Comparative effectiveness of minimally invasive vs open radical prostatectomy

CONTEXT: Minimally invasive radical prostatectomy (MIRP) has diffused rapidly despite limited data on outcomes and greater costs compared with open retropubic radical prostatectomy (RRP). OBJECTIVE: To determine the comparative effectiveness of MIRP vs RRP. DESIGN, SETTING, AND PATIENTS: Population-based observational cohort study using US Surveillance, Epidemiology, and End Results Medicare linked data from 2003 through 2007. We identified men with prostate cancer who underwent MIRP (n = 1938) vs RRP (n = 6899). MAIN OUTCOME MEASURES: We compared postoperative 30-day complications, anastomotic stricture 31 to 365 days postoperatively, long-term incontinence and erectile dysfunction more than 18 months postoperatively, and postoperative use of additional cancer therapies, a surrogate for cancer control. RESULTS: Among men undergoing prostatectomy, use of MIRP increased from 9.2% (95% confidence interval [CI], 8.1%-10.5%) in 2003 to 43.2% (95% CI, 39.6%-46.9%) in 2006-2007. Men undergoing MIRP vs RRP were more likely to be recorded as Asian (6.1% vs 3.2%), less likely to be recorded as black (6.2% vs 7.8%) or Hispanic (5.6% vs 7.9%), and more likely to live in areas with at least 90% high school graduation rates (50.2% vs 41.0%) and with median incomes of at least $60,000 (35.8% vs 21.5%) (all P < .001). In propensity score-adjusted analyses, MIRP vs RRP was associated with shorter length of stay (median, 2.0 vs 3.0 days; P<.001) and lower rates of blood transfusions (2.7% vs 20.8%; P < .001), postoperative respiratory complications (4.3% vs 6.6%; P = .004), miscellaneous surgical complications (4.3% vs 5.6%; P = .03), and anastomotic stricture (5.8% vs 14.0%; P < .001). However, MIRP vs RRP was associated with an increased risk of genitourinary complications (4.7% vs 2.1%; P = .001) and diagnoses of incontinence (15.9 vs 12.2 per 100 person-years; P = .02) and erectile dysfunction (26.8 vs 19.2 per 100 person-years; P = .009). Rates of use of additional cancer therapies did not differ by surgical procedure (8.2 vs 6.9 per 100 person-years; P = .35). CONCLUSION: Men undergoing MIRP vs RRP experienced shorter length of stay, fewer respiratory and miscellaneous surgical complications and strictures, and similar postoperative use of additional cancer therapies but experienced more genitourinary complications, incontinence, and erectile dysfunction.
Source: Hu JC, Gu X, Lipsitz SR, Barry MJ, D'Amico AV, Weinberg AC, Keating NL. Comparative effectiveness of minimally invasive vs open radical prostatectomy. JAMA 2009 Oct;302(14):1557-1564. [PubMed]

Nanoparticle-based bio-barcode assay redefines "undetectable" PSA and biochemical recurrence after radical prostatectomy

We report the development of a previously undescribed gold nanoparticle bio-barcode assay probe for the detection of prostate specific antigen (PSA) at 330 fg/mL, automation of the assay, and the results of a clinical pilot study designed to assess the ability of the assay to detect PSA in the serum of 18 men who have undergone radical prostatectomy for prostate cancer. Due to a lack of sensitivity, available PSA immunoassays are often not capable of detecting PSA in the serum of men after radical prostatectomy. This new bio-barcode PSA assay is approximately 300 times more sensitive than commercial immunoassays. Significantly, with the barcode assay, every patient in this cohort had a measurable serum PSA level after radical prostatectomy. Patients were separated into categories based on PSA levels as a function of time. One group of patients showed low levels of PSA with no significant increase with time and did not recur. Others showed, at some point postprostatectomy, rising PSA levels. The majority recurred. Therefore, this new ultrasensitive assay points to significant possible outcomes: (i) The ability to tell patients, who have undetectable PSA levels with conventional assays, but detectable and nonrising levels with the barcode assay, that their cancer will not recur. (ii) The ability to assign recurrence earlier because of the ability to measure increasing levels of PSA before conventional tools can make such assignments. (iii) The ability to use PSA levels that are not detectable with conventional assays to follow the response of patients to adjuvant or salvage therapies.
Source: Shad Thaxton C, Elghanian R, Thomas AD, Stoeva SI, Lee J, Smith ND, Schaeffer AJ, Klocker H, Horninger W, Bartsch G, Mirkin CA. Nanoparticle-based bio-barcode assay redefines "undetectable" PSA and biochemical recurrence after radical prostatectomy. Proc. Natl. Acad. Sci. U.S.A 2009 Oct 19. [Epub ahead of print] [PubMed]

