented. Source of Funding: None
1684 RISK STRATIFICATION OF MEN CHOOSING SURVEILLANCE FOR LOW RISK PROSTATE CANCER Kenneth S Tseng*, Patricia K Landis, Jonathan I Epstein, H. Ballentine Carter, Baltimore, MD INTRODUCTION AND OBJECTIVES: To predict an unfavorable biopsy in men on prostate cancer surveillance. METHODS: Three hundred seventy-six men (median age = 65.5 years, range = 45.8 - 79.5) with low risk prostate cancer on surveillance had at least one follow-up biopsy after diagnosis. Progression was defined at surveillance biopsy as Gleason pattern 4 or 5, or greater than 2 biopsy cores with cancer, or greater than 50% involvement of any core with cancer. Proportional hazards analysis was used to evaluate the association between covariates and surveillance biopsy results. KaplanMeier survival analysis was used to estimate the probability of disease progression. RESULTS: One hundred twenty-three of 376 (32.7%) men had progression at a median of 5.6 years after diagnosis (range = 0.25 8.5). PSA, the percentage of free PSA, the number of cores positive for cancer, and the maximum percentage core involvement at diagnosis were associated with progression (p<0.20), and allowed stratification of the cumulative incidence of progression at 4 years after diagnosis into a low and high risk group (cumulative incidence of progression = 21.0%; 95% confidence interval = 14.4 to 30.2 versus 50.5%; 95% confidence interval = 41.9 to 59.8, log-rank test, p<0.001). The addition of initial surveillance biopsy results (positive if cancer with favorable pathology versus negative if no cancer) to a base model of commonly-used predictive clinical variables statistically improved the predictive ability of the previous model (Likelihood ratio test, p<0.001) and allowed further stratification of both low and high risk groups (log-rank tests, p<0.0001 and p=0.0092, respectively). CONCLUSIONS: Clinical variables at the time of diagnosis and
607
during follow-up in an active surveillance program can be used to inform men regarding their likelihood of an unfavorable prostate biopsy. This information could improve patient and physician acceptance of active surveillance for carefully selected men. Source of Funding: None
1685 PATHOLOGICAL OUTCOMES OF CANDIDATES FOR ACTIVE SURVEILLANCE UNDERGOING RADICAL PROSTATECTOMY Patrick W Mufarrij*, Alex Sankin, Guilherme Godoy, Herbert Lepor, New York, NY INTRODUCTION AND OBJECTIVES: Active surveillance for the treatment of low risk prostate cancer is highly controversial. We examined the pathological findings, biochemical recurrence rates, and treatment satisfaction for a consecutive cohort of candidates for active surveillance who underwent radical prostatectomy. METHODS: Between October 2000 and February 2008, a single surgeon performed 1,565 open radical retropubic prostatectomies for clinically localized prostate cancer. Cases were selected for extraction if they fulfilled one of two published criteria for active surveillance. A retrospective review of the prospectively collected database was executed to elucidate outcomes of candidates for active surveillance who underwent radical retropubic prostatectomy. Gleason score, pathological stage, and surgical margins were prospectively captured in our database. A 4-level Likert scale self-assessment of treatment satisfaction was conducted at 1, 2, 4 and 7 years postoperatively. The five-year, biochemical-free survival rates were estimated using KaplanMeier analysis. RESULTS: Overall, 51% to 51.7% of cases were pathologically upgraded to a Gleason score q 7. Moreover, 12.3% to 13.7% of cases were found to have a primary Gleason pattern of 4 or 5. Extracapsular extension (pT3a disease) was observed in 7.8% to 10.9% of cases. 28.8% to 32.2% of cases had an estimated percentage of cancer volume in the surgical specimen exceeding 20%. The percentage of men who were satisfied or very satisfied with their decision to have undergone radical prostatectomy ranged from 95.4% to 100% across all time points up to seven years after surgery. The five-year biochemical free survival was estimated to be 83.2% to 92.9%. CONCLUSIONS: Our pathological findings, risk of biochemical recurrence, and satisfaction rates noted following open radical prostatectomy question the wisdom of active surveillance in men with low risk disease who have “long” life expectancies.
