We investigated whether a family history of lethal prostate cancer (PCa) was associated with high-risk disease or biochemical recurrence in patients undergoing radical prostatectomy. A cohort of radical prostatectomy patients was stratified into men with no family history of PCa (NFH); a first-degree relative with PCa (FH); and those with a first-degree relative who had died of PCa (FHD). Demographic, operative and pathologic outcomes were analyzed. Freedom from biochemical recurrence was examined using Kaplan-Meier log rank. A multivariate Cox logistic regression analysis was also performed. We analyzed 471 men who underwent radical prostatectomy at our institution with known family history. The three groups had: 355 patients (75%) in NFH; 97 patients (21%) in FH; and 19 patients (4%) in FHD. The prevalence of a Gleason score ≥8, higher pathologic T stage, and biochemical recurrence (BCR) rates did not significantly differ between groups. On Kaplan-Meier analysis there were no differences in short-term BCR rates (p = 0.212). In this cohort of patients undergoing radical prostatectomy, those with first-degree relatives who died of PCa did not have an increased likelihood of high-risk or aggressive PCa or shorter-term risk of BCR than those who did not.

Importance

Surgical innovations disseminate in the absence of coordinated systems to ensure their safe integration into clinical practice, potentially exposing patients to increased risk for medical error.

Objective

To investigate associations of patient safety with the diffusion of minimally invasive radical prostatectomy (MIRP) resulting from the development of the da Vinci robot.

Design, setting, and participants

A cohort study of 401 325 patients in the Nationwide Inpatient Sample who underwent radical prostatectomy during MIRP diffusion between January 1, 2003, and December 31, 2009.

Main outcomes and measures

We used Agency for Healthcare Research and Quality Patient Safety Indicators (PSIs), which measure processes of care and surgical provider performance. We estimated the prevalence of MIRP among all prostatectomies and compared PSI incidence between MIRP and open radical prostatectomy in each year during the study. We also collected estimates of MIRP incidence attributed to the manufacturer of the da Vinci robot.

Results

Patients who underwent MIRP were more likely to be white (P = .004), have fewer comorbidities (P = .02), and have undergone surgery in higher-income areas (P = .005). The incidence of MIRP was substantially lower than da Vinci manufacturer estimates. Rapid diffusion onset occurred in 2006, when MIRP accounted for 10.4% (95% CI, 10.2-10.7) of all radical prostatectomies in the United States. In 2005, MIRP was associated with an increased adjusted risk for any PSI (adjusted odds ratio, 2.0; 95% CI, 1.1-3.7; P = .02) vs open radical prostatectomy. Stratification by hospital status demonstrated similar patterns: rapid diffusion onset among teaching hospitals occurred in 2006 (11.7%; 95% CI, 11.3-12.0), with an increased risk for PSI for MIRP in 2005 (adjusted odds ratio, 2.7; 95% CI, 1.4-5.3; P = .004), and onset among nonteaching hospitals occurred in 2008 (27.1%; 95% CI, 26.6-27.7), with an increased but nonsignificant risk for PSI in 2007 (adjusted odds ratio, 2.0; 95% CI, 0.8-5.2; P = .14).

Conclusions and relevance

During its initial national diffusion, MIRP was associated with diminished perioperative patient safety. To promote safety and protect patients, the processes by which surgical innovations disseminate into clinical practice require refinement.

Background

The presence of increased B-cell tumor infiltrating lymphocytes (TILs) was seen in mouse prostate cancer (PCa) but has not been fully documented in human PCa. We, therefore, investigated the density of infiltrating B cells within human PCa utilizing a quantitative computational method.

Methods

Archived radical prostatectomy specimens from 53 patients with known clinical outcome and D'Amico risk category were obtained and immunohistochemically (IHC) stained for the B cell marker, CD20. Slides were reviewed by a genitourinary pathologist who manually delineated the tumoral regions of PCa. Slides were digitally scanned and a computer algorithm quantified the area of CD20 stained B-cells as a measure of B cell density within the outlined regions of prostate cancer (intra-tumoral region), versus extra-tumoral prostate tissue. Correlations were analyzed between B-cell density and demographic and clinical variables, including D'Amico risk groups and disease recurrence.

Results

For the entire cohort, the mean intra-tumoral B cell density was higher (3.22 SE = 0.29) than in the extra-tumoral region of each prostatectomy section (2.24, SE = 0.19) (paired t test; P < 0.001). When analyzed according to D'Amico risk group, the intra-tumoral B cell infiltration in low risk (0.0377 vs. 0.0246; p = 0.151) and intermediate risk (0.0260 vs. 0.0214; p = 0.579) patient prostatectomy specimens did not show significantly more B-cells within the PCa tumor. However, patient specimens from the high-risk group (0.0301 vs. 0.0197; p < 0.001) and from those who eventually had PCa recurrence or progression (0.0343 vs. 0.0246; p = 0.019) did show significantly more intra-tumoral CD20+ B-cell staining. Extent of B-cell infiltration in the prostatectomy specimens did not correlate with any other clinical parameters.

Conclusions

Our study shows that higher B-cell infiltration was present within the intra-tumoral PCa regions compared to the extra-tumoral benign prostate tissue regions in prostatectomy sections. For this study we developed a new method to measure B-cells using computer-assisted digitized image analysis. Accurate, consistent quantitation of B-cells in prostatectomy specimens is essential for future clinical trials evaluating the effect of B cell ablating antibodies. The interaction of B-cells and PCa may serve as the basis for new therapeutic targets.