- Email: [email protected]
2117 EFFICACY OF NOVEL COAXIAL OCCLUSION DEVICE TO PREVENT STONE MIGRATION DURING PERCUTANEOUS NEPHROLITHOTOMY (PCNL)
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Vol. 183, No. 4, Supplement, Wednesday, June 2, 2010
(96.7% vs 93.3%, p⬍0.8). The image quality and image noise were also comparable in the ASIR and FBP group (IQ: 3.9 vs 3.8, N 1.7 vs 2.3, p⫽0.1). The average radiation dose reduction achieved with ASIR was 49.9% (range ⫽ 23-81%) compared to FBP technique (ASIR: 5 ⫾ 1.69mSv, FBP: 10.1 ⫾ 3.8mSv, p⫽0.01). CONCLUSIONS: MDCT with ASIR has comparable diagnostic accuracy to standard MDCT with a significant reduction in ionizing radiation delivered to the patient. This technology has the potential to provide improvements in the care of stone patients by reducing exposure to radiation and the theoretical increased risk of radiation-induced malignancy. Source of Funding: None
2115 A VALIDATED QUESTIONNAIRE STUDY COMPARING STENTRELATED SYMPTOMS BETWEEN CONVENTIONAL JJ STENTS AND A NOVEL THERMO-EXPANDABLE SEGMENTAL URETERIC METAL STENT Dharmesh Patel*, Tamer El-Husseiny, Konstantinos Moraitis, Zafar Maan, Junaid Masood, Noor Buchholz, London, United Kingdom INTRODUCTION AND OBJECTIVES: JJ stents have revolutionized the minimally invasive management of malignant and benign ureteric strictures. However, JJ stents are associated with significant morbidity and reduced quality of life. More recently, a permanent thermo-expandable nickel-titanium alloy, segmental ureteric stent (MemokathTM PNN Medical, Denmark) was introduced. We compare symptoms and quality of life in patients with ureteric strictures treated with either JJ stents or Memokath stents. METHODS: Over a one year period, validated ureteral stent symptom questionnaires (USSQ) were sent to 70 consecutive patients 4 weeks after insertion of JJ or Memokath TM stents. During this period, a sub-group of patients underwent insertion of both stents and hence completed two questionnaires. The USSQ is a self-administered multidimensional measure designed to evaluate stent-related morbidity in 6 sections: urinary symptoms, body pain, general health, work performance, sexual matters, and additional problems. RESULTS: The patients’ response rate was 58.5%. Memokath stents were significantly better for the domains of stent related pain, urinary symptoms index and general health compared with JJ stents and also significantly outperformed the JJ stent group in terms of light and heavy activity. Patients opted clearly in favour of Memokath stents for future stent insertion (Table 1). CONCLUSIONS: Patients with Memokath stents have an improved QOL because stent related morbidity is significantly lower than conventional JJ stents. Also Memokath stents don’t require frequent exchanges and are more cost-effective. QOL measure Prospect of living with urinary symptoms
JJ stent
MMK stent
p-value
6.0
3.0
0.02
Urinary symptoms index
32.0
21.5
0.048
Pain
18
7
0.009
Light activities
2.0
1.0
0.02
Heavy activities
3.0
2.0
0.04
Source of Funding: None
2116 DEVELOPMENT OF A NEW METHOD FOR MEASURING SERUM OXALATE USING A TRIS(2,2ⴕ-BIPYRIDYL)RUTHENIUM(II) CHEMILUMINESCENCE ANALYSIS SYSTEM AND IMPORTANCE IN UROLITHIASIS PATIENTS Takahiro Yasui*, Atsushi Okada, Takahiro Kobayashi, Masahito Hirose, Kazunori Nakaoka, Kazumi Taguchi, Yasuhiro Fujii, Kazuhiro Niimi, Yasuhiko Hirose, Masayuki Usami, Syuzo Hamamoto, Yasunori Itoh, Nagoya, Japan; Yasuyuki Yamada, Yatomi, Japan; Keiichi Tozawa, Kenjiro Kohri, Nagoya, Japan INTRODUCTION AND OBJECTIVES: It is important to perform urinary and serum oxalate to evaluate pathogenesis and diagnosis in urolithiasis patients. The measurement of the serum oxalate is difficult, because serum oxalate density is much lower than that of urinary oxalate. Many procedures have been reported for the measurement of urinary oxalate including enzymatic assay, various chromatographies and capillary electrophoresis. We recently developed the method for measuring serum oxalate using a tris(2,2⬘-bipyridyl)ruthenium(II) chemiluminescence analysis system. METHODS: Specimens: Blood samples of 50 calcium oxalate urolithiasis patients (38 men, 12 women) and 6 healthy men and 1 primary hayperoxaluria patient. Measurement method: Blood specimens were centrifuged (for 2,000G⫻10min) after standing at room temperature to separate the serum. An equal amount deproteinization liquid was added to each sample, separated (for 5,000G⫻15min) and the supernatant corrected. The samples were reacted with tris(2,2⬘bipyridyl)ruthenium(II) complex and emission of light was measured with a light detector (FOM-110A, Hokuto, Yokohama, Japan). The detectable range in oxalate was from 0.2 to 10 mol/l. We plotted a fixed-quantity straight line by measuring the control oxalate solution and samples diluted to 2, 4, 8 times and calculated the oxalate density of the specimens. RESULTS: It took only 20 minutes to prepare and measure each sample. The serum oxalate density was approximately constant at each dilution. The serum oxalate densities were 14.8⫾6.1mol/L (urolithiasis men), 13.5⫾5.7mol/L (urolithiasis women), and 4.8⫾1.5 mol/L (healthy men). The serum oxalate density of the primary hyperoxauria patients was 80-90 mol/L, but fell to about 40 mol/L 2 months after liver and renal transplantation. CONCLUSIONS: We developed a measurement method for serum oxalate density. The analytical characteristics of these chemiluminescence substances have high sensitivity, wide detectable range, few contaminations problems and low background levels. In this study serum oxalate level in urolithiasis patients was higher level than that in healthy men. It was thought that the measurement of serum oxalate is useful not only as an index for treatment of primary hyperoxaluria patients but also in screening, evaluation of pathogenesis and prevention for calcium oxalate urolithiasis patients. Source of Funding: None
2117 EFFICACY OF NOVEL COAXIAL OCCLUSION DEVICE TO PREVENT STONE MIGRATION DURING PERCUTANEOUS NEPHROLITHOTOMY (PCNL) Matthew Wosnitzer*, Michael Rothberg, Hiroshi Katsumi, Mantu Gupta, New York, NY INTRODUCTION AND OBJECTIVES: PCNL is often preceded by placement of a ureteral catheter into the collecting system to perform retrograde pyelography (RPG), define pelvicalyceal anatomy, and distend the collecting system to facilitate percutaneous needle access. We tested the safety and efficacy of a new coaxial film-based 15 mm occlusion device, Coaxial Accordion™ (Percsys, Mountain View, CA) designed to facilitate RPG while simultaneously preventing stone migration during PCNL. METHODS: A retrospective review of our institutional PCNL database from January to October 2009 analyzed patient demograph-
Vol. 183, No. 4, Supplement, Wednesday, June 2, 2010
ics, pre-operative imaging, and outcomes following PCNL with the coaxial device. Following cystoscopic placement of a guidewire, the device was passed into the collecting system and deployed at the UPJ. RPG was performed and the patients were placed in prone position. Contrast and/or saline were instilled as necessary during percutaneous access. PCNL was performed in standard fashion. Following conclusion of PCNL the device was withdrawn in retrograde fashion. RESULTS: The device was deployed at the UPJ successfully in 30/30 patients (mean age 61 years) and enhanced the ability of guidewires to bypass severely impacted stones. Initial RPG in supine position was performed successfully in 30/30 patients. RPG in prone position was performed successfully in 29/30 patients with one failure due to kinking of the device shaft in a morbidly obese patient. During PCNL, fragments in the renal pelvis were extracted by ultrasonic lithotripsy and suction with no instances of stone migration into the ureter, even in patients with complete staghorn calculi (mean diameter 2.07 cm; largest 4.0 cm). The device was successfully undeployed and removed in 30/30 patients. Post-operative ureteral stents were placed in 24/30 patients, and nephrostomy tube placed in 24/30 patients. The mean length of stay was 48 hours (18-120) and the mean operative time was 164 minutes (110-250). CONCLUSIONS: The new Coaxial Accordion™ 15 mm device is safe and efficacious for use in PCNL procedures and can improve outcomes by preventing antegrade stone fragment migration, decreasing operative time and length of stay, and improving the stone-free rate. Source of Funding: None
