UP-02.065 Clinical Versus Histological Diagnosis of Advanced Prostate Cancer: Comparative Evaluation of Treatment Outcome After Bilateral Orchidectomy

UP-02.065 Clinical Versus Histological Diagnosis of Advanced Prostate Cancer: Comparative Evaluation of Treatment Outcome After Bilateral Orchidectomy

UNMODERATED POSTER SESSIONS an average of 16 weeks of treatment (4-48). Results: Nineteen evaluable patient with the mean age 73 (61-81) were treated...

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UNMODERATED POSTER SESSIONS

an average of 16 weeks of treatment (4-48). Results: Nineteen evaluable patient with the mean age 73 (61-81) were treated between May 2008 and April 2009. Median PSA was 2. A partial response by RECIST criteria was found in 1 patient (5%) and 11 patients achieved disease stabilization. Mean PFS was 4 months. PSA decreased in 5/19 (26.3%) and PSA stabilization was found in 7/19 (37%).The most common adverse effects were: astenia in 21%, diarrhea in 10% and hand-foot syndrome in 15.7%. Conclusions: The treatment with Sunitinib after failure of Docetaxel in CRPC can offer acceptable results in selected patients with a benefit of 50% and with acceptable tolerance.

UP-02.063 Evaluation of the Early Impact of the LHRH Analogue Treatment in Prostate Cancer Under Psycho-Cognitive, Emotional and Quality of Life Parameters Casu C1, Romero Otero J1, Rodriguez Antolín A1, Angeles Cabeza M2, Clavel M3, Mugica B3, Vara J4, Lanzos E2 1 Dept. of Urology, 2Dept. of Radio Oncology, Hospital Universitario 12 de Octubre, 3Psychosocial Team, Centro de Cuidados Laguna Obra Social La Caixa, 4 Dept. of Rehabilitation, Hospital Universitario 12 de Octubre, Madrid, Spain Introduction and Objective: The castration by means of the employment of analogues LHRH in the control of the prostate cancer (PC) is associated with a wide spectrum of body, metabolic and psychological alterations. The evaluation, the moment of appearance and the severity of these changes are not adequately documented in patients where the interference of the age and comorbidity can mask them. Material and Methods: Prospective and descriptive study in patients submitted to RT and HT of long duration with analogous LHRH included consecutively from September 2009. To all the patients we pass a first evaluation and later at the 3, 6, 12, 24 and 36 months. The visits are carried out by specialized personnel. The administered questionnaires are validated for: 1. Androgenic deficit: AMSS, 2. Cognitive: Minimental test; 3. State of mind and depression: BDI; 4. Quality of life: SF-12. We realized a statistical analysis comparing the variation of the same patient from

the visit of beginning up to the second visit. We used Wilcoxon’s test. Results: There were 25 patients who completed the 6 months of follow-up. The AMSS shows progressive worsening in the punctuation (28 in the first visit, 32 in the 3 months visit an d 33 in 6 months visit, p ⬍0,05). In the emotional area, having evaluated the depression, the BDI shows a worsening of the 0 (3.5) to the 3 months (4.9) (p⫽0.08) that consolidates to them 6 months (5.8) (p⫽0.030). In the cognitive sphere (Minimental test) significant alteration is not demonstrated. Nevertheless, evaluating the quality of life by means of the SF-12 we see a deterioration in the area of the mental health to the 6 months (p⫽0.03); the rest of evaluated parameters do not present modifications. Conclusions: The treatment by means of an LHRH shows from initial stages (3 months) deleterious effects fundamentally in the sexual sphere. At 6 months begins a slight deterioration of the state of mind, which is confirmed in the paragraph of mental health when we evaluated the quality of life. Neither the cognitive capacity, nor the rest of quality parameters of global life seem diminished.

UP-02.064 Safety and Efficacy of Degarelix in the Treatment of Prostate Cancer in a Cohort from a German Office-Based Registry for Uro-Oncological Quality Assurance Geiges G1, Tolle A2, Schulze M1, Gedamke M2 1 IQUO, Interessenverband zur Qualitätssicherung der Arbeit Niedergelassener Uro-Onkologen in Deutschland E.V., Berlin, 2Ferring Arzneimittel GmbH, Kiel, Germany Introduction and Objective: Results from clinical studies are not always reflected in daily practice; therefore, safety and efficacy of the clinical usage of Degarelix should be confirmed in e.g. an uro-oncological quality assurance registry. Materials and Methods: Common clinical and procedural parameters were recorded over a period of up to 19 months for patients with prostate cancer to be treated with Degarelix. In 219 patients, data on previous treatment, concomitant medication and PCa-stage were collected at the beginning of treatment with Degarelix. Moreover, monthly follow-up findings and, if necessary, results after completion of therapy were recorded. Testosterone and PSA values as well as side-effects were also documented.

