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To assess the association between use of 5-alpha reductase inhibitors (eg, finasteride) for BPH and occurrence of hip fracture.
Dutasteride and finasteride are 5alpha-reductase inhibitors (5ARIs) that dramatically reduce serum levels of dihydrotestosterone (DHT).
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Dutasteride is commonly used in patients that are also at risk for prostate cancer (PCa). Therefore, the influence of dutasteride on PCa markers has to be studied. To date, only the effect of dutasteride on serum prostate-specific antigen (PSA) has been studied. This was the first study to investigate the effect of dutasteride on the new PCa marker PCA3, longitudinally and in a dose dependent manner.
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Although the debate on the higher incidence of high-grade prostate cancer among 5-ARI-treated patients remains, our findings indicate that finasteride may attenuate tumor aggressiveness and invasion, which could vary depending on the androgen responsiveness of a patient's prostate cells.
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This double-blind, randomized, placebo-controlled, multicentre study comprised 214 patients with BPH. Placebo was compared with dutasteride 0.5 mg/day 2 weeks before and after TURP, or 4 weeks before and 2 weeks after TURP. Surgical blood loss was measured using a haemoglobin photometer (HemoCue AB, Angelholm, Sweden) and postoperative adverse events were recorded. Microvessel density (MVD) was calculated by immunostaining and light microscopy of the prostatic chips.
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Area under the receiver operating characteristic curves (AUC) were used to compare different models with different predictors. Net reclassification improvement (NRI) and decision curve analysis (DCA) were used to assess changes in risk prediction by adding genetic markers.
Twenty-nine men had 39 bone biopsies. Seventy-seven percent of bone biopsies had at least one positive biopsy core. We determined that lesion size and distance from the skin to the lesion edge correlated with tumor yield on biopsy (median PPC 75% versus 42% for lesions >8.8 cm(3) versus ⩽ 8.8 cm(3), respectively, P=0.05; median PPC 33% versus 71% for distance ⩾ 6.1 versus <6.1 cm, respectively, P = 0.02). There was a trend towards increased tumor yield in patients with increased uptake on radionuclide bone scan, higher calcium levels and shorter duration of osteoclast-targeting therapy, although this was not statistically significant. Ten men had 14 soft tissue biopsies. All soft tissue biopsies had at least one positive biopsy core.
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Patients with International Prostate Symptom Score ≥ 8, total prostatic volume (TPV) >30 mL, and maximum flow rate (Qmax) <15 mL/s were randomly assigned to the 5α-reductase inhibitor (5ARI) discontinue (DC-5ARI) or α-blocker discontinue (DC-α-blocker) group. All patients received combination therapy with dutasteride (0.5 mg QD) and doxazosin (4 mg QD) for 2 years and then discontinued either one drug for 12 months. The primary endpoint was the occurrence of resuming medication. The secondary endpoints were the net parameters changed or the need of transurethral resection of the prostate (TURP).
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Symptomatic BPH patients (n = 118) were randomized to receive 0.2 mg tamsulosin alone or with 0.5 mg dutasteride daily for 12 months. The TZI, International Prostate Symptom Scores, maximum urinary flow rates (Qmax), postvoid residual urine volumes, and prostate-specific antigen (PSA) were evaluated at baseline and after 12 months. The groups were subdivided according to a cut-off TZI value of 0.5 to compare treatment-related changes.
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TARP will be the first study to evaluate the effects of dutasteride and an antiandrogen in patients failing GnRH analogue and help elucidate the potential role of a dual 5ARI in reducing the rate of progression in non-metastatic CRPC.
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The role of steroidal inhibitors of androgen biosynthesis as potential weapons in the treatment of prostatic diseases, such as benign prostatic hyperplasia and prostatic cancer will be reviewed. Two enzymes have been targeted in the development of inhibitors that potentially could be useful in the management of such conditions. 5α-Reductase is primarily of interest in benign prostatic disease, though some role in the chemoprevention of prostatic carcinoma have been considered, whereas the 17α-hydroxylase/17,20-lyase (CYP17) enzyme is of interest in the treatment of malignant disease. An overview of the main achievements obtained during the past years will be presented, however special focus will be made on steroidal molecules that reached clinical trials or have been commercially launched. Relevant examples of such drugs are finasteride, dutasteride, abiraterone acetate and galeterone (TOK-001, formerly known as VN/124-1). This article is part of a Special Issue entitled "Synthesis and biological testing of steroid derivatives as inhibitors".