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PubMed2001

Androgen deprivation therapy for prostate cancer chemoprevention: current status and future directions for agent development.

Prostate cancer chemoprevention is defined as the administration of natural and synthetic agents that inhibit >/=1 steps in the natural history of prostate carcinogenesis. The goal is to find agents that modulate the progression from normal epithelium to dysplasia to high-grade prostatic intraepithelial neoplasia (HGPIN) to locally invasive cancer and systemic disease. Another important goal for chemoprevention is the maintenance of an androgen-sensitive clinical state and delay of the emergence of androgen independence. There is a strong rationale for androgen deprivation therapy (ADT) as a chemoprevention strategy for prostate cancer based on evidence from epidemiologic, experimental, molecular pathophysiologic, and randomized, controlled clinical trials. This includes the fact that HGPIN, the most likely precursor of invasive cancer, is androgen dependent and responds to ADT. Although the large, phase-3 Prostate Cancer Prevention Trial (PCPT) of finasteride versus placebo has established the feasibility and role of ADT for primary prevention, nevertheless, limitations of the anticipated treatment-effect size (eg, 25% reduction) and the potential for selection of androgen resistance provide incentive for finding other effective chemopreventive agents. The availability of novel noncytotoxic pharmaceutical and natural products in clinical development create opportunities for improving the therapeutic index through the principles of combination therapy. The emergence of new powerful tools, such as gene chip complementary DNA microarrays for multiplex gene expression profiling, will accelerate the identification of new molecular targets and the design of rational combinations. Several agent classes have a strong basis for combination with ADT, including antiproliferatives, antioxidant micronutrients (selenium), antiestrogens, and nonsteroidal anti-inflammatory drugs (selective cyclooxygenase-2 inhibitors).

Androgen Antagonists↗
PubMed2002

Nonsurgical management of benign prostatic hyperplasia in men with bladder calculi.

OBJECTIVES: To assess the outcome of men with bladder calculi who did not undergo transurethral resection of the prostate after endoscopic stone removal. Bladder calculi associated with benign prostatic hyperplasia (BPH) have historically been an absolute indication for transurethral resection of the prostate. METHODS: A retrospective analysis of the results of 23 men who underwent endoscopic removal of bladder calculi with subsequent medical management of BPH symptoms was performed. Inclusion criteria included men with bladder stones secondary to BPH, serum creatinine 1.6 mg/dL or less, no evidence of hydronephrosis, and no history of acute urinary retention or neurogenic bladder. The International Prostate Symptom Score and postvoid residual urine volume before and after treatment and the incidence of bladder stone recurrence and associated complications were recorded. All patients were treated with either an alpha-receptor blocker or alpha-receptor blocker and finasteride after bladder stone removal. RESULTS: The follow-up after endoscopic removal of the bladder calculi averaged 30.0 months (range 6 to 96). The International Prostate Symptom Score before and after treatment was 18.3 and 9.4 (P <0.01), respectively. The postvoid residual urine volume before and after treatment was 354 and 179 mL (P <0.01), respectively. Urinary tract infection, acute urinary retention, recurrent calculi, chronic renal insufficiency, or renal failure developed in 21.7% (n = 5), 17.4% (n = 4), 17.4% (n = 4), 4.3% (n = 1), and 0% (n = 0) of the 23 men, respectively. Overall, 18 (78%) did not have any complications. CONCLUSIONS: Many men with bladder stones can be successfully and safely treated with transurethral stone removal and medical management of BPH.

Adrenergic alpha-Antagonists↗
PubMed1997

Tamoxifen for flutamide/finasteride-induced gynecomastia.

