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The effects of a steroidal antiandrogen (AA) and 5-alpha-reductase inhibitor (5ARI) on prostate tissue hormone content and metabolism are not fully elucidated. The objective of this study is to investigate the hormone content and metabolism of the prostate tissues of patients treated with AA or 5ARI using the ultra-sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.
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Prostate cancer is an attractive target for chemoprevention because of its ubiquity, treatment-related morbidity, long latency between premalignant lesions and clinically evident cancer, and defined molecular pathogenesis. Prevention of this disease would have a major impact on disease-associated cost, morbidity, and mortality for a large segment of the population. A major advance in prevention of prostate cancer came in 2003 with the publication of the Prostate Cancer Prevention Trial (PCPT). This overview summarizes the results of that trial, the design of other large-scale trials, and advances in understanding of the molecular mechanisms underlying the effect of other promising agents, including dutasteride, selenium, Vitamin E, Vitamin D, COX-2 inhibitors, lycopene, and green tea.
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We modeled 4294 men treated in the Phase III dutasteride benign prostatic hyperplasia trials. These men were characterized at baseline by a number of parameters, including the American Urological Association Symptom Index, Benign Prostatic Hyperplasia Impact Index questionnaire, prior use of selective alpha1-blockers, prostate volume, prostate-specific antigen level, and maximal flow rate. Cox proportional hazards regression analysis was used to relate these baseline variables to their future probability of AUR/SI within 2 years. The nomogram was internally validated with bootstrapping to assess its discrimination and calibration. Discrimination was quantified as the concordance index.
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Dutasteride increased hair growth and restoration in men with androgenetic alopecia and was relatively well tolerated.
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• We searched MEDLINE and the Cochrane Collaboration Library through June 2010 to identify randomized trials. • We included articles if they examined 5-α-RI vs control, were ≥ 1 year in duration and provided clinical outcomes. • Our primary outcome was prostate cancer period-prevalence 'for-cause'.
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BTB proteins were assessed by immunohistochemistry (n = 16 samples) and mRNA (n = 18 samples) expression levels in available archived testis tissue from a previous study of 22 men who had undergone 8 weeks of gonadotropin suppression and for whom meiotic and post-meiotic germ cell numbers were available. The gonadotropin suppression regimens were (i) testosterone enanthate (TE) plus the GnRH antagonist, acyline (A); (ii) TE + the progestin, levonorgestrel, (LNG); (iii) TE + LNG + A or (iv) TE + LNG + the 5α-reductase inhibitor, dutasteride (D). A control group consisted of seven additional men, with three archived samples available for this study.
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The treatment of men with symptomatic benign prostatic hyperplasia (BPH) has shifted dramatically from surgery to drug therapy over the past decade. The revolution in BPH treatment began with the discovery of congenital 5alpha-reductase (5AR) deficiency, leading to the appreciation of 2 different androgenic hormones: testosterone, which mediates overt masculinization in the adult male, and dihydrotestosterone (DHT), which mediates prostatic growth, acne, facial beard, and male pattern baldness. Inhibition of DHT in adults results in prostatic shrinkage and symptomatic relief in many men, without the side effects seen with conventional androgen-deprivation therapy. The 5AR inhibitor drugs (finasteride and the dual inhibitor, dutasteride) are able to ablate the accumulation of intraprostatic DHT, the mechanism most responsible for prostate growth and maintenance. Not only may these drugs relieve symptoms, but they may also alter the natural history of the BPH process. Future indications for the 5ARI drugs could include chemoprevention of prostate cancer, prophylaxis of BPH-related complications, and treatment of BPH-associated hematuria.
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Tamsulosin monotherapy was sufficient treatment for BPH in Korean men with a prostate volume ≤ 35 ml. Combination tamsulosin and dutasteride therapy provided greater benefits than tamsulosin monotherapy in men with BPH whose prostate volume was > 35 ml.
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A literature review was performed using PubMed/MEDLINE and congress abstracts to examine evidence supporting the potential of 5alpha-reductase inhibitors in the primary prevention of prostate cancer and in limiting the progression of diagnosed disease.
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The average serum and salivary progesterone concentration, Cmax, and the AUC were slightly higher in the dutasteride group, but no significant difference could be noted. Metabolism by the 5α-reductase enzyme is unlikely to affect the bioavailability of progesterone.
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Canadian clinical guidelines recommend the use of the combination of tamsulosin and dutasteride for men with moderate/severe symptoms associated with BPH and enlarged prostate volume. This analysis, using a representational patient group, suggests that the FDC is a more cost-effective treatment option for BPH.
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MAPPED is the first randomised controlled trial to use mpMRI to look at the effect of dutasteride on the volume of prostate cancer. If dutasteride is shown to reduce the volume of prostate cancer, it might be considered as an adjunct for men on active surveillance. Analysis of the placebo arm will allow us to comment on the short-term natural variability of the MR appearance in men who are not receiving any treatment.
During the process development of dutasteride in the laboratory analysis showed some impurity peaks in HPLC ranging from 0.05 to 0.1%. The same samples were analyzed by LCMS method and identified peak at m/z 508 (desmethyl dutasteride), 530 (dihydro dutasteride) and 528 (isomer of dutasteride). These impurities were synthesized individually and characterized based on the spectroscopic data (HPLC, IR, NMR and MS). The structures of these impurities were 17beta-N-[2,5-bis(trifluoromethyl) phenyl]carbamoyl-3-hydroxyl-4-azaestra-1,3,5,7,9-pentaene (desmethyl of dutasteride 2), 17beta-N-[2,5-bis(trifluoromethyl)phenyl]carbamoyl-4-aza-5alpha-androstane-3-one (dihydro impurity of dutasteride 3), and 17beta-N-[2,5-bis(trifluoromethyl) phenyl] carbamoyl-4-aza-5beta-androst-1-ene-3-one (beta-isomer of dutasteride 4), respectively. The formation and synthesis of dutasteride impurities are discussed.
Premedication with dutasteride seems promising to improve prostate cancer detection by using CECD ultrasound.
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Recent studies have both clarified and extended the roles of 5 alpha-reductase inhibitors in benign prostatic hyperplasia, and these may expand further if chemopreventive abilities are proved. In addition, dual isoenzyme inhibition will soon be available.
This study compared the efficacy of dutasteride vs. placebo in the treatment of male pattern hair loss (androgenetic alopecia) in 17 pairs of identical twin males with androgenetic alopecia over a 1-year period.
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Triple negative breast cancer (TNBC) is characterized by lack of expression of both estrogen and progesterone receptor as well as lack of amplification of HER2. Patients with TNBC carry an unfavorable prognosis compared to other breast cancer subtypes given that endocrine or HER2 targeted therapies are not effective, rendering chemotherapy the sole effective treatment option to date. Therefore, there is a high demand for additional novel treatment options.
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EjD related to medical treatments for LUTS.
Fixed-dose combination of dutasteride and tamsulosin (FDCT) produced an Incremental cost-effectiveness ratios of US$1481.92 per Quality adjusted for life-years saved.
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to evaluate the efficacy, safety and tolerability of drugs used for treatment of LUTS in older persons, a systematic review was performed. Papers on clinical trials and summaries of individual product characteristics were analysed regarding efficacy and safety in older persons (≥65 years). The most frequently used drugs were selected based on current prescription data. An interdisciplinary international expert panel assessed the drugs in a Delphi process.
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The primary objective of the REDUCE (REduction by DUtasteride of prostate Cancer Events) Follow-Up Study was to collect data on the occurrence of newly diagnosed prostate cancers for 2 years beyond the 4-year REDUCE study.