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Background Benign prostatic hyperplasia (BPH) is a disease characterized by abnormal proliferation of the prostate, which occurs frequently in middle-aged men. In this study, we report the effect of red ginseng oil (KGC11o) on BPH. Methods The BPH-induced Sprague-Dawley rats were divided into seven groups: control, BPH, KGC11o 25, 50, 100, 200, and finasteride groups. KGC11o and finasteride were administered for 8 weeks. The BPH biomarkers, DHT, 5AR1, and 5AR2, androgen receptor, prostate-specific antigen (PSA), Bax, Bcl-2, and TGF-β were determined in the serum and prostate tissue. The cell viability after KGC11o treatment was determined using BPH-1 cells, and, androgen receptor, Bax, Bcl-2, and TGF-β were confirmed by western blotting. Results In the in vivo study, administration of KGC11o reduced prostate weight by 18%, suppressed DHT (up to 22%) and 5AR2 (up to 12%) levels from administration of 100 mg/kg KGC11o (P Conclusion These results suggest that KGC11o may inhibit the development of BPH by significantly reducing the levels of BPH biomarkers via 5ARI, anti-androgenic effect, and anti-proliferation effect, serving as a potential functional food for treating BPH.

Summary Objective Our objective was to evaluate the absorption of finasteride administered by oral and topical routes for treatment of androgenetic alopecia, by means of computer simulations using the GastroPlus ® software. Material and methods In vivo plasma concentration profile of oral administration of finasteride 1 mg tablets from the literature was used in the software to build a compartmental pharmacokinetic model that was extrapolated to simulate topical administration of finasteride 0.25% solution in the scalp. Results were compared to literature and other drug concentrations (0.1% and 1%) were also predicted. Results Compared to literature data, predictive plasma curve from oral administration of finasteride 1 mg showed good correlation, R2=0.992, and Cmax=4.6769 ng/mL. Simulations of topical administration in the scalp for finasteride 0.25% solution showed good correlation, R2=0.908, and Cmax=0.04325 ng/mL when compared to literature data. Topical administration was also simulated at concentrations 0.1% and 1%, both with low plasma concentrations. Conclusion The results obtained in this study suggest that topical finasteride is a potential treatment for androgenetic alopecia in the concentrations analyzed using computer simulations in GastroPlus ®.

BACKGROUND: A set of enduring conditions have been reported in the literature involving persistent sexual dysfunction after discontinuation of serotonin reuptake inhibiting antidepressants, 5 alpha-reductase inhibitors and isotretinoin.OBJECTIVE: To develop diagnostic criteria for post-SSRI sexual dysfunction (PSSD), persistent genital arousal disorder (PGAD) following serotonin reuptake inhibitors, post-finasteride syndrome (PFS) and post-retinoid sexual dysfunction (PRSD).METHODS: The original draft was designed using data from two published case series (Hogan et al., 2014 and Healy et al., 2018), which represent the largest public collections of data on these enduring conditions. It was further developed with the involvement of a multidisciplinary panel of experts.RESULTS: A set of criteria were agreed upon for each of the above conditions. Features of PSSD, PFS and PRSD commonly include decreased genital and orgasmic sensation, decreased sexual desire and erectile dysfunction. Ancillary non-sexual symptoms vary depending on the specific condition but can include emotional blunting and cognitive impairment. PGAD presents with an almost mirror image of unwanted sensations of genital arousal or irritability in the absence of sexual desire. A new term, post-SSRI asexuality, is introduced to describe a dampening of sexual interest and pleasure resulting from a pre-natal or pre-teen exposure to a serotonin reuptake inhibitor.CONCLUSIONS: These criteria will help in both clinical and research settings. As with all criteria, they will likely need modification in the light of developments.

Background Sexual dysfunction is a common side effect of medical therapy for benign prostatic hyperplasia (BPH), whereas prostatic urethral lift (PUL) offers safe and effective relief of lower urinary tract symptoms while preserving sexual function. Objective To compare the long-term impact on sexual health of PUL or daily medical therapy of doxazosin or finasteride alone or in combination in BPH patients. Design, setting, and participants This was a comparative analysis of sexual function outcomes from PUL studies (L.I.F.T. [n = 107], Crossover [n = 42], and MedLift [n = 39]) and the Medical Therapy of Prostatic Symptoms (MTOPS) trial. The men included were sexually active with International Prostate Symptom Score ≥13, Qmax ≤12 ml/s, and prostate volume 30–80 cm3. MTOPS subjects completed the Brief Male Sexual Function Inventory, while PUL subjects completed the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function. Outcome measurements and statistical analysis Mean percentage changes from baseline in erectile, ejaculatory, and sexual satisfaction domains were compared at 12, 24, 36, and 48 mo. Results and limitations PUL significantly improved erectile function through 24 mo, and ejaculatory function and sexual satisfaction across all time points. Medical therapy did not improve sexual function at any time point. Finasteride significantly decreased erectile function at 48 mo, and combined therapy significantly reduced ejaculatory function at 12 and 24 mo. Comparatively, PUL was superior to finasteride in preserving erectile function at 24 and 48 mo, and superior to doxazosin and combined therapy at 12 mo. PUL outperformed all three medical therapies at all time points in improving ejaculatory function and sexual satisfaction. Limitations include the use of distinct patient-reported questionnaires and narrowed data on comorbidities that influence male sexual function. Conclusions Indirect comparison reveals that PUL is superior to BPH medical therapy in preserving erectile and ejaculatory function and sexual satisfaction. Patient summary In our non–head-to-head study, only patients undergoing PUL for an enlarged prostate experienced improvements in sexual health. Conversely, patients on medical therapy experienced worsening of erectile and ejaculatory function.

