Outpatient Biopsy Research Articles

371 ARE GENETIC VARIANTS THAT PROMOTE PSA EXPRESSION ASSOCIATED WITH MORE FAVORABLE PATHOLOGIC TUMOR FEATURES

cohort of 434 patients with a total PSA 50 ng/mL who were referred to our institution for an initial prostate biopsy. Outpatient transrectal ultrasound-guided prostate biopsies were performed according to a standardized institutional saturation scheme (18-22 cores). Logistic regression models were fitted to test the predictors of PCa at initial biopsy. Predictive accuracy estimates of biopsy outcome predictions were quantified using the area under the receiver-operating characteristic curve (AUC). Differences in AUCs were tested using the DeLong method. Regression coefficients were used to create a nomogram that was internally validated using 200 bootstrap resamples. Finally, the extent of overestimation or underestimation of the observed PCa rate at biopsy was determined with calibration plots. RESULTS: Overall, 179 (41.2%) patients were diagnosed with PCa at initial extended prostate biopsy. In accuracy analyses, PHI emerged as the most informative independent predictor of PCa (AUC: 74.5%; p 0.001). The inclusion of PHI to a multivariable logistic regression model based on established predictors of PCa (age and digital rectal examination) significantly increased the predictive accuracy of a 3.4% extent (from 75.6 to 79.0%; p 0.001). Calibration of the nomogram was good within the whole range of predicted probabilities. CONCLUSIONS: We developed a nomogram based on PHI that can assist clinicians in the decision to biopsy by giving patients an individual risk of PCa. While internal validation provided evidences of good calibration and accuracy of the tool, external validation of our findings is still required.

Accuracy and safety of CT guided transthoracic needle biopsy

Background:Image guided transthoracic needle biopsy (TTNB) has great diagnostic value for the definitive characterization of lung lesions and is an established primary procedure to diagnose pulmonary nodules. It is traditionally performed as an outpatient procedure. It is safe, accurate, sensitive, and can obviate surgical procedure.Objective: to assess the accuracy and safety of CT-guided TTNB in Baghdad Teaching Hospital Patients & Methods: From December 2009 to September 2011, we conducted a prospective study of 43 consecutive outpatient and inpatient lung biopsies. An informed consent was obtained from the patients. No sedation is required. All biopsies were performed using CT guidance without CT fluoroscopy and were performed under local anesthesia using a 16 gauge core biopsy needle with internal automated gun. A posteroanterior inspiratory CXR was obtained 30 minutes after biopsy. All complications were recorded. If there was no pneumothorax, the patient was discharged. If there was a small asymptomatic pneumothorax, serial radiographs has been performed, patients also were discharged if no change in size was noted.Results: A total of 43 patients underwent CT guided TTNB of peripheral lung lesions (mean age 60 years) and a male to female ratio of 28:15. The operation was successful in 40 out of 43 patients. The sample was adequate in 39 out of 43 patients. Complications were recorded in 4 patients (the most common complication was pneumothorax). No patient needed chest tube insertion.Conclusion: CT guided TTNB is safe and an accurate procedure and can be performed as an outpatient procedure under local anesthesia.

Development of an Outpatient Native Kidney Biopsy Service in Low-Risk Patients: A Multidisciplinary Approach

Background: In the US, native kidney biopsies are usually inpatient procedures. We developed an outpatient biopsy protocol for low-risk patients and assessed its safety and efficacy. Methods: Patients with an SBP <140 mm Hg and a BMI ≤35 who were not taking anticoagulants, ASA and NSAIDS in the preceding week were included. Biopsies were performed under ultrasound guidance using a 15-gauge needle that changed to a 14-gauge needle during the study. Patients were discharged after 5 h of observation if there were no signs of bleeding. Complications were carefully recorded. Results: Between November 2008 and April 2011, 105 patients underwent outpatient renal biopsies. A 15-gauge needle was used in 43 patients (group A) while a 14-gauge needle was used in 62 (group B). A median of 25 (range 4–64) glomeruli were obtained in group A versus 39 (range 0–107) in group B (p < 0.001). Complications requiring admission for observation occurred in 7 patients (16%) in group A versus 5 patients (8%) in group B (p = 0.22). One patient in group B had bleeding requiring intervention, while all other complications were minor. Nine complications occurred during the observation period, while 3 patients presented >48 h after biopsy. The mean cost per patient for each outpatient biopsy was USD 976 versus USD 5,489 for inpatients. Conclusions: In a selected low-risk population, outpatient renal biopsy is safe with low complication rates and results in significant cost savings relative to elective inpatient biopsies. The use of a 14-gauge biopsy needle resulted in a greater yield of glomeruli without increased complications.