Gleason 3+4 Gleason 3+5 Gleason 4+3 Gleason 4+4 Gleason 4+5 Gleason 5+3 Gleason 5+4 any upgrading dominant 4 or 5 pattern extracapsular extension (pT3) seminal vesicle involvement
Pathological Characteristics Group I (N=205) Group II (N = 71) #/% #/% 64 (31.2) 255 (33.1) 2 (1) 12 (1.6) 13 (6.3) 56 (7.8) 4 (2) 13 (1.7) 6 (2.9) 19 (2.5) 3 (1.5) 5 (0.7) 2 (1) 2 (0.3) 106 (51.7) 393 (51.0)
p-value 0.607* 0.746** 0.644* 0.766** 0.712* 0.376** 0.196** 0.865*
28 (13.7)
95 (12.3)
0.613*
16 (7.8)
84 (10.9)
0.196*
1 (0.5)
12 (1.6)
0.322**
Estimated Tumor Estimated Tumor Volume #/% Volume #/% < 10% 93 (45.4) 358 (46.4) 0.599* 10-20% 39 (19) 163 (21.1) 0.599* > 20% 1 (0.5) 12 (1.6) 0.599* Gleason 6 104 (50.1) 367 (47.6) 0.546** Gleason 7 77 (37.6) 311 (40.3) 0.546** Gleason q 8 17 (8.3) 51 (6.6) 0.546** * = Chi-square, ** = Fisher’s exact test; all statistical tests performed as twosided tests with significance defined as p < 0.05 Global Satisfaction with Decision to Have Undergone Radical Prostatectomy
606
RESULTS: Laparoscopic modified inguinal lymphadenectomy was successfully completed on both sides. The procedure took 120 minutes per leg. We demonstrate the limits of dissection as well as useful anatomic landmarks used in the procedure. The patient did well without complication. On pathologic review, we obtained 9 and 10 nodes, respectively. CONCLUSIONS: A endoscopic approach to modified inguinal lymphadenectomy is a versatile technique which can be performed in a stepwise manner for a variety of disease conditions. In our experience, oncologic efficacy is maintained. We have demonstrated our technique as well as discuss useful anatomic landmarks. This technique may potentially lead to reduced complications. At our institution, we have performed this surgery in 5 patients (10 legs) without any wound complications. Source of Funding: None
V1681 ROBOT ASSISTED PARTIAL CYSTECTOMY: A NOVEL TECHNIQUE USING SIMULTANEOUS CYSTOSCOPIC AND LAPAROSCOPIC MONITORING WITH STAPLE CONTROL OF TUMOR Alok Shrivastava*, Louis S Krane, Mani Menon, James O Peabody, Detroit, MI INTRODUCTION AND OBJECTIVES: We describe a novel technique of robot assisted partial cystectomy with simultaneous endoscopic and laparoscopic monitoring using the Tile-ProTM. Endovascular stapler was used to prevent potential tumor spillage. METHODS: 78 year old female with recurrent transitional cell carcinoma on the dome of the bladder underwent robotic assisted partial cystectomy with a 6-port approach. Cystoscopy was performed simultaneously in order to delineate the tumor by direct vision and transillumination and this was monitored with side by side video imaging using the Tile-ProTM feature of daVinciTM Surgical System. After identification of the tumor and required tumor margin the endovascular stapler was used to cut across the bladder and to isolate the tumor in an attempt to prevent intra-abdominal tumor spillage. The resected partial cystectomy specimen was then placed in an specimen bag. The staple line on the bladder was then resected and sent for frozen section to assess the completeness of resection. The bladder was then closed in two layers. The patient then underwent an extended pelvic lymph node dissection and bilateral salpingo-oophorectomy. RESULTS: The post-operative bladder volume was 250 ml, length of hospitalization was 1 day and the catheter was removed in one weeks. Final tumor pathological stage was T3a. The surgical margin was free of tumor. CONCLUSIONS: This novel approach to partial cystectomy has the potential advantage of identifying the location of the tumor by simultaneous monitoring both laparoscopically and cystoscopically. Use of the endovascular stapler prevents spillage and stapler line resection confirms the completeness of resection without requiring the extraction of the specimen prior to bladder reconstruction.
Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009
Prostate Cancer: Localized (V) Moderated Poster 55 Tuesday, April 28, 2009
3:30 pm - 5:30 pm
1682 CLINICAL RESULTS OF LONG TERM FOLLOW-UP OF A LARGE ACTIVE SURVEILLANCE COHORT Laurence H Klotz*, Robert Nam, Adam Lam, Alex Mamedov, Andrew Loblaw, Toronto, ON, Canada INTRODUCTION AND OBJECTIVES: In 1995, a prospective phase 2 trial of active surveillance was initiated at our centre. This approach was offered to men with favorable risk prostate cancer as an alternative to radical intervention. Patients were closely followed with serial PSA and periodic biopsy, and intervention was offered based on PSA kinetics or grade progression. Our initial results were reported in 2002 on 231 patients. This report is our 2nd analysis of this group, which now constitutes 453 men. METHODS: This is a prospective, single arm cohort study. Patients with favorable clinical parameters (screen diagnosed patients with Gleason <=6, PSA <=10) were managed with active surveillance. Initially a subset of men > 70 were included with Gleason 3+4 or PSA 10-15. In 2000, the study was restricted to favorable risk disease. Definitive intervention was offered to those patients with a PSA doubling time of < 3 years, Gleason score progression (to 4+3 or greater), or unequivocal clinical progression. PSA doubling time was calculated using the General Linear Mixed Model. RESULTS: Since November 1995, 453 patients have been entered on the program. Median age is 70 (range 45-86). The median followup is 7.2 years (range 1-13 yrs). Overall survival is 83%, and prostate cancer survival is 99%. 5 of 453 patients have died of prostate cancer. 35% of patients have been reclassified as higher risk and offered definitive therapy. The commonest indication for treatment was a PSA DT < 3 years (14%) or Gleason upgrading (6%). Of 137 patients treated radically, the PSA failure rate was 52%. Patients with biochemical failure after radical therapy constitute 15% of the overall cohort. The ratio of non-prostate cancer to prostate cancer mortality was 16 CONCLUSIONS: A policy of watchful waiting with selective delayed intervention based on defined criteria of disease risk reclassification is associated with a low prostate cancer mortality. Patients with favorable risk parameters at baseline who subsequently demonstrate a PSA doubling time < 3 years or pathologic progression to Gleason 4+3 represent a high risk cohort, reflected in a 52% rate of biochemical progression after radical therapy. This strategy offers the benefit of an individualized approach based on reclassification of the risk of progression over time. It may decrease the burden of therapy in patients with indolent disease, while providing definitive therapy for those with more aggressive disease. Source of Funding: Prostate Cancer Research Foundation of Canada
Source of Funding: None
1683 PROSPECTIVE PROTOCOL BASED ACTIVE SURVEILLANCE FOR EARLY PROSTATE CANCER: SHORT-TERM RESULTS OF 500 PATIENTS IN THE PRIAS STUDY Roderick C n van den Bergh*, Rotterdam, Netherlands; Hanna Vasarainen, Helsinki, Finland; Tom Pickles, Vancouver, BCCanada; Riccardo Valdagni, Milan, Italy; Frederic Staerman, Reims, France; Antti Rannikko, Helsinki, Finland; Stijn Roemeling, Monique J Roobol, Fritz H Schröder, Chris H Bangma, Rotterdam, Netherlands INTRODUCTION AND OBJECTIVES: Active surveillance (AS) for early prostate cancer (PCa) may provide a partial solution to the overtreatment dilemma. AS programs, including the multicenter prospective observational PRIAS study, have been initiated to acquire prospective evidence for this strategy. To assess the effect of applying a
THE JOURNAL OF UROLOGY®
Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009
