Análisis del impacto de la curva de aprendizaje de la cistectomía radical asistida por robot con derivación urinaria intracorpórea sobre los resultados perioperatorios / Evaluating the impact of the learning curve on the perioperative outcomes of robot-assisted radical cystectomy with intracorporeal urinary diversion

Introducción La cistectomía radical asistida por robot (CRAR) con derivación urinaria intracorpórea (DUIC) es un procedimiento técnicamente complejo. Nuestro objetivo fue analizar el impacto de la curva de aprendizaje (CA) de la CRAR con DUIC sobre los resultados perioperatorios y patológicos.Material y métodos Estudio retrospectivo de 62 pacientes consecutivos intervenidos mediante CRAR con DUIC por tumor vesical entre 2015 y 2020. Se compararon 3 grupos consecutivos de 20 (G1), 20 (G2) y 22 (G3) pacientes para analizar el impacto de la CA. Los casos de G1 fueron intervenidos por un cirujano sénior con experiencia en cirugía robótica y los de G2-G3 por 2cirujanos júnior sin experiencia, pero tutorizados por el sénior.Resultados Los 3grupos tenían características clínico-patológicas similares. A 15 pacientes (24%) se les realizó una neovejiga y a 47 (75%) un conducto ileal. El tiempo medio operatorio descendió 60 min entre G1 y G3 (p=0,001). Ningún paciente precisó conversión a cirugía abierta ni tuvo complicaciones intraoperatorias. No se objetivaron diferencias en la tasa de márgenes positivos (p=0,6) ni en el número de ganglios extraídos (p=0,061) entre los grupos. La tasa de complicaciones postoperatorias fue del 77% y no varió durante la CA (p=0,49). Se objetivó una tendencia en la reducción de tasa de estenosis ureteroileal del 25% en G1 al 9% en G3 (p=0,217).Conclusiones La incorporación de cirujanos júnior a un programa de CRAR con DUIC a partir de los 20 primeros casos no compromete los resultados perioperatorios ni patológicos. Durante la CA se podría reducir el tiempo operatorio y la tasa de estenosis ureteroileal (AU)

Introduction Robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) is a technically difficult procedure. Our aim was to evaluate the potential impact of the learning curve (LC) on perioperative and pathological outcomes of RARC with ICUD.Material and methods Retrospective study of 62 consecutive patients who underwent RARC with ICUD for bladder cancer between 2015-2020. We compared 3 consecutive groups of 20 (G1), 20 (G2), and 22 (G3) patients to analyze the impact of the LC. G1 cases were performed by a senior surgeon experienced in robotic surgery, while G2-G3 were performed by 2 junior surgeons without experience under the mentorship of the senior surgeon.Results The 3 groups had similar clinical and pathological characteristics. A total of 15 patients (24%) received a neobladder and 47 (75%) an ileal conduit. The mean operative time decreased 60minutes between G1-G3 (P=0.001). No conversions to open approach or intraoperative complications were reported. There were no differences between groups regarding positive margin rates (P=0.6) or the number of lymph nodes removed (P=0.061). The postoperative complication rate was 77% and did not change during the LC (P=0.49). Uretero-enteric stricture rate decreased from 25% in G1 to 9% in G3 (P=0.217).Conclusions The inclusion of júnior surgeons to a RARC with ICUD program after the initial 20 cases does not have an impact on the perioperative and pathological outcomes of the procedure. The operative time and the uretero-enteric stricture rate could be reduced during the LC (AU)

Evaluating the impact of the learning curve on the perioperative outcomes of robot-assisted radical cystectomy with intracorporeal urinary diversion.

INTRODUCTION: Robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) is a technically difficult procedure. Our aim was to evaluate the potential impact of the learning curve (LC) on perioperative and pathological outcomes of RARC with ICUD. MATERIAL AND METHODS: Retrospective study of 62 consecutive patients who underwent RARC with ICUD for bladder cancer between 2015-2020. We compared 3 consecutive groups of 20 (G1), 20 (G2), and 22 (G3) patients to analyze the impact of the LC. G1 cases were performed by a senior surgeon experienced in robotic surgery, while G2-G3 were performed by 2 junior surgeons without experience under the mentorship of the senior surgeon. RESULTS: The 3 groups had similar clinical and pathological characteristics. A total of 15 patients (24%) received a neobladder and 47 (75%) an ileal conduit. The mean operative time decreased 60 min between G1-G3 (p = 0.001). No conversions to open approach or intraoperative complications were reported. There were no differences between groups regarding positive margin rates (p = 0.6) or the number of lymph nodes removed (p = 0.061). The postoperative complication rate was 77% and did not change during the LC (p = 0.49). Uretero-enteric stricture rate decreased from 25% in G1 to 9% in G3 (p = 0.217). CONCLUSIONS: The inclusion of junior surgeons to a RARC with ICUD program after the initial 20 cases does not have an impact on the perioperative and pathological outcomes of the procedure. The operative time and the uretero-enteric stricture rate could be reduced during the LC.