UROLOGY 78 (Supplement 3A), September 2011

Results: Tumour-stages were diagnosed as T1, 27.4%, T2, 19.6%, T3, 26.9, T4, 13.7%, Tx 5.9% and 5.9% were not documented. Lymph nodes were positive in 12.8%, negative in 26.0%, unknown in 45.7% of patients and physician did not document the status in 15.5%. Distant metastases were seen in 21.0%, no distant metastases in 33.3%, unknown in 34.3% and in 11.4% the status was not documented. A Gleason-Score (GS) ⬍7 was found in 24.2%, GS 7 in 30% and GS ⬎7 in 42.1% of the patients, in 3.7% no documentation was available. Median PSA was 12.8ng/mL. Testosterone was above castration level (⬎0.5ng/mL) in 45.8% of patients with previous hormone therapy and available testosterone value at inclusion (n⫽48). The major side effects observed were hot flushes (28%) and erythema at injection site (25.4%). PSA-reduction to ⬍4ng/mL was achieved in 81.3% of all patients, median PSA-reduction in patients without hormone pre-treatment was 93.0% compared to baseline. Average time to PSA-progression (2 consecutive rises above basline) in patients with prior hormone therapy (n⫽60) was 23.9 weeks with a maximum of 57 weeks. Conclusions: The present study demonstrates the efficacy and safety of treatment with Degarelix in daily practice. The clinical usage of Degarelix is comparable to other androgen-deprivation-therapies, which is also reflected by the frequent application in patients with a low risk profile. Patients treated second-line to LHRH-analogues did also benefit from Degarelix therapy.

UP-02.065 Clinical Versus Histological Diagnosis of Advanced Prostate Cancer: Comparative Evaluation of Treatment Outcome After Bilateral Orchidectomy Basson J, Heyns C, Van der Merwe A, Zarrabi A Stellenbosch University and Tygerberg Hospital, Tygerberg, South Africa Introduction and Objective: Previous studies have shown a correlation between serum prostate specific antigen (PSA) and tumour burden in men with adenocarcinoma of the prostate (ACP). Serum PSA ⬎60 ng/ml on its own has a 98% positive predictive value for a needle biopsy diagnosis of ACP. Our aim was to determine whether a clinical (non-histological) diagnosis of ACP based on PSA can be made reliably, thus avoiding the cost, discomfort and possible complications of transrectal prostate biopsy.

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confined prostate cancer and negative lymph nodes.

UP-02.065, Table 1.

Age (years) Stage T3-4 M1 PSA at diagnosis (ng/ml) Followup (months) PSA response (decrease) after BO Nadir PSA (ng/ml) Time to PSA nadir (months) PSA relapse (progression after BO) Time to PSA relapse PSA at last follow-up (ng/ml)

Clinical diagnosis (biopsy not done) 69.1 (40.4-96.3) 93.1% 86% 3768.8 (523-157630) 20.5 (0.6-57.8) 96% 37.7 (0.1-453) 9.6 (0.5-50.9) 70.7% 18.7 (1.5-65) 930.4 (9.5-6633)

Materials and Methods: We analyzed the data of 88 men with a clinical (nonhistological) diagnosis of advanced ACP (PSA ⬎50 ng/ml, clinical T3-4 on digital rectal examination and/or imaging evidence of metastases) and 65 men with a histological diagnosis of ACP treated with bilateral orchidectomy (BO). Statistical analysis was performed using Mann-Whitney and Fisher’s exact tests. Values are expressed as mean (range). Results: The group with clinical only compared to the group with histological diagnosis had more advanced disease and higher PSA at presentation (Table). After BO the serum PSA decreased significantly in 96% and 100% of the patients, and subsequent PSA progression occurred in 71% and 31%, respectively. Conclusion: The findings show that a correct clinical (non-histological) diagnosis of advanced prostate cancer can be reliably made based on serum PSA⬎50 ng/ml and supporting clinical features. This avoids the cost, discomfort and potential complications of prostate biopsy.