protocol for AS in men with small, localized, well-differentiated PCa, we present the short-term results of 500 PRIAS patients. METHODS: Men with T1c/T2 PCa, PSA =a10.0 ng/ml, PSAdensity <0.2 ng/ml/cc, Gleason score a3+3=6, and a2 positive biopsy cores, are eligible for inclusion in PRIAS. The follow-up protocol includes PSA measurements every 3 months, digital rectal examinations every 6 months, and standard re-biopsies at 1st, 4th and 7th year. We analysed baseline characteristics, PSA doubling time (PSA-DT) distributions, findings in re-biopsies regarding Gleason score and number of positive biopsies, the relation between rebiopsies and PSA-DT, clinical stage progression, treatment-free survival, compliance with the protocol, and reasons for treatment change. The interactive decision-tool www.priasproject.org was used for patient and data management. RESULTS: From the start of the PRIAS study in December 2006 to July 2008, a total of 500 European and North American men were included; 13 centres in 5 countries included q10 patients. At the time of this analysis, 151 men had a follow-up >1 year; 159 men received rebiopsies; median follow-up was 0.61 yr. Favorable (>10 yr or negative) and very unfavorable (0-3 yr) PSA-DTs were seen less frequently with longer follow-up. Compliance to re-biopsy after 1 year was 83%. The result of 35% of all re-biopsies was negative; 22% showed upgrading in Gleason score to >6 or >2 positive biopsy-cores. Of these men 66% also had an unfavorable PSA-DT (<10 yr). After 2 years the treatment-free survival was 74%, while this was 78% in a recent retrospective study of similar patients in whom no protocol was applied. Of patients changing to active therapy, 83% did so based on protocol. PC specific mortality will be analyzed when data on longer follow-up are available. CONCLUSIONS: AS is feasible in men with early PCa at diagnosis. However, it must be underlined that a large variation in shortterm clinical outcome occurs and that PSA-DT and re-biopsy findings are often contradictory. So far, the PRIAS study is the largest prospective AS study. It may provide further guidance in AS, helping to optimize future protocols. Updated results will be presented. Source of Funding: None
1684 RISK STRATIFICATION OF MEN CHOOSING SURVEILLANCE FOR LOW RISK PROSTATE CANCER Kenneth S Tseng*, Patricia K Landis, Jonathan I Epstein, H. Ballentine Carter, Baltimore, MD INTRODUCTION AND OBJECTIVES: To predict an unfavorable biopsy in men on prostate cancer surveillance. METHODS: Three hundred seventy-six men (median age = 65.5 years, range = 45.8 - 79.5) with low risk prostate cancer on surveillance had at least one follow-up biopsy after diagnosis. Progression was defined at surveillance biopsy as Gleason pattern 4 or 5, or greater than 2 biopsy cores with cancer, or greater than 50% involvement of any core with cancer. Proportional hazards analysis was used to evaluate the association between covariates and surveillance biopsy results. KaplanMeier survival analysis was used to estimate the probability of disease progression. RESULTS: One hundred twenty-three of 376 (32.7%) men had progression at a median of 5.6 years after diagnosis (range = 0.25 8.5). PSA, the percentage of free PSA, the number of cores positive for cancer, and the maximum percentage core involvement at diagnosis were associated with progression (p<0.20), and allowed stratification of the cumulative incidence of progression at 4 years after diagnosis into a low and high risk group (cumulative incidence of progression = 21.0%; 95% confidence interval = 14.4 to 30.2 versus 50.5%; 95% confidence interval = 41.9 to 59.8, log-rank test, p<0.001). The addition of initial surveillance biopsy results (positive if cancer with favorable pathology versus negative if no cancer) to a base model of commonly-used predictive clinical variables statistically improved the predictive ability of the previous model (Likelihood ratio test, p<0.001) and allowed further stratification of both low and high risk groups (log-rank tests, p<0.0001 and p=0.0092, respectively). CONCLUSIONS: Clinical variables at the time of diagnosis and