Evaluating the impact of the learning curve on the perioperative outcomes of robot-assisted radical cystectomy with intracorporeal urinary diversion. / Análisis del impacto de la curva de aprendizaje de la cistectomía radical asistida por robot con derivación urinaria intracorpórea sobre los resultados perioperatorios.

INTRODUCTION: Robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) is a technically difficult procedure. Our aim was to evaluate the potential impact of the learning curve (LC) on perioperative and pathological outcomes of RARC with ICUD. MATERIAL AND METHODS: Retrospective study of 62 consecutive patients who underwent RARC with ICUD for bladder cancer between 2015-2020. We compared 3 consecutive groups of 20 (G1), 20 (G2), and 22 (G3) patients to analyze the impact of the LC. G1 cases were performed by a senior surgeon experienced in robotic surgery, while G2-G3 were performed by 2 junior surgeons without experience under the mentorship of the senior surgeon. RESULTS: The 3 groups had similar clinical and pathological characteristics. A total of 15 patients (24%) received a neobladder and 47 (75%) an ileal conduit. The mean operative time decreased 60minutes between G1-G3 (P=0.001). No conversions to open approach or intraoperative complications were reported. There were no differences between groups regarding positive margin rates (P=0.6) or the number of lymph nodes removed (P=0.061). The postoperative complication rate was 77% and did not change during the LC (P=0.49). Uretero-enteric stricture rate decreased from 25% in G1 to 9% in G3 (P=0.217). CONCLUSIONS: The inclusion of júnior surgeons to a RARC with ICUD program after the initial 20 cases does not have an impact on the perioperative and pathological outcomes of the procedure. The operative time and the uretero-enteric stricture rate could be reduced during the LC.

Current status of genetic urinary biomarkers for surveillance of non-muscle invasive bladder cancer: a systematic review.

BACKGROUND: Genetic biomarkers are a promising and growing field in the management of bladder cancer in all stages. The aim of this paper is to understand the role of genetic urinary biomarkers in the follow up of patients with non muscle invasive bladder cancer where there is increasing evidence that they can play a role in avoiding invasive techniques. METHODS: Following PRISMA criteria, we have performed a systematic review. The search yielded 164 unique articles, of which 21 articles were included involving a total of 7261 patients. Sixteen of the articles were DNA based biomarkers, analyzing different methylations, microsatellite aberrations and gene mutations. Five articles studied the role of RNA based biomarkers, based on measuring levels of different combinations of mRNA. QUADAS2 critical evaluation of each paper has been reported. RESULTS: There are not randomized control trials comparing any biomarker with the gold standard follow-up, and the level of evidence is 2B in almost all the studies. Negative predictive value varies between 55 and 98.5%, being superior in RNA based biomarkers. CONCLUSIONS: Although cystoscopy and cytology are the gold standard for non muscle invasive bladder cancer surveillance, genetic urinary biomarkers are a promising tool to avoid invasive explorations to the patients with a safe profile of similar sensitivity and negative predictive value. The accuracy that genetic biomarkers can offer should be taken into account to modify the paradigm of surveillance in non muscle invasive bladder cancer patients, especially in high-risk ones where many invasive explorations are recommended and biomarkers experiment better results.

Reexamining treatment of high-grade T1 bladder cancer according to depth of lamina propria invasion: a prospective trial of 200 patients.

