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AUA 2009 Prostate Conditions Education Council Handouts Organizational Overview The Prostate Conditions Education Council (PCEC) formally the Prostate Cancer Education Council, is a national organization, headquartered in Colorado, founded in 1989, and is a non-profit 501-3c organization. Our mission is to save and improve lives through the education and awareness of prostate health issues as well as other men's health issues. We have targeted a variety of demographics including African American and Hispanic but we still need to reach rural areas. In 2008, the Prostate Conditions Education Council reached more than 200 Million People with important, life saving messaging on prostate health and prostate cancer. Based on the data and research from the Screening Sites, we have had an unprecedented Six abstracts accepted into the 2009 AUA and AACR Annual Meetings. Our flagship Prostate Cancer Awareness Week program has screened nearly 4 Million Men for prostate cancer and other men’s health issues. 2009 AUA Related Abstracts/Posters/Pod. Pres. Predictors of the Androgen Deficiency in Men (ADAM) Syndrome in a Prostate Cancer Screening Population Nelson N Stone; Kathryn Sullivan; Wendy Poage; E David Crawford MP34; Moderated Poster #1028; W183B; April 27th 1-3:00pm A Reduced American Urological Association Symptom Score Kathryn Sullivan; Al Barqawi; E David Crawford; Michael O'Leary; Colin O’Donnell; Paul Maroni POD 40; Podium Presentation #1654; W474AB; April 28th 2:20-2:30pm Medical Therapy Use Among Men at Increased Risk of BPH Progression Based on the PSA Threshold of 1.5ng/ml or Greater E David Crawford; Daniel Tandberg; Kathryn Sullivan; Nelson N. Stone; Colin O’Donnell POD 43; Podium Presentation #1796; W474AB; April 28th 3:50-4:00pm Feasibility of the PCA3 Urine Test in a Community-Based Screening Setting Adrie van Bokhoven; KathleenTorkko; Scott Shappell; Paul Arangua; John Fulmer; Stephen Vo; M Scott Lucia; Holly Sullivan; Abraham Woods, III; Al Barqawi; E David Crawford MP60; Moderated Poster 1814; W471AB; April 29, 2009 8-10:00am The Incidence and Characterization of the Metabolic Syndrome in a Prostate Cancer Screening Population Nelson N Stone; Mark Moyad; Frank Staggers; Wendy Poage; E David Crawford MP60; Moderated Poster 2216; W471AB; April 29, 2009 8-10:00am Predictors of the Androgen Deficiency in Men (ADAM) Syndrome in a Prostate Cancer Screening Population Authors: Nelson N Stone*, E. David Crawford, New York, NY Abstract: Introduction and Objective: The ADAM10 is a 10-point questionnaire designed to be utilized in clinical practice to screen for low testosterone. We sought to determine its utility during prostate cancer awareness week (PCAW). Methods: 10530 men attended PCAW 2007 and completed the ADAM questionnaire. A positive (+) ADAM was defined as a score of > 3 or a yes response to Q1 (decreased sex drive) or Q7 (erections less strong). Of the 10530, 4440 had serum testosterone determined and analyzed in a central lab. Associations between ADAM > 3, positive Q1 or Q7 and T cut-points were tested by chi-square analysis (Pearson). The sensitivity/specificity for the most predictive T level was analyzed using ROC curves for ADAM8, Q1 and Q7. One way analysis (ANOVA) was used to test means for T levels against ADAM8, Q1, Q7 and age group. Results: The median patient age was 61 (range 20-93) and the median T was 353 ng/dl (range 10-1650). 32.1%, 37.8%, and 52.3% had positive response to ADAM8, Q1, and Q7, respectively. Mean T levels for +ADAM8 were 357 vs. 375 (p<0.001), +Q1 358 vs. 377 (p<0.001) and for +Q7 363 vs. 378 (p=0.001). The cut point for T (low T) with the greatest area under the curve was <300 ng/dl (ROC: 0.545, 95% CI 0.525-0.564, p<0.001). Of the 4440, 1445 (32.5%) had a T < 300 ng/dl. 38.9% of men with low T had a +ADAM8 vs. 29.7% for those with normal T (p<0.001). 