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POD-11.06: Positive Surgical Margins Do Not Affect Disease Recurrence in Patients with T3a Prostate Cancer
PODIUM SESSIONS
rectal fistula; one of which required surgical correction. No patient has required surgical intervention for incontinence. Three patients (6.4%) have required transurethral resection of the prostate (TURP). No fecal incontinence has been reported. No statistically significant difference in HRQoL was noted between baseline and day 180. Conclusions: Salvage HIFU in this phase II study has shown a low positive biopsy rate of 36.4% and an acceptable toxicity rate, opening the possibility of a new minimally invasive treatment for radiotherapy failures. Further follow-up is needed to determine PSA recurrence rates. POD-11.06 Positive Surgical Margins Do Not Affect Disease Recurrence in Patients with T3a Prostate Cancer Psutka S1, Feldman A1, Rodin D2, Wu C1, McDougal W1 1 Massachusetts General Hospital, Department of Urology, Boston, MA, USA, 2Indian River Urology Associates, Vero Beach, FL, USA Introduction and Objective: To define the role of positive surgical margins (PSM) following radical retropubic prostatectomy (RRP) as a predictor of biochemical failure (BCF). Materials and Methods: Under IRB approved protocol, we retrospectively reviewed 359 patients who underwent RRP between 1993 and 1995. Exclusion criteria included positive lymph nodes in the surgical specimens (10), inadequate minimum postoperative follow-up (24), salvage RRP (1), use of neoadjuvant androgen deprivation therapy (1), and no available Gleason data in the setting of pT0 disease (1). We compared clinical and pathological characteristics with time to progression to BCF for the remaining 322 patients. A Kaplan-Meier time-to-event analysis and univariate and multivariate Cox regression models were used to determine the role of PSM in progression to BCF when controlling for preoperative PSA, Gleason score, tumor stage (pT2, pT3), tumor volume (1-4 quadrants), Seminal Vesical (SV), lymphovascular (LV), and perineural (PN) invasion, and length of PSM. Median follow-up time was 11.9 years (IQR 8.3, 12.6) for patients who never developed BCF. Results: Of 322 patients, 30% had positive margins on surgical pathology. Among all patients, PSM were predictive of more rapid progression to BCF (p⫽0.0004). When stratified by pathologic stage, PSM were correlated with a faster
S36
time to BCF in men with pT2 disease (p⫽0.0002), however, this relationship was lost in men with pT3 disease (p⫽0.5422). Among those pts with pT2 disease and PSM, length of PSM did not correlated with progression to BCF (p⫽0.3 – 0.6 for margin length 1-11mm). When stratified by disease volume, PSM were found to be predictive of shorter time to progression to BCF in patients with disease in high volume disease with 3-4 quadrants involved (p⫽0.0017) but not in low volume disease when confined to 1-2 quadrants (p⫽0.23). Univariate analyses by a Cox proportional hazards model demonstrated that preoperative PSA, PSM, pathologic stage, Gleason score, SV involvement, perineural invasion, and disease volume all correlated with time to BCF. By multivariate Cox regression analysis, PSM predicted a faster time to BCF only in the setting of pT2 disease (HR 2.29, 95% CI 1.32, 3.98), when controlling for preoperative PSA, pathologic stage, Gleason score, SV involvement, PN invasion, and disease volume. In the multivariate model, pT3 disease, SV involvement and Gleason score remained significant predictors of time to BCF. Conclusions: Surgical margin status does not affect future progression to BCF in pT3a disease; however it does affect progression in those patients with pT2 disease. It appears that this effect in pT2 patients is more profound in those with high volume disease irrespective of the length of the positive margin. POD-11.07 Clamp Ablation of the Testes Compared To Bilateral Orchidectomy as Androgen Deprivation Therapy for Advanced Prostate Cancer: A Pilot Study Zarrabi A, Heyns C Department of Urology, University of Stellenbosch and Tygerberg Hospital, Tygerberg, South Africa Introduction and Objective: To compare clamp ablation of the testes (CAT) using the Burdizzo clamp, with bilateral orchidectomy (BO) for surgical androgen deprivation therapy (ADT) in men with advanced adenocarcinoma of the prostate (ACP). Materials and Methods: The protocol was approved by the local institutional review board. Written, informed consent was obtained from men of sound mental status, with advanced ACP, in whom ADT was indicated. Patients were prospectively randomized to undergo BO (group 1) or CAT (group 2) under local anaesthesia.