BACKGROUND: Management of high-grade T1 (HGT1) bladder cancer represents a major challenge. We studied a treatment strategy according to substaging by depth of lamina propria invasion. METHODS: In this prospective observational cohort study, patients received initial transurethral resection (TUR), mitomycin-C, and BCG. Subjects with shallower lamina propria invasion (HGT1a) were followed without further surgery, whereas subjects with HGT1b received a second TUR. Association of clinical and histological features with outcomes (primary: progression; secondary: recurrence and cancer-specific survival) was assessed using Cox regression. RESULTS: Median age was 71 years; 89.5% were males, with 89 (44.5%) cases T1a and 111 (55.5%) T1b. At median follow-up of 71 months, disease progression was observed in 31 (15.5%) and in univariate analysis, substaging, carcinoma in situ, tumour size, and tumour pattern predicted progression. On multivariate analysis only substaging, associated carcinoma in situ, and tumour size remained significant for progression. CONCLUSIONS: In HGT1 bladder cancer, the strategy of performing a second TUR only in T1b cases results in a global low progression rate of 15.5%. Tumours deeply invading the lamina propria (HGT1b) showed a three-fold increase in risk of progression. Substaging should be routinely evaluated, with HGT1b cases being thoroughly evaluated for cystectomy. Inclusion in the TNM system should also be carefully considered.

[Benign retroperitoneal schwannoma, laparoscopic ressection]. / Schwanoma retroperitoneal benigno, exéresis por laparoscopia.

Schwannomas are tumors rarely localized in the retroperitoneum, generally appear in craneal as well as periferic nerves. Seldom cases the diagnosis is preoperatively made just because imaging is very poor in this field. MRI is proven to be the diagnostic method. Radical surgical ressection is standarized treatment. We document a case of a benign retroperitoneal schwannoma where we explain the laparoscopic ressection of this kind of tumors for first time.

Schwanoma retroperitoneal benigno, exéresis por laparoscopia / Benigne retroperitoneal schwannoma, laparoscopic ressection

Los Schwanomas son tumores raramente localizados en el retroperitoneo, ya que habitualmente se encuentran en nervios craneales o periféricos. Raramente se diagnostican preoperatoriamente ya que ninguna de las técnicas de imagen es capaz de determinarlos con certeza. La RMN parece la prueba de elección. La exéresis quirúrgica completa es el tratamiento estándar. El caso que presentamos corresponde aun schwanoma retroperitoneal benigno como hallazgo a partir de dolor lumbar, en el describimos por primera vez la resección laparoscópica de este tipo de tumors (AU)

Schwannomas are tumors rarely localized in the retroperitoneum, generally appear in craneal as well as periferic nerves. Seldom cases the diagnosis is preoperatively made just because imaging is very poor in this field. MRI is proven to be the diagnostic method. Radical surgical ressection is standarized treatment. We document a case of a benign retroperitoneal schwannoma where we explain the laparoscopic resection of this kind of tumors for first time (AU)

Carcinoma urotelial de vejiga estadio T1: subestadiaje, patrones morfológicos de invasión y su significado pronóstico / Bladder urothelial carcinoma stage T1: substaging, invasion morphological patterns and its prognosis significance

Desde 1990 en que se publicaron las primeras series sobre subestadiaje, han aparecido numerosas publicaciones sobre el subnivel de invasión de los carcinomas de alto grado T1. La invasión profunda conlleva un elevado riesgo de progresión (alrededor del 30-35% de casos progresan) frente a los casos de invasión superficial por encima de la muscularis mucosae, en los que la progresión se encuentra alrededor del 10%, por lo que para la mayoría de autores vale la pena tener en cuenta los subT1, en el manejo del paciente. En esta revisión se presentan las series más exhaustivas que han valorado el subestadiaje y se valoran los diferentes métodos de efectuar esta estadificación teniendo en cuenta la dificultad inherente a las muestras que proceden de resección transuretral (RTU)

Since 1990 when the first series on substaging were published, they have published numerous publications on the invasion sublevel of high degree T1 carcinomas. The deep invasion entails a high risk of progression (around 30-35% of cases progress) as opposed to the cases of superficial invasion over “muscularis mucosae”, in which the progression is around 10%, reason why most authors consider subT1, in patient management. In this revision the more exhaustive series that have evaluated substaging are shown and also the different methods to carry out this staging considering the inherent difficulty to the samples that come from transurethral resection (RTU)

[Bladder urothelial carcinoma stage T1: substaging, invasion morphological patterns and its prognosis significance]. / Carcinoma urotelial de vejiga estadio T1: subestadiaje, patrones morfológicos de invasión y su significado pronóstico.