39.4% had +Q1 with low T vs. 28.9% with normal T (p<0.001) and 32.5% had +Q7 with low T compared to 28.7% with normal T (p<0.001). Age by decade also influenced men’s response to the questionnaire. Mean ADAM8 increased from 1.4 for < 40 years to 3.2 > 80 years old (p<0.001). The % of men with +Q1 and +Q7 similarly increased from 22.3% to 65.2% (p<0.001) and from 26% to 80.2% (p<0.001), respectively. However, regression analysis revealed that age was significant only in the 60-70 age group. Conclusions: Data from the PCAW 2007 population supports the use of the ADAM questionnaire to screen for a low T.T level of <300 appears to be the most predictive value for androgen deficiency. Abstract #1028 Medical Therapy Use Among Men at Increased Risk of BPH Progression Based on the PSA Threshold of 1.5 ng/ml or Greater: An Analysis of Data From the Prostate Cancer Awareness Week Screening Program Authors: E David Crawford*, Daniel J. Tandberg, Kathryn F. Sullivan, Aurora, CO; Nelson N. Stone, New York, NY; Colin I. O’Donnell, Aurora, CO Abstract: Introduction and Objective: In a 2006 study by Crawford et. al., men with moderate to severe lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) and elevated serum prostate specific antigen (PSA) were associated with an increased risk of BPH progression (Crawford ED et al. J of Urol, 175(4):1422-1427,2006). In the current study, we report the prevalence of moderate to severe LUTS in a large prostate cancer screening population, and the proportion of these men at high risk of BPH progression based on the PSA threshold of ≥ 1.5 ng/ml. We will also evaluate the population’s use of BPH medical therapy. Methods: A total of 10,706 men participated in the 2007 Prostate Cancer Awareness Week (PCAW) screening program. Of these, 6,245 men completed the self administered questionnaire, the American Urological Association Symptom Score (AUA SS) questionnaire and received a PSA blood test. The questionnaire was designed to gather background health information, including the use of prescription medications for LUTS/BPH. The results were stratified according to decade of age: 40-49, 50-59, 60-69, and 70-79 years. Results: The mean age was 60.51 ± 9.25. The median PSA and total AUA SS were 1.0 ng/mL and 5, respectively. Thirty-three percent of men presented with moderate to severe LUTS based on an AUA SS ≥ 8. Forty percent of the men with moderate to severe LUTS had a PSA of ≥ 1.5 ng/ml and were classified as high risk for BPH progression. The percentage of individuals with PSA of ≥ 1.5 ng/ml increased with each decade of age, 13% (40-49), 26% (50-59), 45% (60-69), and 56% (70-79), respectively (p ≤ .001). Twenty-one percent of these men were receiving medical therapy for LUTS/BPH. Of the men on medical management for LUTS/BPH, 70% were taking an alpha blocker, 8% were taking a 5-alpha reductase inhibitor, 7% were taking a combination of an alpha blocker and a 5-alpha reductase inhibitor, and 15% were taking other prescription medication. Conclusions: We observed that approximately one third of men in a large prostate cancer screening population had moderate to severe LUTS. Of these men, 40% had an increased risk for progression of clinically significant BPH. The proportion of individuals at risk for progression of clinically significant BPH increases with each decade of life. A small percentage of these men were taking a 5-alpha reductase inhibitor either alone or in combination with an alpha blocker in order to minimize risk for BPH progression. Abstract #1796 Feasibility of the PCA3 Urine Test in a Community-Based Screening Setting Authors: Adrie van Bokhoven; KathleenTorkko; Scott Shappell; Paul Arangua; John Fulmer; Stephen Vo; M Scott Lucia; Holly Sullivan; Abraham Woods, III; Al Barqawi; E David Crawford Abstract: Introduction and Objective: PSA, the standard screening test for prostate cancer (CaP), has low sensitivity/specificity. The PCA3 test is a new diagnostic tool that is increasingly used in clinical practice. Its feasibility and performance has not been evaluated in a true screening population. Methods: We evaluated the feasibility of collecting and processing a large volume of urine samples for PCA3 testing in a reliable and standardized manner using the community-based Prostate Cancer Awareness Week (PCAW) screening population at the University of Colorado Denver over a 3 year period (2006-08). PCA3 Scores (PCA3/PSA mRNA x10-3) were determined using transcription mediated amplification (Gen-Probe, Inc) at Avero Diagnostics. Results: A varied group of clinicians, including residents and NPs, received instructions on the extended DRE required to release prostate cells collected in first catch urine. Samples were processed in 1-4 hours and frozen at -80°C. PCA3 results were generated from 349, 311, and 209 men participating in PCAW 2006-08, respectively (some results pending for 2008). In 2006, the informative rate for the PCA3 test was 98.6%, a rate similar to studies in controlled clinical settings. In 