Training robotic surgery in urology: experience and opinions of robot urologists.

BACKGROUND: To answer the research questions: (a) what were the training pathways followed by the first generation of robot urologists; and (b) what are their opinions on the ideal training for the future generation? METHODS: Data were gathered with a questionnaire and semi-structured interviews in a mixed-method research design. RESULTS: The results show that training approaches differed from hardly any formal training to complete self-initiated training programmes, with all available learning resources. The median number of supervised procedures at the start of robot-assisted laparoscopy was five (range 0-100). Before patient-related console time, respondents indicated that the minimum training of robot trainees should consist of: live observations (94% indicated this as essential), video observations (90%), knowledge (88%), table assisting (87%) and basic skills (70%). CONCLUSION: The first generation of robot urologists used different training approaches to start robotic surgery. There is a need for a structured and compulsory training programme for robotic surgery. Copyright © 2014 John Wiley & Sons, Ltd.

[In favour of laparoscopic versus open prostatectomy]. / Voorkeur voor laparoscopische boven open prostatectomie.

The introduction of a new technique typically generates concern regarding the associated time, costs and efforts. The favourable functional results of the laparoscopic approach to prostate cancer must be weighed against the potential disadvantages of this approach. The short-term oncologic results justify further implementation of the laparoscopic technique.

Robotically assisted laparoscopic radical prostatectomy: feasibility study in men.

PURPOSE: We report our early experience of robotically assisted laparoscopic radical prostatectomy. MATERIAL AND METHODS: Five consecutive patients, with an average age of 58 years, PSA 12, 1.6 positive biopsies, Gleason score 6, were operated in our institution over a period of 1 week by the same surgeon. A robotically assisted laparoscopic nerve sparing radical prostatectomy was performed according to the Montsouris technique with the Da Vinci robot (Intuitive Inc., Mountain View, Calif., USA). RESULTS: The mean installation time was 93 min (range 76-149). The mean operating time (starting at the dissection of the seminal vesicles until the final stitch of the anastomosis) was 222 min (range 150-381 min). The average blood loss was 800 cm(3) (range 700-1,600 cm(3)). No postoperative complications were seen. Bladder catheter time: 6.5 days, hospital stay 5.5 days, urine leak 1/5, continence 4/5, positive margin 1/5. CONCLUSION: After this short experience, we conclude that: The use of a tele manipulation system accompanied by a three-dimensional view of the operating field provides a real benefit for the surgeon, and the urethro-anastomosis is easier to perform. The benefit for the patient is presently not very clear in terms of operating time, postoperative course and functional results, our initial results show that the robotically assisted procedure is at least as safe and effective as the conventional laparoscopic procedure.

Histopathological prostate cancer characteristics at radical prostatectomy after population based screening.

PURPOSE: Although early detection of prostate cancer by prostate specific antigen based screening results in a shift towards more clinically organ confined tumors, changes in prostate cancer characteristics after radical prostatectomy are less clear. MATERIALS AND METHODS: We studied 121 totally embedded radical prostatectomy specimens that were obtained from consecutive participants of the European Randomized Study of Screening for Prostate Cancer who were systematically screened and treated surgically. In each specimen pathological stage, Gleason score and proportion of high grade cancer (Gleason pattern 4 or 5) were determined. Lymph node status at operation, stage and grade were compared to a historical series of 72 surgical procedures performed for clinically localized prostate cancer at our hospital before the introduction of serum prostate specific antigen as a diagnostic tool. RESULTS: Although none of the screen detected cases had positive lymph nodes at surgery, operation was discontinued in 13 (18%) of the 72 historical cases because of positive lymph nodes. Compared with the remaining 59 historical prostatectomy specimens, the screen detected specimens showed a definite increase in the frequency of pathologically organ confined tumors and a relative decrease in Gleason score 8 to 10 tumors. However, 60% of screen detected tumors contained areas with high grade cancer (Gleason pattern 4 or 5) and 50% had a Gleason score of 7. The relative amount of high grade cancer in each tumor was related to volume (Kruskal-Wallis test p <0. 001). CONCLUSIONS: Screening for prostate cancer leads to an increase in surgical treatment for relatively small tumors that have a higher probability of being organ confined. Although the frequency of positive lymph nodes at operation decreases dramatically and the proportion of organ confined tumors after surgery increases, there is a shift from Gleason 8 to 10 tumors towards lower grade tumors at radical prostatectomy. Still, judged by the high frequency of focal dedifferentiation in screen detected tumors, most of them and surgically treated tumors are likely to be clinically important. The relatively large accumulation of these tumors in the Gleason 7 category is a concern because it could lead to a decrease in the clinical usefulness of the Gleason score system.

