Biomedical subjects

Hartwig Huland

Publications and source records attributed to Hartwig Huland.

At least 19 recordsLinked to original sources

PubMed2007

Free PSA isoforms and intact and cleaved forms of urokinase plasminogen activator receptor in serum improve selection of patients for prostate cancer biopsy.

Clinicians currently use simple cut-points, such as serum prostate-specific antigen (PSA) >or=4 ng/ml, to decide whether to recommend further work-up for prostate cancer (PCa). As an alternative strategy, we evaluated multivariable models giving probabilities of a PCa diagnosis based on PSA and several circulating novel biomarkers. We measured total PSA, free PSA (fPSA), fPSA subfractions (single-chain fPSA-I and multichain fPSA-N), total human glandular kallikrein 2 (hK2) and full-length and cleaved forms of soluble urokinase plasminogen activator receptor (suPAR) in pretreatment serum from 355 men referred for prostate biopsy. Age and total PSA were combined in a "base" regression model to predict biopsy outcome. We then compared this base model to models supplemented by various combinations of circulating markers, using concordance index (AUC) to measure diagnostic discrimination. PCa prediction was significantly enhanced by models supplemented by measurements of suPAR fragments and fPSA isoforms. Addition of these markers improved bootstrap-corrected AUC from 0.611 for a cut-point and 0.706 for the base model to 0.754 for the full model (p=0.005). This improved diagnostic accuracy was also seen in subanalysis of patients with PSA 2-9.99 ng/ml and normal findings on DRE (0.652 vs. 0.715, p=0.039). In this setting, hK2 did not add diagnostic information. Measurements of individual forms of suPAR and PSA isoforms contributed significantly to discrimination of men with PCa from those with no evidence of malignancy.

Aged↗

PubMed2007

Detection of tumor-specific DNA in blood and bone marrow plasma from patients with prostate cancer.

Tumor tissues, blood plasma and bone marrow (BM) aspirates of 57 prostate cancer patients (PCa) without clinical signs of overt metastases were assessed for LOH (loss of heterozygosity) by a PCR-based fluorescence microsatellite analysis, using a panel of 15 markers. Additionally, micrometastatic tumor cells in BM were monitored by an immunocytological cytokeratin assay. In total, 25 (44%), 32 (56%) and 41 (72%) of the patients had at least 1 LOH in their blood, BM and tumor samples, respectively. Among the informative cases, the frequency of LOH was highest in blood plasma for the markers D8S360 (18%) and D10S1765 (15%), and in BM plasma for THRB (24%) and D8S137 (22%). Comparison of blood plasma and BM with tumors showed discrepant results in 35% and 45% of patients, respectively. Whereas all LOHs at THRB in BM plasma were also detected in the autologous tumor tissues, LOHs at D6S474 and D11S898 in BM were not retrieved in the tumors. The comparison with established risk factors showed a correlation of borderline significance for LOH at D9S1748 in the BM aspirates (p=0.055) and a significant correlation in the tumor samples (p=0.004) with increasing pathologic Gleason scores. Interestingly, 22% of the PCa patients harbored tumor cells in their BM and tended (p=0.065) to have more frequent LOH (16%) in BM plasma compared to patients without tumor cells (9%). These data demonstrate, for the first time, the presence of free tumor-specific DNA in blood and BM of PCa patients and suggest a possible relationship to BM micrometastasis.

Adenocarcinoma↗

PubMed2007

Tumour volume and high grade tumour volume are the best predictors of pathologic stage and biochemical recurrence after radical prostatectomy.

INTRODUCTION: Our goal was to examine to what extent tumour volume (TV) and percentage of high grade tumour volume (%HGTV) affect the rate of positive surgical margins and the rate of biochemical recurrence after radical prostatectomy. MATERIALS AND METHODS: TV and %HGTV were routinely planimetrically quantified in a cohort of 780 consecutive patients. Mean follow-up was 46.7 months. Multivariable regression models addressed two separate endpoints: positive surgical margins and biochemical recurrence. The increase in model predictive accuracy related to the addition of TV and %HGTV to radical prostatectomy stage and grade was assessed, after 200 bootstrap resamples to reduce overfit bias. RESULTS: In multivariable logistic regression models addressing positive surgical margins rate, predictive accuracy increased by 1.9% (p<0.001) when TV was added to other covariates. No further increment was noted when %HGTV was added (p=0.3). In multivariable Cox regression models addressing biochemical recurrence, accuracy increased by 0.6% (p=0.002) when TV was added and an additional increase of 0.7% was recorded when %HGTV (p<0.001) was added. CONCLUSION: Tumour bulk reflected by TV affects local cancer control rate, which is reflected in the rate of positive surgical margins. Conversely, high grade cancer determines the rate of biochemical recurrence. These two variables represent the most powerful predictors of cancer control in men treated for localised prostate cancer. Moreover, they increase the ability of established predictors to predict the outcomes of interest. In consequence, they warrant consideration in future predictive and prognostic tools.