Rapid molecular detection of metastatic head and neck squamous cell carcinoma as an intraoperative adjunct to sentinel lymph node biopsy

Clinical staging of early head and neck squamous cell carcinoma (SCCHN) is often inaccurate, leading to elective neck dissection to detect the 30% of patients with micrometastatic disease. Sentinel node biopsy accurately stages the regional lymphatics, but intraoperative pathology is only moderately sensitive, and final pathology takes several days to complete. To facilitate immediate neck dissection where necessary, we have identified several promising marker genes of SCCHN metastasis and developed a rapid, accurate, and automated quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) assay for intraoperative use. Prospective tissue collection, retrospective pathologic correlation with qRT-PCR. From a 40-gene marker screen, we quantified expression of 11 potential tumor genes using a test set of primary tumors (n = 32) and metastatic (n = 19) and benign (n = 10) lymph nodes. Eight patients' paired primary tumor and metastatic nodes were included. A validation set of 442 grossly tumor-negative nodes was evaluated for expression of the most promising markers, comparing metastasis detection by qRT-PCR with pathologic analysis (hematoxylin and eosin and immunohistochemistry). A novel multiplexed, automated, single-tube qRT-PCR assay was used to analyze more than 100 lymph nodes using a two-marker, 35-minute assay to determine its negative predictive value. Based on expression of 11 tumor-associated genes from the marker screen, the two most promising markers of SCCHN metastasis in the test set, pemphigus vulgaris antigen (PVA) and tumor-associated calcium signal transducer 1 (TACSTD1), also known as epithelial cell adhesion molecule (EpCAM), were selected. Development of a multiplexed qRT-PCR assay for the detection of metastasis compared favorably with pathologic analysis in the additional 442-node set. A rapid, multiplexed assay using PVA and TACSTD1 demonstrated excellent reproducibility, linearity, and accuracy (≈96% negative predictive value) for identifying positive (n = 40) and negative (n = 62) nodes in a validation subset. Detection of metastatic SCCHN using multiplexed qRT-PCR can be rapid, accurate, and automated and may enable sentinel node biopsy to be used for intraoperative decision-making. PCR amplification of tumor marker genes is an effective method of intraoperative molecular staging of SCCHN and could more appropriately guide application of neck dissection in pN+ SCCHN patients, sparing 60% to 70% of pN0 patients from unnecessary neck dissection. This technique may also be used for identifying residual neck disease posttreatment, using outpatient fine-needle aspiration biopsy specimens.

Outpatient blind percutaneous liver biopsy in infants and children: Is it safe?

Background/Aim:We aim to investigate the safety of outpatient blind percutaneous liver biopsy (BPLB) in infants and children with chronic liver disease (CLD).Patients and Methods:BPLB was performed as an outpatient procedure using the aspiration Menghini technique in 80 infants and children, aged 2 months to 14 yrs, for diagnosis of their CLD. Patients were divided into three groups: Group 1 (<1 year), group 2 (1–6 yrs), and group 3 (6–14 yrs). The vital signs were closely monitored 1 hr before biopsy, and then 1, 2, 6, and 24 hrs after biopsy. Twenty-four hours pre- and post-biopsy complete blood counts, liver enzymes, prothrombin time (PT), and abdominal ultrasonography, searching for a biopsy-induced hematoma, were done for all patients.Results:No mortality or major morbidities were encountered after BPLB. The rate of minor complications was 17.5% including irritability or “pain” requiring analgesia in 10%, mild fever in 5%, and drowsiness for >6 hrs due to oversedation in 2.5%. There was a statistically significant rise in the 1-hr post-biopsy mean heart and respiratory rates, but the rise was non-significant at 6 and 24 hrs except for group 2 where heart rate and respiratory rates significantly dropped at 24 hrs. No statistically significant difference was noted between the mean pre-biopsy and the 1, 6, and 24-hrs post-biopsy values of blood pressure in all groups. The 24-hrs post-biopsy mean hemoglobin and hematocrit showed a significant decrease, while the 24-hrs post-biopsy mean total leucocyte and platelet counts showed non-significant changes. The 24-hrs post-biopsy mean liver enzymes were non-significantly changed except the 24-hrs post-biopsy mean PT which was found to be significantly prolonged, for a yet unknown reason(s).Conclusions:Outpatient BPLB performed by the Menghini technique is safe and well tolerated even in infants and young children. Frequent, close monitoring of patients is strongly recommended to achieve optimal patient safety and avoid potential complications.