The changing pattern of prostate cancer at the time of diagnosis: characteristics of screen detected prostate cancer in a population based screening study.

PURPOSE: We describe the clinical and pathological features of prostate cancer diagnosed through serum prostate specific antigen (PSA), digital rectal examination and transrectal ultrasonography in a population based randomized screening study. MATERIALS AND METHODS: Between November 1993 and June 1997, 20,632 volunteers 55 to 76 years old were included in the study. In the screening arm 9,776 men underwent digital rectal examination, transrectal ultrasound and serum PSA determination. Biopsies were taken if the digital rectal examination and/or transrectal ultrasound findings were abnormal or if PSA was 4 ng/ml or greater. A total of 2,262 men underwent biopsy and 474 cases of prostate cancer were diagnosed. RESULTS: The pretreatment data were complete in 459 men, of whom 78% had clinically organ confined disease. Bone or lymph node metastases were seen in 8 cases (1.7%). Of 172 men who underwent radical prostatectomy 2 had lymph node metastases. Overall 66.3% of men treated with radical prostatectomy had organ confined disease. CONCLUSIONS: Comparison of the characteristics of prostate cancer detected through screening of the general population with those in a population based cohort of men in which there was no organized screening revealed stage reduction, primarily with regard to number of metastatic cases. Whether this stage reduction will lead to a decrease in disease specific mortality remains unknown until the study is completed and the end point of prostate cancer specific mortality is evaluated.

Evaluation of prostate needle biopsies in a population-based screening study: the impact of borderline lesions.

BACKGROUND: The finding of isolated high grade prostatic intraepithelial neoplasia (PIN) or borderline lesions (lesions suspicious for malignancy) in prostate needle biopsies warrants repeat biopsies. The reported frequency of these lesions in prostate needle biopsies varies considerably. The authors evaluated the frequency and clinical impact of high grade PIN and borderline lesions in sextant prostate needle biopsies obtained from screened participants in the European Randomized study of Screening for Prostate Cancer (ERSPC). METHODS: A total of 8763 participants in the Rotterdam section of the ERSPC ages 55-75 years were screened systematically for prostate carcinoma. Systematic sextant prostate needle biopsies were prompted by an abnormal digital rectal examination and/or abnormal transrectal ultrasonography findings at serum prostate specific antigen (PSA) levels > or = 1.0 ng/mL or a PSA level > or = 4.0 ng/mL. Repeat biopsies were obtained within 6 months after initial biopsy. RESULTS: Of 1824 biopsied men, 384 (21.1%) were found to have prostate carcinoma on initial biopsy. Twelve participants (0.7%) had isolated high grade PIN and 43 (2.4%) had borderline lesions. Repeat biopsies yielded no carcinoma in 7 participants with initial high grade PIN and 15 tumors (38.5%) in 39 participants with borderline lesions. CONCLUSIONS: In prostate needle biopsies obtained from a screened population, indications for repeat biopsy such as high grade PIN and borderline lesions do not represent large diagnostic subsets. Borderline lesions comprise the most important indication for a repeat biopsy. The low frequency of equivocal biopsy diagnoses in the current study supports the clinical applicability of sextant needle biopsies in population-based screening for prostate carcinoma.

Repeat screening for prostate cancer after 1-year followup in 984 biopsied men: clinical and pathological features of detected cancer.