Adult↗

PubMed2007

Development and external validation of an extended repeat biopsy nomogram.

PURPOSE: We hypothesized that the outcome of repeat biopsy could be accurately predicted. We tested this hypothesis in a contemporary cohort from 3 centers. MATERIALS AND METHODS: The principal cohort of 1,082 men from Hamburg, Germany was used for nomogram development as well as for internal 200 bootstrap validation in 721 and external validation in 361. Two additional external validation cohorts, including 87 men from Milan, Italy and 142 from Seattle, Washington, were also used. Predictors of prostate cancer on repeat biopsy were patient age, digital rectal examination, prostate specific antigen, percent free prostate specific antigen, number of previous negative biopsy sessions and sampling density. Multivariate logistic regression models were used to develop the nomograms. RESULTS: The mean number of previous negative biopsies was 1.5 (range 1 to 6) and the mean number of cores at final repeat biopsy was 11.1 (range 10 to 24). Of the men 370 (30.2%) had prostate cancer. On multivariate analyses all predictors were statistically significant (p < or =0.028). After internal validation the nomogram was 76% accurate. External validation showed 74% (Hamburg), 78% (Milan) and 68% (Seattle) accuracy. CONCLUSIONS: Relative to the previous nomograms (10 predictors or 71% accuracy) our tool relies on fewer variables (6) and shows superior accuracy in European men. Accuracy in American men is substantially lower. Racial, clinical and biochemical differences may explain the observed discrepancy in predictive accuracy.

Adult↗

PubMed2006

Comparison of free and total forms of serum human kallikrein 2 and prostate-specific antigen for prediction of locally advanced and recurrent prostate cancer.

BACKGROUND: We evaluated the association of total and free forms of serum human kallikrein 2 (hK2) and prostate-specific antigen (PSA) with prostate cancers of unfavorable prognosis. METHODS: We retrospectively measured total PSA (tPSA), free PSA (fPSA), and total hK2 (thK2) in preoperative serum samples from 867 men [and assessed free hK2 (fhK2) measured in 577 of these men] treated with radical prostatectomy for clinically localized prostate cancer. Associations between biomarker concentrations and extracapsular extension, seminal vesicle invasion, and biochemical recurrence (BCR) were evaluated. A subset of patients with PSA < or =10 microg/L, the group most commonly seen in clinical practice in the US, was analyzed. RESULTS: thK2 was the strongest predictor of extracapsular extension and seminal vesicle invasion (areas under the ROC curve [AUC], 0.662 and 0.719, respectively), followed by tPSA (AUC, 0.654 and 0.663). All biomarkers were significant predictors of BCR. hK2 forms, but not PSA forms, remained highly significant for predicting BCR in the low-PSA group. Combining tPSA, fPSA, and thK2 in a multivariable model improved prediction compared with any biomarker used individually (AUC, 0.711, 0.755, and 0.752 for this combination predicting extracapsular extension, seminal vesicle invasion, and BCR, respectively; P <0.001 for all). CONCLUSIONS: Increased concentrations of hK2 in the blood are significantly associated with unfavorable features of prostate cancer, and thK2 is predictive of locally advanced and recurrent cancer in patients with PSA < or =10 microg/L. Independent of tPSA and fPSA, hK2 predicts unfavorable prognosis.

Aged↗

PubMed2006

Prediction of pathological stage is inaccurate in men with PSA values above 20 ng/mL.

