Results of the spanish section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). Update after 21 years of follow-up. / Resultados de la rama española del Estudio Randomizado Europeo de Screening del Cáncer de Próstata (ERSPC). Actualización tras 21 años de seguimiento.

INTRODUCTION AND OBJECTIVE: The objective of the European Randomized Study of Screening for Prostate Cancer (ERSPC) is to assess whether prostate cancer (PCa) screening leads to an improvement of cancer-specific survival. This multicenter study (eight European countries) has recruited more than 180,000 asymptomatic men. After a follow-up period of 16 years, it has been shown that PSA screening reduces PCa mortality by 20%, and that it does not affect all-cause mortality. This article provides updated the results of the Spanish arm of the ERSPC after 21 years of follow-up. MATERIALS AND METHODS: The study invited 18,612 men (aged 45 - 70) of the Spanish section (Getafe and Parla, Madrid) to participate. They were randomly assigned to the intervention arm (serum PSA-based screening) and to the control arm (follow-up without intervention). The diagnoses of PCa were recorded, as well as the PCa-specific and all-cause mortality rates. A comparison between the survival curves of both arms of the study and detailed analysis of the causes of death were performed. RESULTS: The study finally included 4,276 men (2,415 intervention arm, 1,861 control arm). The median age, serum PSA and follow-up time were 57 years, 0.9 ng/ml and 21.1 years, respectively. There were 285 cases with PCa diagnosis, 188 (7.8%) from the intervention arm and 97 (5.2%) from the control arm (p<,001). A total of 216 (75.8%) presented organ-confined disease. There were 994 deaths were recorded; 544 (22.5%) in the intervention arm and 450 (24.2%) in the control arm. No significant differences were detected between the arms of the study in terms of cancer-specific (p=.768) or all-cause (p=.192) mortality rates. The main cause of death was malignant tumors (492 patients, 49.5% of overall mortality), and the most frequent sites were lung and bronchus (29.5%), colon and rectum (14.8%), and hematologic (9.8%). Only 20 patients (0.4% of the patients recruited) died from PCa, with no significant difference between study arms. CONCLUSIONS: In this update of the results of the Spanish section of the ERSPC study after 21 years of follow-up, we have not detected a benefit of PCa screening in terms of overall and cancer-specific survival.

[TVT and TOT for surgical correction of female stress urinary incontinence. Comparison between techniques]. / TVT y TOT para la corrección quirúrgica de la incontinencia femenina de stress. Comparacion de ambas técnicas.

OBJECTIVES: Retrospective analysis of a series of patients with stress urinary incontinence that underwent surgery in our department, by means of the TVT and TOT techniques. We evaluate post operative continence, considering "cured" the patient with complete continence and "failure" any type of involuntary stress urine leak, independently of its severity registering the time of its appearance. For this purpose we used the Kaplan-Meier analysis comparing both techniques with the Breslow test. Additionally, postoperative complications were evaluated. RESULTS: 128 patients who underwent surgery by TVT (69 patients, 53.9%) and TOT (59 patients, 46.1%). Mean age was 54.4 years for TVT (95% CI 52.0-56.8) and 59 years for TOT (95% CI 55.9-62.1). Mean follow-up time was 18.7 months for TVT (95% CI 15.6-21.9) and 7.4 months for TOT (95% CI 5.8-8.9). Overall continence rate was 86.7%, 88.4% for TVT and 84.7% for TOT The probability of being continent six months after surgery was 89.1% for TVT and 78.2% for TOT (no significant differences, p = 0.31), with almost all failures within the first six months after surgery. TVT was more frecuently associated with urgency symptoms (33.3%, p = 0.001) and urge incontinence (18.8%,p = 0.16), urinary retention (11.6%, p = 0.38), and prevesical hematoma requiring mesh retrieval. Greater post operative pain was observed with TOT (20.3%, p = 0.005). CONCLUSIONS: Our results evidence a similar efficacy with both techniques, with the failures appearing over the first months after surgery. Complications of the voiding urgency type are significantly more frequent with TVT.

[Clinical significance of prostatic intraepithelial neoplasm and atypical small acinar proliferation: relationship with prostate cancer]. / Significado clínico de la neoplasia intraepitelial prostática y de la proliferación acinar focal atípica: relación con el cáncer de próstata.