Since 1990 when the first series on substaging were published, they have published numerous publications on the invasion sublevel of high degree T1 carcinomas. The deep invasion entails a high risk of progression (around 30-35% of cases progress) as opposed to the cases of superficial invasion over "muscularis mucosae", in which the progression is around 10%, reason why most authors consider subT1, in patient management. In this revision the more exhaustive series that have evaluated substaging are shown and also the different methods to carry out this staging considering the inherent difficulty to the samples that come from transurethral resection (RTU).

Correlation between the biopsies in marginal donor kidneys for transplantation: is it necessary to biopsy both kidneys?

OBJECTIVES: The objective of this study was to analyze the correlation between histological findings in both transplanted kidneys from marginal donors. METHODS: We retrospectively reviewed the histological information on 92 kidneys obtained between January 2001 and January 2004, corresponding to 46 marginal donors. Criteria for biopsy were age greater than 55 years, hypertension, diabetes, and proteinuria. Scores were established by the pathologist including glomerulosclerosis, tubular atrophy, interstitial fibrosis, and arteriosclerosis. The score for each lesion was classified as 0 if absent; 1 if <20%; 2 if >20% and <50%; and 3 if >50%. Finally, we defined an index of renal severity damage (RSD) in order to classify the kidneys for single transplantation (0), double transplantation (1), and unsuitable for transplantation (2). RESULTS: Of the kidneys studied, 82.6% of both kidneys showed similar degrees of glomerulosclerosis (<20% in 71.7% and >20% in 10.9%), while 17.4% showed discrepancies (> vs <20%; P=.008). On the other hand, RSD correlated in 82.6% of both kidneys (in 69.6% RSD=0; in 8.7% RSD=1; and in 4.3% RSD=2), while 17.4% showed discrepancies (P=.001). In one case (2.2%), a great discrepancy was observed; one kidney was valid for single transplantation, and the other one not valid for any transplantation, single or double. CONCLUSIONS: This study demonstrated a correlation between the biopsy findings in both kidneys in 82.6% of marginal organ donors. However, in 17.4% of cases we observed discrepancies. The degree of glomerulosclerosis seemed to be a powerful parameter to define renal severity damage. According to these results we would recommend biopsy of both kidneys.

Behavior of free testosterone in patients with prostate cancer on androgen deprivation therapy.

OBJECTIVES: Determination of free testosterone (FT) serum level is an efficient method to evaluate bioavailable testosterone. We analyzed the behavior of serum FT in patients with prostate cancer receiving androgen deprivation therapy (ADT) and correlated FT with total testosterone (TT). We also analyzed the efficiency of both isoforms in the evaluation of the ADT. METHODS: Serum levels of TT and FT were determined in 191 patients with prostate cancer in a cross-sectional study. A subset of 56 patients submitted only to radical prostatectomy served as control group. The remaining 135 patients with advanced prostate cancer on three-month LHRH agonist treatment comprised the study group. The median age of the population was 73 years (range, 53-86 years) and the median time on ADT was 42 months (6-198). RESULTS: A significant correlation and linear regression between TT and FT was observed (r2 0.948). The efficiency of TT and FT to discriminate patients with and without ADT was similar (AUC: 0.993 and 0.995, respectively, p > 0.05). A castration level of serum FT established at 1.7 pg/mL had a sensitivity of 85.9% and a specificity of 100%, which are similar to the sensitivity and specificity of 50 ng/dL of TT. All patients without ADT had levels of serum TT and FT above the castration level. In 19 of the 135 (14.1%) patients on ADT serum TT was above 50 ng/dL. In 12 of these 19 patients (63.2%) serum FT was below 1.7 pg/mL while in seven patients (5.2%) FT was also above the castration level. CONCLUSIONS: The castration level of FT was established at 1.7 pg/mL. Serum TT and TF correlated very well; however, they seemed to provide complementary information in the evaluation of ADT efficiency. 14.1% of the patients on ADT failed to reach the castration level of serum TT; determination of serum FT in these patients would reduce this rate to 5.2%.

Initial high-grade T1 urothelial cell carcinoma: feasibility and prognostic significance of lamina propria invasion microstaging (T1a/b/c) in BCG-treated and BCG-non-treated patients.

