14 A QUANTITATIVE EVALUATION OF PATIENT INFORMATION AVAILABLE ON THE INTERNET FOR TURP SURGERY

11

What is the cause of poor-response to silodosin treatment in relieving subjective symptoms in BPH patients? Prospective investigation using a pressure-flow study

Matsukawa Y., Hattori R., Matsuo K., Sassa N., Gotoh M. Nagoya University Graduate School of Medicine, Dept. of Urology, Nagoya, Japan Introduction & Objectives: Silodosin is a third-generation alpha 1-adrenoceptor (AR) antagonist, which is purely selective for an alpha 1A-AR subtype. This novel agent has been reported to bring an excellent relief of subjective symptoms in patients with BPH. However, some portion of the patients demonstrate a poor response in improving the symptoms, assessed by the International Prostate Symptom Score（I-PSS）. In this study, we assessed the efficacy of silodosin according to objective parameters based on pressure-flow study (PFS), and compared them between the good-responders and poor-responders to silodosin treatment in relieving subjective symptoms. Materials & Methods: A total of 102 patients with BPH were enrolled in this study. The patients received silodosin 8mg/day for 4 weeks. Before and after drug administration, the I-PSS and OABSS testing was conducted to evaluate subjective symptoms. PFS were conducted to obtain objective findings for storage and voiding functions, in terms of first desire to void (FDV), maximum cystometric capacity (MCC) and occurrence of detrusor overactivity (DO), maximum flow rate (Qmax) and detrusor pressure at Qmax (Pdet Qmax). In this study, we defined a good-responder as a patient with improvement in the I-PSS of 25% or more, and a poor-responder as one with less than 25%. Results: Good-responders and poor-responders comprised 70 and 32 patients, respectively. Mean age and mean prostate volume of the patients in the good- and poor-responders were 69.9 and 68.5 years, and 41.8 and 44.3 ml, respectively. Mean I-PSS and OABSS decreased from 16.9 to 9.1 points (p <0.001) , from 6.2 to 4.1 (p <0.001), in the good responder group, and from 19.7 to 16.8 points (p=0.16), from 6.0 to 5.2 (p=0.56), in the poor responder group. On PFS, in both goodand poor-responders, mean Qmax and mean Pdet Qmax significantly improved, demonstrating that silodosin relieved bladder outlet obstruction (Table). On the other hand, parameters of the storage function on PFS significantly improved in the good-responders, but not in the poor-responders. In particular, DO disappeared in 23 of 33 patients (69.7%) after administration in the good-responders, while in only 5 of 20 patients (25.0%) in the poor-responders (p=0.01). Good-responders (n=70)

Poor-responders(n=32)

FDV (mL)

pre post (p )

102 130 (0.002)

107 134 (p=0.06)

MCC (mL)

pre post (p)

247 278 (0.05)

231 256 (0.19)

Q max (ml/ sec)

pre post (p)

8.6 11.2 (<0.001)

6.8 9.2 (0.008)

Pdet Qmax (cmH2O)

pre post (p)

74.5 52.5 (<0.001)

76.5 55.7 (0.002)

Conclusions: In the poor-responders to silodosin treatment, insufficient improvement in storage function will be responsible to the poor response in IPSS, despite obtaining an improvement in voiding function and bladder outlet obstruction.

12

Performance of free PSA better than total PSA for estimation of prostate volume in elderly men without prostate cancer

Masuda H.1, Kawakami S.1, Sakura M.1, Fujii Y.1, Koga F.1, Saito K.1, Numao N.1, Yoshida S.1, Komai Y.1, Okada Y.1, Ito M.2, Yonese J.2, Fukui I.2, Kihara K.2 1 Tokyo Medical and Dental University, Dept. of Urology, Tokyo, Japan, 2Cancer Institute Hospital, Japanese Foundation for Cancer Research, Dept. of Urology, Tokyo, Japan Introduction & Objectives: Prostate volume (PV) is a key predictor of both progression and response to 5-alpha-reductase inhibitor therapy in patients with benign prostatic hyperplasia (BPH). Total prostate-specific antigen (tPSA) has been proposed as a reasonable proxy marker for PV in men without prostate cancer (PC) and nomograms to predict PV from PSA have been developed. Recently, free PSA (fPSA) or subforms of fPSA has been reported to outperform tPSA as a predictor of prostate enlargement. However, little is known about the association of fPSA and PV in Asian population. Thus, the aim of this study is to evaluate the relationships among age, tPSA, fPSA and PV and analyze whether fPSA performs better than tPSA as a predictor of PV in Japanese patients without PC. Materials & Methods: A total of 2183 Japanese men who were pathologically diagnosed without PC by an extended prostate biopsy with at least 12 cores were enrolled in the study. PV was measured with transrectal ultrasonography. They had a median age of 66 years, a median tPSA of 6.8 ng/ml, a median fPSA of 1.3 ng/ ml and a median PV of 41 ml, respectively. Patients were stratified by age into three groups: 50-59, 60-69 and 70-79 years. Patients aged <50 and ≥80 were excluded because of small number. Pearson’s correlation coefficient and linear regression model were used to evaluate correlations among age, tPSA, fPSA and PV in all and age-stratified cohorts. Receiver　operating characteristic (ROC) curves were