INTRODUCTION: Prostatic intraepithelial neoplasia (PIN) and atypical small acinar proliferation (ASAP) in the setting of prostatic needle biopsies are considered premalignant although questions still remain. OBJECTIVES: In this paper, we have studied the clinical relevance of these histologic findings. MATERIAL AND METHODS: We collected 138 subjects (108 PIN, 30 ASAP); in 67% we performed a second biopsy and the rate of cancer in this late biopsy were 19% and 27% respectively. We cannot identify any clinical factor to predict the finding of cancer in the re-biopsy (PSA, age, digital rectal examination, prostatic volume). RESULTS: In the follow-up, we observed higher rates of cancer for the ASAP; the finding of ASAP was the single clinical or histopathological factor that was an independent predictor of cancer. CONCLUSIONS: We observed that the finding of ASAP was an indication for re-biopsy because of the higher rates of cancer; on the contrary, the paper of PIN in the prostatic needle biopsy still requires further investigation.

[Trends in the incidence of testicular germ cell cancer in a 300.000 inhabitants Spanish population (1991-2005)]. / Tendencia en la incidencia del cáncer testicular de células germinales en un área sanitaria española de 300.000 habitantes (1991-2005).

OBJECTIVE: To describe the features and the time trends of the testicular cancer in a spanish population. MATERIALS AND METHODS: Data on incident cases of testicular germ cell cancer diagnosed in our population were extracted from the Cancer Registry of our Department. We calculed annual incidence rates of testicular cancer, the Spanish population-adjusted annual percent change (APC), age of diagnosis and the different histologic types frequencies. RESULTS: The overall incidence rate rose from 0.84 per 100,000 males to 1.91 per 100,000 males from 1991 till 2005, with a peak of 6.77 per 100,000 males in 2003. The Spanish population-adjusted APC was 2.39%. By histologic subgroup, for seminomas: the incidence rate varied from 0.84 per 100,000 males to 0.64 per 100,000 (1991-2005), with a peak of 5.41 per 100,000 in 2003 and the Spanish population-adjusted APC was 6.06. For nonseminomas, the incidence rate varied from 1.66 per 100,000 to 1.28 per 100,000 (1992-2005), with a peak of 3.65 per 100.000 in 2001 and the Spanish population-adjusted APC was 12.74. Mean ages were 31.23 years (median 30, SD 8.56) for seminomas, and 23.68 years (median 25, SD 6.85) for nonseminomas, with statistic significance (p < 0.0001). DISCUSSION: The increasing testicular cancer incidence observed for this population follows the time trends showed in other European countries.

[Prevalence and clinical meaning of focal and incidental prostate cancers]. / Prevalencia y significado clínico de los cánceres de próstata focales e incidentales.

OBJECTIVES: To calculate the proportion of focal and incidental prostate cancers (PCa) in our setting, to study their relationship with the findings in radical prostatectomy (RP) specimens, and to establish their clinical relevance in terms of progression and survival. MATERIAL AND METHODS: We selected patients with focal cancer, defined as a maximum extent of 3 mm in one or two adjacent prostate biopsy cores (transrectal ultrasound guided, sextant). In addition we included a group of patients with incidental T1a cancers (diagnosed after prostatectomy, nonpalpable, with less than 5% tumor in specimen). The proportion of those cancers over the total of tumors diagnosed in our health area was calculated. Also, clinical characteristics of such cancers were recorded (age, PSA, Gleason grade and score), and also therapy given. In cases that underwent RP, pathological findings were also recorded. Finally, survival analysis (Kaplan-Meier) was carried out to describe the natural history of these patients in terms of time to progression and time to death from PCa. RESULTS: From 819 patients diagnosed of PCa, 46 (5.6%) presented with focal cancer and 23 (2.8%) with stage T1a tumors. None of the patients with incidental cancer (T1a) underwent RP opposed to 17 of 46 focal T1c cancers (37%). Although none of these cases showed extracapsular extension, seminal vesicle invasion, or lymph node invasion, relevant disease (stage pT2b or higher) was found in 15 cases (88.2%) and pathological Gleason score > 7 in 2 cases (2.9%). With a mean follow-up time of 37.6 months (standard error 4.26), the probability of being free from any progression was, for T1a cancers at 2 and 5 years, of 75.4% and 57.1% respectively, and 94.4% and 94.4% respectively for T1c cases. No PCa deaths were recorded in the presented cases during the mentioned follow-up period. CONCLUSION: In our experience, the finding of microscopic or focal cancers in sextant prostate biopsy is related to a high proportion of clinically relevant tumors in RP specimens (88%). We think that expectant management of patients with such findings in prostate biopsy should be questioned.