OBJECTIVES: Current therapies for advanced prostate carcinoma lead to a marked decrease in serum testosterone levels, which renders patients impotent. In preliminary studies, combination therapy with flutamide and finasteride has been used as an alternative therapy for the treatment of prostate carcinoma because potency can be preserved. Both of these agents can cause gynecomastia and breast/nipple tenderness. METHODS: Six men being treated for advanced prostate carcinoma with flutamide/finasteride combination therapy developed painful gynecomastia, which was treated with tamoxifen 10 to 30 mg/day for 1 month. Clinical follow-up included breast measurements and determination of prostate-specific antigen (PSA), testosterone, and estradiol levels. RESULTS: While on this combination therapy for prostate carcinoma, 4 of 6 patients experienced a decrease in PSA level to less than 0.5 ng/mL. All patients remained potent. Serum testosterone increased in each patient who had a baseline level drawn. Estradiol levels were noted to be elevated in 4 of 6 patients at the time of evaluation for gynecomastia. After treatment with tamoxifen, circulating estradiol levels increased in 3 patients from 1.3 to 2.2 times the baseline level. Five patients experienced complete resolution of breast and nipple pain on tamoxifen 10 mg/day within the first month. The other patient had to be treated with 30 mg/day for 1 additional month, which subsequently resulted in pain resolution. CONCLUSIONS: These preliminary results suggest that low-dose tamoxifen is useful in treating painful gynecomastia for those patients on flutamide/finasteride combination therapy for advanced prostate carcinoma.

Aged↗
PubMed2000

Anticonvulsive effect of swim stress in mice.

To explore the possible involvement of glucocorticoids in the previously observed anticonvulsive effect of swim stress, mice were, prior to administration of convulsants, subjected to treatments that diminish or enhance plasma corticosterone levels. Aminoglutethimide, the inhibitor of steroid synthesis, failed to modify convulsant doses of picrotoxin, but enhanced threshold doses of pentylenetetrazole producing myoclonus and death, both in unstressed and stressed animals. The same drug prevented the effect of stress on pentylenetetrazole-induced running bouncing clonus (RB clonus) and abolished the appearance of tonic hindlimb extension (THE). Doses of kainic acid producing convulsions and death were not affected by stress, but they were enhanced by aminoglutethimide. Corticosterone administration could not imitate the effect of swim stress. Finasteride, a 5 alpha-reductase inhibitor, did not interfere with the effect of stress on picrotoxin-induced convulsions. Swim stress failed to modify the binding of the convulsant t[3H]-butylbicycloorthobenzoate [3H]TBOB, to washed mouse forebrain membranes. The results confirmed an anticonvulsant effect of swim stress against convulsions produced by GABA-related convulsants, but they do not support the hypothesis suggesting the involvement of glucocorticoids or neurosteroids in this effect.

5-alpha Reductase Inhibitors↗
PubMed2002

Increase in testosterone metabolism in the rat central nervous system by formalin-induced tonic pain.

The effects of formalin-induced tonic pain (FITP) on testosterone (T) concentrations in the central nervous system (CNS) and serum were investigated in rats. T was nearly eliminated from the brain and spinal cord 1.5 and 24 h after a single subcutaneous injection (100 microl/rat, sc) of 5% formalin and its levels were similar to that seen following castration. In serum, T concentrations were decreased significantly 1.5 h following formalin injection, but after 24 h, the serum level of T was within normal range. T concentrations in the brain, spinal cord, and serum were not modified 20 min after formalin injection. Pretreatment of rats with finasteride, a 5alpha-reductase (5alpha-R) inhibitor (5 mg/kg, sc) blocked T elimination from the brain and spinal cord by FITP, but it failed to prevent decrease in serum T. However, 3 h after administration of exogenous T (5 mg/kg, sc), FITP did not cause a significant decrease in T levels in the CNS and serum. These results suggest that FITP eliminates endogenous T in the brain and spinal cord by increasing 5alpha-R activity in the CNS.

Animals↗
PubMed2001

Docetaxel followed by hormone therapy after failure of definitive treatments for clinically localized/locally advanced prostate cancer: preliminary results.