PURPOSE: We describe the yield of a repeat examination and biopsy procedure 1 year after initial biopsy was negative. We also assessed the parameters responsible for the failure to diagnose these cancers at the primary screening. MATERIALS AND METHODS: We screened 8,103 men randomized to the screening arm of the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer using prostate specific antigen measurement, digital rectal examination and transrectal ultrasound. At the primary screening biopsy of 1,875 men was positive for prostate cancer in 374. Of the remaining 1,501 men 984 underwent repeat screening. RESULTS: Biopsy at repeat screening diagnosed prostate cancer in 49 of 442 men (11%), a rate significantly lower than the 19.9% true positive biopsy rate at the primary screening. Pathological characteristics of the tumors diagnosed were not significantly different in the 2 groups. However, prostate volume in men diagnosed with prostate cancer was significantly greater at repeat versus primary screening (mean 42.6 versus 34.9 cc, p = 0.003). The clinical characteristics were more favorable because of an increased proportion of stage T1C tumors. Prostate volume in men with stage T1C cancer was significantly greater than in those with palpable or visible tumors in whom prostate specific antigen values were in the same range. CONCLUSIONS: The most important factor responsible for the failure to diagnose these cancers at the primary screening was significantly greater prostate volume. Tumor characteristics were not significantly different in the groups. If prostate cancer screening were to become a routine health care policy, efforts would have to be made to improve the chances of diagnosing prostate cancer in larger prostates by repeat biopsy or by increasing the number of cores obtained.

Comparison of prostate-specific antigen corrected for total prostate volume and transition zone volume in a population-based screening study.

OBJECTIVES: To compare the discriminatory potential between prostate cancer and benign conditions of the prostate in a population-based screening study, of serum prostate-specific antigen levels (PSA) and PSA corrected for both the total prostate volume (PSA-D) and the transition zone volume (PSA-T). METHODS: In a randomized population-based screening study (Rotterdam section of the European Randomized Study of Screening for Prostate Cancer), in which 10,865 men have been screened, the biopsy results of 1202 men with PSA levels of 4 ng/mL or more were evaluated. Planimetric and prolate ellipsoid volumes of the total prostate as well as of the transition zone were measured. The measured volumes were compared with the volumes of 57 radical prostatectomy specimens through Spearman's rank correlation coefficient and agreement tests. A receiver operating characteristic (ROC) curve analysis was done of sensitivity and specificity of biopsy indications through PSA and PSA corrected for the volumes measured with transrectal ultrasound. RESULTS: In the 1202 men studied, 361 cases of prostate cancer were diagnosed. Both PSA-D and PSA-T showed a significantly higher area under the ROC curve (0.77 and 0.79, respectively) than PSA alone (area 0.65). There was no significant difference between PSA-D and PSA-T. The use of a PSA-D threshold value of 0. 10 ng/mL/cc would have avoided 28% of biopsies at the cost of 10% of detectable cancers. A PSA-D threshold of 0.15 ng/mL/cc would have avoided 73.8% of biopsies at the cost of not diagnosing 43.8% of detectable cancers. CONCLUSIONS: The planimetrically obtained prostate volume showed a more favorable agreement with the radical prostatectomy volume than the prolate ellipsoid volume. The discriminatory potential of the corrected PSA value is better at predicting the results of needle biopsy of the prostate when compared with PSA alone. The use of the transition zone volume for this correction results in a higher discriminatory potential when compared to the use of the total prostate volume; however, the observed difference was not statistically significant.

Complications of transrectal ultrasound-guided systematic sextant biopsies of the prostate: evaluation of complication rates and risk factors within a population-based screening program.