INTRODUCTION: We hypothesized that either very low (0-2.5 ng/mL) or very high (>20 ng/mL) PSA values may limit the accuracy of pathological stage predictions. To test this hypothesis, we examined 5193 consecutive patients subjected to radical prostatectomy (RP) for localized prostate cancer (PCa). MATERIAL AND METHODS: Patients were divided into three cohorts according to their pre-treatment PSA value: </=2.5 (n=331), 2.51-20 (n=4545) and >20 ng/mL (n=317). Subsequently in each cohort, the ability of PSA, clinical stage and biopsy Gleason sum was tested in multivariable logistic regression models predicting three separate endpoints: extracapsular extension (ECE), seminal vesicle invasion (SVI) and lymph node invasion (LNI). Predictive accuracy represented the performance benchmark. All models were adjusted for year of surgery and subjected to 200 bootstrap resamples to reduce overfit bias. RESULTS: For PSA </=2.5 ng/mL, predictive accuracy was 76.7%, 72.3% and 82.8% for respectively ECE, SVI and LNI. For PSA 2.51-20 ng/mL, the predictive accuracy for the same endpoints was 67.8%, 77.4% and 81.6%. Finally, for PSA >20 ng/mL, predictive accuracy was 63.6%, 63.7% and 70.6%. CONCLUSIONS: The ability to predict pathological stage in patients with PSA values in excess of 20 ng/mL significantly decreased, compared to patients with lower PSA values. Therefore, accurate staging of these patients may require alternative markers or staging schemes.

Adult↗

PubMed2006

Development and internal validation of preoperative transition zone prostate cancer nomogram.

OBJECTIVES: Up to 20% of men may harbor a transition zone (TZ) prostate cancer (PCa) at radical prostatectomy (RP). TZ PCa may be associated with more favorable RP pathologic findings than peripheral zone (PZ) PCa. To identify these men, we developed a model capable of predicting the probability of TZ PCa at RP. METHODS: The study cohort consisted of 945 consecutive men treated with RP, with clinical stage, prostate-specific antigen (PSA) level, and detailed biopsy and RP pathology data available. The preoperative variables were used as predictors in the multivariate logistic regression models to predict the rate of TZ PCa at RP. PCa was defined as a TZ tumor when more than 50% of the planimetrically measured tumor volume was situated within the TZ. Regression coefficients were used to develop nomograms, which were subjected to 200 bootstrap resamples to reduce overfit bias. RESULTS: TZ PCa at the final pathologic examination was recorded in 110 patients (11.6%). After 200 bootstraps, the most parsimonious and most accurate nomogram was 77.3% accurate in predicting the probability of TZ PCa. CONCLUSIONS: This nomogram is ideally suited to identify patients with markedly elevated, nearly metastatic serum PSA levels who harbor a TZ tumor that is highly treatable by RP.

Adult↗

PubMed2006

Body mass index does not improve the ability to predict biochemical recurrence after radical prostatectomy.

PURPOSE: To test whether body mass index (BMI) improves pre- or post-operative biochemical recurrence (BCR) predictions after radical prostatectomy. MATERIALS AND METHODS: Pre- and post-operative data were available in 2416 and 2499 men, respectively. Cox regression models addressed the association between BMI and the rate of BCR after adjusting for pre- and post-operative predictors. Predictive accuracy was quantified using Harrell's concordance index, with and without BMI and subjected to 200 bootstraps to reduce overfit bias. Differences in predictive accuracy were compared using the Mantel-Haenszel test. RESULTS: After adjusting for either pre- or post-operative variables, increasing BMI was a statistically independent risk factor of BCR in both models (both p0.003). Its addition to pre- and post-operative variables respectively increased predictive accuracy measures from 69.6 to 70.2% (+0.6%, p=0.7) and from 78.1 to 78.4% (+0.3%, p=0.8). CONCLUSION: Our data emphasise that despite its significance, inclusion of BMI into models, to predict BCR, does not improve their accuracy.

Body Mass Index↗

PubMed2006

Surgical volume is related to the rate of positive surgical margins at radical prostatectomy in European patients.