Objectives Androgenetic alopecia (AGA) is a well-known cause of hair loss in adults but is an under-recognized cause of hair loss in children and adolescents. We reviewed the existing literature regarding androgenetic alopecia in the pediatric/adolescent population. Methods PubMed searches were performed to identify all articles discussing AGA in a pediatric/adolescent population published up to December 2018. Results We identified 7 articles discussing androgenetic alopecia in patients aged younger than 18. One of these articles was a review containing data from 3 conference abstracts, which were also included in the analysis. A total of 655 cases of androgenetic alopecia were found. Limitations Data are limited to retrospective reviews and case reports/series. Conclusion AGA in the pediatric population is not uncommon, but its incidence and prevalence are unknown. It is associated with a strong family history of AGA and can typically be diagnosed clinically by physical examination and trichoscopy. Topical minoxidil, although not approved, has been used with success. Other treatment modalities are poorly studied in children.

Finasteride is an antiandrogenic drug used for the clinical treatment of chronic nonbacterial prostatitis (CNP). Recently, we reported the anti-CNP activity of Poria cocos polysaccharides (PPs) in a rat model. In this study, we compared the differences between PPs and finasteride in treating CNP, especially their effects on the gut microbiota. Results showed that both PPs and finasteride significantly reduced the prostate weight and prostate index of CNP rats, and improved the histological damages in the inflamed prostate. Moreover, PPs and finasteride inhibited the production of pro-inflammatory cytokines (TNF-α, IL-2 and IL-8) and androgens (dihydrotestosterone and testosterone). By 16S rDNA sequencing, PPs and finasteride were found to reprogram the gut microbiota into distinct profiles. Further analysis presented that PPs but not finasteride recovered CNP-induced changes in the gut microbiota, including Ruminococcaceae NK4A214 group, uncultured bacterium f Ruminococcaceae, Ruminiclostridium 9, Phascolarctobacterium, Coriobacteriaceae UCG-002 and Oribacterium. LDA effect size (LEfSe) analysis revealed that PPs recovered the gut microbiota by targeting Ruminococcaceae NK4A214 group. Our results suggested that PPs alleviated CNP via different mechanisms from finasteride, especially by regulating the gut microbiota, which offers therapeutic target for the treatment of CNP.

Janet DuBois,1 Suzanne Bruce,2 Daniel Stewart,3 Steven Kempers,4 Christy Harutunian,5 Terry Boodhoo,5 Amy Weitzenfeld,6 Joan-En Chang-Lin5 1DermResearch, Inc., Austin, TX, USA; 2Suzanne Bruce and Associates, PA, Houston, TX, USA; 3Midwest Center for Dermatology & Cosmetic Surgery, Clinton Township, MI, USA; 4Associated Skin Care Specialists, Fridley, MN, USA; 5Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA; 6Allergan Aesthetics, an AbbVie Company, Madison, NJ, USACorrespondence: Joan-En Chang-LinClinical Development, Allergan Aesthetics, an AbbVie Company, 2525 Dupont Dr, Irvine, CA, 92612, USATel +1 714-246-4680Email joanen.lin@abbvie.comPurpose: To evaluate oral setipiprant versus placebo for scalp hair growth in men with androgenetic alopecia (AGA).Patients and Methods: Males aged 18 to 49 years with AGA were enrolled in a double-blind, multicenter, 32-week, phase 2a trial; randomized to twice-daily (BID) 1000-mg (2× 500 mg for a total daily dose of 2000 mg) setipiprant tablets or placebo for 24 weeks; and assessed at weeks 4, 8, 16, and 24, with a week 32 follow-up. The study initially included a finasteride 1-mg once-daily group, removed by protocol amendment. Changes from baseline to week 24 in target area hair count (TAHC) and blinded Subject Self-Assessment (SSA) of target area photographs were coprimary efficacy endpoints. Hair growth was also evaluated using blinded Investigator Global Assessment (IGA). Safety assessments included adverse events (AEs) and clinical laboratory tests. Analysis of covariance models were used to test statistical significance for TAHC, SSA, and IGA. Data were summarized without statistical analysis for finasteride.Results: Randomized subjects (N=169) included 74 placebo, 83 setipiprant, and 12 finasteride subjects; 117 (69.2%) and 113 (66.9%) subjects completed week 24 and 32 visits, respectively. Treatment groups had similar baseline characteristics. Neither coprimary efficacy endpoint was met. At week 24, TAHC and SSA findings indicated no hair growth improvements with setipiprant versus placebo. Setipiprant also did not improve hair growth versus placebo per the IGA. Treatment-related AEs, all mild or moderate in severity, occurred in 12.3%, 25.9%, and 25.0% of the placebo, setipiprant, and finasteride groups, respectively. Two treatment-emergent serious AEs (TESAEs), cellulitis and multiple sclerosis, were reported in the placebo group, both unrelated to treatment. No TESAEs were reported with setipiprant or finasteride.Conclusion: Setipiprant 1000 mg BID was safe and well tolerated but did not demonstrate efficacy versus placebo for scalp hair growth in men with AGA.Keywords: scalp, hair loss, hair growth and development, prostaglandin receptors

The term \"alopecia\" is used for abnormal hair loss and it is a chronic dermatological condition observed in both genders and all races. Androgenetic alopecia (AGA) or male pattern baldness is the most common type of alopecia; however, it may be observed in females. Alopecia areata (AA) is the second most common non-scarring alopecia or hair loss around the world. Beyond the fact that alopecia is a disease itself, sometimes it might be one of the major side effects of many drugs including chemotherapeutics. Since healthy hair has been a symbol of well-being, youth, and vitality for centuries, the treatment of alopecia has essential importance to increasing life quality of the individuals that have faced hair loss. Regarding the progressively generated high-throughput data at various omics levels, systems biology has gained importance to better understand biologic processes by utilizing high-throughput data from multiple sources to develop models of biologic processes In this review, we overviewed AGA and AA via systems biology with the aid of omics technologies point of view to highlight not only the molecular mechanisms of the hair loss phenomenon but also potential preventive and therapeutic avenues. We discussed the findings in light of the multi-omics data integration that converges the future of uncovering personalized therapeutic options targeting hair loss.

