Oncologic outcome of robot-assisted laparoscopic prostatectomy in the high-risk setting.

BACKGROUND AND PURPOSE: Previous studies have demonstrated the feasibility of open radical prostatectomy in the high-risk setting. Management of high-risk disease with robot-assisted laparoscopic radical prostatectomy (RALP) is controversial. We examined biochemical recurrence in a selected cohort of high-risk patients who were undergoing RALP. PATIENTS AND METHODS: Men with high-risk prostate cancer who underwent bilateral nerve-sparing, nonsalvage RALP by a single surgeon without adjuvant or neoadjuvant therapy of any kind were identified. High risk was defined by preoperative prostate-specific antigen (PSA) level >10 ng/dL, Gleason score ≥8 on final pathologic evaluation, or stage ≥pT(3). Postoperative PSA value ≥0.2 ng/dL defined biochemical recurrence. RESULTS: A total of 73 men were identified. There was no significant difference in surgical margin positivity (38% overall) or prostate size between recurrence and nonrecurrence cohorts. Biochemical failure was significantly associated with higher pathologic Gleason score (P = 0.0085) but not pathologic stage (P = 0.22) or preoperative PSA level (P = 0.18). With follow-up to 85 months (mean 31.8 mos), biochemical recurrence-free survival was 77% with mean time to recurrence of 7.7 months. Recurrence occurred significantly earlier than later (P < 0.001). CONCLUSIONS: Reasonable short- to intermediate-term biochemical outcomes can be achieved in a recurrence-prone group of high-risk men who are undergoing RALP. RALP is feasible in a selected cohort of high-risk men who are undergoing aggressive local therapy.

"Learning curve" may not be enough: assessing the oncological experience curve for robotic radical prostatectomy.

The use of robot-assisted laparoscopic radical prostatectomy (RALP) is widespread in the community. A definitive RALP "learning curve" has not been defined and existing learning curves do not account for urologists without prior advanced laparoscopic skills. Therefore, an easily evaluable metric, the "oncological experience curve," would be clinically useful to all urologists performing RALP. Positive surgical margin (PSM) status for all subjects undergoing RALP during the first 4 years of a single surgeon's experience was assessed. Univariate and multivariate analyses and logistic regression identified predictors of PSM creation and their correlation with surgeon case volume. The oncological experience curve was defined as the case point at which only pT2 stage, not surgeon volume (and thus surgeon inexperience), predicted PSM in the logistic regression. A total of 469 consecutive subjects comprised our cohort. Overall pT2 and pT3 PSM rates were 20% and 40%, respectively. Preoperative prostate-specific antigen, pathologic stage, and year of surgery were associated with PSM occurrence. Pathologic stage exclusively correlated to PSM in pT2 specimens for the first time during the fourth year, after 290 subjects had been treated. pT2 PSM rate before and after Case 290 was 25% and 10%, respectively (p < 0.001). The oncological experience curve is a clinically meaningful measure to evaluate the RALP learning curve for non-fellowship-trained urologists. The oncological experience curve may be much longer than the previously reported learning curves. Surgeons should consider whether they can build enough experience to minimize suboptimal oncological outcomes before embarking on or continuing a RALP program.

Impact of radical prostatectomy positive surgical margins on fear of cancer recurrence: results from CaPSURE.

PURPOSE: Fear of cancer recurrence (FCR) is a significant source of distress in men with prostate cancer and could affect clinical decision-making, especially in those with positive margins following radical prostatectomy (RP). We examined the influence of positive surgical margin status on fear of cancer recurrence in men undergoing radical prostatectomy. METHODS: Five hundred eight-four men underwent RP from 1999 to 2002 in CaPSURE, a prospective, longitudinal, national cohort. All men had both baseline and follow-up assessment of FCR using a validated Kornblith scale. Statistical analysis included chi(2) test, Wald test, and linear as well as repeated measures ANOVA mixed model. RESULTS: One hundred sixty (27%) men had positive surgical margins. Baseline FCR and clinical variables did not differ based on margin status. Men with positive margins experienced greater FCR after RP than negative margins (OR, 1.94, 95% CI, 1.22-3.07). Men who had received adjuvant therapy experienced greater FCR (OR, 2.78, 95% CI, 1.21-6.39). Repeated measures analysis showed greater FCR over time (14-month mean follow-up, range 2-31 months) for positive vs. negative margins (P = 0.02). This difference in fear widened over time. There were no significant differences in health-related quality of life scores based on margin status. CONCLUSION: Positive surgical margin status is associated with greater fear of cancer recurrence, a difference not alleviated by adjuvant therapy use. Men with positive margins remain more fearful over the course of several years compared with those with negative margins. Clinicians should be aware of the potential stressful impact of positive surgical margins.