OBJECTIVES: This study aimed to determine the prognostic value of depth of lamina propria invasion in initial high-grade T1 bladder tumors. Secondary aims were to evaluate the prognostic significance of concomitant carcinoma in situ (CIS) and the impact of bacillus Calmette-Guérin (BCG) treatment as well as to assess the feasibility of microstaging by pathologists in a community setting. PATIENTS AND METHODS: Ninety-seven tumors were available for study and were substaged according to invasion superficial to, into or beyond the muscularis mucosae (MM) (T1a, T1b, T1c). Outcomes were compared by chi-square analysis. Recurrence-free and progression-free survival estimates were obtained by Kaplan-Meier analysis. BCG treatment impact and prognostic significance of CIS were also evaluated (Cox regression). RESULTS: T1 subclassification was possible in 87% (85/97) of cases: 38 (39.1%) T1a, 10 (10.3%) T1b, and 37 (38.1%) T1c; in 12 patients (12.4%) substaging was not possible. Mean age was 66.4 years and mean follow-up was 53 months. Recurrence rates were similar for all groups. By contrast, the progression rate for deep lamina propria-invasive tumors, i.e. T1b and T1c, was 34% (16/47) in comparison to 8% (3/38) for T1a (p=0.016). Progression-free intervals were significantly different in patients with (T1b, T1c) or without (T1a) deep lamina propria involvement (p=0.003), regardless of BCG treatment (p=0.02). BCG-treated patients (67 cases) showed a slight trend towards a better outcome, but differences were not significant. CIS was associated with more than 50% of cases that progressed. On multivariate analysis, depth of invasion and CIS remained two independent prognostic factors, increasing the hazards ratio of progression to 4.47 and 3.19 respectively. CONCLUSIONS: The depth of invasion in the TURB specimens is an independent prognostic factor for T1 bladder cancer even in BCG-treated patients. Associated CIS significantly increases the risk of progression in these patients. The percentage of cases that can be substaged according to the depth of lamina propria involvement increases over time with the collaboration between urologists and pathologists. Consequently, we support that routine pathological assessment of the level of MM invasion in patients with stage T1 bladder cancer should be included in the histopathological report.

Renal collecting (Bellini) duct carcinoma displays similar characteristics to upper tract urothelial cell carcinoma.

OBJECTIVES: To describe 3 cases of tumors located in the kidney that may relate collecting (Bellini) duct carcinoma (CDC) to urothelial cell carcinoma (UC). We hypothesized that these distinct tumor types may share a common origin. CDC is a subtype of renal cell carcinoma associated with a highly aggressive course, poor prognosis, and limited response to immunotherapy, behaving similarly to UC. METHODS: We present 2 cases of CDC and 1 case of UC of the renal papilla. We compared the clinical presentation and survival rate, together with the radiologic, histologic, and immunostaining (including p53) findings, with strong emphasis on the similarities. RESULTS: One patient with CDC had a previous history of grade 3, Stage Ta bladder UC. The urothelial carcinoma from the kidney papilla (case 3) presented carcinoma in situ of the adjacent urothelium and displayed mixed characteristics with CDC, namely location, positive staining for Ulex europaeus and pyelonephritic changes. p53 staining showed marked positivity in the tumor of patient 2. Disease progression was rapid, with a median survival of 5.6 months (range 5 to 7). CONCLUSIONS: The results of this study suggest that the broad category of renal cell carcinoma includes a spectrum of lesions. In this range of diseases, CDC might be distinct from conventional renal cell carcinoma but share biologic features with UC, with the consequent implications for management. This association between CDC and UC may reflect the common embryologic origin of collecting duct and urothelial cells, since they derive from progressive branching of the mesonephric (wolffian) duct. Furthermore, the differential cytogenetic expression profiles suggest that the molecular events underlying the development of distal nephron and proximal tubule renal cancers are distinct.

Usefulness of prostate-specific antigen nadir as predictor of androgen-independent progression of metastatic prostate cancer.

The objective of this study was to analyze the value of the nadir level of prostate-specific antigen (PSA) to predict androgen-independent progression (AIP) in metastatic prostate cancer patients after androgen deprivation therapy. In a group of 185 metastatic prostate cancer patients who received androgen deprivation therapy serum PSA was determined every three months until AIP occurred. Multiple regression analysis was performed to define independent clinical and PSA-related predictors of AIP. AIP was assumed to be present after two consecutive increases in serum PSA after the PSA nadir. Independent predictors of the duration of AIP-free survival (less than 12 months versus more than 12 months) were the extent of bone involvement (six or fewer hot spots versus more than six) with an odds ratio (O.R.) of 3.95, Gleason score (7 or less versus more than 7) with an O.R. of 3.47, and PSA nadir (2 microg/L or less versus more than 2 microg/L) with an O.R. of 14.63. AIP was independently predicted by the extent of bone involvement with an O.R. of 1.72, Gleason score with an O.R. of 1.74, PSA nadir with an O.R. of 3.22, and time to reach the PSA nadir (9 months or less versus more than 9 months) with an O.R. of 2.84. When patients were stratified according to these predictors, those with three good prognostic factors had a median AIP-free survival of 58 months while those with two, one or no good prognostic factors had a median AIP-free survival of 19 months, 12 months and 7 months, respectively. We conclude that the PSA nadir seems to be a good predictor of AIP in patients with metastatic prostate cancer after androgen deprivation therapy. Time to PSA nadir, extent of bone involvement and Gleason score are also independent predictors. The combination of these prognostic factors allows to stratify metastatic prostate cancer patients for the prediction of AIP.