Background Given its widely accepted efficacy, androgen blockade therapy for hidradenitis suppurativa (HS) has become a standard of care. Although much less frequently used than spironolactone, a small number of HS studies have reported finasteride as an alternative in women. In this study, we describe the response to and perception of finasteride therapy in a diverse cohort of women with HS. Objective We aimed to describe finasteride therapy in a diverse cohort of female patients with HS. Methods We conducted an IRB-approved retrospective chart review and telephone survey of 20 female patients, 18-years or older, with a diagnosis of HS. Finasteride was prescribed by a single provider at a specialized hidradenitis suppurativa center. Results The mean age of patients was 34.3 ± 13.5 years. Finasteride was initiated predominantly because of one or more contraindications to spironolactone or poor responsiveness. Most patients interviewed (90%; n=18) were willing to take finasteride again or continue with therapy if indicated. Ten patients (50%) reported overall satisfaction with finasteride; seven (35%) were neutral, and three (15%) were unsatisfied. No patients reported worsening disease activity while on finasteride, and only one (5%) reported decreased quality of life. When asked about side effects of finasteride, 80% (n=16) reported none; 20% (n=4) experienced one or more of the following: headache, nausea, menstrual irregularities, breast tenderness or reduced libido/sexual function. Conclusions Our study suggests that androgen blockade therapy with finasteride is a safe and effective alternative for female patients with HS who have a contraindication(s) or intolerance to spironolactone.

In the present study, we investigated the inhibitory effect of heat-killed Enterococcus faecalis (E. faecalis) and live E. faecalis on benign prostatic hyperplasia (BPH). The BPH rat model was established by administering male rats with testosterone propionate (TP, 5 mg/kg, in corn oil) via subcutaneous injections daily for four weeks after castration. The rats were divided into five groups: Con, corn oil-injected (s.c.) + DW administration; BPH, TP (5 mg/kg, s.c.) + DW administration; BPH+K_EF, TP (5 mg/kg, s.c.) + heat-killed E. faecalis (7.5 × 1012 CFU/g, 2.21 mg/kg) administration; BPH+L_EF, TP (5 mg/kg, s.c.) + live E. faecalis (1 × 1011 CFU/g, 166 mg/kg) administration; BPH+Fi, TP (5 mg/kg, s.c.) + finasteride (1 mg/kg) administration. In both of BPH+K_EF and BPH+L_EF groups, the prostate weight decreased and histological changes due to TP treatment recovered to the level of the Con group. Both of these groups also showed regulation of androgen-signaling factors, growth factors, and apoptosis-related factors in prostate tissue. E. faecalis exhibited an inhibitory effect on benign prostatic hyperplasia, and even heat-killed E. faecalis showed similar efficacy on the live cells in the BPH rat model. As the first investigation into the effect of heat-killed and live E. faecalis on BPH, our study suggests that heat-killed E. faecalis might be a food additive candidate for use in various foods, regardless of heat processing.

Benign prostatic hyperplasia (BPH) is the most common benign proliferative disease among men during aging. The herbal extract of P. africanus has been used for the treatment of BPH since time immemorial. However microstructural changes of this extract to the prostate of animal or human models are still elusive. Therefore, histological and histomorphometric changes in rats with testosterone-induced BPH due to P. africanus herbal extracts were investigated. Twenty-eight male Wistar rats (200 ± 50 g) were divided into four groups each with 7 rats. Group 1 (Negative control) was given 2 ml/day of olive oil subcutaneously and 2 ml/day of normal saline intragastrically for 28 days. Three groups were induced with BPH by subcutaneous injection of testosterone propionate 3 mg/kg body weight/day for 28 days. Thereafter Group 2 (BPH) was sacrificed, while Group 3 (Positive control) and Group 4 (Treatment group) were administered with finasteride 5 mg/kg/day and P. africanus extract 400 mg/kg/day intragastrically for 28 days, respectively. BPH group revealed thickening and hyperplasia of tubular epithelium with involutions with the stroma showing large spaces and dilated blood vessels. These features were restored with P. africanus extract administration. High epithelial height, large stromal area and lower luminal area observed in the BPH were greatly reversed with P. africanus extract comparable to negative controls. Generally, P. africanus extract restored and ameliorated histological and histomorphometrical changes of the BPH-induced rat’s prostates. Keywords: Benign prostate hyperplasia; Prunus africanus; finasteride; testosterone

Objective: The present paper describes the development and evaluation of a Novel Finasteride (FSD) nanogel topical delivery for the treatment of Androgenetic Alopecia. Nano-based topical formulation was chosen to enhance the solubility, permeability, biocompatibility of drug and to overcome the problems associated with the oral delivery of finasteride. Methods: Various trails batches were prepared by using probe sonication method. Based on stability studies and particle size, NP4 trail was optimized which exhibited a spherical shape with a mean diameter of 113.80±0.72, the polydispersity of 0.28±0.01, zeta potential of-25.2 mV, drug entrapment efficiency of 92.67±0.47 %, and drug loading of 6.15±0.02 %. Storage stability studies demonstrated that the particle size and entrapment efficiency were not changed during 3 mo both at 4 °C and room temperature. Finasteride (FSD) NLCs were characterized for particle size by scanning electron microscope (SEM), chemical state by X-Ray diffraction (XRD), physical stability by centrifugation and thermodynamic stability by Freeze-thaw method. These prepared nanoparticles were transformed into topical nanogel and further evaluated. Results: Among the different trails, C2 trail of NLC gel has shown excellent gelling capacity, clear appearance, good viscosity characteristics and was selected for further evaluation studies. Batches of topical nanogel were characterized through pH, homogeneity, spreadability, viscosity, drug content and in vitro drug release study. Based on pH (6.5-6.8), drug content (91.25±0.9%), spreadability (6.7 cm/sec), C2 batch was subjected to In vitro skin occlusivity study, in-vitro release study and In vitro heamolysis study. Conclusion: The percent cumulative drug release for Finasteride (FSD) gel was found to be 758.52±1.49 µg at 24 h which is quite higher than plain gel and Finasteride (FSD) gel showed maximum occlusiveness and excellent spreadability and found to be stable. In conclusion, prepared Finasteride (FSD) Nanogel could be used with promising potential for the treatment of Androgenetic Alopecia.

