5-YEAR RESULTS OF A MULTI-CENTER STUDY OF COOLED THERMOTHERAPY FOR BENIGN PROSTATIC HYPERPLASIA

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patients catheter-free at discharge. All patients were able to discontinue their prostate medications following surgery. The mean rates of prostate vaporization (3.7 ± 2.2 and 3.0 ± 1.4 mL/min, p=0.11; 0.55 ± 0.33 and 0.59 ± 0.71 mL/kJ, p=0.77) and TRUS volume decrease 12 weeks post surgery (54 ± 14 and 51 ± 12 %, p=0.32) were similar between the two groups. AUASS, Qmax and PVR values showed significant improvement within each group (p<0.05), but the degree of improvement between the two groups did not show statistical significance. CONCLUSIONS: Our experience suggests that 5A-reductase inhibitors do not have a detrimental effect on the efficiency and efficacy of GreenLight HPS™ laser PVP. Source of Funding: None

2120 IS THE URINARY VOIDING CONDITION INFLUENCED BY THE RESIDUAL PROSTATE ADENOMA POST PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE? CONSIDERATION FROM THE EFFICACY IN JAPANESE PATIENTS. Hideo Otsuki*, Yoshitaka Kuwahara, Ichiro Nagakubo, Tokyo, Japan INTRODUCTION AND OBJECTIVE: Photoselective Vaporization of the Prostate (PVP) for the treatment of BPH is a safe and effective surgery. The only problem is residual prostate adenoma. Japanese urologists have surgically aimed for volume reduction of the prostate as much as possible in cases of TURP and HoLEP. Meanwhile, the rate of volume reduction in PVP is less than 50%. It is not clear whether the residual adenoma influences the urinary voiding condition. Therefore, we examined the relationships between the residual adenoma after PVP and urinary voiding condition. METHODS: Since Jan 2006 more than 400 cases underwent PVP and 194 cases have been followed more than 1year. Patients were pre and post-operatively assessed by: IPSS score, QOL score, maximum urinary flow rate (Qmax), prostate volume (Pvol), post-void residual volume (Vres). Changes of outcome parameters were compared in 4 groups classified according to the preoperative prostate volume: <30ml(group A, n=27), 30−50ml (B, n=85), 50−70ml (C, n=56),and 70ml< (D, n=26). RESULTS: Mean operating time and energy are following: 44.2m, 159kj (group A), 66.7m, 266kj (B), 121m, 401kj (C) and 196m, 573kj (D). All parameters (IPSS, QOL score, Qmax, Pvol and Vres) were improved significantly in each group. The postoperative prostate volume (residual adenoma) was the biggest in D group. Changes of IPSS score, QOL score and Qmax are following: -10.0, -2.9, +6.4 ml/s,(group A ), -11.1, -3.1, +7.0 ml/s (B), -15.4, -3.6, +9.7 ml/s (C), -19.5, -4.2, +10.8 ml/s (D). This result shows the cases with the bigger preoperative prostate volume improve the better. CONCLUSIONS: Our PVP experience from Japanese patients indicates the residual prostate adenoma after PVP does not influence urinary voiding condition. PVP is more effective on the cases with the bigger prostate volume. IPSS IPSS QOL QOL Qmax Qmax Pvol Pvol Vres Vres score score score score (ml/s) (ml/s) (ml) (ml) (ml) (ml) Group(Pvol)

pre

post

pre

post

pre

post

pre post pre post

A(<30)

20.6

10.6

5.2

2.3

7.8

14.2

24.4 13.3 114

39

B(30-50)

20.4

9.3

5.3

2.2

9.7

16.7

39.6 23.6 88

24

C(50-70)

22.3

6.9

5.2

1.6

8.1

17.8

58.1 34.4 150

29

D(70<)