2118 PROSPECTIVE, RANDOMIZED TRIAL COMPARING TWO FLEXIBLE DIGITAL URETEROSCOPES: GYRUS ACMI/OLYMPUS INVISIO® DUR-D® AND OLYMPUS URF-V Ketul Shah*, Columbus, OH; Manoj Monga, Minneapolis, MN; Bodo Knudsen, Columbus, OH INTRODUCTION AND OBJECTIVES: The development of flexible digital ureteroscopy promises improved visualization, ergonomics, and patient outcomes. We compare two current generation digital flexible ureteroscopes in a randomized, prospective, clinical trial; the CMOS-based Gyrus ACMI/Olympus Invisio DUR-D and the CCDbased Olympus URF-V. METHODS: Patients scheduled for flexible ureteroscopy were prospectively enrolled and randomized between DUR-D and URF-V. Ureteroscopy was performed in a standardized fashion. Two of each model of scope were used. Patient demographics, total and laser time, laser energy, lower pole time and difficulties encountered were recorded. The surgeon rated the visibility and maneuverability on a scale of 0 to 10. Damaged scopes were sent to the manufacturer for repair and then reintroduced into the study. RESULTS: Preliminary results include 101 patients (58 females) with a mean age of 49.5 (20 – 80) years. Laser lithotripsy (mean stone size 11.8 mm) was performed in 88 patients, while 10 underwent stone basketing and 3 had diagnostic ureteroscopy. Fifteen patients had preoperative stent placement and ureteral access sheaths were used in 86 patients. For the two types of scopes i.e. DUR-D vs. URF-V, the mean total operative time (26.5 vs. 25 min), mean laser time (12.5 vs. 13 min), mean lower pole time (9 vs. 11 min) and mean basket time (14.5 vs. 13 min) were comparable. Mean total energy use was 3.67 kJ for DUR-D and 3.1 kJ for URF-V. In 3/45 (6.6%) and 6/56 (10.7%) of cases the stone could not be reached with the DUR-D and URF-V respectively. An alternative scope was needed to complete the case (Olympus URF-P5) and reached the stone in all cases. On a scale of 0 to 10, the mean visibility was 6.86 and 8.73 (p⬍0.01) and the mean maneuverability was 7.18 and 8.17 (p⬍0.01) for DUR-D and URF-V respectively. The mean upward deflection was 195° (135-240) and 127° (35-205); and downward deflection was 211° (135-265) and 251° (170-270) for DUR-D and URF-V respectively. There were 8 repairs needed, 4 for each type of scope. The DUR-D averaged 11.25 cases per repair and the DUR-D averaged 14.
THE JOURNAL OF UROLOGY姞
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CONCLUSIONS: The CCD-based URF-V offered better visibility and maneuverability as compared to the CMOS-based DUR-D. Both had similar failure rates as compared to previous study with fiber optic scopes. The larger digital scopes were at times unable to reach the stone. Further refinement related to scope size and durability is needed. Source of Funding: None
Prostate Cancer: Markers II Moderated Poster 64 Wednesday, June 2, 2010
3:30 PM-5:30 PM
2119 VALIDATION OF THE PCA3 MOLECULAR URINE TEST FOR PREDICTING REPEAT PROSTATE BIOPSY OUTCOME IN THE PLACEBO ARM OF THE DUTASTERIDE REDUCE TRIAL Leonard Marks*, Los Angeles, CA; Sheila Aubin, Jennifer Reid, Mark Sarno, Amy Blase, Jacqueline Aussie, Harry Rittenhouse, San Diego, CA; Gerald Andriole, St. Louis, MO; Roger Rittmaster, Research Triangle Park, NC; Jack Groskopf, San Diego, CA INTRODUCTION AND OBJECTIVES: The PCA3 molecular urine test has demonstrated utility for predicting prostate biopsy outcome in multiple studies. We assessed PCA3 clinical performance in the placebo arm of the dutasteride REDUCE Trial; this represents the largest repeat biopsy cohort evaluated to date. METHODS: REDUCE was a 4-year prostate cancer risk reduction study, in which men with a negative baseline biopsy and serum PSA (sPSA) 2.5-10 were randomized to dutasteride or placebo (plac), and 10-core biopsies were obtained after 2 (yr2) and 4 years (yr4). PCA3 Scores were determined on urine