Paul R Sieber

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BACKGROUND Bone metastases are a major cause of morbidity and mortality in men with prostate cancer. Preclinical studies suggest that osteoclast inhibition might prevent bone metastases. We assessed denosumab, a fully human anti-RANKL monoclonal antibody, for prevention of bone metastasis or death in non-metastatic castration-resistant prostate cancer. (More)
BACKGROUND Pomegranate juice has been associated with PSA doubling time (PSADT) elongation in a single-arm phase II trial. This study assesses biological activity of two doses of pomegranate extract (POMx) in men with recurrent prostate cancer, using changes in PSADT as the primary outcome. METHODS This randomized, multi-center, double-blind phase II,(More)
PURPOSE We evaluated changes in bone mineral density (BMD), fat-free mass (FFM) and serum lipid levels during bicalutamide 150 mg monotherapy compared with medical castration for 2 years. MATERIALS AND METHODS A total of 103 men with localized or locally advanced prostate cancer (T1-T4, Nx, M0) for whom immediate androgen deprivation was indicated were(More)
PURPOSE A randomized, double-blind, dose finding, placebo controlled, parallel group clinical study was done to determine the incidence of prostate cancer in men with high grade prostatic intraepithelial neoplasia treated with toremifene. MATERIALS AND METHODS A total of 514 patients with high grade prostatic intraepithelial neoplasia and no evidence of(More)
PURPOSE Androgen deprivation therapy is associated with fracture risk in men with prostate cancer. We assessed the effects of toremifene, a selective estrogen receptor modulator, on fracture incidence in men receiving androgen deprivation therapy during a 2-year period. MATERIALS AND METHODS In this double-blind, placebo controlled phase III study 646 men(More)
PURPOSE A retrospective review of a large group of transrectal ultrasound guided biopsies was performed to determine the symptomatic urinary tract infection rate associated with a consistent and defined antibiotic prophylaxis regimen. MATERIALS AND METHODS A total of 4,439 biopsies was performed using an 18 gauge needle with ultrasound guidance. Patients(More)
BACKGROUND The 4Kscore combines measurement of four kallikreins in blood with clinical information as a measure of the probability of significant (Gleason ≥7) prostate cancer (PCa) before prostate biopsy. OBJECTIVE To perform the first prospective evaluation of the 4Kscore in predicting Gleason ≥7 PCa in the USA. DESIGN, SETTING, AND PARTICIPANTS(More)
Zoledronic acid (ZA) or denosumab treatment reduces skeletal-related events; however, the safety of prolonged therapy has not been adequately studied. Here, we describe safety results of extended denosumab therapy in patients with bone metastases from the open-label extension phase of two phase 3 trials. Patients with metastatic breast or prostate cancer(More)
BACKGROUND Overactive bladder (OAB) syndrome is characterized by urinary frequency and urgency with or without urge incontinence, and often accompanied by nocturia. The prevalence of OAB increases with aging; it is a particularly common condition among the elderly, affecting at least 25% of people aged > or = 65 years. OBJECTIVE The goal of this study was(More)
PURPOSE We evaluated the effects of toremifene on bone mineral density, a surrogate for fracture risk, in men receiving androgen deprivation therapy for prostate cancer. MATERIALS AND METHODS In an ongoing, multicenter, phase 3 fracture prevention study 1,392 men 50 years or older with prostate cancer receiving androgen deprivation therapy were randomized(More)