OBJECTIVE: To assess the association between surgical volume (SV) and the rate of positive surgical margins (PSM) after radical prostatectomy (RP) in a large single-institution European cohort of patients. PATIENTS AND METHODS: In all, 2402 men had a RP by a group of 11 surgeons, all of whom were trained by the surgeon with the highest SV; all surgeons used the same surgical technique. Variables assessed before RP were prostate-specific antigen (PSA) level, clinical stage and biopsy Gleason sum; variables assessed after RP were PSA level, extracapsular extension, seminal vesicle invasion, lymph node invasion and pathological Gleason sum. These were used to predict the rate of PSM in models before or after RP. Multivariate models were complemented with SV to test its independent and multivariate statistical significance and to quantify its impact on the model's overall (and 200 bootstrap-corrected) predictive accuracy. RESULTS: The mean (range) SV was 201 (1-1293) RPs; the mean (median, range) rate of PSM was 20.2 (21.4, 0-32.9)%. In multivariate models, SV was a highly statistically significant independent predictor of PSM (P < 0.001) and increased the predictive accuracy in multivariate models both before (2.0%) and after RP (1.5%, both P < 0.001). However, when the surgeon with the highest SV, who contributed to 1293 cases, was removed from the analyses, the multivariate independent prediction and the gains in predictive accuracy related to adding SV, disappeared in the models both before (P = 0.9, accuracy gain 0.1%) and after (P = 0.4, accuracy gain - 0.3%) RP. CONCLUSIONS: These results indicate that patients treated by surgeons with a very high volume can expect to have a significantly lower rate of PSM, after accounting for clinical and pathological case-mix differences. However, SV is not a predictor of PSM when analyses are restricted to intermediate- and low-volume surgeons.

Clinical Competence↗

PubMed2006

Development and external validation of an extended 10-core biopsy nomogram.

OBJECTIVES: To test the accuracy of a previously externally validated sextant biopsy nomogram in referred men exposed to > or =10 or more biopsy cores. Moreover, we explored the hypothesis that a more accurate predictive tool could be developed. METHODS: Previous nomogram predictors (age, digital rectal examination, prostate-specific antigen, and percent free PSA) were used to assess the accuracy of our previous nomogram in a cohort consisting of 2900 men referred for prostatic evaluation. Moreover, these variables were complemented with sampling density (SD) (i.e., ratio of gland volume and the number of planned biopsy cores) within multivariable logistic regression models (LRM) predicting presence of prostate cancer (pCA) on the initial 10 or more core biopsy. The LRMs were used to develop and internally validate (200 bootstrap resamples) a new nomogram in 1162 men from Hamburg, Germany. The LRMs' external validity was tested in three separate cohorts (Hamburg, n=582; Milan, n=961; Seattle, n=195). RESULTS: The contemporary external validation of the previously validated sextant nomogram demonstrated 70% accuracy. Internal validation of the new nomogram demonstrated 77% accuracy, and external cohorts demonstrated 73-76% accuracy. CONCLUSIONS: In the era of extended biopsy schemes, previously developed predictive models are less accurate in predicting the probability of pCA on initial biopsy. We developed a new tool that allows obtaining more accurate predictions. Moreover, before biopsy, it also allows defining the ideal ratio between gland volume and the number of planned biopsy cores that would yield the ideal biopsy rate.

Adult↗

PubMed2006

Prostate cancer nomograms: an update.

OBJECTIVE: Several nomograms have been developed to predict outcomes related to prostate cancer (PCa). METHODS: We provide a descriptive and an analytic comparison of nomograms. Further, we report a set of recent PCa nomograms, in which we recorded predictor variables, number of patients used to develop each nomogram, and nomogram-specific features. Moreover, accuracy estimates and type of validation are considered. RESULTS: Our findings suggest a demand for updated nomograms in selected fields of PCa outcomes. Moreover, an increasing number of nomograms address important end points such as prostate-specific antigen recurrence, distant metastases, or androgen-independent PCa-specific survival. CONCLUSION: Our results suggest that nomograms are available for many PCa-related outcomes. They represent a valid methodologic approach if correct criteria are met.

Biopsy↗

PubMed2006

Initial biopsy outcome prediction--head-to-head comparison of a logistic regression-based nomogram versus artificial neural network.

OBJECTIVES: Nomograms and artificial neural networks (ANNs) represent alternative methodologic approaches to predict the probability of prostate cancer on initial biopsy. We hypothesized that, in a head-to-head comparison, one of the approaches might demonstrate better accuracy and performance characteristics than the other. METHODS: A previously published nomogram, which relies on age, digital rectal examination, serum prostate-specific antigen (PSA), and percent-free PSA, and an ANN, which relies on the same predictors plus prostate volume, were applied to a cohort of 3980 men, who were subjected to multicore systematic prostate biopsy. The accuracy and the performance characteristics were compared between these two approaches. RESULTS: The accuracy of the nomogram was 71% versus 67% for the ANN (p=0.0001). Graphical exploration of the performance characteristics demonstrated virtually perfect predictions for the nomogram. Conversely, the ANN underestimated the observed rate of prostate cancer. CONCLUSIONS: A 4% increase in predictive accuracy implies that the use of the nomogram instead of the ANN will result in 40 additional patients who will be correctly classified between benign and cancer.