OBJECTIVES: Screening for prostate cancer to reduce the mortality and morbidity from this disease has become an important issue in recent years. Of all procedures used to diagnose prostate cancer, biopsy of the prostate is the cause of most complications. To evaluate the safety of the screening procedure, we have studied the complications and risk factors for complications within the screened population of the European Randomized Study of Screening for Prostate Cancer (ERSPC), Rotterdam section. METHODS: Between June 1994 and July 1996, 1687 transrectal ultrasound-guided systematic sextant biopsies were performed after screening 6198 men through prostate-specific antigen level, digital rectal examination, and transrectal ultrasonography. RESULTS: From these 1687 biopsies, 302 cases of prostate cancer were diagnosed. Mild complications such as hematuria and hematospermia were reported frequently with rates of 23.6% and 45.3%, respectively. More severe complications were far less frequently seen. Fever, usually of low grade, was seen after 4.2% of biopsies. Seven men (0.4%) were admitted to a hospital after biopsy. Risk factors for complications could not be identified. CONCLUSIONS: Review of the literature concerning transrectal biopsies of the prostate shows that the complication rates within this screened population are comparable to those reported within referred patients. The admittance rate is slightly lower. Transrectal ultrasound-guided systematic sextant biopsy of the prostate is a safe procedure for the diagnosis of prostate cancer within the general population; however, identification of risk factors for complications might further improve the safety of the screening procedure.

The free-to-total prostate specific antigen ratio improves the specificity of prostate specific antigen in screening for prostate cancer in the general population.

PURPOSE: The ratio between free and total prostate specific antigen (PSA) in serum improves the specificity of total serum PSA for the detection of prostate carcinoma in select populations. The value of the free-to-total PSA ratio for a PSA of 4.0 to 10.0 ng./ml. was analyzed in a screening population. MATERIALS AND METHODS: From 4,800 participants 55 to 76 years old 977 biopsies were obtained because of an abnormal digital rectal examination, suspicious transrectal ultrasonography and total serum PSA 4.0 ng./ml. or more. Of 191 patients with prostate carcinoma detected 101 had a serum PSA of 4.0 to 10.0 ng./ml. and 54 of them underwent radical prostatectomy. A free-to-total PSA ratio of 0.20, age specific PSA reference ranges and a PSA density of 0.12 ng./ml./cc were evaluated for the ability to increase the specificity of total serum PSA in predicting positive prostate biopsy results. RESULTS: Receiver operating characteristics curves for the free-to-total PSA ratio showed a significant increase in specificity compared to PSA. Retrospective application of age specific PSA reference ranges, the free-to-total PSA ratio and the PSA density decreased the number of biopsies significantly by up to 40% in our study, with a decrease in cancer detection rate of 12%. When used in combination with digital rectal examination, the pathological stage of undetected carcinomas appeared favorable. CONCLUSIONS: The free-to-total PSA ratio may be used to decrease biopsies in patients with an intermediate PSA of 4.0 to 10.0 ng./ml.

Prostate-specific antigen as a screening test. The Netherlands experience.

At the Rotterdam site of the ERSPC approximately 9600 men between 54 and 76 years old have been randomized at the time of writing, of which 50% for screening by PSA (Hybritech Tandem E), DRE, and TRUS until March 1996. The cancer detection rate is 4.3%, and the overall biopsy-to-carcinoma rate is 5.1. By clinical staging 91% of cancers are organ-confined (T2c or less), by pathologic staging after radical prostatectomy 64% of tumors are specimen-confined. The best sole predictor of a positive biopsy is total serum PSA, followed by DRE. The specificity of PSA in the intermediate PSA range between 4 and 10 ng/mL can be improved significantly by application of the f-PSA/t-PSA ratio, PSA density and age-specific reference ranges. The f-PSA/t-PSA ratio with a cut-off value of 0.20 appears to be the most effective parameter and reduces in combination with DRE the number of biopsies in the intermediate PSA range by 38% with 12% of carcinomas undetected. This leads to an overall biopsy-to-carcinoma ratio of 4.6. The evaluation of TRUS-, DRE-, and PSA-driven biopsies will lead to a change of the screening procedure within the study.

Screening for prostate cancer.