The impact of robotic surgery on pelvic lymph node dissection during radical prostatectomy for localized prostate cancer: the Brown University early robotic experience

INTRODUCTION: Open pelvic lymph node dissection (PLND) remains the gold standard in patients with intermediate and high-risk prostate cancer undergoing radical retropubic prostatectomy (RRP). Recently, our institution has adopted robotic assistance for performing radical prostatectomy. We sought to determine whether robot-assisted laparoscopic PLND yields comparable numbers of lymph nodes compared to open PLND. METHODS: The medical records of patients undergoing open or robot-assisted laparoscopic radical prostatectomy (RALRP) with concurrent pelvic lymph node dissection (PLND) between 2003 and 2008 were reviewed. Demographic factors including age, PSA, and Gleason score were recorded. Pathology reports were reviewed to determine the number of pelvic lymph nodes obtained during PLND. Lymph node yield was further evaluated based on surgeon. Student's t-test was used to compare the number of lymph nodes obtained with each method. RESULTS: A total of 61 patients undergoing open RRP with PLND and 62 patients undergoing RALRP with PLND were included. The mean number of lymph nodes obtained via open PLND was 7.3 while the mean number obtained via robotic PLND was 3.3. These means were significantly different with a p value < 0.001. One patient in the open cohort (1.6%) and two patients in the robotic cohort (3.2%) had micrometastatic disease on PLND. CONCLUSION: Robot-assisted laparoscopic PLND yielded fewer lymph nodes compared to open PLND at the time of radical prostatectomy for organ confined disease. Patients with higher risk disease may benefit from open prostatectomy with PLND early in a program's robotics experience. These findings may be related to the relative youth of our robotics program and further comparisons as our data mature will be revealing.
Source: Yates J, Haleblian G, Stein B, Miller B, Renzulli J, Pareek G. The impact of robotic surgery on pelvic lymph node dissection during radical prostatectomy for localized prostate cancer: the Brown University early robotic experience. Can J Urol 2009 Oct;16(5):4842-4846. [PubMed]

Men older than 70 years have higher risk prostate cancer and poorer survival in the early and late prostate specific antigen eras

PURPOSE: We clarified whether men older than 70 years have a higher risk of prostate cancer and poorer survival in the early and late prostate specific antigen eras. MATERIALS AND METHODS: A cohort of 4,561 men who underwent radical prostatectomy were stratified into 3 age groups (younger than 60, 60 to 70 and older than 70 years), and early and late prostate specific antigen eras based on the year of surgery (before 2000 and 2000 or later). Race, body mass index, prostate specific antigen, prostate weight, tumor volume, pathological Gleason sum, pathological tumor stage, extracapsular extension, seminal vesicle invasion and surgical margin status were submitted for univariate and multivariable analyses against the previously mentioned groups. Survivals (prostate specific antigen recurrence, distant metastasis and disease specific death) were compared among the 3 age groups using univariate and multivariable methods. RESULTS: Compared with younger age groups (younger than 60, 60 to 70 years) men older than 70 years had a higher proportion of pathological tumor stage 3/4 (33.0 vs 44.3 vs 52.1%, p <0.001), pathological Gleason sum greater than 7 (9.5% vs 13.4% vs 17.2%, p <0.001) and larger tumor volume (3.7 vs 4.7 vs 5.2 cc, p <0.001). Pathological Gleason sum in men older than 70 years did not differ between the early and late prostate specific antigen eras (p = 0.071). Men older than 70 years had a higher risk of prostate specific antigen recurrence, distant metastasis and disease specific death on univariate (p <0.05) but not multivariable analysis. CONCLUSIONS: Men older than 70 years had higher risk disease and poorer survival in the early and late prostate specific antigen eras. Pathological Gleason sums did not change between the 2 eras. Patient age was an important variable in prostate specific antigen screening, biopsy, treatment and prognosis.
Source: Sun L, Caire AA, Robertson CN, George DJ, Polascik TJ, Maloney KE, Walther PJ, Stackhouse DA, Lack BD, Albala DM, Moul JW. Men older than 70 years have higher risk prostate cancer and poorer survival in the early and late prostate specific antigen eras. J. Urol 2009 Nov;182(5):2242-2248. [PubMed]