Adult↗

PubMed2006

Zonal origin of localized prostate cancer does not affect the rate of biochemical recurrence after radical prostatectomy.

OBJECTIVE: To investigate whether transition zone (TZ) prostate cancers demonstrate different rates of biochemical recurrence after radical prostatectomy compared to peripheral zone (PZ) cancers. METHODS: In 1262 consecutive patients treated with radical prostatectomy, computerized planimetry defined tumour origin as either TZ tumours (>70% TZ location) or PZ. Kaplan-Meier and multivariate Cox regression models tested the association between zonal origin and the rate of biochemical recurrence (prostate-specific antigen >0.1ng/ml and rising). We used the Harrell's concordance index to quantify the accuracy of various Cox regression models. RESULTS: TZ prostate cancers were diagnosed in 115 patients (9.1%). Biochemical recurrence was recorded in 16 TZ and in 201 PZ prostate cancers patients. In multivariate Cox models, the rate of biochemical recurrence was not significantly different between TZ and PZ prostate cancers (p=0.4). Combined multivariate predictive accuracy of biochemical recurrence predictions was 81.2% accurate when zonal origin was included versus 81.0% when zonal origin was omitted. CONCLUSIONS: The zonal origin of prostate cancers does not affect the rate of biochemical recurrence after radical prostatectomy.

Humans↗

PubMed2006

Nerve distribution along the prostatic capsule.

OBJECTIVES: Recent literature describes indications for a more-complex course of fibres of the neurovascular bundle (NVB), despite the widely held assumption that it is gathered at the rectolateral side of the prostate. The objective of this study therefore was to determine the typical pattern of nerve distribution along the prostatic capsule. MATERIALS AND METHODS: Permanent sections of 31 patients, who underwent non-nerve-sparing radical prostectomy (RP) at our institution, were investigated. A total of 186 slides taken from the apex, mid-part, and base of the prostate was analyzed by microscopy. Before microscopy, slides were divided into 12 sectors and numbered clockwise starting from "1" for left ventral sides to "6" for the rectal sides (accordingly, "12"-"7" for right half). Every single nerve and ganglion in the prostatic capsule and the periprostatic tissue was counted in each sector. RESULTS: The majority of nerves found in the sectors corresponded to the typical location of the NVB at the rectolateral sides of the prostate (4/5 or 8/9 o'clock sectors). In these two sectors, a median of 45.9-65.6% of counted nerves per half was found. However, a significant amount of nerves (21.5%-28.5%) was detected above the horizontal line. CONCLUSIONS: We conclude that 1/5-1/4 of nerves can be found along the ventral circumference of the prostatic capsule. To preserve a maximum number of nerves, we therefore recommend a modification of the surgical technique by focusing on a high incision for nerve sparing on the ventral parts of the prostate.

Humans↗

PubMed2006

High incidence of prostate cancer detected by saturation biopsy after previous negative biopsy series.

OBJECTIVES: We explored the yield of saturation biopsy and developed a nomogram predicting the probability of prostate cancer (PCa) on the basis of saturation biopsy. MATERIALS AND METHODS: Between 2001 and 2004, saturation biopsies (average of 24 cores) were performed in 161 men with persistently elevated prostate specific antigen (PSA) level (median, 9 ng/ml). All had at least two previously negative, eight-core biopsy sessions. PCa predictors on saturation biopsy were integrated within multivariate nomograms. RESULTS: PCa detection was 41% (n=66 of 161). PSA density and transition zone volume were the most significant predictors of PCa on saturation biopsy. The accuracy of the nomogram with the best performance characteristics was 72%. CONCLUSIONS: Saturation biopsy may be indicated in men with a persistent suspicion of PCa. High-risk individuals can be identified accurately with our nomogram.

Adult↗

PubMed2006

Institutional variability in the accuracy of urinary cytology for predicting recurrence of transitional cell carcinoma of the bladder.

