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Chemoprevention of prostate cancer is an attractive idea that appeals to many struggling with the treatment of this disease. Many details inherent in any preventive strategy must be considered before embarking on this course, no matter how seductive it may appear. Critical issues of effectiveness, cost, difficulties in implementation, side effects, duration of the preventive cycle, and public acceptance may thwart prevention of prostate cancer from being implemented in the near future.
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While defining the no effect level for the 5 alpha-reductase inhibitor finasteride in the Hershberger assay, we encountered an inverted-U low-dose trophic effect on the prostate gland of the rat. Two attempts to confirm this observation were unsuccessful, and we concluded that the positive effect initially observed was associated with normal biologic variability. During the same period we attempted, unsuccessfully, to repeat our own observation of weak uterotrophic activity in the rat for the sunscreen 3-(4-methylbenzylidene)camphor (4MBC). Further evaluation led us to conclude that 4MBC is uterotrophic only when the control uterine weights are at the low end of their normally encountered range. This led us to reevaluate our earlier mouse uterotrophic assay data for bisphenol A (BPA). Originally we had concluded that BPA gave irreproducible evidence of weak uterotrophic activity, but upon ordering the eight experiments we had conducted, according to decreasing control uterine weight, we confirmed reproducible weak uterotrophic activity for BPA when the control uteri were at the low end of their normal range. In this article, we describe these observations, together with a reanalysis of the data associated with several reported instances of weak or low-dose endocrine effects that have proven difficult to confirm in independent laboratories. These include the activity of BPA on the CF1 mouse prostate; the activities of BPA, octylphenol, and nonylphenol on the rat testis; and the effect of polycarbonate caging on control mouse uterine weight. In all of these cases, variability among controls provides a major obstacle to data interpretation and confirmation. Our recommendations on experimental design are also presented, with a view to ending the current impasse on the reality, or otherwise, of low-dose or weak endocrine toxicities.
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Upon re-presentation, investigations included measurement of serum PSA levels, pelvic CT, transrectal ultrasound-guided prostate biopsy, histological examination of the biopsy specimen and immunohistochemical staining.
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Chronic prostatitis/chronic pelvic pain syndrome continues to pose a treatment challenge for urologists. Most commonly prescribed medications, such as antibiotics, a-blockers, androgen inhibitors, and anti-inflammatory agents, have been shown to help some patients. However, the efficacy and durability of such treatments lack consistency among men suffering from this disorder. The rationale for such treatments is described in this article, along with possible explanations for the apparent shortcomings. Also included is a brief summary of alternative therapies, which are growing in popularity among patients and gaining acceptance in our medical communities.
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(1) A hypospadias SD rats model can be established by Finasteride and it is easily reproducible. (2) The Atrazine was teratogenic to the SD rats, embryotoxic effects were observed at the low dose level and associated with no severe maternal toxicity.
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Retrospective pharmacovigilance disproportionality analysis.
Global evaluation of hair loss in male subjects affected by androgenetic alopecia has been proposed as a means for monitoring changes over time, including placebo-controlled drug efficacy studies. Because of the potential impact of subjectivity (e.g. placebo effect) of clinical investigators, global photographs (GPs) have been introduced as a more objective record. Examination of paired before and after pictures and rating on a seven-point scale (from greatly decreased -3 to greatly increased +3) have been historically introduced by United States of America (US) experts.
Previous work has clearly demonstrated that inhibition of 5 alpha-dihydrotestosterone (DHT) formation in vivo is not as effective as total androgen ablation (castration) in causing involution of the prostate. It is likely that this is due to the fact that testosterone is partially effective in maintaining androgen action. To provide insight into this observation, the androgenic metabolites of testosterone, androstenedione, and 5 alpha-DHT, were measured in prostate tissue and in blood of 5 alpha-reductase inhibitor (finasteride)-treated adult male rats. Finasteride treatment caused a significant decrease in prostatic DHT levels and a profound increase in prostatic testosterone and androstenedione levels. Similarly, circulating DHT levels were decreased in finasteride-treated rats (0.02 ng/ml compared with 0.05 ng/ml seen in control rats); and circulating androstenedione and testosterone levels were significantly elevated in finasteride-treated animals compared with controls. The in vitro effects of finasteride were assessed on the metabolism of [3H]testosterone in a tissue-slice assays. In the prostate, the inhibition of 5 alpha-reductase activity resulted not only in the decreased formation of 5 alpha-reduced metabolites (primarily DHT and 5 alpha-androstanedione), but also an increase in the 17-oxo metabolite androstenedione. In contrast, the tissues derived from the embryonic wolffian duct (seminal vesicle and epididymis) formed relatively low amounts of 17-keto steroids. Because DHT is a high affinity ligand for the androgen receptor and androstenedione shows very little, if any, affinity for the receptor, these studies suggest that 5 alpha-reduction of testosterone may be a mechanism to amplify androgen action in urogenital tissues such as the prostate by preventing catabolism of testosterone to the inactive androgen, androstenedione, at the site of hormone action.