UP-02.066 Is Radical Prostatectomy a Viable Treatment Option in Patients with Initial PSA > 20ng/ml? Hinev A1, Hadjiev V2, Anakievski D1, Softova E3 1 Clinic of Urology; 2Dept. of Statistics, University of Economics; 3Dept. of Pathology, ’St. Marina’ University Hospital, Varna, Bulgaria Introduction and Objective: Initial PSA ⬎ 20ng/ml is generally considered as an adverse prognostic feature in prostate cancer (PC), often used as a contraindication for radical surgical treatment. Our objectives were to estimate the impact of radical prostatectomy (RP) on disease-specific survival of patients with PC and PSA ⬎ 20ng/ml and to identify a subset of pa-

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Histological diagnosis (biopsy done) 68.4 (52.8-89.1) 46.2% 42% 421.8 (2.4-14390) 41.6 (3.8-108) 100% 3.6 (0-70.2) 21.1 (1.6-85.6) 31.3% 26.1 (7.7-56.8) 179 (5.4-1381)

p-value p⫽0.854 p⬍0.001 p⬍0.001 p⬍0.001 p⬍0.001 p⫽0.255 p⬍0.001 p⬍0.001 p⬍0.001 p⫽0.017 p⬍0.001

tients who might have a favorable oncological outcome. Material and Methods: A total of 205 men with localized or locally advanced PC, who underwent RP by a single expert surgeon, were retrospectively examined. Patients were stratified into 2 groups: group A, comprising 131 men with initial PSA ⱕ 20ng/ml and group B, comprising 74 men with initial PSA ⬎ 20ng/ml. Clinicopathological variables and outcome data were compared across the two groups using chi-square and log-rank tests. Multivariate Cox proportional hazards analysis was used to determine the significant predictors of outcome among men with PSA ⬎ 20ng/ml. Results: The mean follow-up in the entire series was 50.9 months (⫾ 46.5 SD). Men with initial PSA ⬎ 20ng/ml had significantly higher clinical stage and biopsy Gleason score, and were more likely to have concomitant extraprostatic extension, lymph node involvement and positive surgical margins on final pathology. The Kaplan-Meier estimates of the diseasefree, the overall and the cancer-specific survival at the 10th year after surgery were 79.6%, 71.7% and 87.9% for patients in group A, and 20.7%, 55.7% and 65.0% for patients in group B, respectively. Using multivariate analysis, the pathological T stage (p ⫽ 0.009) and the lymph node status (p ⫽ 0.034), were found to be independent predictors of PSA failure among men with PSA ⬎ 20ng/ml. Patients with favorable combination of these prognostic variables (pT2, N0) had significantly longer disease-free (p ⫽ 0.001) and cancer-specific (p ⫽ 0.011) survival, similar to those of men with initial PSA ⱕ 20ng/ml. Conclusion: High initial PSA values do not uniformly indicate poor prognosis after radical prostatectomy. Patients who might benefit the most from complete surgical excision are those with organ-

UP-02.067 The Low Dose CDDPⴙUFT Therapy Brings a Decrease of PSA to the Docetaxel Resistance Prostate Cancer Katsuhiro F1, Yasuyuki Y1, Hiroki K1, Masahito H1, Yasumichi N1, Kenji Y2, Noriyasu K3, Keiichi T3, Kenjiro K3 1 Kainan Hospital, Yatomi, Japan; 2 Chunichi Hospital, Nagoya, Nagoya, Japan; 3Dept. of Nephro-Urology, Nagoya City University, Nagoya, Japan Introduction and Objective: UFT is metabolized with the liver and becomes 5-FU, and demonstrates the antitumor effect. UFT is reported to be effective in the stomach and the colon cancer in recent years. On the other hand, CDDP obstructs the inflow of the methionine in the cell. As a result, it is reported to reinforce DNA synthesis obstruction action of 5-FU. In this study, we examined whether to show utility in the Docetaxel resistance prostate cancer by using a small amount of CDDP together with UFT. Fifteen cases of prostate cancer patients where PSA had risen were targeted though Docetaxel was administered. Moreover, the case where PSA rises continuously three times was defined as the Docetaxel resistance. Materials and Methods: First of all, CDDP (5mg/body) and UFT (600mg/body) were administered five times a week. This menu was done for three weeks, and this treatment was continued every four weeks. The cases with decreased PSA enforced the maintenance therapy by the outpatient. Maintenance therapy, CDDP (10mg/body) administered once every two weeks. UFT (600mg/body) administered five times a week. The steroid was used together while treating anti-cancer drug. Results: PSA has decreased in 60% of patients. There were two patients who were reducing the metastasis in lymph node or the prostatic cancer among patients where PSA had risen. The side effects of this treatment were anorexia, general fatigue, and diarrhea. However, a serious side effect like leucocyte decrease was not admitted. Two of six patients where PSA had risen died of cancer. Conclusions: The establishment of the treatment to the docetaxel resistance prostate cancer is important because there is little effective treatment method to the docetaxel resistance cancer. It was suggested that the anti-cancer chemotherapy using low dose CDDP ⫹ UFT was few

UROLOGY 78 (Supplement 3A), September 2011