Clinical Outcomes In Men Research Articles

Consequences of Switching 5α-Reductase Inhibitors on Prostate Specific Antigen Velocity

The 5alpha-reductase inhibitors improve urinary symptoms related to benign prostatic hyperplasia, deter benign prostatic hyperplasia progression and provide prostate cancer chemoprevention. Currently there are a number of 5alpha-reductase inhibitor formularies, including Proscar, generic finasteride and dutasteride. While all formularies decrease serum prostate specific antigen (a proxy for prostate volume), they may not accomplish this to the same degree, which may have dramatic effects on prostate specific antigen kinetics in men changing 5alpha-reductase inhibitor formularies. We examined prostate specific antigen velocity after changes in 5alpha-reductase inhibitor formularies. We identified patients treated with 2 or more 5alpha-reductase inhibitor formularies who had sufficient prostate specific antigen values to calculate prostate specific antigen velocity during each 5alpha-reductase inhibitor treatment. Patient data were grouped depending on the formularies received. Statistical analysis was done to compare prostate specific antigen velocity at various time points while on different 5alpha-reductase inhibitors. Eight men changed from dutasteride to generic finasteride (group 1), 21 changed from dutasteride to Proscar (group 2), 49 changed from Proscar to dutasteride (group 3) and 77 changed from Proscar to generic finasteride (group 4). We noted a significant increase in prostate specific antigen velocity in groups 1 and 2 (p <0.05), and 4 (p <0.005). The increase was greater than 0.35 ng/ml per year, the common cutoff for prostate biopsy recommendations, in more than a third of patients. Results confirm that changing 5alpha-reductase inhibitors drugs can be associated with a clinically significant change in prostate specific antigen velocity. These prostate specific antigen velocity changes could place patients at risk for unnecessary prostate biopsy. Additional prospective studies are warranted.

Two drugs slow progression more effectively than one

Original article Roehrborn, C. G. et al. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur. Urol. 55, 461–471 (2009). PubMed

The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study

BackgroundCombination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and prostatic enlargement. ObjectiveTo investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention (AUR), BPH-related surgery, and BPH clinical progression over 4 yr in men at increased risk of progression. Design, setting, and participantsThe Combination of Avodart® and Tamsulosin (CombAT) study was a 4-yr, multicenter, randomised, double-blind, parallel-group study in 4844 men ≥50 yr of age with a clinical diagnosis of BPH, International Prostate Symptom Score ≥12, prostate volume ≥30cm3, prostate-specific antigen 1.5–10ng/ml, and maximum urinary flow rate (Qmax) >5 and ≤15ml/s with minimum voided volume ≥125ml. InterventionOral daily tamsulosin, 0.4mg; dutasteride, 0.5mg; or a combination of both. MeasurementsThe 4-yr primary end point was time to first AUR or BPH-related surgery. Secondary end points included BPH clinical progression, symptoms, Qmax, prostate volume, safety, and tolerability. Results and limitationsCombination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery. Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression. Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr. Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies, with the exception of an imbalance in the composite term of cardiac failure among the three study arms. The lack of placebo control is a study limitation. ConclusionsThe 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement. Clinicaltrials.gov identifierNCT00090103 (http://www.clinicaltrials.gov/ct2/show/NCT00090103).

Effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: Four-year results from the CombAT study

Effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: Four-year results from the CombAT study

Early Versus Delayed Hormonal Therapy for Prostate Specific Antigen Only Recurrence of Prostate Cancer After Radical Prostatectomy