25.3

5.8

5.4

1.2

5.2

16.0

93.9 49.7 206

27

Source of Funding: None

769

2121 COMPARISON OF PHOTOSELECTIVE VAPORIZATION AND STANDARD TRANSURETHRAL RESECTION OF THE PROSTATE ON URODYNAMICS IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA Narihito Seki*, Hiroyuki Nomura, Akito Yamaguchi, Seiji Naito, Fukuoka, Japan INTRODUCTION AND OBJECTIVE: To compare the effects of photoselective vaporization of the prostate (PVP) and conventional transurethral resection of the prostate (TURP) on the efficacy outcomes and urodynamic parameters of patients with benign prostatic hyperplasia. METHODS: The efficacy and morbidity following PVP (78 patients) and TURP (51 patients) were compared in a prospective, nonrandomized trial. The primary outcome variables included the rate of improvement in the International Prostate Symptom Score, quality-oflife score, peak urinary flow rate and post-void residual urine volume at 3, 6 and 12 months postoperatively. The secondary outcomes were the change of urodynamic variables, including the index of bladder outlet obstruction and detrusor contractility based on the urodynamic results at baseline and at 6 months of follow-up. RESULTS: The rate of improvement in all outcome variables after PVP was comparable with that observed following TURP within 12 months. Outcome of the urodynamic parameters, including the relief of bladder outlet obstruction (pre/post of median value of bladder outlet obstruction index in the PVP group 63/2 versus in TURP group 61/5) and detrusor overactivity (pre/post of rate of detrusor overactivity in the PVP group 49%/27% versus in TURP group 53%/29%), was similar with a minimal change in the detrusor contractility. The grade of detrusor contractility according to the Schafer nomogram was identical to the baseline range in 84.6% (66/78) and in 86.3% (44/51) of the patients after PVP and TURP, respectively. The overall morbidity was comparable in both groups. One patient with PVP and 2 with TURP required transurethral electric coagulation for postoperative bleeding. Two patients in each group required re-catheterization for a failed initial trial of voiding. Dysuria was noted in 14.1% of the patients after a PVP and in 5.9% of the patients after a TURP. There were 5 newly documented instances of urethral stricture (2 in PVP, 3 in TURP) for which a postoperative intervention was required. One patient in each group developed stress urinary incontinence and it continued until 3 months after the PVP and until 5 months after TURP. CONCLUSIONS: The outcome within 12 months after PVP is as effective as conventional TURP, providing a compatible relief of bladder outlet obstruction and detrusor overactivity without affecting the detrusor contractility. Source of Funding: None

2122 5-YEAR RESULTS OF A MULTI-CENTER STUDY OF COOLED THERMOTHERAPY FOR BENIGN PROSTATIC HYPERPLASIA Claus G Roehrborn*, Dallas, TX; Lance Mynderse, Rochester, MN; Alan W Partin, Baltimore, MD; Glenn M Preminger, Durham, NC; Eric Coté, Richmond, VA INTRODUCTION AND OBJECTIVE: The Cooled ThermoCath® (CTC) from Urologix, Inc, used in the treatment of BPH, combines high energy TUMT with an advanced cooling system. Early studies documented that the 28.5-minute CTC treatment is able to produce interstitial treatment temperatures and post-treatment necrosis comparable to Targis® 60-minute treatment. Data from a multicenter US IDE study supported this hypothesis, and longer-term patient outcome data is now becoming available. METHODS: 70 patients were enrolled to undergo a single CTC treatment in an outpatient setting with oral and topical analgesia only. Primary enrollment criteria included AUA Symptom Score q 8 and peak urinary flow rate (Qmax) a 15 mL/sec. At enrollment, patients were 67.2 ± 8.3 years old, had exhibited BPH symptoms for 6.9 ± 4.2 years, and