[Urinary stress incontinence: surgical experience in our center]. / Incontinencia de esfuerzo: experiencia quirúrgica en nuestro centro.

INTRODUCTION: For the treatment of the urinary stress incontinence, there are many techniques, and today the gold standard is that described by Burch. We compared the global and each technique results about rates of postoperative continence and complications seen in our experience. MATERIALS AND METHODS: We made a retrospective analysis of 292 women that have the first surgery for urinary stress incontinence in our centre, between 1991 and 2006. We considered cure the patient who did not have any level of incontinence postoperative, we made a Kaplan-Meier analysis for the postoperative continence evaluation. Besides we studied the behaviour of the postoperative complications found. RESULTS: Mean age was 53.6 years old, and mean time of follow up was 15.6 months. The vaginal techniques were the most practised (138), followed by the TVT (57), abdominal Burch (38), vaginal wall Sling (33), and the less was the laparoscopic Burch (26). The best rates of postoperative continence after 2 years were observed in the patients treated by TVT (87.6%), then with vaginal wall Sling (84.9%), laparoscopic Burch (59.3%), abdominal Burch (59.1%), and the worst with vaginal techniques (48.2%) (p = 0.007). We found more urgency and urge incontinence in the patients treated by TVT (36.8% y 21.1% respectively), and postoperative pain with vaginal techniques (36.2%). Postoperative urine retention and postoperative high residual urine more with the vaginal wall sling (54.5%) and vaginal techniques (26.1%) respectively. CONCLUSIONS: We have the best results for the incontinence treatment in our population with the TVT technique.

[Natural history of metastasic prostate cancer treated with androgen deprivation therapy and secondary hormonal therapy efficiency]. / Historia natural del cáncer de próstata metastásico sometido a bloqueo hormonal y eficacia del tratamiento hormonal de segunda línea.

OBJECTIVE: to analyze metastatic prostate cancer progression in patients treated with hormonal blockade as well as second line hormonal treatments outcomes. PATIENTS AND METHODS: 199 metastatic patients were selected from a 455 hormonal treated patients pool. Time to biochemical progression was studied with Kaplan Meier analysis and patients were stratified according to pathological differentiation. Second line treatment lasting and efficacy were also assessed. RESULTS: 74 patients out of 192 metastatic patients (56.1%) progressed in terms of PSA. Median time to biochemical progression was 1.7 years (1.2-2.3, CI 95%). We did not find stadistical differences on pathological differentiation (p = 0.238). Second line treatment's efficacy, applied to 41 patients was 34.1%, without any stadistical differences among these treatments. Response treatment median time was 6.8 months without stadistical differences among different treatments (p = 0.220). CONCLUSIONS: hormonal blockade efficacy in metastatic prostate cancer has a limited value in time in our experience. One third of these patients have a limited response to a second line treatment although this response is even shorter in duration.

[Smoking habit and superficial bladder tumours' natural history]. / Efecto del tabaco sobre la evolución de los tumores de vejiga.

OBJECTIVES: To disclose the features of bladder cancer in current smokers at diagnosis and to study the differences in recurrence and progression between smokers and non-smokers. PATIENTS & METHODS: 786 consecutive patients with bladder cancer from 1991 to 2004 were studied in a retrospective manner and characteristics of smokers tumours were compared to non smokers. RESULTS: 377 (48%) patients were smokers at diagnosis. There were no differences in terms of age and T stage between smokers and non smokers (t student and Chi square). We found statistical differences in tumours grade, size and multiplicity ( Chi square, p=0.046, p=0.001 and p=0.12 respectly). No differences were found between smokers and non smokers according to recurrence. (Log Rank, Breslow y Tarone-Ware N.S.). We did find differences according to progression (Log Rank p=0.03, Breslow p=0.05 y Tarone-Ware p=0.03) although it did not support multivariate study. CONCLUSIONS: Currents smokers present bigger and higher grade tumors and, more frequently in a multiple fashion at diagnosis than non-smokers.

[The meaning of PSA progression after radical prostatectomy. Preliminary results]. / Significado de la progresión de PSA tras prostatectomía radical. Resultados preliminares.