specimens (n⫽1140) collected from men in the plac arm who were scheduled for biopsy at y2 and/or y4. The last PCA3 Score available for each subject was correlated with biopsy outcome. Multivariate logistic regression (LR) was also performed using PCA3, sPSA, % free PSA (fPSA), prostate volume, age and family history. RESULTS: For the urine specimens tested, 1072/1140 (94%) yielded sufficient RNA for PCA3 analysis; 18% of these 1072 subjects were biopsy positive for CaP. PCA3 was associated with positive biopsy rate (P⬍0.0001): 6% CaP for PCA3 ⬍5, 57% CaP for PCA3 ⬎100. PCA3 AUC of 0.693 was greater than sPSA (0.612, P⫽0.008 vs. PCA3) or fPSA (0.637, P⫽0.065). The LR model yielded an AUC of 0.753 (P⫽0.0025 vs. PCA3 alone). PCA3 was significantly correlated with biopsy Gleason Score (GS ⬎ 7 vs. ⬍7, P⫽0.0017). PCA3 determined at y2 was a significant predictor of y4 biopsy outcome (AUC ⫽ 0.634, P⫽0.0002); sPSA and fPSA were not predictive (P⫽0.328 and 0.678, respectively). CONCLUSIONS: PCA3 clinical utility for predicting repeat biopsy outcome was confirmed in a multi-center worldwide clinical trial. Assay informative rates were similar to previously published studies. PCA3 outperformed sPSA, and a predictive model incorporating sPSA, fPSA and other clinical information significantly increased diagnostic accuracy. PCA3 correlated with biopsy GS, providing further evidence that PCA3 might be useful for identifying more aggressive CaP. Finally, PCA3 may be detecting undiagnosed cancers, as we found that PCA3 Scores measured from biopsy negative men at year 2 of the trial predicted biopsy outcome at year 4. Source of Funding: Gen-Probe, Inc
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Vol. 183, No. 4, Supplement, Wednesday, June 2, 2010
(96.7% vs 93.3%, p⬍0.8). The image quality and image noise were also comparable in the ASIR and FBP group (IQ: 3.9 vs 3.8, N 1.7 vs 2.3, p⫽0.1). The average radiation dose reduction achieved with ASIR was 49.9% (range ⫽ 23-81%) compared to FBP technique (ASIR: 5 ⫾ 1.69mSv, FBP: 10.1 ⫾ 3.8mSv, p⫽0.01). CONCLUSIONS: MDCT with ASIR has comparable diagnostic accuracy to standard MDCT with a significant reduction in ionizing radiation delivered to the patient. This technology has the potential to provide improvements in the care of stone patients by reducing exposure to radiation and the theoretical increased risk of radiation-induced malignancy. Source of Funding: None
2115 A VALIDATED QUESTIONNAIRE STUDY COMPARING STENTRELATED SYMPTOMS BETWEEN CONVENTIONAL JJ STENTS AND A NOVEL THERMO-EXPANDABLE SEGMENTAL URETERIC METAL STENT Dharmesh Patel*, Tamer El-Husseiny, Konstantinos Moraitis, Zafar Maan, Junaid Masood, Noor Buchholz, London, United Kingdom INTRODUCTION AND OBJECTIVES: JJ stents have revolutionized the minimally invasive management of malignant and benign ureteric strictures. However, JJ stents are associated with significant morbidity and reduced quality of life. More recently, a permanent thermo-expandable nickel-titanium alloy, segmental ureteric stent (MemokathTM PNN Medical, Denmark) was introduced. We compare symptoms and quality of life in patients with ureteric strictures treated with either JJ stents or Memokath stents. METHODS: Over a one year period, validated ureteral stent symptom questionnaires (USSQ) were sent to 70 consecutive patients 4 weeks after insertion of JJ or Memokath TM stents. During this period, a sub-group of patients underwent insertion of both stents and hence completed two questionnaires. The USSQ is a self-administered multidimensional measure designed to evaluate stent-related morbidity in 6 sections: urinary symptoms, body pain, general health, work performance, sexual matters, and additional problems. RESULTS: The patients’ response rate was 58.5%. Memokath stents were significantly better for the domains of stent related pain, urinary symptoms index and general health compared with JJ stents and also significantly outperformed the JJ stent group in terms of light and heavy activity. Patients opted clearly in favour of Memokath stents for future stent insertion (Table 1). CONCLUSIONS: Patients with Memokath stents have an improved QOL because stent related morbidity is significantly lower than conventional JJ stents. Also Memokath stents don’t require frequent exchanges and are more cost-effective. QOL measure Prospect of living with urinary symptoms