An increasingly important issue in the management of prostate cancer is the occurrence of biochemical failure (ie, increasing serum prostate-specific antigen [PSA] levels) in patients with clinically localized prostate cancer who initially underwent definitive treatments with curative intent (prostatectomy and/or radiation therapy). This pilot trial evaluated chemotherapy followed by hormone therapy for a defined period in patients with biochemical (and possibly clinical) recurrence after initial local therapies for localized/locally advanced prostate cancer. Patients who developed increasing PSA > 4 ng/mL after initial prostatectomy and/or radiation therapy received docetaxel, 70 mg/m(2) every 3 weeks for up to 6 courses, followed by 4 months of total androgen suppression (using a luteinizing hormone-releasing hormone agonist plus bicalutamide, 50 mg/d) and 8 months of peripheral androgen blockade (using finasteride, 5 mg/d, plus bicalutamide, 50 mg/d). Twenty-seven patients have enrolled to date, 23 of whom received four or six cycles of docetaxel before hormonal therapies. Seventeen (74%) of 23 patients who completed four to six cycles of chemotherapy had a > or =40% decrease in PSA, and 16 (89%) of 18 patients who completed 4 months of total androgen suppression achieved PSA values of < or =0.1. The most common hematologic toxicity was grade (3/4) neutropenia; grade 3 nonhematologic toxicities were rare, and no grade 4 nonhematologic toxicities were reported. Thus, the preliminary results suggest that docetaxel before hormonal therapy includes a PSA response in many prostate cancer patients with biochemical failure after definitive local therapies.

Adenocarcinoma↗
PubMed2002

Biomarker-based methods for determining noncompliance in a prevention trial.

The Prostate Cancer Prevention Trial (PCPT) is a 7-year randomized trial of 18000 men designed to test a daily dose of finasteride (5 mg/d) for the primary prevention of prostate cancer. Compliance is assessed every 6 months by determining the percentage of pills consumed since the previous visit. In addition, levels of 5 alpha-dihydrotestosterone (DHT) are measured at yearly intervals in a random subset of 5% of participants in the trial as part of a substudy to investigate the potential of this biomarker for monitoring compliance. Motivated by this substudy, we outline three biomarker-based rules for monitoring compliance over time in prevention trials. We make comparisons among the rules using receiver operating characteristic curves. We illustrate the methods using the biomarker DHT in the PCPT substudy with pill counts as a gold standard, and in a simulation study under a hypothetical true gold standard. Our results indicate that simple absolute threshold monitoring rules perform just as well as more complicated rules that utilize the entire biomarker history.

Aged↗
PubMed2002

Storage (irritative) and voiding (obstructive) symptoms as predictors of benign prostatic hyperplasia progression and related outcomes.

OBJECTIVES: To assess the utility of voiding and filling symptom subscores in predicting features of benign prostatic hyperplasia (BPH) progression, including acute urinary retention (AUR) and prostate surgery. METHODS: The Proscar Long-term Efficacy and Safety Study (PLESS) was a 4-year study designed to evaluate the effects of finasteride versus placebo in men with lower urinary tract symptoms (LUTS), clinical evidence of BPH, and no evidence of prostate cancer. A self-administered questionnaire was employed to quantify LUTS at baseline. Receiver operating characteristics (ROC) curves were used to assess baseline characteristics from patients treated with placebo as predictors of outcomes. The characteristics assessed included the overall symptom score (Quasi-AUA SI), separate voiding and filling subscores, prostate volume (PV) and serum prostate-specific antigen (PSA) levels. RESULTS: PV and PSA were superior to the symptom scores at predicting episodes of spontaneous AUR and all types of AUR. The Quasi-AUA SI and the filling and voiding subscores were effective at predicting progression to surgery; however, PSA was more effective at predicting this outcome. To better evaluate symptoms as predictors of surgery, patients who experienced a preceding episode of AUR were excluded from the surgery analysis. In the absence of preceding AUR, the best predictors of future surgery were the Quasi-AUA SI and the filling subscore. CONCLUSIONS: Among men with LUTS, clinical BPH and no history of AUR, the overall symptom score and storage subscore are useful parameters to aid clinicians in identifying patients at risk for future prostate surgery. PV and PSA were the best predictors of AUR, while PSA was the best predictor of prostate surgery (for all indications).

Acute Disease↗
PubMed2003

Drug treatment of benign prostatic hyperplasia and hospital admission for BPH-related surgery.