OBJECTIVES: To report our findings regarding to the natural history of prostate cancer (PCa) that shows recurrence after radical prostatectomy (RP), in terms of time to development of metastatic disease and death from PCa. To identify independent predictors of PSA recurrence. MATERIAL AND METHODS: Retrospective analysis of 227 patients with clinically localized PCa who underwent RP. The event PSA recurrence was defined as the presence of a postoperative PSA level of 0,2 ng/ml or higher at least 3 months after surgery. Hence, cases with shorter follow-up time were excluded from analysis. No adjuvant therapy (radiotherapy or hormonal therapy) was performed in the included population. Recurrence free survival was calculated during the follow-up period (Kaplan-Meier analysis). Uni and multivariate study was performed in order to assess the ability of factors as preoperative PSA level, Gleason score in surgical specimen, capsular penetration, positive surgical margins (excluding urethral), extracapsular extension, positive pelvic lymph nodes, and seminal vesicle invasion, to predict PSA recurrence. Finally, we selected the group of patients with PSA recurrence and calculated the probability of being free from distant metastatic disease during the follow-up period. Also, function of disease-specific survival was calculated. RESULTS: A total of 208 records were finally included in the study. Median age was 61 years. A total of 47 (22.6%) presented with extracapsular extension. Median follow-up time was 35.8 months, and 49 (23.6%) developed PSA recurrence. Recurrence free survival was 79.9% and 67.4% at 2 and 5 years, respectively. Only three factors were identified with the aid of multivariate analysis as independent predictors of recurrence: preoperative PSA >= 10 ng/ml (hazard ratio--HR--3.03), Gleason score in surgical specimen 8 or higher (HR 3.42), and the finding of capsular penetration (HR 2.17). When only patients with PSA recurrence were considered, 16.3% developed distant metastasis. Probabilities of being free from distant disease after PSA recurrence were 97.7% and 86.9% at 2 and 5 years respectively (actuarial median time 110.8 months). Only 2 patients died from PCa, therefore disease-specific mortality analysis was not performed. CONCLUSIONS: Although an important proportion of patients present with PSA recurrence after RP in our setting, the prognosis in term of development of metastatic disease is acceptable in the short-medium term. Anyway, further analysis will be needed to ascertain the evolution of these patients in the long term.

[Effect of polyphenols from the Mediterranean diet on proliferation and mediators of in vitro invasiveness of the MB-49 murine bladder cancer cell line]. / Efecto de polifenoles de la dieta mediterránea sobre la proliferación y mediadores de la invasividad "in vitro" de la linea de cancer vesical murino MB-49.

OBJECTIVE: To evaluate the effect of different polyphenols on the proliferation and invasive capacity of MB-49 murine bladder tumor cell lines and to identify the mediators involved in this process. MATERIALS AND METHODS: MB-49 murine bladder cancer cells were cultured in media supplemented with resveratrol, rutin, morin, quercetin, gallic acid and tannic acid (all of them are polyphenols usually present in Mediterranean diet) for periods of 24, 48 and 72 hours to quantify the expression of urokinase-type plasminogen activator (uPA) and its receptor (uPAR) in the culture medium, as well as of metalloproteinase-9 (MMP-9) and cell proliferation. RESULTS: All the polyphenols studied significantly inhibited proliferation of MB-49 cells, varying according to the time periods and doses used. The cells in the media supplemented with the nutrients to study did not show inhibition of mRNA expression of urokinase-type plasminogen activator (uPA) or its high affinity receptor (uPAR). It was even slightly increased in certain cases. However, mRNA expression of metalloproteinase-9 was strongly inhibited. CONCLUSIONS: The polyphenols present in our usual diet exert an effect on the proliferation and mediators of bladder tumor invasiveness in MB-49 cells.

[Left inferior vena cava with renal cell carcinoma]. / Vena cava renal izquierda en un paciente con carcinoma de células renales.

We presented a case of inferior vena cava on the left side diagnosed by abdominal CT scan during the study of a renal cell carcinoma in the right side. This anomaly is very rare but it may suppose a more difficult approach to the nephrectomy.

[Acute urinary retention and hematuria secondary to metastatic renal clear-cell carcinoma to the penis]. / Retención urinaria aguda y hematuria secundarias a metástasis peneanas por carcinoma renal de células claras.

Renal cell carcinoma have a great capacity of dissemination and have a great variety of clinical presentation. We exposed a clinical note of a patient diagnosed of renal cell carcinoma who developed hematuria and acute urinary retention due to a penis metastasis. Next we review the literature about this topic.