JJ stent
MMK stent
p-value
6.0
3.0
0.02
Urinary symptoms index
32.0
21.5
0.048
Pain
18
7
0.009
Light activities
2.0
1.0
0.02
Heavy activities
3.0
2.0
0.04
Source of Funding: None
2116 DEVELOPMENT OF A NEW METHOD FOR MEASURING SERUM OXALATE USING A TRIS(2,2ⴕ-BIPYRIDYL)RUTHENIUM(II) CHEMILUMINESCENCE ANALYSIS SYSTEM AND IMPORTANCE IN UROLITHIASIS PATIENTS Takahiro Yasui*, Atsushi Okada, Takahiro Kobayashi, Masahito Hirose, Kazunori Nakaoka, Kazumi Taguchi, Yasuhiro Fujii, Kazuhiro Niimi, Yasuhiko Hirose, Masayuki Usami, Syuzo Hamamoto, Yasunori Itoh, Nagoya, Japan; Yasuyuki Yamada, Yatomi, Japan; Keiichi Tozawa, Kenjiro Kohri, Nagoya, Japan INTRODUCTION AND OBJECTIVES: It is important to perform urinary and serum oxalate to evaluate pathogenesis and diagnosis in urolithiasis patients. The measurement of the serum oxalate is difficult, because serum oxalate density is much lower than that of urinary oxalate. Many procedures have been reported for the measurement of urinary oxalate including enzymatic assay, various chromatographies and capillary electrophoresis. We recently developed the method for measuring serum oxalate using a tris(2,2⬘-bipyridyl)ruthenium(II) chemiluminescence analysis system. METHODS: Specimens: Blood samples of 50 calcium oxalate urolithiasis patients (38 men, 12 women) and 6 healthy men and 1 primary hayperoxaluria patient. Measurement method: Blood specimens were centrifuged (for 2,000G⫻10min) after standing at room temperature to separate the serum. An equal amount deproteinization liquid was added to each sample, separated (for 5,000G⫻15min) and the supernatant corrected. The samples were reacted with tris(2,2⬘bipyridyl)ruthenium(II) complex and emission of light was measured with a light detector (FOM-110A, Hokuto, Yokohama, Japan). The detectable range in oxalate was from 0.2 to 10 mol/l. We plotted a fixed-quantity straight line by measuring the control oxalate solution and samples diluted to 2, 4, 8 times and calculated the oxalate density of the specimens. RESULTS: It took only 20 minutes to prepare and measure each sample. The serum oxalate density was approximately constant at each dilution. The serum oxalate densities were 14.8⫾6.1mol/L (urolithiasis men), 13.5⫾5.7mol/L (urolithiasis women), and 4.8⫾1.5 mol/L (healthy men). The serum oxalate density of the primary hyperoxauria patients was 80-90 mol/L, but fell to about 40 mol/L 2 months after liver and renal transplantation. CONCLUSIONS: We developed a measurement method for serum oxalate density. The analytical characteristics of these chemiluminescence substances have high sensitivity, wide detectable range, few contaminations problems and low background levels. In this study serum oxalate level in urolithiasis patients was higher level than that in healthy men. It was thought that the measurement of serum oxalate is useful not only as an index for treatment of primary hyperoxaluria patients but also in screening, evaluation of pathogenesis and prevention for calcium oxalate urolithiasis patients. Source of Funding: None
2117 EFFICACY OF NOVEL COAXIAL OCCLUSION DEVICE TO PREVENT STONE MIGRATION DURING PERCUTANEOUS NEPHROLITHOTOMY (PCNL) Matthew Wosnitzer*, Michael Rothberg, Hiroshi Katsumi, Mantu Gupta, New York, NY INTRODUCTION AND OBJECTIVES: PCNL is often preceded by placement of a ureteral catheter into the collecting system to perform retrograde pyelography (RPG), define pelvicalyceal anatomy, and distend the collecting system to facilitate percutaneous needle access. We tested the safety and efficacy of a new coaxial film-based 15 mm occlusion device, Coaxial Accordion™ (Percsys, Mountain View, CA) designed to facilitate RPG while simultaneously preventing stone migration during PCNL. METHODS: A retrospective review of our institutional PCNL database from January to October 2009 analyzed patient demograph-