Eur Urol Suppl 2011;10(2):32

constructed to evaluate and compare the ability of tPSA and fPSA at estimating the PV. Results: TPSA, fPSA, %fPSA and PV significantly increased with advancing age cohort, respectively (p < 0.001 in each). In all patients, fPSA had a stronger correlation with age (fPSA=0.35, tPSA=0.18) or PV (fPSA=0.55, tPSA=0.24) than did tPSA. All stratified age cohorts showed the same findings. The degree of correlation was the highest among those aged 60-69 year. The ROC curves (for PV greater than 30, 40, and 50 ml) showed that fPSA (area under the curve [AUC]=0.79, 0.75 and 0.76) outperformed tPSA (AUC=0.67, 0.65 and 0.67) in its ability to predict clinically significant PV enlargement. Moreover, addition of age significantly increased the AUC for all above PV cut off points based on tPSA alone without increasing them based on fPSA alone. Optimal serum fPSA cut off points (ng/ml) to determine prostate enlargement (> 30, > 40 and > 50 ml) were 0.88, 1.06 and 1.20, respectively, according to ROC curves (both sensitivity and specificity ≥70%). Conclusions: Although tPSA significantly correlated with PV in Japanese men without PC, the correlation between fPSA and PV was much stronger and fPSA performed significantly better than tPSA at predicting thresholds of PV. Also, these predicting models were not affected by age. FPSA could be a useful tool in making therapeutic decisions and longitudinal follow-up with BPH in Japanese men.

13

Estimation of clinically relevant prostate volumes by digital rectal examination – a comparative study

Ahmad S., Manecksha R.P., Cullen I.M., McDermott T.E.D., Flynn R.F., Grainger R.G., Thornhill J.A. Adelaide and Meath Hospital Tallaght, Dept. of Urology, Dublin, Ireland Introduction & Objectives: Reliable estimation of prostate volume is important to select patients with symptomatic benign prostatic hyperplasia (BPH) for appropriate medical therapy, [e.g. 5 α - reductive inhibitors (5ARIs)] and in selecting most appropriate surgical approach. We present results of a prospective study assessing reliability of digital rectal examination (DRE) compared with Trans rectal ultrasound (TRUS) in estimating prostate volume. Materials & Methods: Patients requiring TRUS guided prostate biopsy (between August 2009 - April 2010), were recruited. DRE was performed twice, first at initial presentation and second prior to prostate biopsy. Clinicians categorized prostate size on DRE into small, medium, large, and estimated prostate volume in cc. TRUS volumes were measured using 2101 Falcon ultrasound machine. Furthermore, a national survey was performed to determine how urologists typically assessed prostate volume. Results: From the survey, 62% of urologists estimate prostate volume routinely by DRE, 16% with TRUS and 21% use both. In total 248 patients were recruited (mean age 64 yrs). Positive correlation (r = 0.86) seen in estimation of prostate volume between first and second DRE. The estimation of prostate volume on DRE was effected by the TRUS measured volume (Table). However, for clinical relevant prostate volumes (above 30 cc), 94% patients were accurately estimated on DRE. Furthermore, presence of malignancy (clinical or pathological) did not affect the volume estimation by DRE. TRUS measured prostate volumes

Correctly estimated on DRE*

Underestimated on DRE*

Overestimated On DRE*

< 30 cc (n = 87)

43 (49.5%)

0

44 (50.6%)

30 -79.9 cc (n = 145)

137 (94.5%)

8 (5.5%)

0

> 80 cc (n = 16)

6 (37.5%)

10 (62.5%)

0

Table: Accuracy of DRE in estimation of clinically relevant prostate volumes (* 1st DRE). Conclusions: The 5ARIs are beneficial for symptomatic BPH patients with prostate volumes over 30 cc. We have shown that DRE had positive predictive value of 94% in identifying prostate above 30 cc. Hence, when considering treatment with 5ARIs, DRE may be sufficient to identify suitable patients for 5ARIs therapy. However, for prostate volumes between 25-30 cc and above 80 cc, TRUS may be required.