This is a critical review of the current literature data about sexual dysfunction as a potential side effect related to drugs commonly used for the treatment of Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms. In this narrative review, we analyzed data from the literature related to the development of sexual dysfunctions during the treatment of BPH or LUTS. Both α-blockers and 5-alpha reductase inhibitors (5-ARIs) can induce erectile dysfunction, ejaculatory disorders and a reduction in sexual desire. The sexual side effect profile of these drugs is different. Among the α-blockers, silodosin appears to have the highest incidence of ejaculatory disorders. Persistent sexual side effects after the discontinuation of finasteride have been recently reported; however, further studies are needed to clarify the true incidence and the significance of this finding. However, most of the published studies are affected by a weak methodology and other important limitations, with only a few RCTs available. Therefore, it is desirable that future studies will include validated tools to assess and diagnose the sexual dysfunction induced by these medications, especially for ejaculation and sexual desire disorders.

Significant androgenetic hair loss occurs in men older than 50 years, and in women it occurs in many who are perimenopausal, menopausal, and postmenopausal. By age 60 years, it is estimated that 80% of women experience hair loss. Other nonandrogenetic forms of hair loss occur due to various dermatologic disorders as well as systemic disorders. Children may also experience significant hair loss, often due to genetic abnormalities and incidences of trauma. In this article the author discusses a combination approach to hair loss for men, women, and children.

Background Perioperative bleeding is the most common complication related to transurethral resection of prostate; the aim of the study was to compare the effect of pre-operative use of finasteride versus cyproterone acetate (CPA) on blood loss with monopolar TURP. Methods This prospective randomized controlled study was conducted on (60) patients with BPH underwent monopolar TURP between July 2019 and July 2020. Patients were distributed into three equal groups; CPA group: 20 patients received cyproterone acetate 50 mg tab BID for two weeks before TURP, finasteride group: 20 patients received single daily dose of finasteride 5 mg for two weeks before TURP, control group: 20 patients received no treatment before TURP, all patients underwent monopolar TURP, and then histopathological examination of the resected tissues was done with assessment of the microvascular density of the prostate. Results Our study showed that there was significant decrease in intraoperative blood loss and operative time in CPA and finasteride groups in comparison with control group (p = 0.0012) (p p p p Conclusion Cyproterone acetate is more effective than finasteride in decreasing perioperative bleeding with TURP by decreasing microvascular density of the prostate.

Finasteride use has been associated with a reduced incidence of bladder cancer. However, the majority of studies have been conducted primarily in East Asian or White populations. Given differences in the incidence of bladder cancer among racial/ethnic groups, it is important to determine whether the effect of finasteride use on bladder cancer varies by race/ethnicity.We identified all patients with a diagnosis of benign prostatic hyperplasia between 2000 and 2016 at our academic health center in Bronx, New York via an electronic medical record database. We then identified patients who were prescribed finasteride, and those who developed bladder cancer during followup. We used competing risk analysis to examine associations of finasteride use with risk of bladder cancer, adjusting for age, smoking and race/ethnicity.We identified 42,406 patients with benign prostatic hyperplasia (average±SD age 67±12.9 years), of whom 27.7% were Black and 14.8% were Hispanic. Finasteride was prescribed in 5,698 patients (13.4%). Bladder cancer was diagnosed in 84 of 5,698 finasteride users (1.5%), compared to 762 of 36,708 nonusers (2.1%, log-rank p=0.003). Finasteride was associated with a 36% reduction in risk of bladder cancer (HR: 0.64, 95% CI: 0.51-0.80; p0.0001) among all patients. When data were stratified by race/ethnicity, finasteride use was associated with a reduction in risk of bladder cancer in White men (HR: 0.61, 95% CI: 0.43-0.86; p=0.005) and Hispanic men (HR: 0.44, 95% CI: 0.21-0.90; p=0.026), but there was no association among Black men (HR: 1.01, 95% CI: 0.67-1.51; p=0.964).Our study corroborates previous findings that men who are on finasteride have a lower bladder cancer incidence. However, the reduction in risk was seen only in White and Hispanic men, but not among Black men. Therefore, race/ethnicity represents an important stratification factor for future larger studies on finasteride as chemoprevention for bladder cancer.

Background Dutasteride has been proposed as an effective therapy for frontal fibrosing alopecia (FFA). Objectives We sought to describe the therapeutic response to dutasteride and the most effective dosage in FFA compared with other therapeutic options or no treatment. Methods This was a retrospective observational study including patients with FFA with a minimum follow-up of 12 months. Therapeutic response was evaluated according to the stabilization of the hairline recession. Results A total of 224 patients (222 females) with a median follow-up of 24 months (range 12-108 months) were included. The stabilization rate for the frontal, right, and left temporal regions after 12 months was 62%, 64%, and 62% in the dutasteride group (n = 148), 60%, 35%, and 35% with other systemic therapies (n = 20), and 30%, 41%, and 38% without systemic treatment (n = 56; P = .000, .006, and .006, respectively). Stabilization showed a statistically significant association with an increasing dose of dutasteride (88%, 91%, and 84% with a weekly treatment of 5 or 7 doses of 0.5 mg [n = 32], P Limitations Limitations included the observational and retrospective design. Conclusions Oral dutasteride was the most effective therapy with a dose-dependent response for FFA in real clinical practice compared with other systemic therapies or no systemic treatment.

In this study we have analyzed the use of finasteride which is a type P-selective 5a-reductase inhibitor. By decreasing dihydroxytestestrone (DHT) level, it is found to be effective in the treatment of male androgenic alopecia. In this study, we compared the effect of topical vs. systemic finasteride in the treatment of androgenic alopecia. Our study is a randomized clinical trial study having 30 male patients. They have come for alopecia treatment at Nesam hospital, Coimbatore, India. We have selected male patients with androgenic alopecia and divided them into two groups (A, B), randomly having 15 patients in each group. For group A, Topical finasteride (0.1%) with minoxidil (5%) solution was given. Group B patients received topical minoxidil with oral finasteride (1mg) tablets. All patients were regularly followed up till the end of 6 months. A Patient had a first review in the first week followed by monthly follow up. Following parameters were taken into account: size of bald area, total hair count, and terminal hair. Data was analyzed by Chi-square statistical test. Each month the terminal hair, size of bald area and hair count between the two groups were compared. In the initial few months group, A showed good improvement. But Serial measurements indicated that a significant increase in hair counts and terminal hair counts is seen in both groups. This study showed that on long term follow-up of more than 3 months, both topical and systemic finasteride groups had similar results.