OBJECTIVE: To investigate whether there is a difference in the risk of progressing to BPH-related prostatic surgery between patients using alpha-blockers and patients using the 5-alpha-reductase inhibitors (5-ARIs). METHODS: A population-based cohort study was conducted, using data from the PHARMO Record Linkage System. We identified 5671 patients (> or =50 years old, no history of using both alpha-blockers and 5-ARIs, more than one year of database history prior to the first date of BPH drug-dispensing), who filled at least one prescription for either alpha-blockers (alfuzosin, tamsulosin, terazosin) or 5-ARIs (finasteride). The incidence of BPH-related surgery was compared between patients treated with alpha-blockers and patients treated with 5-ARIs. RESULTS: The cumulative incidence of BPH-related prostatic surgery was 15.2% and mainly involved transurethral resection of the prostate (TURP) (13.4%). Patients using alpha-blockers had a significantly increased risk of BPH-related prostatic surgery compared to patients using 5-ARIs, which remained after adjusting for age, calendar time, type of prescriber and chronic disease score (adjusted HR: 1.52, 95% CI: 1.24-1.88). The difference between alpha-blockers and 5-ARIs was sustained after stratification of time period (<1995, > or =1995) and exclusion of patients with prostatic surgery within one month of treatment initiation. CONCLUSIONS: It is concluded that alpha-blocker treated patients had a higher risk of BPH-related surgery compared to 5-ARI treated patients. Additional research on the long-term outcomes and risk factors for the natural progression of BPH is necessary to identify the optimal medical treatment for BPH patients according to their baseline characteristics.

5-alpha Reductase Inhibitors↗
PubMedDate not supplied

Progesterone metabolism in human fibroblasts is independent of P-glycoprotein levels and Niemann-Pick type C disease.

Progesterone inhibits intracellular transport of lysosomal cholesterol in cultured cells, and thus at least in part mimics the biochemical phenotype of Niemann-Pick type C disease (NPC) in human fibroblasts. The goal of this study was to determine whether metabolism of progesterone to other steroids is affected by the NPC mutation or by P-glycoprotein (a known progesterone target). We found that human fibroblasts metabolize progesterone in three steps: rapid conversion to 5alpha-pregnane-3,20-dione, which is then reduced to 5alpha-pregnane-3beta(alpha)-ol-20-one with subsequent 6alpha-hydroxylation. The pattern and rates of progesterone metabolism were not significantly different in a variety of fibroblasts from normal individuals, NPC patients, and obligate heterozygotes. Inhibition of steroid 5alpha-reductase with finasteride completely blocked metabolism of progesterone but had no effect on inhibition of LDL-stimulated cholesterol esterification (IC50 = 10 microM). Progesterone also partially inhibited 25-hydroxycholesterol-induced cholesterol esterification, with similar dose-dependence in normal and NPC fibroblasts. P-glycoprotein levels varied significantly among the various fibroblasts tested, but no correlation with NPC phenotype or rate of progesterone metabolism was noted, and P-glycoprotein inhibitors did not affect conversion of progesterone to products. These results indicate that metabolism of progesterone in human fibroblasts is largely independent of its ability to interfere with cholesterol traffic and P-glycoprotein function.

ATP Binding Cassette Transporter, Subfamily B, Mem↗
PubMed2000

Minority recruitment in the prostate cancer prevention trial.

PURPOSE: African American men have a higher prostate cancer risk profile than that of other men in the United States. The purpose of this manuscript is to summarize the challenges associated with enrolling and randomizing African American and other minority participants in the Prostate Cancer Prevention Trial (PCPT). METHODS: The PCPT is a randomized trial of finasteride versus placebo for preventing prostate cancer in healthy men age 55 years and older; it is coordinated by the Southwest Oncology Group. The manuscript describes demographic and lifestyle characteristics of the PCPT randomized sample (18,882 men) by four racial and ethnic groups (Caucasian, African American, Hispanic, and other). African American men comprised 4% of the total randomized sample compared to our goal of 8%. Minority recruitment was emphasized through the Study Manual and training that occurred at trial activation. Supplemental minority recruitment activities were initiated a year after study activation and continued through the end of the accrual period. Minority recruitment was emphasized as follows: minority recruitment presentations at PCPT training seminars (held during twice yearly Southwest Oncology Group meetings); distribution of additional minority recruitment materials; engagement of four consultants for minority recruitment; production of a Minority Recruitment Manual; and a small pilot study involving minority outreach recruiters at five PCPT sites. RESULTS: The consultants were helpful in implementing the pilot project and in suggesting and reviewing materials for minority recruitment. The five-site pilot project did not increase either enrollment or randomization of minorities (with a possible exception at one site). CONCLUSIONS: We suggest that a long-term perspective is required for successful recruitment of minority participants in clinical trials. Likewise, extensive minority recruitment efforts must be ready to implement at trial activation.