Evaluation during the procedure, and at 3 days, 7 days, 6 weeks and then every 3 months included visual analog pain score, analgesic use, complications, serum testosterone (TT), luteinizing hormone (LH) and prostate specific antigen (PSA) levels, as well as testicular volume measurement. Men in group 2 whose testosterone at 6 weeks was ⬎ 1.7 nmol/L underwent BO. Statistical analysis was performed using GraphPad InStat software. Results: The mean duration of the procedure was significantly longer for BO than for CAT. Mean pain scores during and after the procedure did not differ significantly between groups. In group 1 the mean serum TT was significantly lower compared with baseline from day 3 onwards. In group 2 the mean serum TT was significantly lower than baseline on days 3 and 7, but not at 6 weeks, and it was significantly higher than in group 1 on days 3 and 7 and at 6 weeks. LH increased significantly in group 1 from day 3, and in group 2 from day 7. PSA was significantly lower compared to baseline in group 1 at 6 weeks and 3 months, but did not show a significant decrease in group 2. Testis volume on ultrasound in group 2 showed an initial increase, followed by a significant decrease from baseline. Complications related to the procedure occurred in 89% in group 1 and 40% in group 2 (p ⫽ 0.057). Conclusions: CAT was quicker to perform and had fewer complications than BO. CAT caused significant but transient testicular ischaemic injury, but was not as effective as BO in achieving androgen deprivation. Further study to determine optimal CAT technique is ongoing. POD-11.08 Diabetes and Risk of Death from Cancer of the Prostate, Kidney, and Urinary Bladder Chung H1,2, Chen S1, Li M3 1 Department of Urology, Mennonite Christian Hospital, Taiwan, Taiwan; 2Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MD, USA; 3MJ Health Screening Center, Taiwan, Taiwan Introduction and Objective: We evaluated the associations between diabetes mellitus (DM) and the risk of deaths from cancer of the prostate, kidney, and urinary bladder (UB) among a large health check-up population in Taiwan during an up to 10-year follow-up period. Materials and Methods: The Taiwan MJ Cohort Study consists of 54,751 men aged 40-80 years who completed a comprehen-
UROLOGY 74 (Supplment 4A), October 2009
rectal fistula; one of which required surgical correction. No patient has required surgical intervention for incontinence. Three patients (6.4%) have required transurethral resection of the prostate (TURP). No fecal incontinence has been reported. No statistically significant difference in HRQoL was noted between baseline and day 180. Conclusions: Salvage HIFU in this phase II study has shown a low positive biopsy rate of 36.4% and an acceptable toxicity rate, opening the possibility of a new minimally invasive treatment for radiotherapy failures. Further follow-up is needed to determine PSA recurrence rates. POD-11.06 Positive Surgical Margins Do Not Affect Disease Recurrence in Patients with T3a Prostate Cancer Psutka S1, Feldman A1, Rodin D2, Wu C1, McDougal W1 1 Massachusetts General Hospital, Department of Urology, Boston, MA, USA, 2Indian River Urology Associates, Vero Beach, FL, USA Introduction and Objective: To define the role of positive surgical margins (PSM) following radical retropubic prostatectomy (RRP) as a predictor of biochemical failure (BCF). Materials and Methods: Under IRB approved protocol, we retrospectively reviewed 359 patients who underwent RRP between 1993 and 1995. Exclusion criteria included positive lymph nodes in the surgical specimens (10), inadequate minimum postoperative follow-up (24), salvage RRP (1), use of neoadjuvant androgen deprivation therapy (1), and no available Gleason data in the setting of pT0 disease (1). We compared clinical and pathological characteristics with time to progression to BCF for the remaining 322 patients. A Kaplan-Meier time-to-event analysis and univariate and multivariate Cox regression models were used to determine the role of PSM in progression to BCF when controlling for preoperative PSA, Gleason score, tumor stage (pT2, pT3), tumor volume (1-4 quadrants), Seminal Vesical (SV), lymphovascular (LV), and perineural (PN) invasion, and length of PSM. Median follow-up time was 11.9 years (IQR 8.3, 12.6) for patients who never developed BCF. Results: Of 322 patients, 30% had positive margins on surgical pathology. Among all patients, PSM were predictive of more rapid progression to BCF (p⫽0.0004). When stratified by pathologic stage, PSM were correlated with a faster
