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strategies of coping with cancer: fighting spirit (FS), helpless-ness/hopelessness (HH), fatalism (FAT), anxious preoccupation(AP) and avoidance (AV). Repeated measure analyses of variancewere performed to test changes over time and Bonferroni correc-tion was used for pair time comparisons.Results: The mean age of study population at T0 was 66.2 years(median 66, range 42–79). Repeated measure analyses of varianceshowed the following significant changes over time: SWB de-creased from T0 to T3 (p=0.001); PCS decreased between T0 andT3 (p=0.014); EWB increased between both T0 and T2 (p=0.016)as well as T0 and T3 (p=0.001). As far as Mini-MAC scores, bothAP and AV significantly decreased from T0 and T2 (p=0.0001 andp=0.035, respectively).Conclusions: Patients on AS reported high levels of physical andpsychological wellbeing throughout the first two years. QoL wasnot impaired by the idea of living with an untreated cancer. Itis particularly interesting that anxious preoccupation, i.e. worryabout disease progression, decreased over the first year on ASand then remained stable. The decrease in the perception of so-cial wellbeing could be related to the fact that support from fam-ily/friends is likely to be higher in the period immediately follow-ing the diagnosis. The increase of PCa-related symptoms is unex-pected and needs to be further detailed. Our results are consistentwith those of North European and North American studies, thusconfirming that the acceptance of AS is feasible in the Mediter-ranean culture.Acknowledgements: Foundations I. Monzino and ProADAMOOnlus.

P079Cultural adaptation of the memorial anxiety scale for prostatecancer: Preliminary results

L. Bellardita1, M.F. Alvisi1, T. Magnani1, T. Rancati1, S. Villa1,B. Avuzzi2, S. Morlino2, S. Stagni3, R. Salvioni3, R. Valdagni4.1Fondazione IRCCS Istituto Nazionale Tumori, Prostate CancerProgram, Milan, Italy; 2Fondazione IRCCS Istituto Nazionale Tumori,Radiation Oncology 1, Milan, Italy; 3Fondazione IRCCS IstitutoNazionale Tumori, Urology, Milan, Italy; 4Fondazione IRCCS IstitutoNazionale Tumori, Prostate Cancer Program, Radiation Oncology 1,Milan, Italy

Introduction & Objectives: The Memorial Anxiety Scale forProstate Cancer (MAX-PC) is a self-report questionnaire devel-oped to assess PCa-related anxiety in English-speaking popula-tion. The aim of this study was to present the procedures for cul-tural adaptation in a different language, together with the prelim-inary results of its psychometric properties in the Italian popula-tion.Material & Methods: Patients (pts) with localized PCa enrolled inActive Surveillance (AS) were recruited. The questionnaire con-sists of 18 items divided into 3 subscales measuring general “PCaanxiety” (“I felt kind of numb when I thought about prostate can-cer”), “anxiety related to prostate specific antigen (PSA)” (“I havebeen so anxious about my PSA test that I have thought about de-laying it”), and “fear of recurrence” (“Because cancer is unpre-dictable, I feel I cannot plan for the future”). The translation of theoriginal English version into Italian followed standard forward-backward procedure: it was translated into Italian by two inde-pendent researchers; the two translations were then pooled intoa common version. This interim version underwent the back-ward translation by two native English-speaking independenttranslators. Back translations were then discussed in a consen-sus meeting and finally a definitive Italian version was obtained.Psychometric properties were assessed to obtain reliability in-dexes. Specifically, a) descriptive analyses were performed to de-tect floor/ceiling effect, b) Cronbach’s alpha coefficients were cal-culated to estimate the internal consistency of the total MAX-PC