Aged↗
PubMedDate not supplied

Hormonal prevention of prostate cancer.

Prostate cancer is disease in which the mortality rate is highly variable among populations. An increasing risk with migratory changes suggests that some environmental factor or factors influence prostate cancer risk. It is well established that the prostate is hormonally influenced. Carcinogenesis is a process of malignant transformation evolving over time, involving cellular growth and division. There is evidence suggesting that androgenic influences over a period time encourages the process of prostate carcinogenesis. Studies of prostate biology support the concept that dihydrotestosterone is the principal androgen responsible for both normal and hyperplastic growth of the prostate gland. It may be that androgen causes prostate carcinogenesis. Suppression of dihydrotestosterone synthesis may inhibit carcinogenic transformation. Some preclinical and clinical observations support this hypothesis. A placebo controlled randomized trial using finasteride, an inhibitor of 5-alpha-reductase, the enzyme that converts testosterone to dihydrotestosterone, is ongoing. The endpoint of this trial is reduction of prostate cancer incidence.

3-Oxo-5-alpha-Steroid 4-Dehydrogenase↗
PubMed2002

Androgenetic alopecia: pathogenesis and potential for therapy.

Androgenetic alopecia occurs in men and women, and is characterised by the loss of hair from the scalp in a defined pattern. Determining factors appear to be genetic predisposition coupled with the presence of sufficient circulating androgens. The prevalence of this condition is high (up to 50% of white males are affected by 50 years of age) and, although there are no serious direct health consequences, the loss of scalp hair can be distressing. Knowledge of the pathogenesis of androgenetic alopecia has increased markedly in recent years. Pre-programmed follicles on the scalp undergo a transformation from long growth (anagen) and short rest (telogen) cycles, to long rest and short growth cycles. This process is coupled with progressive miniaturisation of the follicle. These changes are androgen dependent, and require the inheritance of several genes. To date, only one of these genes, which encodes the androgen receptor (AR), has been identified. Of the many treatments available for androgenetic alopecia, only two (finasteride and minoxidil) have been scientifically shown to be useful in the treatment of hair loss. However, these therapies are variable in their effectiveness. Discovery of the involvement of the AR gene, and the identification of other genes contributing to the condition, might lead to the development of new and more effective therapies that target the condition at a more fundamental level.

5-alpha Reductase Inhibitors↗
PubMed2003

[Hair loss].

Hair loss includes excessive shedding of hair (effluvium) and the alopecias, in which there is a decrease in the amount of hair. Both may occur diffusely, or in a circumscribed manner. The localization and pattern of circumscribed hair loss may give a clue to its cause. On the basis of morphologic criteria the alopecias are further classified into non-scarring and scarring types. Non-scarring alopecias (diffuse alopecia, androgenetic alopecia, alopecia areata) are essentially hair cycling disorders, while scarring alopecias result from irreversible destruction of the hair follicles with recognizable loss of follicular osita. Scalp biopsy should be an early step in the evaluation of any case of alopecia, in which scarring is suspected. Too little scalp hair is not a vital problem, but represents a major health care challenge. Only recently the psychological impact of hair loss has been appreciated by the medical community, though throughout history, too little hair has been a concern to mankind, and the object of cosmetic interest and quackery. Recent advances of the medical sciences have led to a better understanding of the underlying pathogenic processes and opened the venue to effective pharmacotherapy (minoxidil, finasteride) and technologies (autologous hair transplantation) for the treatment of the most common disorders. Together with the availability of such treatments, high technical standards for evaluating their efficacy have been developed and have become mandatory for appraisal of any hair growth promoting agent, both in clinical studies and in the individual patient.

Adult↗
PubMed2002

Testosterone stimulates proliferation and inhibits interleukin-6 production of normal and hereditary gingival fibromatosis fibroblasts.