OBJECTIVE: To assess the contemporary inter-institutional accuracy of urinary cytology in predicting the recurrence of transitional cell carcinoma (TCC) of the bladder, in a large multi-institutional cohort from four continents, as cystoscopy and urinary cytology represent the 'gold standards' for surveillance of TCC recurrences, but the ability of cytology to predict recurrence varies. PATIENTS AND METHODS: Ten institutions contributed 2542 patients with a history of superficial TCC, of whom 898 had TCC recurrence. Age- and gender-adjusted logistic regression models were used to evaluate the association between urine cytology and TCC recurrence. The predictive accuracy derived from the logistic regression model was tested using the area under the receiver operating characteristic curve. The resulting predictive accuracy estimates were internally validated with 200 bootstrap re-samples. RESULTS: The mean (range across institutions) age of the patients was 65 (48-69) years and 75 (67-87)% were men. Cytology was positive in 19 (10-38)% of patients; recurrence was identified in 35 (27-54)% of patients. The sensitivity was 38-65% across institutions. Urinary cytology varied significantly in its ability to predict recurrence of bladder cancer. Institution-specific predictive accuracy adjusted for gender and age was 0.627-0.893. Stratifying by grade and stage only partly attenuated the discrepancies between centres. CONCLUSIONS: The variability of urinary cytology results was very appreciable among the 10 centres and ranged from poor (63%) to excellent (89%).

Aged↗

PubMed2006

Enhanced discrimination of benign from malignant prostatic disease by selective measurements of cleaved forms of urokinase receptor in serum.

BACKGROUND: Early detection of prostate cancer (PCa) centers on measurements of prostate-specific antigen (PSA), but current testing practices suffer from lack of specificity and generate many unnecessary prostate biopsies. Soluble urokinase plasminogen activator receptor (uPAR) is present in blood in both intact and cleaved forms. Increased uPAR in blood is correlated with poor prognosis in various cancers, but uPAR has not been shown to be useful in PCa diagnostics. We assessed the ability of immunoassays for specific uPAR forms to discriminate PCa from benign conditions. METHODS: We measured total PSA (tPSA), free PSA (fPSA), intact uPAR [uPAR(I-III)], intact uPAR + cleaved uPAR domains II+III [uPAR(I-III) + uPAR(II-III)], and cleaved uPAR domain I [uPAR(I)] in sera from 224 men with and 166 men without PCa. We assessed differences in serum concentrations between the PCa and noncancer groups within the entire cohort and in men with tPSA concentrations of 2-10 microg/L. The diagnostic accuracy of individual analytes and analyte combinations was explored by logistic regression and ROC analyses and evaluations of sensitivity and specificity pairs. RESULTS: Serum uPAR(I) and uPAR(II-III) were higher in PCa than in benign disease. In men with tPSA between 2 and 10 microg/L, the combination of %fPSA with the ratio uPAR(I)/uPAR(I-III) had a greater area under the ROC curve (0.73) than did %fPSA (0.68). CONCLUSIONS: Specific measurements of different uPAR forms in serum improve the specificity of PCa detection. The uPAR forms may therefore be complementary to PSA for PCa detection, most importantly in men with moderately increased PSA.

Adult↗

PubMed2006

Frozen section for the management of intraoperatively detected palpable tumor lesions during nerve-sparing scheduled radical prostatectomy.

OBJECTIVES: The intraoperative finding of palpable tumor lesions has been described as a contraindication for nerve-sparing (NS) radical prostatectomy (RP). However, its evaluation is subjective. Especially in patients with a strong demand to regain postoperative erectile function, a surgeon might be reluctant to sacrifice neurovascular bundles (NVBs) based on this information. We investigated the use of frozen section (FS) analysis to monitor the safety and efficiency of NS during RP in patients with intraoperatively identified subcapsular tumor lesions. METHODS: In 83 of 608 patients, who underwent NS-RP, intraoperative FS was performed because of a lesion palpable close to the capsule. A wedge of 4cm in diameter including the lesion was cut off and stained differently for capsule and intraprostatic margin. In case of presence of carcinoma adherent to the capsule, the NVB was resected; otherwise, the NVB remained in situ. RESULTS: Patients with palpable tumor lesions had pT3 tumors in 36% and 61% had Gleason 4 pattern, compared to 18% and 42% for the control group. Carcinoma was found in 93% of the FS specimens. In 42% of the FS samples, tumor had contact with the capsule and 14% of secondary resected NVB specimens demonstrated a carcinoma invasion. In 52% NVBs could be preserved despite an ipsilateral nodule without negatively affecting the margin status. However, the false-negative rate of the FSs was 6%. Conversely, FSs set the intraoperative decision to remove the NVB in 42% of FS patients, resulting in an additional 36% of negative margins. CONCLUSIONS: In patients with intraoperatively detected tumor lesions during a NS planned RP, FS objectively supports the decision of secondary NVB resection as well as preservation.

Carcinoma↗