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We performed a retrospective study of 587 men enrolled in an AS programme, who had no history of 5-ARI use. Chi-squared and t-tests were used to compare characteristics of 5-ARI users and non-users. Univariable and multivariable proportional hazards models, treating 5-ARI use as a time-dependent covariate, were used to evaluate the influence of 5-ARIs on the risk of a subsequent biopsy no longer meeting criteria for continued AS (i.e. reclassification).
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Randomized studies of Serenoa repens, alone or in combination with other plant extracts, have provided the strongest evidence for efficacy and tolerability in treatment of BPH in comparison with other phytotherapies. Serenoa repens appears to be a useful option for improving lower urinary tract symptoms and flow measures. Hypoxis rooperi and Secale cereale also appear to improve BPH symptoms although the evidence is less strong for these products. Pygeum africanum has been studied extensively but inadequate reporting of outcomes limits the ability to conclusively recommend it. There is no convincing evidence supporting the use of Urtica dioica or Curcubita pepo alone for treatment of BPH. Overall, phytotherapies are less costly, well tolerated and adverse events are generally mild and infrequent. Future randomized controlled trials using standardized preparations of phytotherapeutic agents with longer study durations are needed to determine their long-term effectiveness in the treatment of BPH.
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Incidences of prostate cancer in most countries are increasing owing to better detection methods; however, prevention with the use of finasteride, a very effective steroid 5α-reductase type II inhibitor, has been met with mixed success. A wide interindividual variation in response exists and is thought to be due to heritable factors. This article summarizes the literature that attempts to elucidate the molecular mechanisms of finasteride in terms of its metabolism, excretion and interaction with endogenous steroid molecules. We describe previously reported genetic variations of steroid-metabolizing genes and their potential association with finasteride efficacy. Based on the literature, we outline directions of research that may contribute to understanding the interindividual variation in finasteride prevention and to the future development of personalized medicine.
Finasteride, a 5-alpha-reductase inhibitor, dramatically suppresses the production of dihydrotestosterone in men; thus, attention has turned to this agent for the treatment of benign prostatic hyperplasia (BPH). A number of randomized clinical trials have studied finasteride's effects on prostate size, BPH symptoms, flow rate, and prostate-specific antigen (PSA) level. Although the decrease in symptoms with finasteride therapy has been modest compared with more invasive treatments, its use has resulted in sustained reductions in prostatic volume and PSA level with minimal adverse effects. Fewer surgeries for BPH, as well as a decreased incidence of acute urinary retention, have also been seen with finasteride therapy. More research is needed to maximize the effectiveness of such medical therapy for BPH.
The Prostate Cancer Prevention Trial is the first phase III (randomized, placebo-controlled, prospective) population-based study to determine whether the risk of prostate cancer can be reduced. Between 1994 and 1997, 18,882 men were randomized to either finasteride or placebo at 219 sites in the United States. The study design included annual digital rectal examination and PSA determinations with PSA performed centrally with reports provided to sites corrected for treatment arm (as finasteride lowers PSA level). Because of a number of potential biases that could confound disease ascertainment all patients were scheduled for an end-of-study prostate biopsy. End-of-study prostate biopsies began in 2000, and the final biopsy is expected in 2004, with results of the study anticipated shortly thereafter. The high participant interest and extensive data collected for this study demonstrate the extraordinary opportunity for chemoprevention trials of prostate cancer in the United States
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Androgen deprivation therapy has become well-established in the treatment of prostate cancer. Luteinizing-hormone-releasing hormone (LHRH) agonists, anti-androgens, orchiectomy, and combination hormonal therapy are treatment options offered to select patients. The prospect of intervention prior to the development of adenocarcinoma is appealing, and high-grade prostate intra-epithelial neoplasia (PIN), the only known precursor, is the best possible target. There is a decrease in the incidence of high-grade PIN in patients treated with combination androgen deprivation therapy (LHRH agonist and anti-androgen). Changes include increased apoptosis, decreased mitotic activity, less conspicuous nucleoli, and basal-layer prominence. Treatment with the 5alpha-reductase inhibitor finasteride results in a significant decrease in the incidence of high-grade PIN. The effect of 5alpha-reductase inhibitors and selective estrogen receptor modulators on histopathologic evaluation remains unclear, as the number of cases evaluated is small, but new data will be forthcoming with completion of multiple clinical trials.