S36
time to BCF in men with pT2 disease (p⫽0.0002), however, this relationship was lost in men with pT3 disease (p⫽0.5422). Among those pts with pT2 disease and PSM, length of PSM did not correlated with progression to BCF (p⫽0.3 – 0.6 for margin length 1-11mm). When stratified by disease volume, PSM were found to be predictive of shorter time to progression to BCF in patients with disease in high volume disease with 3-4 quadrants involved (p⫽0.0017) but not in low volume disease when confined to 1-2 quadrants (p⫽0.23). Univariate analyses by a Cox proportional hazards model demonstrated that preoperative PSA, PSM, pathologic stage, Gleason score, SV involvement, perineural invasion, and disease volume all correlated with time to BCF. By multivariate Cox regression analysis, PSM predicted a faster time to BCF only in the setting of pT2 disease (HR 2.29, 95% CI 1.32, 3.98), when controlling for preoperative PSA, pathologic stage, Gleason score, SV involvement, PN invasion, and disease volume. In the multivariate model, pT3 disease, SV involvement and Gleason score remained significant predictors of time to BCF. Conclusions: Surgical margin status does not affect future progression to BCF in pT3a disease; however it does affect progression in those patients with pT2 disease. It appears that this effect in pT2 patients is more profound in those with high volume disease irrespective of the length of the positive margin. POD-11.07 Clamp Ablation of the Testes Compared To Bilateral Orchidectomy as Androgen Deprivation Therapy for Advanced Prostate Cancer: A Pilot Study Zarrabi A, Heyns C Department of Urology, University of Stellenbosch and Tygerberg Hospital, Tygerberg, South Africa Introduction and Objective: To compare clamp ablation of the testes (CAT) using the Burdizzo clamp, with bilateral orchidectomy (BO) for surgical androgen deprivation therapy (ADT) in men with advanced adenocarcinoma of the prostate (ACP). Materials and Methods: The protocol was approved by the local institutional review board. Written, informed consent was obtained from men of sound mental status, with advanced ACP, in whom ADT was indicated. Patients were prospectively randomized to undergo BO (group 1) or CAT (group 2) under local anaesthesia.
Evaluation during the procedure, and at 3 days, 7 days, 6 weeks and then every 3 months included visual analog pain score, analgesic use, complications, serum testosterone (TT), luteinizing hormone (LH) and prostate specific antigen (PSA) levels, as well as testicular volume measurement. Men in group 2 whose testosterone at 6 weeks was ⬎ 1.7 nmol/L underwent BO. Statistical analysis was performed using GraphPad InStat software. Results: The mean duration of the procedure was significantly longer for BO than for CAT. Mean pain scores during and after the procedure did not differ significantly between groups. In group 1 the mean serum TT was significantly lower compared with baseline from day 3 onwards. In group 2 the mean serum TT was significantly lower than baseline on days 3 and 7, but not at 6 weeks, and it was significantly higher than in group 1 on days 3 and 7 and at 6 weeks. LH increased significantly in group 1 from day 3, and in group 2 from day 7. PSA was significantly lower compared to baseline in group 1 at 6 weeks and 3 months, but did not show a significant decrease in group 2. Testis volume on ultrasound in group 2 showed an initial increase, followed by a significant decrease from baseline. Complications related to the procedure occurred in 89% in group 1 and 40% in group 2 (p ⫽ 0.057). Conclusions: CAT was quicker to perform and had fewer complications than BO. CAT caused significant but transient testicular ischaemic injury, but was not as effective as BO in achieving androgen deprivation. Further study to determine optimal CAT technique is ongoing. POD-11.08 Diabetes and Risk of Death from Cancer of the Prostate, Kidney, and Urinary Bladder Chung H1,2, Chen S1, Li M3 1 Department of Urology, Mennonite Christian Hospital, Taiwan, Taiwan; 2Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MD, USA; 3MJ Health Screening Center, Taiwan, Taiwan Introduction and Objective: We evaluated the associations between diabetes mellitus (DM) and the risk of deaths from cancer of the prostate, kidney, and urinary bladder (UB) among a large health check-up population in Taiwan during an up to 10-year follow-up period. Materials and Methods: The Taiwan MJ Cohort Study consists of 54,751 men aged 40-80 years who completed a comprehen-
UROLOGY 74 (Supplment 4A), October 2009