Vol. 183, No. 4, Supplement, Wednesday, June 2, 2010
ics, pre-operative imaging, and outcomes following PCNL with the coaxial device. Following cystoscopic placement of a guidewire, the device was passed into the collecting system and deployed at the UPJ. RPG was performed and the patients were placed in prone position. Contrast and/or saline were instilled as necessary during percutaneous access. PCNL was performed in standard fashion. Following conclusion of PCNL the device was withdrawn in retrograde fashion. RESULTS: The device was deployed at the UPJ successfully in 30/30 patients (mean age 61 years) and enhanced the ability of guidewires to bypass severely impacted stones. Initial RPG in supine position was performed successfully in 30/30 patients. RPG in prone position was performed successfully in 29/30 patients with one failure due to kinking of the device shaft in a morbidly obese patient. During PCNL, fragments in the renal pelvis were extracted by ultrasonic lithotripsy and suction with no instances of stone migration into the ureter, even in patients with complete staghorn calculi (mean diameter 2.07 cm; largest 4.0 cm). The device was successfully undeployed and removed in 30/30 patients. Post-operative ureteral stents were placed in 24/30 patients, and nephrostomy tube placed in 24/30 patients. The mean length of stay was 48 hours (18-120) and the mean operative time was 164 minutes (110-250). CONCLUSIONS: The new Coaxial Accordion™ 15 mm device is safe and efficacious for use in PCNL procedures and can improve outcomes by preventing antegrade stone fragment migration, decreasing operative time and length of stay, and improving the stone-free rate. Source of Funding: None
2118 PROSPECTIVE, RANDOMIZED TRIAL COMPARING TWO FLEXIBLE DIGITAL URETEROSCOPES: GYRUS ACMI/OLYMPUS INVISIO® DUR-D® AND OLYMPUS URF-V Ketul Shah*, Columbus, OH; Manoj Monga, Minneapolis, MN; Bodo Knudsen, Columbus, OH INTRODUCTION AND OBJECTIVES: The development of flexible digital ureteroscopy promises improved visualization, ergonomics, and patient outcomes. We compare two current generation digital flexible ureteroscopes in a randomized, prospective, clinical trial; the CMOS-based Gyrus ACMI/Olympus Invisio DUR-D and the CCDbased Olympus URF-V. METHODS: Patients scheduled for flexible ureteroscopy were prospectively enrolled and randomized between DUR-D and URF-V. Ureteroscopy was performed in a standardized fashion. Two of each model of scope were used. Patient demographics, total and laser time, laser energy, lower pole time and difficulties encountered were recorded. The surgeon rated the visibility and maneuverability on a scale of 0 to 10. Damaged scopes were sent to the manufacturer for repair and then reintroduced into the study. RESULTS: Preliminary results include 101 patients (58 females) with a mean age of 49.5 (20 – 80) years. Laser lithotripsy (mean stone size 11.8 mm) was performed in 88 patients, while 10 underwent stone basketing and 3 had diagnostic ureteroscopy. Fifteen patients had preoperative stent placement and ureteral access sheaths were used in 86 patients. For the two types of scopes i.e. DUR-D vs. URF-V, the mean total operative time (26.5 vs. 25 min), mean laser time (12.5 vs. 13 min), mean lower pole time (9 vs. 11 min) and mean basket time (14.5 vs. 13 min) were comparable. Mean total energy use was 3.67 kJ for DUR-D and 3.1 kJ for URF-V. In 3/45 (6.6%) and 6/56 (10.7%) of cases the stone could not be reached with the DUR-D and URF-V respectively. An alternative scope was needed to complete the case (Olympus URF-P5) and reached the stone in all cases. On a scale of 0 to 10, the mean visibility was 6.86 and 8.73 (p⬍0.01) and the mean maneuverability was 7.18 and 8.17 (p⬍0.01) for DUR-D and URF-V respectively. The mean upward deflection was 195° (135-240) and 127° (35-205); and downward deflection was 211° (135-265) and 251° (170-270) for DUR-D and URF-V respectively. There were 8 repairs needed, 4 for each type of scope. The DUR-D averaged 11.25 cases per repair and the DUR-D averaged 14.