14

A quantitative evaluation of patient information available on the internet for TURP surgery

Kar A.K., Neffendorf J.E., Mayer E.K. St Mary’s Hospital, Imperial College Healthcare NHS Trust, Dept. of Surgery and Cancer, London, United Kingdom Introduction & Objectives: Transurethral resection of the prostate (TURP) remains a common intervention for bladder outflow obstruction. When considering their treatment options, patients are increasingly gaining access to further medical information and advice using the internet. However there have been concerns regarding the reliability and quality of websites. The Health On the Net Foundation (HON) has devised the HONcode certification which provides accreditation to health information websites. The LIDA tool is an online validated instrument that has been developed to evaluate the accessibility, usability and reliability for health care websites. This study objectively assesses medical websites providing information on TURP.

Materials & Methods: We searched the keywords “TURP” in the most popular three search engines: Google, Yahoo and MSN/Bing. The top 50 websites were evaluated from each search engine (n=150). Readability of the websites was assessed using the Gunning-Fog Index (GFI, measure of years of schooling needed to understand content) and the Flesch Reading Ease Score (FRES, standard readability index rating – score/100). Websites were checked for HONcode certification and the information evaluated using the LIDA tool. Results: 45 out of 150 sites were analysed with the others excluded for irrelevant content (48), repetitions (54), or inaccessible links (3). Interestingly only four of those were HONcode-certified and none included the British Association of Urological Surgeons (BAUS) website; a recognised source for online patient information in the UK. Mean results for readability showed a GFI = 10.9 (SD=2.6) implying that the average TURP website was at a level similar to reading Time/ Newsweek magazines. The mean FRES was 56.9 (SD=14.1), below the universally encouraged target of 60-70. When analysing TURP websites we found the mean. Total LIDA score was 65.7% (SD=13.2) and specifically the Accessibility=76.8% (SD=12.7), Usability=63.7% (SD=23.6) and Reliability=48.1% (SD=23.0). The BAUS website was significantly better with total LIDA score = 89% (Accessibility=94%, Usability=100% and Reliability=73%). Conclusions: Our study has evaluated websites for patients searching for information on TURP and has shown there is overall poor accessibility, readability and reliability of information on the internet. Moreover, despite measures to ensure certification, very few of the most popular websites are even accredited. The BAUS website has been objectively shown to be reliable, accessible and readable in providing information on TURP but is not in the most popular 150 searches or HONcode certified. We suggest that with increasing emphasis in the outpatient clinic on patient choice and informed decision making, the role of the clinician should also be in ensuring we guide and help patients identify valid sources of information, particularly on the internet e.g. by offering specific portals such as the BAUS website.

Poster Session 2 PROSTATE CANCER SCREENING Saturday, 19 March, 08.30-10.00, Hall E1

15

The positive effect of prostate cancer screening on metastatic disease is increasing

Van Leeuwen P.J., Roobol M.J., Bul M., Zhu X., Schröder F.H. ErasmusMC, Dept. of Urology, Rotterdam, The Netherlands

save one men from PCa metastases was 23. Conclusions: A relative reduction in PCa metastases of 30% was observed in the intervention population relative to the control population of the ERSPC section Rotterdam. Longer follow up is likely to demonstrate an increasing benefit of PSA screening terms of distant metastases.