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had pre-treatment prostatic size of 49.4 ± 21.5 gm. Treatment tolerance was measured with a Visual Analog Scale (VAS - scale 0-10). In a subset of patients, 1-week post-treatment volume of necrosis was measured by MRI. Follow-up evaluations conducted yearly measured AUA Symptom Score (AUASS), quality of life score (QOL), and Qmax. RESULTS: No severe treatment-related adverse events were reported. Previously reported preliminary results showed statistically significant improvement in the efficacy measurements, and that has continued as more patients report in for long-term follow-up (see below; p<0.0001 for all follow-up unless marked below). At 4 years, freedom from any additional therapy was 70.4%, and freedom from surgical treatment was 90.5%. A complete five year data set will be available in the spring.

to a level above 4 (Table). The proportion of CaPdiagnosed during 7 years of follow up increased with higher baseline PSA levels (0.60% to 23.29% in men with an initial PSA <1ng/mL and between 3-4 ng/mL, respectively). CONCLUSIONS: We have reported that 98.68% of men with PSA < 1ng/ml at baseline would remain negative (i.e., PSA a 4ng/ml) after 5 subsequent years of annual PSA testing, and that 99.1% of men with a baseline PSA of 1-2ng/ml would have a negative PSA test the following year. As a result of further follow-up a strategy of PSA screening every 5 years for men with PSA < 1ng/ml and every 2 years for men with PSA in the 1-2ng/ml range would produce an approximate 70% reduction in the number of PSA tests, but result in only a small percentage of men missing an earlier potentially positive test. The estimated cost savings of this strategy is on the order of a billion dollars per year.

Results Through 5-Years Post Treatment (unpaired)

Cumlative proportion of men converting from a baseline PSA level of a4ng/mL to a PSA level of >4ng/mL through 5 annual screening rounds PSA (ng/mL) at Year 0 0-0.99 1-1.99 2-2.99 3.-4.0 Number (%) coverting (N=14,114) (N=9,739) (N=3,763) (N=1,962) 42 88 164 534 Year 1 (0.30%) (0.90%) (4.36%) (27.22%) 77 198 393 881 Year 2 (0.55%) (1.03%) (10.44%) (44.90%) 109 347 679 1082 Year 3 (0.77%) (3.56%) (18.04%) (55.15%) 142 476 887 1189 Year 4 (1.01%) (4.89%) (23.57%) (60.6%) 680 1119 1299 187 Year 5 (1.32%) (6.98%) (29.74%) (66.21%) No. (%) prostate cancers (diagnosed 85 352 433 457 within 7 years of trial entry) (0.60%) (3.61%) (11.51%) (23.29%)

Baseline

1Y

2Y

3Y

4Y

5Y

AUASS (mean/n)

20.8/66

8.4/62 9.2/53 10.2/46 11.7/42 11.4/28

QOL (mean/n)

3.9/66

1.7/61 1.7/52 1.9/45 1.9/42 2.2/27

Qmax (mean/n)

8.3/66

13.0/59 12.7/45 11.7/34 13.0/37 11.6/26

Subjects w/ any retreatment (cumulative) Subjects w/ surgical retreatment (cumulative)

n/a

5

12

15

18

19

n/a

2

5

5

6

6

CONCLUSIONS: The CTC 28.5-minute treatment demonstrates efficacy and durability through at least 4 years in all three major BPH evaluation criteria: Qmax, AUASS, & QOL.

No. (%) Gleason q7

Source of Funding: Urologix, Inc.

20 (0.14%)

108 (1.11%)

136 (3.61%)

123 (6.27%)