and the three subscales, c) item to total correlation analyses wereconducted to assess subscales internal consistency and identifyitems to be deleted.Results: MAX-PC was completed by 118 pts. No floor/ceiling ef-fect (defined as more than 15% of respondents having respectivelythe lowest/highest score) was found except for the “PSA anxi-ety” subscale (floor effect, 71% of respondents). The Cronbach’salpha coefficients were high for total score (α=0.75, 0.70 con-sidered good internal consistency), as well as for “PCa anxiety”(α=0.80), “fear of recurrence” (α=0.83) and “PSA anxiety” (α=0.95)subscales. The means of item to total correlation coefficients wereas follows: “PCa anxiety” = 0.66 (range 0.51–0.76), “PSA anxiety”= 0.75 (range 0.46–0.90), “fear of recurrence” = 0.78 (range 0.75–0.80) (scores below 0.75 suggest deleting the item).Conclusions: MAX-PC is a reliable tool which can be translatedand adapted for use in different countries. It can be very usefulfor the assessment of PCa-specific anxiety to physicians involvedin the PCa-care management. In particular, MAX-PC can be valu-able to address potential concern of pts on AS, as it specificallymeasures anxiety related to taking the PSA test (which is repeat-edly required to pts in the AS protocols) and to PCa progression.Acknowledgements: Foundations I. Monzino and ProADAMOOnlus.

P080Quality of life among prostate cancer survivors:A longitudinal population based study

W. Schaake1, M. De Groot2, W. Krijnen2, J.A. Langendijk1,A.C.M. Van Den Bergh1. 1University Medical Center Groningen,Dept. of Radiation Oncology, Groningen, The Netherlands; 2HanzeUniversity of Applied Sciences, Professorship In Health Care andNursing, Groningen, The Netherlands

Introduction & Objectives: To investigate the course of Qualityof Life (QoL) among prostate cancer patients treated with exter-nal beam radiotherapy (RT) and to compare the results with QoLof a normal age-matched reference population.Material & Methods: The study population was composed of 227prostate cancer patients, treated with radiotherapy. The Euro-pean Organization for Research and Treatment of Cancer Qual-ity of life Questionnaire C30 (EORTC QLQ-C30) was used to as-sess QoL before radiotherapy, and six months, one year, two yearsand three years after completion of radiotherapy. To investigatechanges in QoL before and after treatment a mixed model for re-peated measures was used. Additionally, the QoL of prostate can-cer survivors three years after radiotherapy was compared to theQoL of a normative cohort of 519 male individuals using a MAN-COVA model.Results: Quality of life after radiotherapy decreased amongprostate cancer patients, compared to both baseline levels andcompared to normative data (p<0.001). Although the majority ofthe functioning and symptom scales showed a statistically sig-

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nificant decline in QoL, the effect sizes were small. Patients withcoronary heart disease and or chronic obstructive pulmonary dis-ease or asthma had a significantly worse course in QoL.Conclusions: Prostate cancer patients experience a small wors-ening of QoL as compared with baseline and as compared witha normal reference population. As co-morbidity modulates pa-tients’ post-treatment QoL, a proper assessment of co-morbidityshould be included in future longitudinal analyses on QoL. Thisstudy shows that curative radiotherapy offers the opportunity totreat prostate cancer in an effective manner, without substan-tially affecting the QoL.

P081Safety of using testosterone for the treatment of androgendeficiency syndrome in adult patients treated for prostatecancer

A. Jimenez Pacheco1, A. Jimenez Pacheco2, M. Nogueras Ocaña3,M. Verdu Martinez1, A. Lopez Luque1. 1Santa Ana Hospital, Dept.of Urology, Granada, Spain; 2Traumatology and RehabilitationCenter. Virgen De Las Nieves Hospital University, Dept. ofRehabilitation, Granada, Spain; 3San Cecilio University Hospital,Dept. of Urology, Granada, Spain

Introduction & Objectives: For years, there is a paradigm thattestosterone is a possible factor for the development of prostatecancer. However, there is no conclusive evidence that circulatingtestosterone levels in individuals diagnosed with prostate cancerare higher than in controls. The aim of this study is to analyze thepublished literature to date.Material & Methods: We conducted a search of the PubMeddatabase by using the keywords “testosterone replacement ther-apy and prostate cancer” We identified 241 studies published be-fore June 2013. We then selected of studies that were publishedin English or Spanish; and that analyzed the relationship betweentestosterone replacement therapy and prostate cancer.Results: Since early 1940, when Huggins showed severe reduc-tions in serum testosterone by castration or estrogen therapycaused regression of prostate cancer, it is assumed that higherlevels of testosterone produced an increase in growth of prostateand testosterone replacement therapy carries a risk of turning outhidden cancer clinical one. Prostate cancer rate in the trials car-ried out with testosterone hormone replacement therapy is of 1%,similar to detection rates in screening programs. Furthermore, itwas observed that low testosterone levels prior to radical prosta-tectomy are correlated with a high risk of progression biochem-istry in localized prostate cancer, which makes an independentpredictor of post-prostatectomy biochemical failure. Similarly,low testosterone levels were statistically significantly associatedwith metastasis of lymph nodes in patients undergoing radicalprostatectomy, and even seems to be a predictor of extraprostaticextension in patients with localized prostate cancer. In short, lowtestosterone levels are associated with increased risk of prostate,tumor aggressiveness and a higher Gleason score.Also, it wasfound that boys born with a lack of the enzyme 5 alpha-reductaseinhibitors do not develop prostate cancer, stimulating interest inthe development of these drugs. A meta-analysis in 3886 menwith prostate cancer and 6438 controls concluded that endoge-nous hormones, including testosterone were not associated withprostate cancer.Conclusions: Therefore, the available data suggest that testos-terone replacement therapy can be used with caution in somemen with hypogonadism previously treated for low risk prostatecancer with curative intention and no evidence of active disease.