607
during follow-up in an active surveillance program can be used to inform men regarding their likelihood of an unfavorable prostate biopsy. This information could improve patient and physician acceptance of active surveillance for carefully selected men. Source of Funding: None
1685 PATHOLOGICAL OUTCOMES OF CANDIDATES FOR ACTIVE SURVEILLANCE UNDERGOING RADICAL PROSTATECTOMY Patrick W Mufarrij*, Alex Sankin, Guilherme Godoy, Herbert Lepor, New York, NY INTRODUCTION AND OBJECTIVES: Active surveillance for the treatment of low risk prostate cancer is highly controversial. We examined the pathological findings, biochemical recurrence rates, and treatment satisfaction for a consecutive cohort of candidates for active surveillance who underwent radical prostatectomy. METHODS: Between October 2000 and February 2008, a single surgeon performed 1,565 open radical retropubic prostatectomies for clinically localized prostate cancer. Cases were selected for extraction if they fulfilled one of two published criteria for active surveillance. A retrospective review of the prospectively collected database was executed to elucidate outcomes of candidates for active surveillance who underwent radical retropubic prostatectomy. Gleason score, pathological stage, and surgical margins were prospectively captured in our database. A 4-level Likert scale self-assessment of treatment satisfaction was conducted at 1, 2, 4 and 7 years postoperatively. The five-year, biochemical-free survival rates were estimated using KaplanMeier analysis. RESULTS: Overall, 51% to 51.7% of cases were pathologically upgraded to a Gleason score q 7. Moreover, 12.3% to 13.7% of cases were found to have a primary Gleason pattern of 4 or 5. Extracapsular extension (pT3a disease) was observed in 7.8% to 10.9% of cases. 28.8% to 32.2% of cases had an estimated percentage of cancer volume in the surgical specimen exceeding 20%. The percentage of men who were satisfied or very satisfied with their decision to have undergone radical prostatectomy ranged from 95.4% to 100% across all time points up to seven years after surgery. The five-year biochemical free survival was estimated to be 83.2% to 92.9%. CONCLUSIONS: Our pathological findings, risk of biochemical recurrence, and satisfaction rates noted following open radical prostatectomy question the wisdom of active surveillance in men with low risk disease who have “long” life expectancies.
Gleason 3+4 Gleason 3+5 Gleason 4+3 Gleason 4+4 Gleason 4+5 Gleason 5+3 Gleason 5+4 any upgrading dominant 4 or 5 pattern extracapsular extension (pT3) seminal vesicle involvement
Pathological Characteristics Group I (N=205) Group II (N = 71) #/% #/% 64 (31.2) 255 (33.1) 2 (1) 12 (1.6) 13 (6.3) 56 (7.8) 4 (2) 13 (1.7) 6 (2.9) 19 (2.5) 3 (1.5) 5 (0.7) 2 (1) 2 (0.3) 106 (51.7) 393 (51.0)
p-value 0.607* 0.746** 0.644* 0.766** 0.712* 0.376** 0.196** 0.865*
28 (13.7)
95 (12.3)
0.613*
16 (7.8)
84 (10.9)
0.196*
1 (0.5)
12 (1.6)
0.322**
Estimated Tumor Estimated Tumor Volume #/% Volume #/% < 10% 93 (45.4) 358 (46.4) 0.599* 10-20% 39 (19) 163 (21.1) 0.599* > 20% 1 (0.5) 12 (1.6) 0.599* Gleason 6 104 (50.1) 367 (47.6) 0.546** Gleason 7 77 (37.6) 311 (40.3) 0.546** Gleason q 8 17 (8.3) 51 (6.6) 0.546** * = Chi-square, ** = Fisher’s exact test; all statistical tests performed as twosided tests with significance defined as p < 0.05 Global Satisfaction with Decision to Have Undergone Radical Prostatectomy