Background Androgen deprivation therapy (ADT) improves outcomes in unfavorable-risk prostate cancer (PCa) treated with radiation therapy (RT). It was hypothesized that replacing luteinizing hormone-releasing hormone (LHRH) agonists with a 5-α-reductase inhibitor (5-ARI) would improve hormonal health-related quality of life (HRQOL) without differentially suppressing androgen-responsive (AR) gene expression. Methods Patients with localized unfavorable-risk PCa, aged ≥70 years or Charlson Comorbidity Index score ≥2 were treated with oral ADT (oADT), consisting of 4 months of bicalutamide, a 5-ARI, and RT at 78 Gy. The primary end point was Expanded Prostate Cancer Index Composite HRQOL at 6 months ≤30%, and improvement compared with a synchronous standard of care (SOC) cohort receiving 4 months of bicalutamide and long-term LHRH agonist with RT. RNA sequencing was performed from matched pre-/post-ADT prostate tumor biopsies in a subset of men. Differential gene and pathway expressional changes were examined using gene set enrichment. Results Between 2011 and 2018, 40 and 30 men were enrolled in the oADT and SOC cohorts, respectively. Median follow-up was 40 months. Those with ≤30% decline in hormonal HRQOL at 6 months was 97% (oADT) and 93% (SOC). The average 6-month hormonal decline was 1% (oADT) versus 12% (SOC; P = .04). The 4-year freedom from biochemical failure was 88% (oADT) versus 81% (SOC; P = .48). RNA sequencing (n = 9) showed similar numbers of downregulated and upregulated genes between the treatment groups (fold-change = 2; false-discovery rate-adjusted P ≤ .05). Both treatments comparably decreased the expression of 20 genes in canonical androgen receptor signaling. Conclusions For men with PCa undergoing RT, oral versus standard ADT may improve 6-month QOL and appears to have a similar impact on androgen-responsive gene expression.

Androgenic alopecia (AGA) is the most common form of non-scarring alopecia, affecting millions of men and women in the United States (U.S.). This review highlights alternative and complementary treatment options for AGA. The treatment regimens for AGA have increased in pharmacotherapeutics, surgical, and complementary (CAM) categories. Each of the different treatment approaches can now be utilized by dermatologists to combat patient hair loss. The U.S. Food and Drug Administration (FDA) has approved only two agents to treat AGA: prescription-only, oral finasteride and over-the-counter (OTC), topical minoxidil. Increased availability of therapies claiming hair regrowth properties, coupled with limited pharmacotherapeutic options for AGA, lead patients to seek alternative treatments. Increased awareness of the current evidence supporting complementary and alternative therapies among dermatologists will facilitate appropriate and timely education of AGA patients.

Background Low dose ( Aim To evaluate the role of oral minoxidil 1.25mg versus oral minoxidil 2.5mg along with platelet rich plasma in AGA METHODS: Group A consisted of fourty seven patients which included patients on OM 1.25mg daily and Platelet rich plasma therapy and Group B consisted of patients on OM 2.5 mg daily and Platelet rich plasma therapy. Photographs were taken before and after treatment along with trichoscopic evaluation. Selection of the dermoscopic variables was based on the published literature. Results At 24 weeks, marked improvement on GCP were seen in 19 (19/47;40.4%) in Group A and 28 (28/48;58.3%) patients in Group B with P value of 0.058. The total increase in total hair/cm2 was around 24 and 36 in group A and B respectively with P>0.05. The percentage increase in mean total hair count/cm2 after 6 month of treatment was 15.41% in group A and 22.15% in group B, but they were not statistically significant. The patient satisfaction score on a likert scale between both group were statistically significant. Conclusion This is a pilot study where OM along with PRP at different dosage has been compared, this can be used in patients who are a bit apprehensive on taking finasteride or dutasteride and are less responsive to topical minoxidil.

Background: Prostatic diseases which include prostatitis, benign prostatic hyperplasia (BPH) and prostate cancer are the benign or malignant disorders that affect the prostate. Phytotherapies have been adopted as the alternative treatment/ management option especially for BPH since the current modern methods of treatment presents a lot of adverse effects. Methodology: The literature was searched using different databases including Medline/PubMed, Cochrane library, Scopus, Proquest library, Embase, EBooks and Google Scholar for relevant records for a period from 1988 to 2018 to identify all the published articles of S. serrulata regarding treatment of prostatic diseases. The key search terms were Serenoa serrulata, S. repens, Saw palmetto, Prostate cancer treatment with Serenoa serrulata, treatment of Benign Prostatic Hyperplasia with Serenoa serrulata, phytochemicals of Serenoa serrulata, ethnobotanical uses of Serenoa serrulata, toxicity of Serenoa serrulata, pharmacological activities of Serenoa serrulata and also traditional management and treatment of prostatic diseases using Serenoa serrulata and also clinical trials on treatment of prostatic diseases with Serenoa serrulata. The retrieved articles were reviewed, synthesized and analyzed qualitatively. The reference list of the retrieved articles was also reviewed and synthesized. The original research articles which reported an investigation of S. serrulata of any study design, original published research articles, any time of publication and grey literature (conference papers, reported articles, academic thesis) were included. The articles whose full texts were not freely available by the time of search and those without clear information about methodology and study design were excluded. Results: This review reported that Serenoa serrulata belonging to the Arecaceae family commonly known as saw palmetto is used traditionally for treating prostatic disease conditions and other infertility conditions in both men and women. Phytochemical screening of hexanic and ethanolic extracts of S. serrulata comprised of free fatty acids and phytosterols which together contribute to their antiprostatic activities. These extracts of S. serrulata exhibited antiandrogenic, anti-inflammatory and anti-proliferative activities through inhibition of both isoenzymes 5α- reductase and inhibition of binding of dihydrotestosterone (DHT) to the cytosolic androgen receptors. This is a similar mechanism exhibited by finasteride and Tamsulosin both antiprostatic conventional drugs though the plant phytochemicals do not interfere with PSA secretion. S. serrulata has also been reported to be non-toxic in both non clinical and clinical trial studies. The medicinal plants reported by this review to be used in combination include; stinging nettle (Urtica dioca), Zingiber officinalis, Echinacea angustifolia and pumpkin (Cucurbita pepo). The antiprostatic conventional drugs reported include finasteride and Tamsulosin. Conclusion and Recommendation: The results showed that S. serrulata is effective in treating prostatic diseases. The potency and safety is improved when used in combination with Urtica dioca, Cucurbita pepo, Zingiber officinalis and Echinacea angustifolia as compared with anti-prostatic conventional drugs Finasteride and Tamsulosin alone. The plant combination has also been shown to have improvement in the quality of life and as well enhancing the synergy of Finasteride and Tamsulon and their adverse effects. Effective medicinal plant combinations should be formulated into products and integrated into the usual treatment for prostatic diseases.