Purpose Hormonal therapy (HT) is the current mainstay of systemic treatment for prostate specific antigen (PSA) only recurrence (PSAR), however, there is virtually no published literature comparing HT to observation in the clinical setting. The goal of this study was to examine the Department of Defense Center for Prostate Disease Research observational database to compare clinical outcomes in men who experienced PSAR after radical prostatectomy by early versus delayed use of HT and by a risk stratified approach. Materials and Methods Of 5,382 men in the database who underwent primary radical prostatectomy (RP), 4,967 patients were treated in the PSA-era between 1988 and December 2002. Of those patients 1,352 men who had PSAR (PSA after surgery greater than 0.2 ng/ml) and had postoperative followup greater than 6 months were used as the study cohort. These patients were further divided into an early HT group in which patients (355) received HT after PSA only recurrence but before clinical metastasis and a late HT group for patients (997) who received no HT before clinical metastasis or by current followup. The primary end point was the development of clinical metastases. Of the 1,352 patients with PSAR clinical metastases developed in 103 (7.6%). Patients were also stratified by surgical Gleason sum, PSA doubling time and timing of recurrence. Univariate and multivariate Cox proportional hazard models were used to evaluate the effect of early and late HT on clinical outcome. Results Early HT was associated with delayed clinical metastasis in patients with a pathological Gleason sum greater than 7 or PSA doubling time of 12 months or less (Hazards ratio = 2.12, p = 0.01). However, in the overall cohort early HT did not impact clinical metastases. Race, age at RP and PSA at diagnosis had no effect on metastasis-free survival (p >0.05). Conclusions The retrospective observational multicenter database analysis demonstrated that early HT administered for PSAR after prior RP was an independent predictor of delayed clinical metastases only for high-risk cases at the current followup. Further study with longer followup and randomized trials are needed to address this important issue.

Inverse correlation between body mass index and clinical outcomes in men with advanced castration–recurrent prostate cancer

Obesity has a variety of adverse health outcomes, but to the authors' knowledge, the effect of obesity on outcome in patients with advanced prostate cancer is not known. For this reason, the correlation between an elevated body mass index (BMI) and clinical outcomes in patients with metastatic, castration-recurrent prostate cancer (CRPC) was evaluated. A total of 1226 men with CRPC who were enrolled in 9 prospective clinical trials conducted by the Cancer and Leukemia Group B (CALGB) for the treatment of metastatic disease were considered. Eligible patients had progressive prostate cancer during androgen deprivation therapy (with documented castrate levels of testosterone); an Eastern Cooperative Oncology Group performance status of 0 to 2; and adequate hematologic, renal, and hepatic function. Patients were classified based on BMI as normal (18.5-24.9 kg/m(2)), overweight (25-29.9 kg/m(2)), and mildly to severely obese (> or =30 kg/m(2)). Approximately 24% of the patients had a normal BMI, 43% were overweight, and 33% were mildly to severely obese. On multivariable analysis, BMI was found to be a statistically significant predictor of overall survival and prostate cancer-specific mortality. Compared with men with normal BMIs, the hazard ratios for death for overweight men and mildly to severely obese men were 0.80 (95% confidence interval [95% CI], 0.68-0.93; P = .001) and 0.80 (95% CI, 0.68-0.94; P = .010), respectively. In patients with metastatic CRPC, obesity (as defined by an elevated BMI) appears to have a protective effect against overall mortality and prostate cancer-specific mortality. Alternatively, a higher BMI may reflect different cancer biology (ie, the lack of cachexia-producing substances). Further studies to gain a more comprehensive understanding of the mechanisms behind these clinical observations are needed.

Transobturator Sling Suspension for Male Urinary Incontinence Including Post-Radical Prostatectomy