Source of Funding: National Cancer Institute

Prostate Cancer: Markers (I) 2124 Moderated Poster 74 Wednesday, April 29, 2009

DISTRIBUTION OF PSA VELOCITY BY TOTAL PSA LEVEL: DATA FROM THE BALTIMORE LONGITUDINAL STUDY OF AGING. 1:00 pm - 3:00 pm

2123 POTENTIAL FOR INCREASE IN SCREENING INTERVAL BASED ON INITIAL PSA: DATA FROM THE PROSTATE, LUNG, COLORECTAL AND OVARIAN (PLCO) CANCER SCREENING TRIAL E David Crawford*, Denver, CO; Amanda Black, Bethesda, MD; Robert L Grubb, III, St Louis, MO; David Chai, Los Angeles, CA; Gerald L Andriole, Jr, St Louis, MO; Douglas Reding, Marshfield, WI; Philip C Prorok, Christine D Berg, Paul F Pinsky, Richard B Hayes, David L Levin, Barrett S Kramer, Bethesda, MD INTRODUCTION AND OBJECTIVE: The value of early detection of prostate cancer remains to be established. However, PSA screening is commonplace and is generally conducted on an annual basis. The effects of a change in screening patterns are unknown. We assessed the chances of an initially normal PSA rising to a level > 4 ng/mL over 5 years of screening. METHODS: The PLCO Trial is a large controlled trial that recruited 76,693 men aged 55-74, and randomized them to a screening arm or usual care arm. PSA was determined at 6 annual screening rounds; DRE was performed at the first four exams. We evaluated changes in PSA over 5 years among 29,582 men in the screening arm who had baseline PSA levels a 4 ng/mL and at least one subsequent PSA exam. The cumulative proportion of men who converted from PSA a4 ng/mL at baseline to PSA >4 ng/mL at years 1 through 5 was determined. These men were followed for up to 7 years from trial entry for prostate cancer (CaP) diagnosis. Only those cancers with available Gleason grading were included. RESULTS: PSA levels in 3,285 (11.1%) men with an initial PSA level a4 ng/mL increased to >4 ng/mL through 5 subsequent screening rounds. Across increasing initial PSA strata, there was a larger proportion of men converting to levels > 4 ng/mL; where only 1.32% of men with an initial PSA <1 converted, two thirds of men with an initial PSA of 3-4 ng/mL converted

Stacy Loeb*, H. Ballentine Carter, Edward M. Schaeffer, Anna Kettermann, Luigi Ferrucci, E. Jeffrey Metter, Baltimore, MD INTRODUCTION AND OBJECTIVE: Our group previously reported that a PSA velocity (PSAV) >0.35 ng/ml/year was associated with a 5-fold increased risk of prostate cancer death more than a decade later. How frequently does a PSAV of this magnitude occur in unaffected community men, and does the prevalence depend on total PSA? Our objective was to describe the distribution of PSAV in different total PSA ranges among men from a longitudinal aging study. METHODS: From the Baltimore Longitudinal Study of Aging, we identified 792 men with serial PSA measurements, yielding a total of 3548 PSAV observations. First we examined the PSAV distribution for observations within various total PSA ranges, both in controls and in participants diagnosed with prostate cancer. In addition, we calculated the proportion of observations with a PSAV >0.4 or >2 ng/ml/year (also previously associated with prostate cancer mortality), stratified by the total PSA level. RESULTS: In the overall population, the mean age was 61.7 ± 13.7 years. The median PSA and PSAV were 1.0 ng/ml (range, 0-352) and 0.04 ng/ml/year (range, -7.8 to 138.7), respectively. PSAV was significantly higher among men with prostate cancer than in the control group for observations at PSA levels <3 ng/ml (p=0.02) and from 3 to 10 ng/ml (p=0.0008). As shown in the Table, the mean PSAV rose continuously with increasing PSA range in both the control and prostate cancer populations (p<0.0001). The proportion of observations with a PSAV >0.4 or >2 ng/ml/year was also highly dependent on the total PSA level (Table). CONCLUSIONS: There is a strong association between PSAV and total PSA in men with and without prostate cancer. Over 90% of controls with a PSA <3 ng/ml had a PSAV <0.4 ng/ml/year, and fewer than 5% of observations had a PSAV >2 ng/ml/year in any PSA range. The PSAV distribution was significantly higher in prostate cancer cases than controls within all PSA ranges studied. To enable the optimal