BackgroundBenign prostatic hyperplasia (BPH) is a common disease which causes various health problems for elderly men such as urinary retention, recurring urinary tract infection and bladder stones. The aim of this study is to evaluate the therapeutic effects ofJuniperus communisL.seed extract (JCS) on BPH in male Wistar rats.MethodsTo this end, 30 rats were divided into 5 groups (N = 6): group 1 (vehicle), group 2 (disease control), group 3 (standard medicine; 10 mg/kg finasteride), and groups 4 and 5 were treated with 300 mg/kg and 600 mg/kg of the hydroalcoholic JCS seed extract, respectively. Groups 2, 3, 4 and 5 received testosterone enanthate to induce prostatic hyperplasia. At the end of experimental period (28 days), prostate glands were cut off under anesthesia. Histopathological examination was done and biochemical parameters such as Malondialdehyde, Glutathione and protein carbonyl were also measured. Their body weights were also observed during the study. At the end of the experiment, prostate weights and prostate specific antigen (PSA) levels were measured. Prostate index, inhibition prostate weight and inhibition prostate index were also calculated.ResultsBoth histopathological examination and biochemical parameter results showed significant improvements in rats treated with finasteride and 600 mg/kg JCS extract (p ConclusionsOral administration of JCS extract is effective on preventing testosterone-induced benign prostatic hyperplasia.

Objectives: Maintaining the quality of the pharmaceutical drug product during its shelf life is highly desirable. The crystalline form of the drug having the great thermodynamic stability is essential for the manufacturers in pharmaceutical industry in view of their profit and also for the safety of the customer. Many pharmaceutical drugs have the tendency to exhibit polymorphism which is unwanted for pharmaceutical companies, where they have experienced market shortages due to these unpredicted polymorphic and/or pseudomorphic changes. The property of a drug exhibiting more than one crystal form is considerably regarded as polymorphism and each of the crystalline form has its own physicochemical properties, namely, solubility, heat capacity, melting point, and sublimation point. To relieve this ultimate effect on the drug quality and stability, a prior detection of polymorphism in the final dosage form is highly recommended. Hence, many analytical techniques have been proposed for the detection of polymorphism in pharmaceutical drug products. Methods: Fourier transform (FT)-Raman spectrometer is used for the investigation of drug polymorphism and the instrument is advanced with charge coupled device detectors, ease of sample preparation and handling, mitigation of sub-sampling problems using different geometric laser irradiance patterns and having different optical components of Raman spectrometers. Results: In this work, we carefully studied the Raman spectral patterns for Lamivudine as well as Finasteride drug substances for the detection of polymorphism. Further, we have highlighted the advantages of FT-Raman spectroscopy over other polymorphism detection techniques. For example, Raman spectra showed invariably sharp, well resolved bands compare to IR spectra due to the minor contribution of overtone vibrations in Raman spectra, resulting in much less broadening and a better resolution of bands. Besides, Raman spectroscopy does not suffer from the sampling problems that are common in X-ray powder diffraction, where preferred orientation and specimen displacements are serious restrictions for the application of quantitative method. Conclusion: Here, in this paper, we are presented and compared the experimental results regarding the detection of polymorphism in Lamivudine and Finasteride drugs using FT-Raman spectroscopy, to illustrate the advantages of the technique in the detection of polymorphism over other techniques.

Background Finding new agents for prevention and/or treatment of benign prostatic hyperplasia (BPH) especially from natural sources is a demanding field. Objectives This study aimed to evaluate the effect of black mulberry (BM) (Morus nigra) fruit hydroalcoholic extract on the establishment of BPH in rats. Materials and methods Forty-nine adult male rats were randomly assigned into 7 equal groups: I: Sham control (SC), a sham surgery was performed. II: positive control (PC), rats were castrated and received testosterone propionate, at 10 mg/kg/day S.C. for BPH induction. III: comparative control (CC), BPH was induced and the rats received finasteride at 5 mg/kg/day P.O. IV–VII: (T1–T4): BPH was induced and the rats received BM extract at 25, 50, 100 and 200 mg/kg/day P.O. for 4 consecutive weeks. Results Finasteride and/or BM extract especially at the two higher dosages, significantly affected prostate weight, prostatic index, percent of inhibition, serum and prostatic levels of dihydrotestosterone (DHT), serum prostate-specific antigen (PSA), antioxidant parameters of prostatic tissue as well as histopathological and histomorphometric parameters (epithelial thickness and acinar area) of prostate. Conclusions BM extract has protective effects against experimentally-induced BPH in rats with regard to histopathological and biochemical parameters which may be related to its antioxidant as well as DHT reducing properties in prostatic tissue.