ObjectiveTo study the anatomical effects of placing a transobturator tape (TOT) in cadavers as well as determining the clinical outcome in men with urinary incontinence. MethodsThe study was a two stage study. The first phase was a cadaver study to examine the placement of the sling. The second part involved the placement of the sling in 20 men with incontinence, which occurred post-radical prostatectomy in 15 men. All patients had pre-operative and post-operative videourodynamics, maximum flow rate (Qmax) and residual urine measurement. Urethral pressure profiles and membranous urethral length were measured in five patients pre- and postoperatively. Incontinence was assessed on the basis of pad usage. Patients’ satisfaction was recorded using a non-validated patient questionnaire at 6 weeks post-operatively. ResultsThe cadaver study revealed that a leak point pressure of 60cmH2O was achieved on tensioning of the tape. In the clinical series, the mean (range) urethral closure pressure improved from 13.2 (8–22) to 86.4 (70–100) cmH2O following placement of the TOT. The membranous urethral length increased from a mean (range) of 3 (0–7) to 17.2 (10–22) mm following tensioning of the tape. No significant differences in Qmax pre- and postoperatively were observed. Incontinence cure rate (no pad usage) was 40% and improved rate (1–2 pads per day) was 30%. The majority of patients (12/20) were very satisfied with the procedure. ConclusionsThe TOT, a novel procedure for treatment of post-radical prostatectomy incontinence, was shown to be effective and well accepted by patients.

The use of prostate‐specific antigen testing in men presenting with haematuria

To analyse prostate-specific antigen (PSA) levels and clinical outcome in men presenting with haematuria, to develop an evidence-base for the use of PSA testing in this setting, as haematuria is a known complication of locally invasive prostate cancer, and so PSA levels are often measured in patients presenting with haematuria. We reviewed the records of 637 men presenting with haematuria to our urology department between April 2002 and June 2005. Of 373 men aged 50-79 years, 278 (75%) had their PSA level measured, and 50 were abnormal. Prostate biopsies were taken in 27 men with an abnormal PSA level (54%) and one man with a normal PSA level but an abnormal digital rectal examination. Prostate cancer was detected in 22 patients (8% of those tested, and 71% of those biopsied); 4.7% of all men presenting with macroscopic haematuria and aged 50-79 years were found to have prostate cancer, vs 8.5% of those with microscopic haematuria. We report a higher proportion of prostate cancers in men presenting with haematuria and aged 50-79 years than reported in previous screening studies, and a cancer detection rate of 71% of those biopsied, which is at least double the detection rates seen in screening studies. In the absence of a prospective controlled trial, PSA testing will remain part of our protocol for both macroscopic and microscopic haematuria.

An elevated body mass (BMI) index predicts for better clinical outcomes in men with metastatic hormone refractory prostate cancer (HRPC)

4556 Background: Previous articles have reported that an elevated BMI was associated with an increased risk of biochemical failure in hormone sensitive patients. We asked the question as to whether an elevated BMI predicts for worst clinical outcomes, namely overall survival (OS) and prostate-cancer survival (PCS), among 1,216 men with HRPC. Methods: Patients were enrolled on eight clinical trials conducted by the Cancer and Leukemia Group B (CALGB). Eligible patients had progressive prostate cancer during androgen deprivation therapy (with documented castrate levels of testosterone), an ECOG performance status of 0–2, adequate hematologic, renal and hepatic function. We used the NIH definition to classify patients as: normal (&lt;25 kg/m2), overweight (25–29 kg/m2 ), mildly obese (30–34 kg/m2), and moderately to severely obese (≥35 kg/m2). PCS was defined as the time from study entry to the time of death due to prostate cancer. The proportional hazards model was used to explore the prognostic significance of BMI in predicting OS and PCS. Results: The median BMI was 27.7 kg/m2 (inter-quartile range = 25.2–31.0 kg/m2 ). Twenty three percent (285/1216) of the patients had normal BMI, 46% (555/1216) were overweight, 23% (280/1216) were mildly obese, and 8% (96/1216) were moderately to severely obese. In multivariate analysis, adjusting for age, race, performance status, hemoglobin, PSA, LDH, alkaline phosphatase, testosterone, years since diagnosis, presence of visceral disease and Gleason scores, BMI was a statistically significant predictor of OS and PCS. Compared to normal men, the hazard ratios (HR) of overweight patients was 0.80 (95% CI = 0.69–0.93, p-value = 0.003), for mildly obese patients was 0.86 (95% CI = 0.72–1.02, p-value = 0.087) and for moderately to severely obese men it was 0.60 (95% CI = 0.47–0.78, p-value &lt; 0.001). In addition, the HRs for PCS for overweight patients was 0.83 (95% CI = 0.70–0.97, p-value = 0.023), was 0.88 (95% CI = 0.72–1.06, p-value = 0.179) for mildly obese and for moderately to severely obese was 0.62 (95% CI = 0.47–0.81, p-value = 0.001) compared to men with normal BMI. Conclusions: Contrary to what was reported, these findings demonstrate an inverse relationship between BMI and clinical outcomes in men with HRPC. [Table: see text]