16

Development of the European Randomized study of Screening for Prostate Cancer (ERSPC) risk calculator for high grade PCa and assessing and comparing its performance with the PCPT risk calculator in a Canadian cohort

Roobol M.J.1, Schröder F.H.1, Trottier G.2, Fernandes K.A.2, Kranse R.3, Fleshner N.E.2 1 Erasmus University Medical Center, Dept. of Urology, Rotterdam, The Netherlands, 2 Princess Margaret Hospital, University Health Network, University of Toronto, Dept. of Urology, Toronto, Canada, 3Comprehensive Cancer Center, Rotterdam, Rotterdam, The Netherlands Introduction & Objectives: Risk stratification to identify men at increased risk of having prostate cancer (PC) is often done with risk calculators (RC). Two often used RC are the PCPT RC and the ERSPC RC [1,2]. The PCPT RC can also calculate the risk of high grade PC. This feature is currently lacking in the ERSPC RC. Here we report of the development of the ERSPC RC for high grade (HG) or advanced PC and validate and compare this new RC with the PCPT RC using a contemporary Canadian cohort. Materials & Methods: The dataset for the ERSPC RC for HG or advanced PC consists of 3616 men all biopsied at 1st screening in ERSPC Rotterdam. A total of 885 PC cases were detected (24.5%), 431 (48.7%) could be classified as Gleason >= 7 and/or T-stage > T2B. Logreg analysis with Log transformed centered PSA and prostate volume, outcome of DRE and TRUS (1/0) was used to construct the ERSPC RC for HG or advanced disease. Validation and comparison with the PCPT RC was done on 982 men in a Canadian patient cohort. PC was diagnosed in 46% and HG disease (any primary or secondary Gleason pattern ≥4) in 23% of men. Outcomes were compared with predictions on the basis of PSA alone. Results: The newly developed ERSPC RC for HG or advanced PC showed an AUC of 0.86 (95%CI 0.84-0.86) on the ERSPC dataset (AUC PSA alone 0.74). AUC’s of the ERSPC RC and the PCPT RC for HG PC on the validation cohort were 0.76 (0.72-0.79) and 0.68 (0.64-0.72), p < 0.0001 res. AUC PSA alone was 0.61.The PCPT RC has minor under prediction in risk ranges < 30% and over prediction in risk ranges > 40% while ERSPC tends to under estimate risk in risk ranges up to 60% (figure). The PCPT RC is slightly better calibrated for the Canadian cohort, while the ERSPC RC is a better discriminatory model.

Introduction & Objectives: Prostate specific antigen (PSA) screening on prostate cancer (PCa) was shown to reduce the PCa specific mortality in screened men, aged 50-69 years. A second main endpoint of a population-based screening trial is the effect on the quality of life. Therefore, the effect of PSA screening on the incidence of PCa distant metastases is assessed. Materials & Methods: A total of 35153 men, aged 55-69 years, were randomized to receive systematic screening (intervention arm) or usual care (control arm) in the European Randomized Study of Screening for Prostate Cancer (ERSPC) section Rotterdam. All men were followed for a PCa diagnosis and PCa distant metastases up to December 31, 2008. Presence of distant metastases was defined by a positive isotope bone scan, or by a serum PSA concentration ≥100.0 ng/ml, in case an isotope bone scan was not performed.

Results: Median follow up was 11.0 years. Up to the end of 2008, a total of 2,036 (11.6%) men were diagnosed with PCa in the intervention arm and a total of 902 (5.1%) men were diagnosed with PCa in the control arm. The rate in PCa metastases was 0.62 men per 1000 person-years in the intervention arm and 0.88 men per 1000 person-years in the control arm. The relative reduction in PCa metastases in the intervention relative to the control arm was 30%; RR 0.70 (95%CI, 0.55-0.89, p=0.003). As shown, the cumulative hazard in PCa metastases started to differ after five years of observation and became statistically significant more than seven years after start observation (Figure 1). After a median of 11 years, the absolute reduction in PCa metastases was 2.80 per 1000 men. Overall, the associated NNS to save one man from PCa metastases was 357, the NNT to

Conclusions: The new ERSPC RC for HG or advanced PC performs well in a contemporary cohort (AUC of 0.76). The nature of the development cohorts (ERSPC: Population based, one single sextant biopsy, PCPT: Low risk cohort, 14% with multiple sextant biopsies over 7 yr period) is reflected in the outcomes when applying both RC to the validation cohort. Despite these differences risk stratification on the basis of a RC outperforms stratification using only PSA. 1. http://deb.uthscsa.edu/URORiskCalc/Pages/uroriskcalc.jsp 2. http://www.prostatecancer-riskcalculator.com/via.html

Eur Urol Suppl 2011;10(2):33