Economic impact of tumor markers in bladder cancer surveillance.

OBJECTIVES: Bladder cancer invokes the highest cost per patient from diagnosis to death and is the fifth most expensive cancer to treat overall, exceeding $3.4 billion annually. Current surveillance regimens require intense follow-up contributing to high cost and emotional burden. Bladder tumor markers hold the promise to reduce these costs, yet have not been widely adopted in oncological practice. We assessed the cost-effectiveness of bladder tumor markers in surveillance routines. METHODS: A MEDLINE search of all available literature concerning bladder tumor markers and cost-effectiveness was performed. We reviewed retrospective and prospective studies, reviews, opinion papers, decision analyses, and cost-effectiveness analyses. RESULTS: Bladder tumor markers exist in various stages of development and efficacy. Sensitivity and specificity values have been reported across a wide range, with tumor markers generally possessing a higher sensitivity and lower specificity than urine cytology. Several cost-effectiveness analyses have shown tumor markers significantly lower the cost of bladder cancer surveillance when using a modified regimen that lengthens intervals between cystoscopies. However, many of the studies rely on overconfident sensitivity and specificity estimates and do not incorporate data specific to recurrent bladder cancer. No comprehensive study incorporating utility analysis has been performed. CONCLUSIONS: Bladder tumor markers cannot definitively replace cystoscopy in surveillance regimens given the current evidence. Recent reports suggest potential for tumor markers to control the financial and emotional cost of bladder cancer care and improve quality of life. Until prospective analyses incorporating quality of life outcomes are performed, wider adoption of bladder tumor markers will be hampered.

The use of hemostatic agents and sealants in urology.

PURPOSE: While hemostatic agents and sealants have long been used in the fields of surgery and urology, confusion persists about their indications for use and the optimal agent choice. We comprehensively defined and evaluated the scientific basis for hemostatic agent and sealant use in urology, and provide a conceptual framework for future research and discussion. MATERIALS AND METHODS: A MEDLINE search of all available literature concerning hemostatic agents in urology was performed, including topical hemostats, anti-fibrinolytics, fibrin sealants and matrix hemostats. Select references were also chosen from the broader surgical literature. Animal studies, case reports, retrospective and prospective studies, and opinion articles were reviewed. RESULTS: Hemostatic agents include a wide range of components. Recent literature has focused on fibrin sealants and matrix agents. Two main indications exist for hemostatic agents, including 1) hemostasis and 2) sealant. The best evidence for efficacy and safety exists for hemostasis, especially for nephrectomy and trauma. Newer data highlight urinary tract reconstruction, fistula and percutaneous tract closure, suture line strengthening and infertility as potential uses. Novel drug delivery and tissue engineering are areas with large clinical potential. CONCLUSIONS: Hemostatic agent use is promising and yet unproven for most conditions currently treated in urology. Hemostasis continues to be the main indication, which is well established. Few trials have examined comparative efficacy among hemostatic agents and further prospective studies are needed to justify additional indications as well as determine the optimal mode of use. Minimally invasive surgery will further drive the use of hemostatic agents and sealants. Cost-effective, evidence based hemostatic agent use will continue to challenge all urologists.

Impact of prior biopsy scheme on pathologic features of cancers detected on repeat biopsies.

The object of our study was to characterize the biopsy features of cancers detected in a repeat biopsy population stratified on the basis of the type of prior negative biopsy. We studied 218 patients with a prior negative biopsy who underwent a 10-core extended systematic biopsy scheme, and a subset (n = 139) underwent additional 6 anteriorly directed biopsies. Clinicopathologic features of patients with cancer on the biopsy were compared as a function of type of prior negative biopsy. Overall and unique cancer detection rates were calculated for each of the biopsy sites. Cancer detection rates tended to be higher in patients who had undergone a prior sextant biopsy compared to a prior extended biopsy scheme (39% vs. 28%). Trends towards more positive cores and greater total core length of cancer involvement were seen in patients who had undergone a prior negative sextant biopsy. Apical and laterally directed biopsies had higher overall and unique cancer detection rates in patients who had undergone a prior negative sextant biopsy. Anteriorly directed biopsies had a low unique cancer detection rate in all patients. We conclude that in patients undergoing repeat biopsy, the detection rate is affected by the extent of the prior biopsy. Clinicopathologic features of cancers detected on repeat biopsy tend to be worse in patients who have undergone a prior negative sextant biopsy compared to a negative prior extended biopsy.