Trends and predictors of aggressive therapy for clinical locally advanced prostate carcinoma

To determine the patterns and predictors of aggressive local therapies for patients with clinically advanced (cT3) prostate carcinoma, as the USA National Cancer Institute considers external beam radiotherapy (EBRT) to be the most appropriate treatment for these patients, and currently there is less evidence supporting the use of radical prostatectomy (RP). We used the Surveillance, Epidemiology and End Results (SEER) cancer registries to identify patients diagnosed with cT3 disease between 1995 and 2001. Sociodemographic and clinical data included patient age, race/ethnicity, marital status, SEER registry, year of diagnosis, tumour stage and grade, and treatment. Multivariate logistic regression was used to identify significant predictors of receiving (i) RP vs EBRT, (ii) any aggressive local treatment (RP or EBRT) or no treatment. Between 1995 and 2001, the proportion of men receiving aggressive local therapy for cT3 disease increased by 11% (58.4% to 69.4%), with a 20% increase in EBRT (40.3% to 60.2%) but a decline by half in RP (18.1% to 9.3%). Younger age was the strongest predictor of receiving RP rather than EBRT, and younger age with being married being a predictor of receiving aggressive local therapy (adjusted relative risk for marriage 1.33, 95% confidence interval 1.18-1.87). Black men were significantly less likely than non-Hispanic white men to receive aggressive therapy, with a relative risk of 0.56 (0.45-0.69). By 2001, 70% of patients with cT3 disease were receiving aggressive local therapy, with EBRT 6.5 times more common than RP. Clinical trials are needed to rigorously assess the effects of different local treatment strategies on clinical outcomes in men with cT3 prostate carcinoma.

Markers of bone metabolism in prostate cancer

Although bone metastases from prostate cancer are described as osteoblastic, markers of both osteoblastic and osteoclastic activity are strikingly elevated in men with metastatic prostate cancer. Elevated markers of osteoblastic and osteoclastic activity are associated with adverse clinical outcomes in men with prostate cancer--outcomes including shorter time to skeletal complications, disease progression, and death. Bone marker measurement appears to be a promising method for monitoring the efficacy of bone-targeted therapy. Additional studies are needed to assess the potential role of bone markers in identifying men at highest risk for development of bone metastases.

The impact of age on clinical outcomes in men with hormone refractory prostate cancer

4622 Background: To determine if men 65 years of age and older have worse clinical outcomes than men younger than 65 years of age with hormone refractory prostate cancer (HRPC). Methods: Data from eight multicenter trials (four phase II and four randomized phase III studies) conducted by the Cancer and Leukemia Group B (CALGB) from 1992–2003 were combined. Eligible patients had progressive adenocarcinoma of the prostate after androgen ablation (with castrate testosterone levels), an ECOG performance status of 0–2, and adequate hematologic, renal and hepatic function. Endpoints were overall survival (OS) and progression-free survival (PFS). Age was analyzed as binary and continuous variables. The log-rank statistic was used to compare OS and PFS between the two groups. In addition, the proportional hazards model was used to assess the prognostic importance of age adjusting for baseline factors in predicting OS and PFS. Results: Of the 1,216 men, 910 (75%) were 65 years or older. Older men were more likely to have had prior radiation (55%) compared to younger men (47%, p=0.01) and had lower alkaline phosphatase levels (median= 153, inter-quartile range (IQR) =95–324) than younger men (median = 172, IQR=105–347, p=0.04). The median survival time was 14.1 months (95% Confidence Interval (CI) = 12.9–15.5) for older men compared to 13.9 months (95% CI=12.63–16.8, p=0.97). The median time to progression was 2.6 months (95% CI=2.4–2.8) compared to 2.4 months (95% CI= 2.1–2.8, p=0.37) for older and younger men, respectively. In multivariate analysis, the hazard ratio (HR) was 2.57 (95% CI= 0.59–11.30, p=0.21) for men 65 years of age and older compared to younger men. Age, on the other hand, was a statistically significant predictor of OS with a HR = 1.07 (95% CI= 1.00–1.1, p=0.023) when analyzed as continuous covariate. Conclusions: There were no statistical significance differences in OS and PFS between older (>=65 years) and younger men (<65 years) with HRPC enrolled on these clinical trials. However, age was a significant predictor of OS when modeled as a continuous variable. It is unknown if these results would hold true in a less selected patient population. No significant financial relationships to disclose.

