Faculty Bibliography

OBJECTIVES: To investigate the long-term efficacy and safety of tamsulosin in patients with benign prostatic hyperplasia and to monitor the increases and decreases in therapeutic response over time. Tamsulosin, a uroselective alpha-adrenergic receptor antagonist for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia, targets alpha(1A)-adrenergic receptors of prostatic smooth muscle with greater affinity than the vascular alpha(1B) receptors. Since the alpha(1A)-adrenoceptor subtype mediates prostatic smooth muscle tension, alpha(1A)-adrenoceptor antagonists may diminish toxicity, with few unwanted effects on blood pressure, while still providing efficacious treatment. METHODS: This study extended two 13-week trials and one 40-week extension trial for an additional 64 weeks. On study entry, all patients (n = 949) received 0.4 mg/day tamsulosin. Baseline values were taken from either those of the previous trials for patients who had been treated with tamsulosin or the first visit of this study for patients not previously exposed to the drug. The primary efficacy parameters were the changes in the total American Urological Association (AUA) symptom score, mean peak urinary flow rate (Qmax), and percentage of patients having 25% or greater improvement in the total AUA symptom score and 30% or more improvement in the Qmax. Safety was assessed primarily on the incidence and severity of adverse events and discontinuations due to adverse events. RESULTS: Improvements from baseline were seen in all primary efficacy parameters and were maintained throughout the study. The changes from baseline for the total AUA symptom score and Qmax were statistically significant (P <0.001) at all 3-month intervals. Tamsulosin was well tolerated, and the incidence of adverse events did not increase over time. The mean sitting vital signs did not vary from baseline or relative to the treatment duration. CONCLUSIONS: Tamsulosin was safe and effective in long-term treatment (longer than 1 year) of benign prostatic hyperplasia.

OBJECTIVES: To evaluate, using five experienced surgeons, the efficacy of the first-generation Cavermap Surgical Aid to identify the cavernous nerves intraoperatively and to predict the recovery of sexual function. This study was not designed to determine whether this device improves the ability to preserve the nerves or improve outcome. METHODS: Fifty men younger than 60 years old (mean age 52.5 years; range 43 to 59) with clinically localized prostate cancer (76% T1c, mean Gleason score 6, prostate-specific antigen level less than 10 ng/mL) underwent nerve-sparing radical prostatectomy (90% bilateral). Intraoperatively, the Cavermap device was used to test for the presence of the cavernous nerves once the neurovascular bundle was identified visually and to determine whether the nerves were intact after the prostate was removed. Erectile function was evaluated using the International Index of Erectile Function; men were considered potent if they were able to achieve unassisted intercourse in at least one half of their attempts. RESULTS: Before the removal of the prostate, the tumescence response to stimulation of the neurovascular bundle was 87.8%; when tissue not containing the neurovascular bundle was stimulated, no tumescence response occurred in 54%. After prostatectomy, a bilateral response to stimulation occurred in 90%, a unilateral response in 5%, and no response in 5%. Postoperatively, 71% of the patients were potent at 12 months. In the patients who demonstrated bilateral stimulation after removal of the prostate, 78% were potent at 12 months. CONCLUSIONS: After radical prostatectomy performed by experienced surgeons, patient-reported potency rates in men younger than 60 years of age were high. Cavermap stimulation demonstrated an 87.8% sensitivity and 54% specificity in locating the neurovascular bundle as identified by experienced surgeons. The lack of specificity of this first-generation device limits its application for deciding which structures can be safely preserved or excised. Because virtually all patients demonstrated a positive response after removal of the prostate, the value of stimulation to predict the recovery of sexual function is yet to be determined.

Metastatic prostate cancer is classically associated with bony or pelvic lymphatic metastasis. This case review represents an unusual case of prostate cancer presenting with a large left supraclavicular neck mass.

This article discusses the basic elements of chemoprevention trial designs using cohorts of men following radical prostatectomy who either have prostate-specific antigen (PSA) failure indicative of recurrence or are at high risk for recurrence (positive surgical margins, extracapsular extension, seminal vesicle invasion, positive lymph nodes, Gleason score of greater than or equal to 8, preoperative serum PSA less than 20 ng/mL). Two ongoing randomized, double-blind, placebo-controlled clinical trials with soy protein as intervention in these 2 populations are described. In the trial with men at high risk for recurrence, participants started intervention within 4 months after surgery and were followed for up to 2 years; primary endpoints were PSA failure rate and time-to-PSA failure. In the trial with men with PSA failure (PSA 0.1 to 2.0 ng/mL), participants received treatment for 8 months and the primary endpoint is rise in PSA over time. The strengths and limitations of these designs are discussed and interim experience using studies with soy protein as the intervention agent are summarized