Air Embolism Involving the Coronary and Pulmonary Circulation: An Unusual Cause of Sudden Cardiac Death

A 58-year-old man with a history of cirrhosis and hepatocellular carcinoma status post liver and kidney transplantation, coronary artery disease, and ventricular arrhythmia status post ICD placement underwent an outpatient fine-needle aspiration biopsy of a pulmonary nodule under computed tomography (CT) guidance at an outside hospital (Figure 1). After the procedure, the patient was noted to have persistent altered mental status that was out of proportion to the degree of sedation administered. He subsequently …

Outpatient Renal Needle Biopsy of the Transplanted Kidney: Safety Profile

Since May 2005, we began performing renal graft biopsies as outpatient procedures when the patient's condition did not require hospitalization. To evaluate the safety profile of the 137 procedures performed in 111 patients, we performed a retrospective analysis of complications after all biopsies between 4 May 2005 and 6 January 6, 2011. The analysis focused on types of complications as well as needs for hospitalization with length of stay, for blood transfusion or for a further intervention. There were complications in 10.9% of procedures ( n = 15) with 8% requiring hospitalization ( n = 11). The complications were: gross hematuria ( n = 10) including blockage of urinary flow ( n = 2) with one subject requiring urologic intervention, and one patient experienced severe pain at the puncture site. Neither renal graft nor patient survival was threatened; there was no hemodynamic decompensation needing blood transfusions. The average hospital stay was 2.27 days (range = 1–8). Outpatient renal biopsies in 111 patients (137 procedures) had an 8% incidence of complications requiring admission and an average length of hospitalization of 2.27 days. Gross hematuria the most frequent problem, in no way compromised patient or graft survival showing it to be a safe outpatient procedure.

Single Use of Romiplostim Thrombopoietin Analogue (TPO) in Severe Thrombocytopenia for Outpatient Percutaneous Liver Biopsy in Patients with Chronic Liver Disease (CLD) - A Randomized Double Blinded Prospective Clinical Pilot Trial: 2011 ACG Presidential Poster

Single Use of Romiplostim Thrombopoietin Analogue (TPO) in Severe Thrombocytopenia for Outpatient Percutaneous Liver Biopsy in Patients with Chronic Liver Disease (CLD) - A Randomized Double Blinded Prospective Clinical Pilot Trial: 2011 ACG Presidential Poster

Outpatient Brain Tumor Surgery and Spinal Decompression: A Prospective Study of 1003 Patients

Outpatient craniotomy, biopsy, and spinal decompression have been performed at our center for more than a decade. Early feasibility studies suggest that they are safe, successful, cost-effective, and well-tolerated by patients. However, a large-scale study of this magnitude has not been performed. To characterize postoperative complications and the rate of successful discharge from the day surgery unit (DSU). We also discuss patient satisfaction and benefits to flow of care. From August 1996 to December 2009, 1003 consecutive patients were prospectively selected as outpatient candidates. Retrospective chart review was performed for all procedures and analyzed by intent to treat. Of 249 patients who underwent a craniotomy, 92.8% were successfully discharged from the DSU, 5.2% were admitted from the DSU, and 2.0% were discharged and later readmitted. Of 602 patients who underwent spinal decompression, 97.3% were successfully discharged from the DSU, 2.5% were admitted from the DSU, and 0.2% were discharged and readmitted at a later date. Of 152 patients who underwent a brain biopsy, 94.1% were successfully discharged from the DSU, 4.6% were admitted from the DSU, and 1.3% were discharged and later readmitted. No patients experienced a negative outcome as a result of early discharge. Outpatient craniotomy, biopsy, and spinal decompression are safe, successful, and cost-effective.