Alopecia is a condition in which some or all of the hair from the scalp is lost. One recent preventative measure is the inhibition of the enzyme 5-α-reductase. Inhibition of the enzyme 5-α-reductase converts circulating testosterone to its more potent metabolite, dihydrotestosterone. Ethnobotically, Merremia peltata is used as a baldness medicine by utilising compounds contained within the leaves. This research aimed to test activity of 18 known compounds contained within M. peltata) as anti-alopecia. Activity was based on their interaction with the androgen receptor (PDB code 4K7a) using molecular docking and ADME-Tox prediction. The stages of research performed were: preparation of androgen protein structure databases; preparation and optimization of three-dimensional structures of compounds using ChemDraw 8.0; molecular docking to the androgen receptor protein using Autodock 1.5.6.; and ADME-Tox prediction using the pkCSM tool. The following test compounds had strong bond energies (ΔG): compound 16 (olean-12-en-3beta-ol, cinnamate)-7.71 kcal/mol, compound 17 (alpha-amyrine)-6.34 kcal/mol, and Finasteride-6.03 kcal/mol. Interestingly, the ΔG of compound 16 (olean-12-en-3beta-ol, cinnamate) is better than of minoxidil (-4.8 kcal/mol) and also to gold-standard treatment compound, finasteride. ADME-Tox prediction for compound 16 showed favorable results in several metrics such as skin permeability, absorption, and distribution. Compound 16 (olean-12-en-3beta-ol, cinnamate) is therefore a potential androgen receptor antagonist and may be beneficial in the treatment of alopecia.

Background: Prostate cancer (PC) is recognised as the leading cancer diagnosis in Canadian men and the third-highest cause of cancer mortality. Despite its prevalence increasing with age, in Canada, funding for PC research is much lower when compared to other forms of cancer. Androgenic alopecia (AA) is a medical condition known to affect more than a third of all men and women. Studies show that AA is a medical condition with significant physical and psychological harms to the patient but one that can be treated effectively by a general practitioner. Objective: The objective is to determine the possibility of using finasteride to concurrently treat AA and prevent PC for men with more than one PC risk factor, one of which being AA. Methods: Numerous databases were searched, including OVID, Cochrane, Medline and PubMed. Additional internet searches were done using keywords such as dihydrotestosterone (DHT), AA, male pattern baldness, prostate-specific antigen, PC and finasteride, including a Medical Subject Headings search combining these words. Results and Conclusion: As a risk indicator for a PC diagnosis, early recognition of AA is important. Considering AA in conjunction with other risk factors for PC provides a more accurate risk assessment for patients. Finasteride has been shown to be effective in treating AA. By reducing DHT, a determining factor of both AA and PC development, finasteride has been demonstrated to reduce the risk of PC development by 25%. Finasteride therapy is an effective, low-risk, AA treatment option with the benefit of protecting potentially more susceptible men from PC. Given its excellent safety profile, as demonstrated in long-term studies of benign prostatic hyperplasia treatment, finasteride should be offered routinely to men with AA.

Background and objectives: Most benign prostatic hyperplasia patients do not present obvious indicators for surgical intervention, so most of these patients are treated initially with medical therapy. This study aimed to compare the incidence of acute urinary retention after treatment with monotherapy with the incidence after combination therapy and determine the need for surgery in both methods. Methods: This is a retrospective study of the medical records of 248 benign prostatic hyperplasia patients who had attended Rizgary Teaching Hospital from May 2012 to June 2017. These patients were divided into two groups of 138 and 110 patients who have been treated by 0.4 mg tamsulosin capsule once daily and 0.4 mg tamsulosin capsule plus 5mg finasteride tablet once daily, respectively. Benign prostatic hyperplasia outcomes (acute urinary retention, benign prostatic hyperplasia related surgery) were compared between these two groups according to prostate volume and serum prostate specific antigen. Results: The combined treatment had significantly reduced the incidence of acute urinary retention and benign prostatic hyperplasia related surgery than monotherapy (P = 0.006 and 0.044, respectively). Similarly, when prostate volume and prostate specific antigen were above the cutoff value, both acute urinary retention and benign prostatic hyperplasia related surgery were lower in the combination therapy group than the monotherapy group. Conclusion: Combined therapy (0.4 mg tamsulosin plus 5mg finasteride) was significantly superior to 0.4 mg tamsulosin alone in the reduction of the incidence of acute urinary retention and benign prostatic hyperplasia related surgery among benign prostatic hyperplasia patients. Keywords: Benign prostatic hyperplasia; Acute urinary retention; Benign prostatic hyperplasia related surgery; Prostate volume; Prostate specific antigen.

5-Alpha-reductase inhibitors (5-ARIs) are used in the treatment of benign prostate hypertrophy (BPH). 5-ARIs, such as finasteride and dutasteride, suppress the biosynthesis of dihydrotestosterone (DHT), a precursor of androgen, which is closely related to the incidence of prostate cancer (PCa). A previous meta-analysis demonstrated a relationship between finasteride use and the incidence of PCA. However, there have been no meta-analyses on the relationship between PCa and dutasteride alone. This meta-analysis was performed to examine the prevalence of PCa in adult males taking dutasteride. We searched PubMed for reports regarding PCa risk and dutasteride use. The study was conducted according to the PRISMA guidelines for systematic reviews and meta-analyses. The analytic hierarchy process (AHP) method was used to weight the studies. Odds ratios (ORs), 95% confidence intervals (CIs), and P-values were calculated using fixed- and random-effects models. A total of eight articles were included in the meta-analysis. The overall OR for both the fixed- and random-effects models was 0.669 and the 95% CI for the random-effects model (0.526–0.851; P = 0.006) was wider than that for the fixed effects model (0.548–0.817; P < 0.001). This study confirmed that the incidence of PCa was significantly reduced by taking dutasteride.

Introduction: Klinefelter syndrome (KS) is defined as (a chromosomal disorder in which males have an extra X chromosome). KS presents clinically with signs of androgen deficiency including low testosterone. Androgenetic alopecia (AGA) develops as a response of the hair follicle cells to androgens in individuals with genetic predisposition. Case Presentation: We describe a 17-year-old male patient with KS who developed AGA with a Ludwig pattern. Conclusion: Our patient had a good response to oral minoxidil, finasteride, and low-level light therapy.