Positive family history of prostate cancer not associated with worse outcomes after radical prostatectomy

To determine the clinical outcomes in men with (FH) and without (NFH) a family history of prostate cancer after radical prostatectomy. We performed a retrospective analysis of 557 men with localized prostate cancer treated by radical prostatectomy between 1989 and 2000. We defined a positive FH as having one or more first-degree relatives such as a father or brother with prostate cancer. The clinical and pathologic features, as well as biochemical disease-free survival, defined as an undetectable prostate-specific antigen level (less than 0.2 ng/mL), were compared between the FH and NFH groups. Compared with the NFH group, the FH men were younger at surgery (median 62 years versus 64 years, P = 0.01), had a lower median preoperative prostate-specific antigen level (7.2 ng/mL versus 7.8 ng/mL, P = 0.05), and were more likely to have only low-grade disease at the final pathologic evaluation (26.2% versus 17.8%, P = 0.05). At a median follow-up of 7.5 years (mean 7.6 +/- 2.9 years), 17% of the FH group had biochemical disease recurrence compared with 30% in the NFH group. The actuarial disease-free survival rate at 5 and 10 years for the two groups was 86% and 80% compared with 73% and 66%, respectively (P = 0.01). When controlled for pathologic variables in a multivariate analysis, FH was not an independent predictor of disease-free survival. The association of improved disease-free survival in the FH patients may have been driven by an earlier age at diagnosis and more favorable pathologic features.

Early versus delayed hormonal therapy for prostate specific antigen only recurrence of prostate cancer after radical prostatectomy. Moul JW, Wu H, Sun L, McLeod DG, Amling C, Donahue T, Kusuda L, Sexton W, O'Reilly K, Hernandez J, Chung A, Soderdahl D, Department of Surgery, Uniformed Services University of the Health Sciences, National Naval Medical Center, Bethesda, MD.J Urol 2004;171:1141–7

Hormonal therapy (HT) is the current mainstay of systemic treatment for prostate specific antigen (PSA) only recurrence (PSAR), however, there is virtually no published literature comparing HT to observation in the clinical setting. The goal of this study was to examine the Department of Defense Center for Prostate Disease Research observational database to compare clinical outcomes in men who experienced PSAR after radical prostatectomy by early versus delayed use of HT and by a risk stratified approach. Of 5382 men in the database who underwent primary radical prostatectomy (RP), 4967 patients were treated in the PSA-era between 1988 and December 2002. Of those patients 1352 men who had PSAR (PSA after surgery greater than 0.2 ng/ml) and had postoperative follow-up greater than 6 months were used as the study cohort. These patients were further divided into an early HT group in which patients [355] received HT after PSA only recurrence but before clinical metastasis and a late HT group for patients [997] who received no HT before clinical metastasis or by current follow-up. The primary end point was the development of clinical metastases. Of the 1352 patients with PSAR clinical metastases developed in 103 (7.6%). Patients were also stratified by surgical Gleason sum, PSA doubling time and timing of recurrence. Univariate and multivariate Cox proportional hazard models were used to evaluate the effect of early and late HT on clinical outcome. Early HT was associated with delayed clinical metastasis in patients with a pathological Gleason sum greater than 7 or PSA doubling time of 12 months or less (Hazards ratio = 2.12, p = 0.01). However, in the overall cohort early HT did not impact clinical metastases. Race, age at RP and PSA at diagnosis had no effect on metastasis-free survival ( p > 0.05). The retrospective observational multicenter database analysis demonstrated that early HT administered for PSAR after prior RP was an independent predictor of delayed clinical metastases only for high-risk cases at the current follow-up. Further study with longer follow-up and randomized trials are needed to address this important issue.