Comparison of Two Sampling Procedures for Diagnosing Endometrial Carcinoma and Hyperplasia: Outpatient Tissue Biopsy Versus Cytologic Examination

Background: We compared the sensitivity of 2 diagnostic procedures—tissue biopsy and cytologic examination— for detecting endometrial carcinoma and hyperplasia in outpatients. The patients’ degree of acceptance of these methods was also evaluated. Methods: The study included 124 women who had been diagnosed with carcinoma and hyperplasia by histological examination in private clinics or were suspected to have endometrial carcinoma and hyperplasia—for example, those presenting with uterine bleeding and/or abnormal endometrial morphology on cytologic examination—at Jikei University Hospital, University of Yamanashi Hospital and National Hospital Organization Kure Medical Center from January 28, 1999, to August 28, 2006. Both cytologic examination (using Endocyte ® ) and tissue biopsy (using Suresample ™ ) of the endometrium were performed before complete curettage and/or hysterectomy. The diagnosis made using these two outpatient procedures was compared to the final diagnosis made using curettage and/or hysterectomy. McNemar’s chi-square test was used to evaluate the statistical significance. Results: The sensitivity of tissue biopsy for detecting endometrial carcinoma and hyperplasia was 84% and 91%, respectively, and that of cytologic examination was 78% and 55%, respectively. There was a significant difference in the sensitivity of the 2 methods for detecting hyperplasia (p =0.045). No patients complained of severe pain, and no other complication occurred during both methods. Both methods were well tolerated by the patients. Conclusion: Our data indicate a certain diagnostic superiority of tissue biopsy over cytologic examination.

Experience with outpatient computed tomographic-guided renal biopsy

Native kidney biopsy is still performed primarily with hospital inpatient observation period. Experience with outpatient Computed Tomographic (CT)-guided renal biopsy at Yale New Haven Medical Center was studied to assess efficacy and safety. A total of 146 outpatient native kidney biopsies were identified between 1995 and 2001. Records were reviewed for demographics, clinical, and laboratory data and details of the procedure. Time of admission to the outpatient unit, duration of procedure and post-biopsy observation period were recorded. Complications such as bleeding, infection, admission to the hospital, transfusion, or intervention for continued bleeding were noted. Mean age was 43.9 ± 14.9 years and mean serum creatinine was 1.8 ± 1.4 mg/dl. Renal size averaged 11.4 cm. Post-procedure observation time of 4 - 6 h appeared to be adequate. Diagnostic tissue was successfully sampled in 98.6% of cases. Procedure was well tolerated with no hemodynamically significant changes. Hematocrit and hemoglobin concentration changes averaged 3.6 ± 2.5% and 1.0 ± 0.9 mg/dl, respectively (p < 0.001). There were no instances of death or need for intervention. Transfusion was required in 1 patient while 6 patients had detectable bleeding and were hospitalized for observation. Outpatient CT-guided kidney biopsy provides adequate tissue and appears to be safe with very low complication rates.

Living Donor Liver Transplantation for Dorfman-Chanarin Syndrome With 1 Year Follow-up: Case Report

A 27-year-old Japanese man underwent liver transplantation because of uncompensated cirrhosis due to Dorfman-Chanarin syndrome (DCS). At birth, the patient displayed ichthyosis and liver dysfunction. Moreover, mental retardation appeared and intracytoplasmic vacuoles were observed within peripheral blood neutrophils. A fatty liver was also noticed, leading to the diagnosis of DCS. When he was referred to our hospital, his American Society of Anesthesiologists score was 3. The findings of computed tomography showed liver atrophy, splenomegaly, and ascites. The Child-Pugh score was B, and the Model for End-stage Liver Disease score was 14. The pathophysiology was DCS with uncompensated liver cirrhosis. Therefore, living donor liver transplantation (LDLT) was performed from the patient's brother. The histological appearance of the resected liver revealed macrovesicular steatosis in most hepatocytes with excess fibrous tissue in the portal areas. These findings were compatible with nonalcoholic steatohepatitis. Although the patient's mental retardation and characteristic appearance have not improved, good liver function has been maintained since LDLT. An outpatient protocol liver biopsy performed at 12 months after LDLT did not show recurrence of macrovesicular steatosis.