Hereditary gingival fibromatosis (HGF) is a rare oral condition characterized by a slow and progressive enlargement of the gingiva, involving both the maxilla and mandible. In vitro, HGF fibroblasts demonstrate a proliferative index significantly higher than fibroblasts from normal gingiva (NG). The objective of this study was to determine the effect of dihydrotestosterone on the proliferation of gingival fibroblasts derived from patients with HGF (n = 4) and from four healthy individuals. Additionally, we analyzed the effect of dihydrotestosterone on interleukin-6 (IL-6) production and determined the expression levels of androgen receptors in NG and HGF fibroblasts. Gingival fibroblasts from NG and HGF were incubated with increasing concentrations of dihydrotestosterone with or without androgen blockers, and cultured for 24 h, and the proliferation index was determined by automated cell counter. IL-6 production, in this system, was quantified using a "capture" enzyme-linked immunosorbent assay (ELISA). Semi-quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) was performed to measure the mRNA expression of androgen receptors. The results indicated that dihydrotestosterone simultaneously downregulates the production of IL-6 and upregulates the cell proliferation. Finasteride and cyprosterone acetate, two anti-androgens, partially reversed these effects. Androgen receptor mRNA expression was identified in both NG and HGF fibroblasts; however, the levels in NG were higher than those observed in HGF. These results show that testosterone coordinates the proliferation and production of IL-6 of normal and HGF fibroblasts.

5-alpha Reductase Inhibitors↗
PubMed2005

Can prostate cancer be prevented?

The goal of primary chemoprevention is to decrease the incidence of a given cancer, simultaneously reducing both treatment-related adverse events and mortality. Prostate cancer is an attractive and appropriate target for primary prevention because of its incidence, prevalence, and disease-related mortality; its long latency and molecular pathogenesis; and epidemiologic data indicating that modifiable environmental factors may decrease risk. The Prostate Cancer Prevention Trial (PCPT) demonstrated that finasteride can prevent prostate cancer, albeit with an apparently increased risk of high-grade disease. A substantial amount of epidemiologic, molecular, and clinical evidence suggests that both selenium and vitamin E might also prevent prostate cancer, and this combination is being tested in the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Ultimately, the adoption of a preventive strategy hinges on its potential benefits weighed against the potential risks of the specific agents used.

Clinical Trials as Topic↗
PubMed2006

Estrous cycle-dependent changes in basal and ethanol-induced activity of cortical dopaminergic neurons in the rat.

The influence of the estrous cycle on dopamine levels in the rat medial prefrontal cortex under basal and ethanol-stimulated conditions was evaluated by microdialysis. The basal dopamine concentration in the dialysate varied markedly during the estrous cycle, being highest in estrus and lowest in proestrus. Furthermore, a challenge intraperitoneal administration of ethanol (0.5 g/kg) induced a significant increase in dopaminergic output (+50%) during estrus but had no effect in diestrus or proestrus. Ovariectomy or pretreatment with either finasteride (a 5alpha-reductase inhibitor) or clomiphene (an estrogen receptor antagonist) prevented this ethanol-induced increase in dopamine concentration. The effect of ethanol was restored in ovariectomized rats by pretreatment with estrogen but not by that with progesterone. Our results thus show that the basal levels of dopamine in the prefrontal cortex are dependent on the phase of the estrous cycle. Furthermore, this dependence appears to be attributable to the effects of ovarian steroid hormones and results in a differential sensitivity of the dopaminergic neurons to ethanol. The hormone-induced changes in the activity of these neurons might contribute to the differences in drug sensitivity and mood state apparent among phases of the estrous cycle and between the sexes.

Animals↗
PubMed1999

The psychosocial consequences of androgenetic alopecia: a review of the research literature.

Androgenetic alopecia is a common dermatological condition, with potentially adverse psychosocial sequelae. The present review critically examines scientific evidence concerning the effects of androgenetic hair loss on social processes and psychological functioning, as well as the psychosocial outcomes of medical treatments. Research confirms a negative but modest effect of visible hair loss on social perceptions. More importantly, androgenetic alopecia is typically experienced as a moderately stressful condition that diminishes body image satisfaction. Deleterious effects on self-esteem and certain facets of psychological adjustment are more apparent among women than men and among treatment-seeking patients. Various 'risk factors' vis-à-vis the psychological adversity of androgenetic alopecia are identified. Medical treatments, i.e. minoxidil and finasteride, appear to have some psychological efficacy. A conceptual model is delineated to explain the psychological effects of hair loss and its treatment. Directions for needed research are discussed. Strategies are presented for the clinical management of psychological issues among these patients.

Alopecia↗