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166HE UTILITY OF PSA FOR DETECTION OF PROSTATE CANCERN MEN TREATED WITH DUTASTERIDE: RESULTS FROM THEEDUCTION BY DUTASTERIDE OF PROSTATE CANCER EVENTSREDUCE) STUDY

.L. Andriole1, D. Bostwick2, O. Brawley3, L. Gomella4, M. Marberger5,∗ , F. Montorsi 6,

. Pettaway7, T. Tammela8, C. Teloken9, D. Tindall 10, T.H. Wilson11, M. Somerville11, I.owler11, R.S. Rittmaster11, on behalf of the REDUCE Study Group

Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA, 2 Bostwick Laboratories,ichmond, Virginia, USA, 3 Emory School of Medicine, Emory University, Atlanta, Georgia, USA, 4 Kimmelancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA, 5 University of Vienna, Vienna,ustria, 6 Universita Vita Salute San Raffaele, Milan, Italy, 7 The University of Texas, M. D. Anderson Can-er Center, Houston, Texas, USA, 8 Department of Urology, Tampere University Hospital, Tampere, Finland,Fundacão Faculdade Federal de Ciências Médicas de Porto Alegre e Complexo Hospitalar Santa Casa, Portolegre, Brazil, 10 Mayo Clinic, Rochester, Minnesota, USA, 11 GlaxoSmithKline, Research Triangle Park, Northarolina, USA-mail address: uroldep@meduniwien.ac.at (M. Marberger).

ackground: Using data from the 4-year REDUCE study we explored the effect of dutasteriden PSA sensitivity and specificity for prostate cancer (PCa) detection. By inhibiting PSA synthe-is in benign prostate tissue and low-grade PCa, dutasteride may enhance the utility of PSA iniagnosing PCa, particularly high-grade PCa.

ethods: REDUCE was a 4-year, randomized, double-blind, placebo-controlled study evaluatinghe efficacy and safety of dutasteride in PCa risk reduction in men aged 50—75 years with aerum PSA 2.5—10.0 ng/mL and a single prior negative prostate biopsy. The primary endpointesult at 4 years has been reported. Here we compare PCa sensitivity and specificity profiles inutasteride- and placebo- treated men for the initial decline in PSA, final PSA before biopsy andhange in PSA (from Month 6 to final PSA) by calculating area under the curve (AUC) valuesrom receiver operating characteristic (ROC) curves for both treatment groups, separately.

esults: Analyses included 3303 men (81.6%) in the dutasteride group and 3423 men (84.1%) inhe placebo group, who underwent at least one study biopsy. Following 6 months of dutasteride,imilar reductions in mean PSA were observed in men with no cancer, Gleason score 5—6 PCand Gleason score 7—10 (high-grade) PCa (47.0%, 45.4% and 46.3% decrease, respectively). There-fter, for both arms, PSA was highest in men with high-grade PCa, whereas PSA was similarmong men with low-grade or no cancer. Final and change from Month 6 to final PSA per-ormed better in men who received dutasteride vs. placebo for overall PCa diagnosis (AUC 0.624s. 0.572, p = 0.0017; 0.637 vs. 0.529, p<0.0001, respectively) and Gleason score 7—10 PCa diag-osis (0.700 vs. 0.650, p = 0.0487; 0.699 vs. 0.593; p = 0.0001, respectively). In men who receivedutasteride, any increase in PSA from Month 6 to final was associated with a higher likelihoodf biopsy detectable PCa, Gleason score 7—10 PCa, and higher mean tumor volume on biopsy,ompared with no increase in PSA.

onclusion: Dutasteride enhances the utility of PSA for PCa detection, particularly high-gradeCa, in men at increased risk for this disease but with a previous negative biopsy. The ini-ial decrease in PSA with dutasteride does not predict the presence or grade of PCa; however,ny subsequent increase in PSA from Month 6 in men taking dutasteride can identify men atncreased risk of PCa overall and high-grade tumors, who would therefore benefit from confir-atory biopsy.

oi:10.1016/j.jomh.2009.08.163

167FFECT OF THE LONG-ACTING PARENTERAL TESTOSTERONENDECANOATE IN ERECTILE DYSFUNCTION

oon Yong Kim

Philip and Paul Medical Institute-mail address: kjy2344@naver.com.

urpose: Long acting parenteral testosterone undecanoate(TU) has been widely prescribed for late onsetypogonadism. To assess the effects of long-acting injectable testosterone undecanoate (TU, Nebido) inate onset hypogonadism (LOH) Patients with erectile dysfunction, we investigated the changes in erectileunction(IIEF-5, 5 Item Version of International Index of Erection) and serum testosterone concentration.