Effect of high-grade prostatic intraepithelial neoplasia on total and percent free serum prostatic-specific antigen.

OBJECTIVE: To analyze the influence of high-grade prostatic intraepithelial neoplasia (HGPIN) on total serum prostatic-specific antigen (PSA) and percent free PSA. METHODS: Total and free serum PSA were determined in 81 consecutive patients with clinical T1c prostate cancer who underwent radical prostatectomy. HGPIN was detected in 62 specimens (76.5%). RESULTS: Median total PSA was 9.2 ng/ml when there was not HGPIN and 8.1 ng/ml when it existed, p>0.05. Median percent free PSA was 11.7 and 9.1%, respectively, p<0.03. However, a multiple linear regression analysis demonstrated there was no effect of HGPIN on total PSA nor on percent free PSA. Percent free serum PSA was significantly influenced by total PSA and the pathological tumor stage. CONCLUSION: HGPIN does not seem to contribute significantly on serum total PSA and percent free PSA.

Intraindividual variations of total and percent free serum prostatic-specific antigen levels in patients with normal digital rectal examination.

PURPOSE: To analyze intraindividual variations of total and percent free serum prostate-specific antigen (PSA) in patients with normal digital rectal examination. MATERIAL AND METHODS: Total and free serum PSA were determined in two blood samples corresponding to 107 nonconsecutive patients. The period between both determinations ranged from 23 to 60 days. Prostatic biopsy was done after both determinations in all except 17 patients because the two serum PSA concentrations were <4 ng/ml. Total and free PSA were determined using double monoclonal antibody immunoassay Tandem and Tandem free (Hybritech Inc.). The diagnosis was benign prostatic hyperplasia (BPH) in 63 patients and prostate cancer (PCA) in 44. RESULTS: The variations of PSA ranged between -6.8 and +3.2 ng/ml in BPH patients and between -2.8 and +9.0 in patients with PCA. The median coefficients of variation were 15.4 and 15.7% respectively. The variations in the percent free PSA were between -30.7 and +40.9 in the BPH group and between -17.9 and +15.8 in the PCA group. The median coefficients of variation were 32.2 and 32.3% respectively. If prostatic biopsy had been indicated when percent free PSA had been

[Effect of finasteride on the percentage of free PSA: implications in the early diagnosis of prostatic cancer]. / Efecto del finasteride en el porcentaje de PSA libre: implicaciones en el diagnóstico precoz del cáncer de próstata.

OBJECTIVE: To analyze the behaviour of free PSA percentage in finasteride-treated patients and to evaluate whether this ratio allows an increased PSA specificity in the early diagnosis of prostate cancer. MATERIAL AND METHODS: Evaluation of PSA serum levels and free PSA ratio in 336 patients initially diagnosed with prostate benign hyperplasia (PBH). A group of 82 patients were treated with finasteride for 14 to 58 months. A second group of 254 patients received no treatment. All patients were within the same age range and had similar PSA serum levels. In total, 141 prostate biopsies were performed: 19.5 (16/82) and 49.1 (125/254) respectively. RESULTS: Median PSA level in PBH patients was 1.6 ng/mL for the finasteride-treated group and 3.5 for the untreated group, p < 0.0001. Free PSA ratio was 18.6 and 18.8%, respectively, p > 0.05. Carcinoma detection rate was 25% (4/16) for the finasteride group and 27.2% (34/125) for the untreated group. If biopsy had been requested when PSA percentage was below 25%, 17.7 and 19.8% respectively would have been prevented and all carcinoma detected. CONCLUSION: Long-term treatment with finasteride reduces PSA serum concentration about 50% without changing the free PSA ratio. Carcinoma detection rate was similar in finasteride-treated and untreated patients. Free PSA ratio allows to increase PSA specificity and avoid unnecessary biopsied also in finasteride-treated patients.