[Natural history of localized prostate cancer. Preliminary data on progression and mortality]. / Historia natural del cáncer de próstata localizado. Datos preliminares de progresión y mortalidad.

OBJECTIVE: To address the effect of therapy options and other factors on the natural history of localized prostate cancer (PCa). METHODS: Men with diagnosed clinically localized PCa who underwent radical prostatectomy (RP), radiotherapy (RT) or watchful waiting (WW). Rates of biochemical progression (BQP) and clinical progression (CLP) were calculated. The effects of therapy, initial PSA, presence of palpable tumor and Gleason score were assessed with Kaplan-Meier analysis and log-rank test. Similar methods were used to study overall and disease-specific survival. RESULTS: A total of 228 patients were studied (135 underwent RP, 46 RT, and 47 WW). Median followup time was 2.5 years. Forty patients presented with BQP. The probability of being free from BQP after 2 and 5 years was 76.8% and 57.9% respectively for the whole population, 70.9% and 57.6% for RP patients, 100% and 100% for RT, and 87.1% and 47.2% for WW (p = 0.031). Nineteen patients presented with CLP, with no significant differences with regard to therapy option. A poorly differentiated Gleason score favoured the probability of presenting with CLP (p = 0.022) and shift to metastatic disease (p < 0.001). No cancer-specific mortality was recorded in the studied population. CONCLUSIONS: Short and medium-term prognosis is excellent for localized prostate cancer in terms of survival. Nevertheless, some patients show a higher risk of progressing to metastatic disease (poorly differentiated Gleason score).

[Genitourinary cancer incidence in a health geographic area of 300,000 people]. / Incidencia del cáncer urológico en un área sanitaria de 300,000 habitantes.

OBJECTIVE: To provide descriptive information on site-specific urological cancer occurrence we computed 10-year cancer incidence rates in the geographic area of Getafe (Madrid, Spain, 300,000 people). MATERIALS AND METHODS: Only histologically confirmed genitourinary cancer (bladder, prostate, kidney, testicle and penis) throughout 1992-2001 was considered. Cancers were classified according to the international rules. 10 years age-standardized population-adjusted incidence rates per 100,000 people (or per 100,000 men when appropriate) were calculated. Overall and cancer-specific yearly increments were also evaluated. The most recent release of National Statistics (2001) was used for population adjusting. RESULTS: Prostate cancer (PC) accounted for the majority of diagnostics. A strong correlation was detected between the total number of new cancer diagnostics and the overall population. While the correlation was frail between the number of new cancer diagnostics in females and the female population, the association remained significant in males. Nevertheless, only the number of new prostate cancer diagnostics was firmly and significantly associated with the population. CONCLUSIONS: Incidence rates of every cancer type increased throughout the last decade. Nevertheless, this increases didn't parallel the population increment perhaps translating environmental factors.

[Detection of prostatic cancer in the PSA range between 3 and 3.9 ng/ml]. / Deteccion del cáncer de próstata en el rango de PSA entre 3 y 3,9 ng/ml.

OBJECTIVE: In our study, we analyze the benefit of lowering the PSA cutoff point for which a prostate biopsy is indicated from 4 to 3 ng/ml. MATERIALS AND METHODS: We have considered 4.278 individuals coming from a prostate cancer screening program. We studied 1.217 interventions in which PSA was determined, indicating the prostate biopsy with PSA > or = 3 ng/ml. Digital rectal examination was never the indication for the biopsy. All biopsies were sextant and assisted by transrectal ultrasound. We compared the performance of the biopsy using 4 and 3 ng/ml as cut points. RESULTS: Of the 1.217 interventions performed, 947 had PSA values lower than 3 ng/ml, 80 between 3 and 3.9 ng/ml and 190 over 4 ng/ml. A total of 189 patients (70% of these two last groups) underwent a prostate biopsy. With 4 ng/ml as the cut point, 134 biopsies were indicated, detecting 28 cancers (positive predictive value 20.9%). However 189 biopsies were indicated and 34 cancers detected by lowering the cut point to 3 ng/ml (positive predictive value 17.9%). The reduction in the biopsy performance was not statistically significant (OR = 0.89). None of the 6 additional cancers detected was palpable or ecographically visible (T1c), all of them had a Gleason score under 7 and half of them could be considered clinically relevant. CONCLUSIONS: Lowering PSA cutoff point from 4 to 3 ng/ml improved the detection rate in 21.4% not jeopardizing the biopsy performance. Therefore we think that the group of patients with PSA between 3 and 3.9 ng/ml as candidates for prostate biopsy, should be included in screening programs.