THE JOURNAL OF UROLOGY姞
e823
CONCLUSIONS: The CCD-based URF-V offered better visibility and maneuverability as compared to the CMOS-based DUR-D. Both had similar failure rates as compared to previous study with fiber optic scopes. The larger digital scopes were at times unable to reach the stone. Further refinement related to scope size and durability is needed. Source of Funding: None
Prostate Cancer: Markers II Moderated Poster 64 Wednesday, June 2, 2010
3:30 PM-5:30 PM
2119 VALIDATION OF THE PCA3 MOLECULAR URINE TEST FOR PREDICTING REPEAT PROSTATE BIOPSY OUTCOME IN THE PLACEBO ARM OF THE DUTASTERIDE REDUCE TRIAL Leonard Marks*, Los Angeles, CA; Sheila Aubin, Jennifer Reid, Mark Sarno, Amy Blase, Jacqueline Aussie, Harry Rittenhouse, San Diego, CA; Gerald Andriole, St. Louis, MO; Roger Rittmaster, Research Triangle Park, NC; Jack Groskopf, San Diego, CA INTRODUCTION AND OBJECTIVES: The PCA3 molecular urine test has demonstrated utility for predicting prostate biopsy outcome in multiple studies. We assessed PCA3 clinical performance in the placebo arm of the dutasteride REDUCE Trial; this represents the largest repeat biopsy cohort evaluated to date. METHODS: REDUCE was a 4-year prostate cancer risk reduction study, in which men with a negative baseline biopsy and serum PSA (sPSA) 2.5-10 were randomized to dutasteride or placebo (plac), and 10-core biopsies were obtained after 2 (yr2) and 4 years (yr4). PCA3 Scores were determined on urine specimens (n⫽1140) collected from men in the plac arm who were scheduled for biopsy at y2 and/or y4. The last PCA3 Score available for each subject was correlated with biopsy outcome. Multivariate logistic regression (LR) was also performed using PCA3, sPSA, % free PSA (fPSA), prostate volume, age and family history. RESULTS: For the urine specimens tested, 1072/1140 (94%) yielded sufficient RNA for PCA3 analysis; 18% of these 1072 subjects were biopsy positive for CaP. PCA3 was associated with positive biopsy rate (P⬍0.0001): 6% CaP for PCA3 ⬍5, 57% CaP for PCA3 ⬎100. PCA3 AUC of 0.693 was greater than sPSA (0.612, P⫽0.008 vs. PCA3) or fPSA (0.637, P⫽0.065). The LR model yielded an AUC of 0.753 (P⫽0.0025 vs. PCA3 alone). PCA3 was significantly correlated with biopsy Gleason Score (GS ⬎ 7 vs. ⬍7, P⫽0.0017). PCA3 determined at y2 was a significant predictor of y4 biopsy outcome (AUC ⫽ 0.634, P⫽0.0002); sPSA and fPSA were not predictive (P⫽0.328 and 0.678, respectively). CONCLUSIONS: PCA3 clinical utility for predicting repeat biopsy outcome was confirmed in a multi-center worldwide clinical trial. Assay informative rates were similar to previously published studies. PCA3 outperformed sPSA, and a predictive model incorporating sPSA, fPSA and other clinical information significantly increased diagnostic accuracy. PCA3 correlated with biopsy GS, providing further evidence that PCA3 might be useful for identifying more aggressive CaP. Finally, PCA3 may be detecting undiagnosed cancers, as we found that PCA3 Scores measured from biopsy negative men at year 2 of the trial predicted biopsy outcome at year 4. Source of Funding: Gen-Probe, Inc