Early versus delayed hormonal therapy for prostate specific antigen only recurrence of prostate cancer after radical prostatectomy. Moul JW, Wu H, Sun L, McLeod DG, Amling C, Donahue T, Kusuda L, Sexton W, O'Reilly K, Hernandez J, Chung A, Soderdahl D, Department of Surgery, Uniformed Services University of the Health Sciences, National Naval Medical Center, Bethesda, MD.: J Urol 2004;171:1141–7

Purpose Hormonal therapy (HT) is the current mainstay of systemic treatment for prostate specific antigen (PSA) only recurrence (PSAR), however, there is virtually no published literature comparing HT to observation in the clinical setting. The goal of this study was to examine the Department of Defense Center for Prostate Disease Research observational database to compare clinical outcomes in men who experienced PSAR after radical prostatectomy by early versus delayed use of HT and by a risk stratified approach. Materials and methods Of 5382 men in the database who underwent primary radical prostatectomy (RP), 4967 patients were treated in the PSA-era between 1988 and December 2002. Of those patients 1352 men who had PSAR (PSA after surgery greater than 0.2 ng/ml) and had postoperative follow-up greater than 6 months were used as the study cohort. These patients were further divided into an early HT group in which patients [355] received HT after PSA only recurrence but before clinical metastasis and a late HT group for patients [997] who received no HT before clinical metastasis or by current follow-up. The primary end point was the development of clinical metastases. Of the 1352 patients with PSAR clinical metastases developed in 103 (7.6%). Patients were also stratified by surgical Gleason sum, PSA doubling time and timing of recurrence. Univariate and multivariate Cox proportional hazard models were used to evaluate the effect of early and late HT on clinical outcome. Results Early HT was associated with delayed clinical metastasis in patients with a pathological Gleason sum greater than 7 or PSA doubling time of 12 months or less (Hazards ratio = 2.12, p = 0.01). However, in the overall cohort early HT did not impact clinical metastases. Race, age at RP and PSA at diagnosis had no effect on metastasis-free survival (p > 0.05). Conclusions The retrospective observational multicenter database analysis demonstrated that early HT administered for PSAR after prior RP was an independent predictor of delayed clinical metastases only for high-risk cases at the current follow-up. Further study with longer follow-up and randomized trials are needed to address this important issue.

Early Versus Delayed Hormonal Therapy for Prostate Specific Antigen Only Recurrence of Prostate Cancer After Radical Prostatectomy