[Selective bladder sparing with transrectal resection of muscle-infiltrating tumors]. / Preservación vesical selectiva mediante resección transuretral de los tumores músculo-infiltrantes.

OBJECTIVE: To disclose te ability of TUR as monotherapy in muscle invasive bladder cancer. MATERIAL AND METHODS: 27 patients with muscle-invasive bladder cancer recruited throughout 1991-1999 were allocated into a protocol based on TUR. 30-45 days after the first TUR a second procedure was performed. The number of recurrences and progressions was registered. Progression-free survival and survival were analyzed using Kaplan-Meier estimates. RESULTS: Two patients were excluded due to persistence of muscle-invasive disease after the second resection. 8 subjects (32%) were lost in follow-up. 17 were eventually evaluable. 12 patients (70.5%) had recurrences. Eventually, 4 more cystectomies were undertaken for invasive recurrences (4/17, 23.5%). During the study period, 3 deaths were recorder (3/17, 17.6%). The actuarial probability of progression at 93 months was estimated on 60%. CONCLUSIONS: 75% of patients retained their bladders. The proportion of patients lost in follow-up was very high. Patients must commit to a close surveillance.

[Preliminary results of the treatment of high grade (T1G3) superficial tumors of the bladder with transurethral resection]. / Resultados preliminares del tratamiento de los tumores vesicales superficiales de alto grado (T1G3) mediante resección transuretral.

OBJECTIVE: To examine the results of monotherapy with TUR in the treatment of primary T1G3 transitional cell carcinoma (TCC). METHODOLOGY: Thirty-two patients with primary TCC of the bladder were allocated into a surveillance program. Risk factors for progression to muscle-invasive disease were determined. Immediately, projections of disease-free and progression-free survival were calculated. RESULTS: Five patients (15.6%) were lost in follow-up. Twenty-three (85%) had superficial recurrences. Four patients (14.8%) progressed to muscle-invasive or metastatic disease. No independent risk-factors for progression were disclosed. Median disease-free survival was 8 months. Projection of the risk of recurrence at 79 months was 84.9%. Median time to progression has not been reached yet. Projection of progression at 79 months was 46.3%. CONCLUSIONS: The above mentioned treatment schedule is associated with very high recurrence rates. In addition, recurrences are very frequent. Nevertheless, in the medium run, projections of progression suggest that surveillance can be an alternative to other treatments in the management of T1G3 TCC of the bladder.

[Role of PSA velocity in the detection of prostate cancer. A study of 986 males]. / Papel de la velocidad del PSA en la detección del cáncer de próstata. Un estudio con 986 varones.

OBJECTIVE: To analyze the role of PSA velocity (PSAV) in the detection of prostate cancer (Pca) when compared to other valid alternatives. PATIENTS AND METHODS: From a Pca screening program, 986 men were evaluated in two visits (601 of them agreed for a third visit). Serum PSA was performed in every visit (PSA1, PSA2 and PSA3). All Pca diagnosed after PSA1 were excluded. Criteria for biopsy (PSA2 and PSA3) were PSA > 4 ng/ml, or PSAV > 0.7 ng/ml/year. Diagnostic performance of PSAV was compared with other options (PSA alone, DRE, and PSA density -PSAD-). RESULTS: Median age was 57 years. Median interval between visits were 679 days and 852.5 days respectively. During PSA2, 122 biopsies were indicated (91 performed). After PSA3, 78 were indicated and 24 done. This great proportion of not biopsied men was due to refusal. Seven Pca were detected during PSA2, and 5 during PSA3. Sensitivity of PSAV (two draws) was 0.86, specificity 0.95, missed 1 cancer of 7 and needed 7.5 biopsies per cancer. When three PSA samples available, PSAV missed 2 cancers of 5, and 2.7 biopsies per cancer needed. PSA alone detected 86% of the cancers, multiplying by 2 the number of biopsies needed. Not DRE, nor PSAD improved the diagnostic performance of PSAV when combined with this parameter. CONCLUSIONS: Diagnostic performance of PSAV was found to be unacceptable in our hands. The need for a third biopsy in these studies make them difficult to reproduce. Validation of PSAV is a difficult task to achieve, we think its role remains questioned.