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A 43-year-old man presented suffering from decreasing vision in both eyes for 3 months. The patient's visual acuity was 6/20 (non-corrected) in the right eye and 6/10 (-1.75/-1.00 x 91) in the left. Ocular examination of both eyes revealed anterior subcapsular opacities of both lenses with the right eye being more severe than the left. He had been taking finasteride (Propecia; Merck, Sharp and Dohme) at 1 mg/day for 3 years to treat early stage of androgenic alopecia. It was highly suspected that finasteride was associated with the anterior subcapsular opacity on the lens, and the patient therefore discontinued use of finasteride. He underwent uneventful cataract extraction surgery and intraocular lens implantation of the right eye. One month after cataract surgery in the right eye, the best-corrected visual acuity was right 6/6 (-1.25) and left 6/10 (-2.00/-0.50 x 100). To the best of the authors' knowledge, this is the first reported case of Propecia-associated cataract.
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We assessed the frequency and cost of care for benign prostatic hyperplasia (BPH) among approximately 165,000 subscribers to Fallon Community Health Plan (FCHP), a group model health maintenance organization located in central Massachusetts. We computed rates of episodes of medical services for BPH using automated utilization files, and we estimated costs using Medicare reimbursement schedules and medication average wholesale prices. We identified 3919 men who visited a physician for BPH from January 1, 1991, until December 31, 1994, during which time they contributed 8336 person-years to the analysis. This population comprises approximately 12% of men at least 40 years old at FCHP. From 1991 to 1994, 696 (18%) men received terazosin, 219 (6%) men underwent a prostatectomy, and 41 (1%) men received finasteride. Men averaged 1.66 office visits per year to a physician for BPH. Most office visits (61%) were to a primary care physician, with 39% of the visits to a urologist. Among patients who received terazosin, the frequency of office visits increased slightly after receiving terazosin, from 2.14 to 2.62 visits per year. Among surgery patients, the frequency of visits declined after prostatectomy, from 6.31 visits per year to 1.67 visits. The individual annual cost rate for BPH care ranged from $25.00 to $25,352.00, with an average of $364.00 per person and a median cost of $126.00. The major components of the overall costs were hospital admissions (35%), terazosin dispensings (29%), and physician office visits (19%), with outpatient hospital care and ambulatory procedures accounting for the remaining 17%. Among men receiving terazosin, the average cost was $1190.00 per person-year, and among patients undergoing prostatectomy, the cost was $2630.00 per person-year. The prostatectomy rate declined by nearly 80% during the study period, while the dispensing rate for terazosin doubled, resulting in an overall decline in the total cost of care for BPH from 1991 to 1994.
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Testosterone (T) treatment suppresses serum gonadotropins and reduces sperm output sufficiently for contraceptive efficacy in approximately 70% of Caucasian men. In the remaining 30% of men, an increase in 5alpha-reductase activity may maintain testicular androgen activity, thus accounting for the failure of sperm suppression. The form of T therapy is a major consideration in the safety and acceptability of T-based contraception. As compared to T ester injections, T implants provide a more physiological serum T profile and fewer side effects, but have not yet been used in contraceptive efficacy studies. We have used T implants (800-1200 mg every 3 months) in 29 normal men for 3-16 months. T implants produced long-term suppression of sperm densities below 1 million/mL in approximately 70% of men without significant androgenic side effects. No pregnancies occurred in 214 months of exposure. In 16 men failing to suppress within 3 months of T 800 mg, no evidence of enhanced spermatogenic suppression was seen with the co-administration of the type 2 5alpha-reductase inhibitor, finasteride, for 3 months when compared to placebo. We conclude that: 1) T implants provide adequate spermatogenic suppression in approximately 70% of Caucasian men, a rate comparable to intramuscular T injections but with minimal side effects; and, 2) the inclusion of a type 2 5alpha-reductase inhibitor does not enhance spermatogenic suppression.
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Nude mice bearing androgen-sensitive LNCaP xenograft were castrated and followed up for 7-10 days before being randomized into various androgen manipulations, consisting of continuous castration (C) or testosterone replacement (T) in the absence or presence of dutasteride (D), a 5alpha-reductase inhibitor that blocks the conversion of testosterone to DHT. Testes-intact animals in the absence or presence of D were used as controls. The expression of five androgen-responsive genes, including the tumor suppressor U19/Eaf2, was determined using real-time RT-PCR, 3 days after randomization.
Clinical treatment of patients with hidradenitis suppurativa. Measurement/participants: Five publications described the use for hidradenitis suppurativa. Four global case reports cited 13 individual patients, four male and nine female. Females included three adolescent patients and a child aged seven with precocious puberty. In the United States, finasteride in obese male adults was mentioned to be helpful.
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Finasteride is a well-tolerated and effective alternative to watchful waiting in the treatment of moderate BPH.
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Double-blind randomized study.