P082External validation of a model for the prediction of acute GItoxicity in prostate cancer patients

B. Avuzzi1, T. Rancati2, C. Stucchi3, E. Pignoli3, S. Villa1,C. Fiorino4, V. Carillo4, C. Cozzarini5, R. Valdagni6. 1FondazioneIRCCS Istituto Nazionale Dei Tumori, Dept. of Radiation Oncology 1,Milan, Italy; 2Fondazione IRCCS Istituto Nazionale Dei Tumori,Prostate Cancer Program, Milan, Italy; 3Fondazione IRCCS IstitutoNazionale Dei Tumori, Dept. of Medical Physics, Milan, Italy; 4SanRaffaele Scientific Institute, Dept of Medical Physics, Milan, Italy;5San Raffaele Scientific Institute, Dept of Radiation Oncology, Milan,Italy; 6Fondazione IRCCS Istituto Nazionale Tumori, Prostate CancerProgram and Dept. of Radiation Oncology 1, Milan, Italy

Introduction & Objectives: External independent validation of amodel (nomogram, Red J 71(4) 2008) for the prediction of acuteGI toxicity (tox, within 1 month after treatment end) in prostatecancer patients (pts) treated with radical radiotherapy (RT).Material & Methods: Grade ≥2 acute GI tox is the endpoint of thenomogram. It includes: Mean rectal dose, presence of haemor-rhoids, use of anticoagulants/antiaggregants, neoadjuvant andro-gen deprivation, diabetes and pelvic node irradiation. The popula-tion (POP) used to develop the model consisted of pts accrued in amulticenter prospective trial and treated in 2002-04 with 3DCRT,median dose 74 Gy, 2 Gy/fr. Tox was scored through pt assessedquestionnaire. The independent POP used for external validationcomprises prospective evaluated pts enrolled in 2 centers (whichdid not participate in the previous trial) and treated in 2010-12with IMRT, median dose 78 Gy, 2 Gy/fr or moderate hypofrac-tionation (hypo, 2.3–2.65 Gy/fr). Tox was scored with the samequestionnaire and same timing. Calibration of the model in theindependent POP was judged using Hosmer-Lemeshow (HL) test,discriminating capability was assessed using AUC.Results: 149 pts were enrolled, 40 (26.8%) exhibited grade ≥2acute GI tox. Hypo was used in 43 (28.9%) pts. Rectal doses in thehypo subgroup were corrected using the linear-quadratic model(alpha/beta = 10 Gy) and total treatment time/dose recovery cor-rections (assumed = 0.7 Gy/day). Calculate tox probabilities in theindependent POP ranged from 10% to 50%. Calibration was verygood, p of HL test = 0.76, i.e. no significant difference between ex-pected vs observed tox probabilities in 5 consecutive intervals:13% vs 14%, 23% vs 25%, 28% vs 21%, 30% vs 24% and 40% vs 44%.Discrimination was poor (AUC=0.61) but comparable to the onein the original POP (AUC=0.62). The model has satisfactory speci-ficity (75%, with a cut-off = 30%), but poor sensitivity (42%).

Conclusions: The purpose of a predictive model is to providevalid outcome predictions for new pts. Essentially, the data setused to develop a model is not of interest other than to learn forthe future. Validation hence is an important aspect of the pro-cess of predictive modelling. External validation of a model for