118 Outpatient core needle biopsy to assess a multigene assay for prognostic information in breast cancer

118 Outpatient core needle biopsy to assess a multigene assay for prognostic information in breast cancer

The effectiveness of levonorgestrel releasing intrauterine system in the treatment of endometrial hyperplasia in Korean women

Levonorgestrel releasing intrauterine system (LNG-IUS) has been shown to treat patients with non-atypical & atypical endometrial hyperplasia (EH) successfully in many western studies. Our purpose was to examine the effectiveness of LNG-IUS in the treatment of Korean women with EH. We conducted a prospective observational study of 12 women diagnosed with EH and treated with LNG-IUS insertion between February 2007 and August 2009 at the Department of Gynecology of Gangnam CHA Hospital, CHA University School of Medicine. Baseline endometrial biopsies were done before insertion of LNG-IUS, and outpatient follow-up endometrial biopsies were undertaken at 3-month intervals after insertion of LNG-IUS. We investigated the regression rate and the time to regression. Four patients had simple hyperplasia without atypia, 7 patients complex hyperplasia without atypia, and just 1 patient complex atypical hyperplasia. Complete regression of EH was achieved in all cases (100%, 12/12), with the significant proportion (66%, 8/12) achieving it within 3 months. The mean duration to regression was 4.5 months. All cases had regression within 9 months. In the case of complex atypical hyperplasia, the regression was attained at the 9th month after insertion of LNG-IUS. The mean follow-up duration was 12 months (range, 3 to 27 months). As long as LNG-IUS was maintained, the EH did not recur. LNG-IUS appears to be as highly effective in treating Korean women with EH.

ASDIN: Percutaneous Renal Biopsy: Outpatient Observation without Hospitalization Is Safe

Percutaneous renal biopsy may be complicated by hemorrhage. Patients are frequently hospitalized for overnight observation. We evaluated prospectively the feasibility and safety of an outpatient renal biopsy protocol. During a 20-month period, 100 consecutive patients underwent outpatient renal biopsy using a standardized protocol. The biopsy was performed by Nephrology Fellows, under direct faculty supervision. All biopsies were carried out under real-time ultrasound guidance with a 16-gauge spring-loaded biopsy gun, and followed immediately by color Doppler ultrasound to exclude active bleeding. Blood pressure, heart rate, hemoglobin, and hematocrit were monitored for 8 hours postbiopsy. If there were no complications, the patients were discharged home after the observation period. A total of 91 patients required one or two needle passes, and nine needed three or four passes. A mean of 12.7 +/- 9.7 glomeruli were obtained per patient. No major complications were encountered. A small (<2 x 2 cm) perinephric hematoma was observed postbiopsy in 13 patients. Four patients were hospitalized for overnight observation due to a >4% decrease in their hematocrit, but none required a transfusion or intervention. No patient experienced a delayed biopsy-related complication. Outpatient, real-time, ultrasound-guided percutaneous renal biopsy is safe and effective, and minimizes the need for postbiopsy hospitalization. It can result in significant cost savings without exposing the patients to an increased risk of complications.

Patient Response to Total Intravenous Sedation (TIVS) for Outpatient Ultrasound-Guided Prostate Biopsy

Patient Response to Total Intravenous Sedation (TIVS) for Outpatient Ultrasound-Guided Prostate Biopsy

MP-4.09: TargetScan ®: A Novel Approach for Outpatient Prostate Biopsy with the Potential for Use as an Aid to Focal Prostate Therapy

MP-4.09: TargetScan ®: A Novel Approach for Outpatient Prostate Biopsy with the Potential for Use as an Aid to Focal Prostate Therapy

A Retrospective Analysis of the Safety of Outpatient Percutaneous Liver Biopsy in Patients with Von Willebrand Disease