aterials and Methods: Of those patients who visited our clinic for PADAM(Partial Androgen Deficiencyn the Aging Male) symptoms and had decreased serum levels of total testosterone, men with erectile dys-unction were reviewed. We evaluated 38 medical records of late onset hypogonadism patients who havead received parenteral testosterone undecanoate (TU) 1000mg every 12 weeks. Compared to pretreat-ent, changes of serum total(free) testosterone, lipid profile, CBC, PSA and IIEF-5 score were evaluated.

esults: Mean age, duration of therapy were 46.7 years and 217.5days. Initial and final serum testosteroneevels(ng/dl) was were 3.12, and 5.63, respectively. Plasma testosterone immediately before the follow-ng injection was evaluated. Compared to pretreatment, serum total testosterone level was significantlyncreased through treatment. TU also improved IIEF-5 score from 11 to 18.

onclusions: In this study, injectable long acting testosterone undecanoate effectively elevated serumestosterone level. These results suggest that an optimal prescription of injectable long acting testosteronendecanoate can effectively increase the serum concentration of testosterone and improve erectile func-ion. For a more conclusive of findings on the effectiveness of injectable testosterone undecanoate, largerospective studies are will be required.

ncited references

[1—4].

eferences

[1] Schubert M, Minnemann T, Hubler D, Rouskova D, Christoph A, Oettel M, Ernst M, Mellinger U,Krone W, Jockenhovel F. Intramuscular testosterone undecanoate: Pharmacokinetic aspects of a novel

testosterone formulation during long-term treatment of men with hypogonadism. J Clin EndocrinolMetab 2004;89:5429—34.

[2] Harle L, Basaria S, Dobs AS. Nebido: a long-acting injectable testosterone for the treatment of malehypogonadism. Expert Opin Pharmacother 2005;6:1751—9.

[3] Yassin AA, Saad F. Treatment of sexual dysfunction of hypogonadal patients with long-acting testos-terone undecnoate (Nebido). World J Urol 2006;24:639—44.

[4] Yassin AA, Saad F, Traish A. Testosterone undecanoate restores erectile function in a subset of patientswith venous leakage: a series of case reports. J Sex Med 2006;3:727—35.

oi:10.1016/j.jomh.2009.08.164

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168NNOVATION IN THE MEDICAL TREATMENT OF ADVANCEDROSTATE CANCER

ksam A. Yassin

Departments of Urology & Andrology, Rathauallee, Norderstedt-Hamburg, Germany-mail address: yassin@t-online.de.

ackground: Search for more effective and safer therapy to obtain better efficacy, effectiveness and sur-ival in patients with advanced prostate cancer.

ethods: Review of related literature of recent therapy methods such as vaccinations and LH/RH antag-nist. Literature search through Pubmed and Medline and comparative review of related articles. Fourcientific posters and four papers had been considered in this work.

esults: Principle of vaccination tumors in general and prostate cancer in particular, thus two basic waysor production but one mechanism of action involving the dendritic cells.

Almost 16 years of modern research passed to harness a patient’s own immune system to fightheir prostate cancer. It started in basic research with Bessler from Freiburg University in Germany,nd later on together with a Russian group in clinical research and acknowledged treatment in Russianederation und Eastern Europe for 7 years. Immunomax, (an Antigen Vaccine), an acidic peptidoglycanf a molecular mass 1000—40000 kDa, constitutes a novel immune stimulant obtained from potatoprouts. In animal experiments, the substance stimulates NO production in murine bone marrow derivedacrophages and activates murine splenocytes comparable to bacterial lipopeptides. It works as immune

timulant in humans with bacterial, fungial and/or viral infections including also those with Ureaplasma,ycoplasma and Chlamydia. In addition, patients with HIV- or hepatitis could make remarkable therapyrofit. Immunomax therapy also shows a therapeutic benefit in prostatitis as well. In preliminary stud-es, patients responded well to the treatment with significant reductions of leukocytes in the ex-primaterine, and in increase of life quality as determined by the National Institutes of Health, Chronic Prostati-is Symptom Index (NIH-CPSI). In Germany, in case reports on advanced prostate cancer patients, theyhowed to respond well to the treatment with a reduction of PSA. Thus, this immune stimulant acts as aotent macrophage activator in animal studies and is, in human patients, a novel useful therapeutic agentor the therapy of disorders of the urogenital tract and maybe other kinds of tumors or malignancies.i.m. injections once a week for 6 weeks. No side effects).