Hormonal therapy (HT) is the current mainstay of systemic treatment for prostate specific antigen (PSA) only recurrence (PSAR), however, there is virtually no published literature comparing HT to observation in the clinical setting. The goal of this study was to examine the Department of Defense Center for Prostate Disease Research observational database to compare clinical outcomes in men who experienced PSAR after radical prostatectomy by early versus delayed use of HT and by a risk stratified approach. Of 5382 men in the database who underwent primary radical prostatectomy (RP), 4967 patients were treated in the PSA-era between 1988 and December 2002. Of those patients 1352 men who had PSAR (PSA after surgery greater than 0.2 ng/ml) and had postoperative followup greater than 6 months were used as the study cohort. These patients were further divided into an early HT group in which patients (355) received HT after PSA only recurrence but before clinical metastasis and a late HT group for patients (997) who received no HT before clinical metastasis or by current followup. The primary end point was the development of clinical metastases. Of the 1352 patients with PSAR clinical metastases developed in 103 (7.6%). Patients were also stratified by surgical Gleason sum, PSA doubling time and timing of recurrence. Univariate and multivariate Cox proportional hazard models were used to evaluate the effect of early and late HT on clinical outcome. Early HT was associated with delayed clinical metastasis in patients with a pathological Gleason sum greater than 7 or PSA doubling time of 12 months or less (Hazards ratio = 2.12, p = 0.01). However, in the overall cohort early HT did not impact clinical metastases. Race, age at RP and PSA at diagnosis had no effect on metastasis-free survival (p >0.05). The retrospective observational multicenter database analysis demonstrated that early HT administered for PSAR after prior RP was an independent predictor of delayed clinical metastases only for high-risk cases at the current followup. Further study with longer followup and randomized trials are needed to address this important issue.

Beneficial Lipid Outcome of Medical Nutrition Therapy for Men with Combined Hyperlipidemia in an Ambulatory Setting

LEARNING OUTCOME: To quantify the effect of medical nutrition therapy in men with combined hyperlipidemia in an ambulatory setting We asked if medical nutrition therapy (MNT) by registered dietitians could lead to a beneficial clinical outcome in men diagnosed with combined hyperlipidemia (hypercholesterolemia and hypertriglyceridemia) [CHL]. We conducted a retrospective chart review of 73 men diagnosed with CHL who were being considered for a lipid lowering drug study. Subjects participated in an 8-week nutrition intervention program as a qualifying requirement prior to initiating pravastatin therapy. Patient records were reviewed to determine the beginning and ending plasma lipid concentrations and the number and length of dietitian sessions. Complete information was available on 43 subjects, mean±SD 60.7±10.1 years. Total dietitian intervention time was 168.8±18.5 minutes in 2.7±0.6 sessions (range=2 to 4) during 6.5±2.2 weeks of MNT (range=4 to 8 weeks). MNT lowered total cholesterol (T-C) 11%, low density lipoprotein cholesterol (LDL-C) 9%, triglyceride (TG) 22% and body mass index (BMI) 2% and raised high density lipoprotein cholesterol (HDL-C) 4%. Pre and post treatment lipids were: T-C 259.5±36.6 vs 230.7±36.2 mg/dl (p<0.001); LDL-C 171.0±29.6 vs 147.1±33.6 mg/dl (p<0.001), TG 368.0±182.3 vs 268.0±142 mg/dl (p<0.001), HDL-C 32.7±8.3 vs 33.4±8.0 mg/dl (NS) and T-C/HDL-C ratio 8.35±2.05 vs 7.23±1.79 (p<0.0001). Based on the National Cholesterol Education Program treatment guidelines algorhythm, 50% (30 vs 15) were no longer eligible for a cholesterol lowering medication post treatment. Not including the cost of monitoring, the direct cost savings (in 1997 dollars) from discontinuing pravastatin eligibility for 6.5 weeks was $40.50 on a per case basis or $324.85 annually. For the entire sub-group (n=15) the annual cost savings is $4,872.75. We conclude that 3 individualized dietitian visits of 56 minutes/visit over 7 weeks has a beneficial effect in treating patients with combined hyperlipidemia.

Effect of laparoscopic pelvic lymph node dissection on the natural history of D1 (T1-3, N1-3, MO) prostate cancer