Over the past few decades it has become clear that prostate cancer is a serious health problem in elderly men. The population of most Western countries is ageing and the number of deaths from prostate cancer patients is increasing. The most promising way to deal with this problem seems to be through early detection of the disease, which can be accomplished through case finding and screening of the male population at risk. The basic purpose of screening for a given disease is to separate from a large group of apparently healthy individuals those who have a high probability of having the disease under study. These individuals may be given a diagnostic workup, and if the diagnosis is established they can be brought to treatment. The concept of prostate cancer screening, however, is an extensively debated issue. The limited knowledge of the natural history, uncertainties about the effectiveness of treatment in reducing mortality and the adverse effects of treatment lead to fear of overdiagnosis and subsequent overtreatment. Routine application of screening for prostate cancer should not take place before the results of multicentre prospective randomised studies demonstrate a reduction in prostate cancer mortality through screening of the male population.

Comparison of pathologic characteristics of T1c and non-T1c cancers detected in a population-based screening study, the European Randomized Study of Screening for Prostate Cancer.

In recent years the introduction of serum prostate-specific antigen (PSA) determination as a screening tool for early detection of prostate cancer in asymptomatic men has led to a markedly increased detection of prostate cancers that are neither palpable nor visible with transrectal ultrasonography (stage T1c). In this preliminary study we assessed pathologic features and aspects that are indicative of clinical significance in T1c tumors and tumors with palpable or visible lesions (non-T1c tumors). Between June 1994 and December 1995, 51 consecutive radical prostatectomies were performed on screened participants in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). After determination of pathologic stage and Gleason score, morphometric analysis was performed to determine tumor volume. Radical prostatectomy specimens were divided into three mutually exclusive subsets: T1c tumors, non-T1c tumors with preoperative PSA levels below 4 ng/ml, and non-T1c tumors with PSA levels equal to or greater than 4 ng/ml. These subsets were compared for differences in the distribution of tumor volume, pathologic stage, and Gleason score. An arbitrarily constructed categorization model was used to assess clinical significance. In all, 17 (33%) of the patients had clinical stage T1c disease. In our categorization mode, 88% of the T1c tumors fit the criteria for clinically significant tumors. T1c tumors, however, were significantly smaller (P < 0.01) and were more likely to be organ-confined (P = 0.01) as compared with non-T1c tumors in patients with an elevated preoperative serum PSA level. In contrast, tumors detected at preoperative PSA levels of < 4 ng/ml had comparably the lowest pathologic stages and tumor volumes in our series. In our categorization model, 42% of these tumors fit the criteria for minimal tumor. This group of radical prostatectomies was therefore most likely to harbor clinically insignificant cancer, a finding that was consistent in two other categorization models derived from earlier reports. T1c tumors comprise a large fraction of the tumors found in population-based screening. As judged by their pathologic characteristics. T1c tumors are clinically significant tumors. The overall low pathologic stage and Gleason score of these tumors make these patients excellent candidates for curative treatment by radical prostatectomy or radiotherapy. In contrast, some concern should be raised on the detection of tumors at low serum PSA levels by means of digital rectal examination and transrectal ultrasound alone, since a substantial proportion of these tumors could be considered clinically insignificant. Long-term follow-up, however, is necessary to substantiate this view.

Prospective evaluation plan for randomised trials of prostate cancer screening. The International Prostate Cancer Screening Trial Evaluation Group.

To enable pooled analyses of continuing and planned randomised trials of prostate cancer screening, guidelines for minimal data required for such analyses were developed in the recent meeting of the International Prostate Screening Trial Evaluation Group (IPSTEG). The aim of the pooled analysis with data on individual level will be: (a) Estimation of the effect of screening on prostate cancer mortality with greater precision than individual studies (b) Assessment of optimal screening procedures and interval (c) Identification of subgroups within the populations that might receive most benefit from screening (d) Evaluation of the quality of life effects and cost effectiveness of screening. All studies included in the combined analysis share a common core protocol with minimum data requirements. The protocol allows, however, adaptation of the procedures to local circumstances within defined options. It should be noted that the process is continuing and the protocol is subject to evaluation and revision in the meetings of the IPSTEG on a regular basis.