Another agent (Lymphocytes solution), is designed also to treat the disease rather than prevent it.hysicians collect specialized immune cells called dendritic cells from the patient’s blood, mix them withroteins collected from the surface of tumor cells and inject them back into the patient (i.v. injections) inhree doses at two-week intervals. This will be much easier for patients than going through chemother-py because there are no side effects (S. Gerson, University Hospitals Ireland Cancer Center, Cleveland).In a previous study released in 2007, it had been found that vaccine increased survival in patients withetastatic disease by 18 weeks compared with patients given a placebo. After three years, 34% of those

n the vaccine group survived, compared with 11% of those in the placebo group. The new double-blindtudy involved 512 patients with advanced prostate cancer. Two-thirds received lymphocytes vaccine, andhe rest received a placebo. Median survival in the vaccine group was 26 months, compared with 22onths in the placebo group. (P. Schellhammer of Eastern Virginia Medical School in Norfolk). whereas

he current treatment for such patients is Taxotere, known generically as Docetaxel, which extends sur-ival two to three months at most and has often-disabling side effects. Many men refuse to take it, sideffect profile can include bone and muscle pain, allergic reactions, decreases in white and red blood cells,nd neuropathy.Promising class of agents that might address these shortcomings is the GnRH blockers. GnRH blockers,

ike GnRH agonists, bind to the GnRH receptor, but produce immediate LH and testosterone suppressioni.e. with no initial testosterone flare), as has been reported for Degarelix, the most promising agent inhis class to date.

onclusive Discussion: Therapeutic vaccination, antigenic or cellular, extended average survival by fouronths compared with a placebo, nearly twice as long as the best available chemotherapy, and increased

hree-year survival by 38%, researchers said at a Chicago meeting of the American Urological Association009.Degarelix (regimens of 240/80 and 240/ 160mg) induced testosterone and PSA suppression significantly

aster than leuprolide; PSA suppression was also maintained throughout the studies. Degarelix representsn effective therapy for inducing and maintaining androgen deprivation for up to 1 year in patients withrostate cancer, and has a different mechanism of action from traditional GnRH agonists.Its immediate onset of action achieves a more rapid suppression of testosterone and PSA than leupro-

ide. Furthermore, there is no need for anti-androgen supplements (complete androgen blockade) to pre-ent the possibility of clinical ‘flare’.

oi:10.1016/j.jomh.2009.08.165

169OUPLE SATISFACTION TO DIFFERENT THERAPEUTIC MODAL-TIES FOR ORGANIC ERECTILE DYSFUNCTION

. Hassan a,∗ , M. El-Hadidy b, B.S. El-Deeck c, T. Mostafa d

Dermatology and Andrology Department, Faculty of Medicine, Mansoura University, Egypt, b Psychiatric Department,aculty of Medicine, Mansoura University, Monsoura, Egypt, c Community Medicine Department, Faculty of Medicine,

ansoura University, Mansoura, Egypt, d Andrology and Sexology Department, Faculty of Medicine, Cairo University,airo, Egypt-mail address: ashrafhahmed@hotmail.com (A. Hassan).

ackground: Erectile dysfunction (ED) treatment studies do not measure treatment response and treat-ent satisfaction where dissatisfaction reflects an aspirations/achievement gap.

im: To test the subjective implications of satisfaction to various therapeutic modalities for pure orixed organic ED, and to address changes in the health-oriented quality of life (QoL) and the relationf psychiatric status of these patients to treatment satisfaction.

ethods: A prospective study included of 354 couples classified according to their line of therapy intoive treated groups: testosterone, sildenafil citrate, intracavernosal injection, external negative vacuumevice, and penile prosthesis.

ain Outcome Measures: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and the Inter-ational Index of Erectile Function (IIEF). Satisfied patients were compared to unsatisfied cases using theCASEE scale for QoL and Middlesex Hospital Questionnaire (MHQ) for psychiatric status.

esults: Sildenafil citrate-treated group represented the highest mean value of satisfaction score onDITS, erectile function, orgasmic function, and overall satisfaction domains of IIEF. Penile implants-reated group was the second for satisfaction score on EDITS. The testosterone-treated group representedhe highest mean value for sexual desire domain score of IIEF. Low scores in various domains of QoL

ere significantly improved among satisfied cases more than unsatisfied subjects after therapy. Highssociation was found between dissatisfaction and scores for anxiety, obsession, and phobia, followedy scores of depression and somatic concomitant of anxiety.

onclusion: ED is best conceived as intermingle of somatic, lifestyle, psychological, and partner relation-hip determinants. This should be taken into account to increase sexual satisfaction with improved QoL,nd not only to produce rigid erection.

oi:10.1016/j.jomh.2009.08.166

jmh Vol. 6, No. 3, pp. 229–275, September 2009 269