Reports of abdominal wall tumor implantation after laparoscopic procedures have raised questions regarding the safety of laparoscopic surgery when applied to patients with malignancies. Our objective was to determine if laparoscopic pelvic lymph node dissection (LPLND) had a negative effect on tumor behavior and clinical outcome in men with Stage T1-3, N1-3, M0 (D1) prostate cancer. Fifty-two men were retrospectively identified at four institutions who had pelvic nodes positive for metastatic prostate adenocarcinoma at LPLND and at least 1 year of follow-up. Operative and clinical records were reviewed to determine morbidity, adjuvant treatment, onset of hormone-resistant disease, and survival. During a mean follow-up of 3.1 years, there were no cases of trocar site tumor implantation. There were four perioperative complications, including enterotomy, epigastric vessel injury, abscess, and symptomatic lymphocele formation. There were three deaths from prostate cancer (5.8%) occurring 3 to 4 years after LPLND. For the 45 men treated with early androgen ablation, the 5-year biochemical prostate-specific antigen and clinical progression free rates were 45% and 55%, respectively. Abdominal wall tumor implantation after LPLND for prostate cancer was not demonstrated, even in patients who developed hormone-resistant disease. LPLND in men with Stage D1 disease did not alter short-term disease progression. Longer follow-up in a larger cohort is necessary to determine if LPLND will have an impact on the 5 and 10-year disease progression and survival rates for patients with Stage D1 prostate cancer.

Transurethral fulguration of the prostate with the roller ball

Objectives To assess the histologic changes in the prostate and the clinical outcome in men with symptomatic benign prostatic hyperplasia (BPH) following transurethral fulguration of the prostate (TUFP) with the roller ball. Methods The study was conducted in two phases. In the first phase of the study, histologic changes in the prostate following fulguration with the roller ball were studied in 10 men with BPH who were already scheduled for transurethral resection of the prostate (TURP). In the second phase of the study, 20 male patients with symptomatic BPH underwent TUFP with the roller ball. All patients had preoperative assessment with history and physical examination, urinalysis, uroflow, transrectal ultrasound of the prostate, serum prostatespecific antigen, serum hemoglobin and electrolytes, and cystoscopy. The procedure was performed under general or spinal anesthesia using standard equipment and 3-mm roller ball. The patients were seen in follow-up at 1, 3, 6, 9, and 12 months. Results The results of the first phase of the study indicate that the coagulating current results in thermal destruction of prostatic tissue in the form of coagulative necrosis with minimal if any vaporization. The cutting current results in tissue vaporization with minimal coagulative necrosis. Twenty men have enrolled in the second phase of the study. Their mean age is 63.2 ± 7.5 years and their mean follow-up is 4.6 months (range, 1 to 12). Their mean American Urological Association (AUA) symptom score declined from 22.9 ± 4.2 preoperatively to 6.4 ± 4.9, 5.3 ± 3.2, 4.3 ± 1.9, 6 ± 2.9, and 9 at 1, 3, 6, 9, and 12 months, respectively. The mean maximum flow rate (Q max) increased from 8.9 ± 3.4 mL/s preoperatively to 24.3 ± 1.9 mL/s at 3 months, 22 ± 4.4 mL/s at 6 months, 17.6 + 5 mL/s at 9 months, and 21 mL/s at 12 months postoperatively. The mean prostate volume was 31.9 ± 10 mL and the mean operative time was 44.9 ± 10 minutes. No significant changes were seen in serum hemoglobin and serum sodium. The mean hospital stay was 0.7 day (0 to 2). Nineteen patients had their catheters removed within 24 hours and 1 patient had his catheter removed 48 hours postoperatively. No patient experienced impotence, incontinence, urethral stricture, post-transurethral resection syndrome, or required blood transfusion. In 1 patient (5%) bladder neck stenosis developed at 9 months and 1 patient required TURP for residual apical adenoma at 3 months. Conclusions The nature and the degree of tissue changes in the prostate following fulguration with the roller ball are well controlled and predictable. When the cutting current is used, prostatic tissue can be removed safely and effectively. The clinical outcome after TUFP with the roller ball demonstrates significant improvement in subjective (AUA symptom score) and objective (Q max) parameters, with reduced morbidity and short hospital stay. These early results compare favorably with those seen after TURP and laser ablation of the prostate. Larger series with longer follow-up are necessary to establish the long-term efficacy of TUFP in the treatment of BPH.