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Pretreatment of 3alpha, 5alpha-THP (0.5-2.5 mug/rat, i.c.v.) or neurosteroidogenic agents such as 3alpha, 5alpha-THP precursor progesterone (5 or 10 mg/kg, i.p.), 11-beta hydroxylase inhibitor metyrapone (50 or 100 mg/kg, i.p.) or the GABA(A) receptor agonist muscimol (25 ng/rat, i.c.v.) significantly potentiated the anti-anxiety effect of ethanol (1 g/kg, i.p.). On the other hand, the GABAergic antagonistic neurosteroid dehydroepiandrosterone sulphate (DHEAS) (1 mg/kg, i.p.), the GABA(A) receptor blocker bicuculline (1 mg/kg, i.p.), the 5alpha-reductase inhibitor finasteride (50 x 2 mg/kg, s.c.) or the mitochondrial diazepam binding inhibitory receptor antagonist PK11195 (1 mg/kg, i.p.) reduced ethanol-induced preference of time spent and number of entries into open arms. Anti-anxiety effect of ethanol was abolished in adrenalectomized (ADX) rats as compared to sham-operated control. This ADX-induced blockade was restored by prior systemic injection of progesterone, signifying the contribution of peripheral steroidogenesis in ethanol anxiolysis. Socially isolated animals known to exhibit decreased brain 3alpha, 5alpha-THP and GABA(A) receptor functions displayed reduced sensitivity to the effects of ethanol and 3alpha, 5alpha-THP in EPM test.
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We found a sharp increase in the excretion of 6β-hydroxycortisol over cortisol (P < 0.001), indicative of a strong induction of the major drug-metabolizing enzyme cytochrome P450 3A4. The contribution of 6β-hydroxycortisol to total glucocorticoid metabolites increased from 2% (median, interquartile range 1-4%) to 56% (39-71%) during mitotane treatment. Furthermore, we documented strong inhibition of systemic 5α-reductase activity, indicated by a significant decrease in 5α-reduced steroids, including 5α-tetrahydrocortisol, 5α-tetrahydrocorticosterone, and androsterone (all P < 0.001). The degree of inhibition was similar to that in patients with inactivating 5α-reductase type 2 mutations (n = 23) and patients receiving finasteride (n = 5), but cluster analysis of steroid data revealed a pattern of inhibition distinct from these two groups. Longitudinal data showed rapid onset and long-lasting duration of the observed effects.
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Two pH optima of 5 alpha-reductase activity in dog prostatic homogenates are described, comparable to the pH optima of rat and human 5 alpha-reductase isozymes. Kinetic analysis of 5 alpha-reductase enzymatic activity at pH 7.0 revealed isozymes with a low apparent affinity constant (Km = 2.67 nM) and a high apparent affinity constant (Km = 1.23 microM). These apparent affinity constants compare favorably to the human and rat isozymes types II and I, respectively. The human type II inhibitor finasteride selectively inhibited the low Km isozyme, whereas the human type I inhibitor MK386 preferentially inhibited the high Km isozyme. The human type I inhibitor LY306089 was nonspecific for the dog isozymes.
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The management of androgenetic alopecia (AGA) has been materially altered by the availability of the 5 alpha-reductase type 2 inhibitor, finasteride. Nevertheless, this agent is only one component of successful management, and an understanding of the role of camouflage agents, surgical options, and other medical treatments is important. Because no treatment completely reverses baldness, it is important to communicate the limitations of each modality to the patient so that he has appropriate expectations of the outcome of any intervention. Patient counseling and support are also often relevant.
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The Hershberger bioassay is designed to identify suspected androgens and antiandrogens based on changes in the weights of five androgen-responsive tissues (ventral prostate, paired seminal vesicles and coagulating glands, the levator ani and bulbocavernosus muscles, the glans penis, and paired Cowper's or bulbourethral glands). Protocol sensitivity and reproducibility were tested using two androgen agonists (17alpha-methyl testosterone and 17beta-trenbolone), four antagonists [procymi-done, vinclozolin, linuron, and 1,1-dichoro-2,2-bis-(p-chlorophenyl)ethylene (p,p'-DDE)], and a 5alpha-reductase inhibitor (finasteride). Sixteen laboratories from seven countries participated in phase 2.
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In the androgen deprivation medium, autophagic punta increased markedly in PWR-1E cells, and blockage of autophagy by 3-methyladenine significantly promoted PWR-1E cells' apoptosis rate. In vivo, the expression of LC3 protein (an important autophagic marker) in hyperplasia prostate tissue significantly increased after 5-α reductase inhibitor treatment. Meanwhile, the prostate-specific antigen, as an inner control, decreased.
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Data were collected on availability and cost of medications and physician Internet visits, requirements for physician prescriptions, and geographic location of Web-based companies and consulting physicians. Costs of comparable physician visits were obtained from Medicare and managed care organizations in the Philadelphia region. Costs of medications came from five Philadelphia community pharmacies.