Purpose: Liver biopsy remains the gold standard for the diagnosis of chronic liver diseases. Outpatient percutaneous biopsy is generally safe with a mortality rate of 0.17% and hospitalization rate for bleeding of 3%. Von Willebrand Disease (VWD) is the most common inherited hematological disorder with a prevalence of 1–3% globally. There are 3 major types of VWD – type 1 (low levels of VW factor), type 2 (several qualitative abnormalities of VWF) and type 3 (extremely reduced or undetectable levels of VWF with low concentration of factor VIII). Type 1 is the mildest and most common form of VWD, while type 3 is the most serious, but very rare. Whether VWD increases the risk of bleeding in invasive procedures is not known. The purpose of this review is to determine the safety of outpatient percutaneous liver biopsies in patients with VWD. Methods: 120 patients who underwent outpatient percutaneous liver biopsies from 1997 to 2007 were included in the study. Demographics, PT/INR, platelet count, VW factor antigen, VW factor ristocetin cofactor, Factor VIII activity, and VW factor multimers were collected. Patients had not received salicylates, NSAIDs or anticoagulants for at least 5 days prior to biopsy. Exclusions included prior known coagulation diathesis, familial bleeding history, arteriovenous malformations, collagen vascular diseases and congestive heart failure. Results: Of the 120 patients biopsied, 66 (55%) had hepatitis C, 24 (20%) hepatitis B, 10 (8.3%) alcoholic hepatitis, 20 (16%) other diagnoses. Overall, 30 (25%) had minor local bleeding that resolved with pressure and 53 (48%) had biopsy site ecchymosis after 24 hours. Twelve (10%) patients were diagnosed with VW factor deficiency, of these 5 (41%), 7 (56%), and 0 had type 1, 2 and 3 respectively. No VWD patients had major bleeding that required transfusion, hospitalization or surgery but 9 (75%) had minor local bleeding and all had ecchymoses, which resolved spontaneously within a week. Conclusion: Patients with VWD types 1 and 2 without prior bleeding diathesis can undergo percutaneous liver biopsy without major bleeding. Minor bleeding may occur at a slightly higher rate. VWD type 1 and type 2 does not appear to be a contraindication to percutaneous liver biopsy. The safety of percutaneous biopsy in VWD type 3 patients is unknown. We concur with the AGA guideline that outpatient percutaneous liver biopsy is safe and non-threatening in the setting of concomitant minor inherited bleeding diathesis without prior history of excessive bleeding. Routine screening for undiagnosed VW syndrome is not recommended.

Bleeding Complications After Transcutaneous Kidney Biopsy in Patients With Systemic Amyloidosis: Single-Center Experience in 101 Patients

Bleeding is one of the most common complications after kidney biopsy. Amyloidosis is thought to be 1 of the risk factors, but this has not been confirmed in a large study. We performed this study to assess the risk of bleeding after kidney biopsy in patients with amyloidosis. Retrospective study. 101 patients with and 188 patients without amyloidosis undergoing outpatient percutaneous kidney biopsy at a major medical center in the absence of abnormal partial thromboplastin time, prothrombin time international normalized ratio, or platelet count and/or uncontrolled hypertension. Clinical diagnosis of amyloidosis. Post-kidney biopsy bleeding confirmed by means of imaging. Bleeding was defined as major if it required blood transfusion, hospital admission, or other invasive procedures and minor if none of these interventions were needed. Post-kidney biopsy bleeding was observed in 9.9% of patients with amyloidosis and 10.6% of controls (P = 0.8). Bleeding was major in 4% of patients with amyloidosis and 2.1% of controls (P = 0.4). Three patients from each group required blood transfusions and selective renal angiography. All except 1 patient from the control group underwent embolization. Retrospective data analysis and overall low event rate did not allow for independent risk-factor analysis. The present study suggests that in the absence of a hematostatic disorder and/or uncontrolled hypertension, bleeding risk during kidney biopsy is not increased in patients with systemic amyloidosis. Kidney biopsy can be performed safely using the same screening criteria as for patients without amyloidosis.

PSA Doubling Time as a Predictor of the Outcome of Random Prostate Biopsies Prompted by Isolated PSA Elevation in Subjects Referred to an Outpatient Biopsy Facility in a Routine Clinical Scenario

To assess the validity of PSA doubling time (PSADT) as a predictor of prostate sextant biopsy outcome in patients with PSA levels in the 4-10 ng/mL range. A consecutive series of 355 sextant biopsies performed during 2001-2007 in subjects with negative digital rectal examination and transrectal ultrasonography was considered. Variables tested as possible predictors were age, total and free/total PSA value, PSA velocity and PSA doubling time. While PSA at time of biopsy and free/total PSA were determined with a standardized method undergoing strict quality control, previous PSA values used to assess velocity/doubling time came from other labs using different assays over widely varying intervals of time. The association with biopsy outcome (cancer vs non-cancer) was investigated by univariate and multivariate analysis. Apart from free/total PSA ratio, no other studied variable showed a statistically significant and independent association with biopsy outcome, either at univariate or multivariate analysis. No studied variable had a good performance as a biopsy indicator. Depending on the variable considered, 1.17 to 1.97 cancers would be missed to spare 10 benign biopsies. When based on PSA data determined with different assays over widely varying intervals and in the absence of an underlying protocol for PSA surveillance, PSA velocity and doubling time should never discount a biopsy prompted by total PSA elevation.