Comparison of percent free prostate specific antigen and prostate specific antigen density as methods to enhance prostate specific antigen specificity in early prostate cancer detection in men with normal rectal examination and prostate specific antigen between 4.1 and 10 ng./ml.

PURPOSE: We analyzed the behavior of prostate specific antigen (PSA) density and percent free PSA to enhance the specificity of PSA in the early diagnosis of prostate cancer in men with normal digital rectal examination and PSA serum level between 4.1 and 10 ng./ml. MATERIALS AND METHODS: PSA serum level, PSA density and percent free PSA were analyzed in 74 men with normal digital rectal examination and PSA serum level between 4.1 and 10 ng./ml. All men underwent systematic prostate biopsy, and the diagnosis was benign prostate hyperplasia in 52 and prostate cancer in 22. Furthermore, we determined the decrease in unnecessary biopsies and the cancer detection rate using 0.10 versus 0.15 as cut points for PSA density, and 20 versus 25 as cut points for percent free PSA. RESULTS: In patients with benign prostatic hyperplasia and prostate cancer, respectively, the median PSA level was 6.7 and 7.0 ng./ml. (p > 0.05), median prostate volume was 50 and 37 cc (p < 0.04), median PSA density was 0.14 and 0.19 (p < 0.007) and median percent free PSA was 18.9 and 10.1 (p < 0.005). Using PSA density cut points of 0.15 and 0.10, the decrease in negative biopsies was 53.8 and 36.5% with a sensitivity of 86.4 and 90.9%, respectively. However, using percent free PSA cut points of 20 and 25, the decrease in negative biopsies was 36.5 and 26.9% with a sensitivity of 77.3 and 95.5%, respectively. CONCLUSIONS: Although both methods could minimize unnecessary biopsies in men with normal digital rectal examination and PSA serum level between 4.1 and 10 ng./ml., the percent free PSA was more cost-effective since transrectal ultrasound was not required. In this small series of symptomatic patients a percent free PSA cut point of 25 could detect at least 95% of prostate cancers and decrease 26.9% of negative biopsies.

Measurement of free PSA in the diagnosis and staging of prostate cancer.

The purpose of this study was to analyze the role of total prostate-specific-antigen (PSA) and free-PSA levels in the diagnosis and clinical staging of prostate cancer. We determined total-PSA serum concentration and free-PSA percentage in 352 patients, 234 with benign prostatic hyperplasia (BPH) and 118 with prostate cancer. Clinical stage of patients with prostate cancer was T1 N0 M0 in 17, T2 N0 M0 in 27, T3-4 N0 M0 in 34 and T1-4 N0-3 M0-1 in 40. Median total-PSA serum concentration was 3.1 ng/ml in patients with BPH and 26.9 ng/ml in patients with prostate cancer, p < 0.0001. Median free-PSA level was 16.7% in patients with BPH and 8.1% in patients with prostate cancer, p < 0.0001. A cutpoint of 4.0 ng/ml detected 96.6% of the prostate cancer, but the percent rate of negative biopsies was 42.1%. For a free-PSA level of 25% in patients with total PSA greater than 4.0 ng/ml, the sensitivity was 97.4%, and the decrease in negative biopsies was 21%. Median total-PSA serum concentration in patients with prostate cancer according to clinical stage was 8.9 ng/ml for T1 N0 M0, 12.9 ng/ml for T2 N0 M0, 29.9 ng/ml for T3-4 N0 M0 and 317 ng/ml for T1-4 N1-3 M0-1, p < 0.001. Median free-PSA levels were 10.1%, 8.1%, 8.4% and 6.1% respectively, p > 0.05. According to the Gleason score, median total-PSA serum concentration was 10.6 ng/ml in patients between 2 and 4, 22.3 ng/ml between 5 and 7 and 77.0 ng/ml between 8 and 10, p < 0.05. Free PSA levels were 7.7%, 8.7% and 6.6% respectively, p > 0.05. Determination of percentage of free PSA appears to be a helpful method for enhancing the specificity of total PSA. A cutpoint of 25% could detect more than 95% of prostate cancers and avoid 21% of negative biopsies in patients with total PSA above 4.0 ng/ml. However, this parameter does not provide additional information about the clinical staging of prostate cancer.