2007/2008, the rates were 96.9 and 99.5%. The participants were 71%, 73%, and 78% Caucasian (C) for each year, 17%, 18%, and 13% African American (AA), and 9%, 7%, and 7% Hispanic (H). For each of the years, C men tended to be older (mean range 64-66) than either AA (57-59) or H (58-59) men. The positive rate for PCA3 (≥35) for each year was 25%, 25%, 26% for C men, 42%, 35%, 22% for AA, and 16%, 17%, 18% for H. The proportions for both PCA3+/PSA+ tests (≥2.5 ng/ml) were lower in H men (0-6% in 3 years) compared to C (9-11%) and AA (4-12%). The proportions of PCA3+/ PSA- tests were higher in AA men (18-30%) compared to C (15-16%) and H (10-18%). Rates of PCA3-/PSA+ tests were similar in all racial groups (9-16%). In a separate screening study (2008 African American Men’s Health Summit) targeting AA men specifically, the PCA3 test (n=276) was informative in 98.6%. Similar observations of a higher proportion of men with PCA3+/PSA- results were noted: 4% PCA3+/PSA+, 15% PCA3+/PSA-, 6% PCA3-/PSA+. Conclusions: The PCA3 assay is acceptable to men and can be performed in a busy screening setting. The excellent informative rate shows the robustness of this test. Because AA men are at highest risk for CaP and tend to have their disease diagnosed at a higher stage and grade compared to other racial groups, the difference seen in the proportion of AA men PSA- but PCA3+ may help improve early detection in AA men. Abstract #1814 The Incidence and Characterization of the Metabolic Syndrome in a Prostate Cancer Screening Population Authors: Nelson N Stone; Mark Moyad; Frank Staggers; Wendy Poage; E David Crawford Abstract: Introduction and Objective: The metabolic syndrome (MS) has been linked to various genitourinary disorders but its incidence and association to these disorders have never been fully established in a prostate cancer screening population. We investigated its link to urinary symptoms, sexual health, serum testosterone (T) and androgen deficiency in aging male (ADAM) during Prostate Cancer Awareness Week (PCAW) 2007. Methods: 3230 men attended PCAW 2007 at several longitudinal sites and filled out quality of life questionnaires, including the American Urologic Score (AUA), the sexual health inventory for men (SHIM) and the 10 point ADAM. In addition, data on high blood pressure (HBP), type 2 diabetes (AODM), high cholesterol (HC), height, weight, and waist size were collected. Serum T and cholesterol were analyzed in a central lab. The MS was identified according to the American Heart Association guidelines and included any three of the following: body mass index > 30, HC, HBP, AODM, waist size > 40 inches, and HC > 200. Associations were tested between the presence of MS and serum T, total AUA, SHIM and ADAM by one way anova. Association between MS and prostatitis, enlarged prostate (EP) and race were tested by chi square analysis (Pearson). Results: The median values for the tested variables are shown in the table. The MS was present 818/3220 (25.3%). Men with MS had lower T (323 vs 391, p<0.001), higher AUA score (7.5 vs 6.6, p<0.001), lower SHIM (15 vs 16.5, p<0.001), and higher ADAM scores (3.3 vs 2.3, p<0.001). 30.4% of the men with MS complained of diminished sex drive compared to 22.3% of those without MS (OR 1.56, 95% CI 1.29-1.80, p<0.001) while 61.2% stated their erections were less strong if they had MS as opposed to 47.9% without MS (OR 1.71, 95% CI 1.45-2.02, p<0.001). More men who had MS claimed to be taking T replacement therapy (3.2% vs 2% p=0.06). While 44/3220 (1.4%) had prostate cancer, prostate cancer was present in 17/818 (2.1%) of those with the MS (p=0.041). There were no associations of the MS with age, PSA, prostatitis, EP or race. Conclusions: MS occurs in one quarter of men attending prostate cancer awareness. Urologists need to be aware of the impact MS may have on the treatment and management of sexual health, low T, urinary symptoms, and prostate cancer. Abstract #2216 Council of Physicians E. David Crawford, M.D Chairman, PCEC University of Colorado John Lynch, M.D. Georgetown University David G. McLeod, M.D. Walter Reed Army Mack Roach, M.D. UC San Francisco Frank E. Staggers, M.D. National Med. Association Nelson N. Stone, M.D. Mount Sinai Daniel Petrylak, M.D Columbia-Presbyterian Mark Moyad, M.D., M.P.H. University of Michigan Prostate Conditions Education Council 7009 S. Potomac Street, Suite 125 Centennial, CO 80112 866-4Prost8 www.prostateconditons.org