Introduction: Discovered in the 1990s, the endocannabinoid system (ECS) is involved with maintaining cellular homeostasis by downregulating the damaging inflammatory response and upregulating regenerative processes. Cannabidiol (CBD) has novel therapeutic effects, different from and synergistic with current hair regrowth therapies. CBD is fat-soluble and poorly absorbed past the epidermis, but topical application of CBD easily reaches hair follicles where it is a CB1 antagonist and agonist of vanilloid receptor-1 (TRPV1) and vanilloid receptor-4 (TRPV4). All these ECS receptors relate to hair follicle function. Blocking the CB1 receptor on the hair follicle with CBD has been shown to result in hair shaft elongation; in addition, the hair follicle cycle (anagen, catagen, and telogen phases) is controlled by TRPV1. The effects of CBD on hair growth are dose dependent and higher doses may result in premature entry into the catagen phase via a different receptor known as TRPV4. CBD has also been shown to increase Wnt signaling, which causes dermal progenitor cells to differentiate into new hair follicles and maintains anagen phase of the hair cycle. Objective: This study was conducted to determine if daily topical application of a hemp oil high in CBD concentration would result in significant hair regrowth in the area of the scalp most affected by androgenetic alopecia (AGA). Methods: A study was done of 35 (28 men and 7 women) subjects with AGA. Participants used a once daily topical CBD formulation, averaging about 3-4mg per day for 6 months. A hair count of the greatest area of alopecia was carried out before treatment started and after 6 months of treatment. To facilitate consistent hair count analysis, a clear acrylic mold, containing a 1cm2 cutout, was made of each subject’s head. Results: The results revealed that men did slightly better than women, and the vertex area did better than the temporal areas. On average, there was a statistically significant 93.5% increase in nonvellus hair after 6 months of once daily use. All subjects had some regrowth. There were no reported adverse effects. Discussion: Though the exact mechanism of therapeutic effects is not known, CBD is most likely functioning as a CB1 receptor antagonist and potentially also via Wnt messaging. Topical CBD formulation has comparable results to finasteride and comparable results to 5% minoxidil once daily foam. Since the CBD works through novel mechanisms different from finasteride and minoxidil, it can be used in conjunction with these current drugs and would be expected to have synergistic effects. However, safety of this combination would need to be evaluated.

Background: The primary aim of the medical therapy for BPH is to improve quality of life by relieving the lower urinary tract symptoms and prevent complications. Objectives: To compare efficacy and safety of double dose of tamsulosin monotherapy with combination of conventional dose of tamsulosin and finasteride in symptomatic BPH. Methods: This was a prospective study carried out in the Department of Urology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh during the period of July 2005 to June 2006. Total 60 patients of 45-80 years of age were consequently selected according to inclusion criteria. After completion of baseline clinical evaluation and investigations, participants were divided into two groups, group A and group B. Group A were given tamsulosin 0.4 mg for 1 week. Then double dose of tamsulosin (0.8 mg) were given from 2nd week for 12 months. Group B were given tamsulosin 0.4 mg and finasteride 5 mg for the same duration. Efficacy was evaluated at 6 month and 12 month follow up visit and a comparison was made between them. During follow up each was observed for any adverse effect. The parameters monitored were International Prostate Symptom Score (IPSS), Maximum urine flow rate (Qmax), Post Voidal Residual Volume (PVR) and Prostate volume. Results : Both double dose of tamsulosin 0.8 mg and combination of conventional dose of tamsulosin 0.4 mg and finasteride 5 mg are effective in relieving symptoms of BPH but combination dose is superior to double dose monotherapy. Outcome parameters at end point follow up after 12 months showed significant improvement of IPSS (p

Human steroid 5α-reductase 2 (SRD5A2) is an integral membrane enzyme in steroid metabolism and catalyzes the reduction of testosterone to dihydrotestosterone. Mutations in the SRD5A2 gene have been linked to 5α-reductase deficiency and prostate cancer. Finasteride and dutasteride, as SRD5A2 inhibitors, are widely used antiandrogen drugs for benign prostate hyperplasia. The molecular mechanisms underlying enzyme catalysis and inhibition for SRD5A2 and other eukaryotic integral membrane steroid reductases remain elusive due to a lack of structural information. Here, we report a crystal structure of human SRD5A2 at 2.8 Å, revealing a unique 7-TM structural topology and an intermediate adduct of finasteride and NADPH as NADP-dihydrofinasteride in a largely enclosed binding cavity inside the transmembrane domain. Structural analysis together with computational and mutagenesis studies reveal the molecular mechanisms of the catalyzed reaction and of finasteride inhibition involving residues E57 and Y91. Molecular dynamics simulation results indicate high conformational dynamics of the cytosolic region that regulate NADPH/NADP+ exchange. Mapping disease-causing mutations of SRD5A2 to our structure suggests molecular mechanisms for their pathological effects. Our results offer critical structural insights into the function of integral membrane steroid reductases and may facilitate drug development., Human steroid 5α-reductase 2 (SRD5A2) is an integral membrane enzyme and catalyzes 5α-reduction of testosterone to dihydrotestosterone. Structural analysis accompanied by computational and mutagenesis studies reveal the mechanisms of catalysis and inhibition by clinically relevant drugs targeting SRD5A2.

Depressed mood and suicidality reported with 5α-reductase inhibitors (finasteride and dutasteride) during post-marketing surveillance resulted in the addition of depression risk to finasteride labeling. As peer reviewed studies are limited and have reported mixed findings, we further evaluated 5α-reductase inhibitor exposure and depression risk using sequence symmetry analysis.National Veterans Health Administration administrative data were used to identify 53,848 male patients initiating 5α-reductase inhibitor therapy during fiscal year 2014. Incident depression events were assessed separately using the 2 measures of antidepressant prescription and depression diagnosis. Symmetry ratios were calculated as the ratio of patients with an incident depression event in the year following 5α-reductase inhibitor initiation to the year preceding initiation. An identical exposure counterfactual analysis was conducted among veterans initiating α1-adrenergic receptor antagonists.Incident antidepressant prescribing was observed in 2,563 patients following 5α-reductase inhibitor initiation and 3,051 patients preceding 5α-reductase inhibitor initiation (SR 0.84, 95% CI 0.80-0.89). Similar findings were observed for incident depression diagnosis (SR 0.83, 95% CI 0.79-0.86). Stratification by age group, 5α-reductase inhibitor agent, antidepressant class, prior α1-adrenergic receptor antagonist exposure and depression diagnosis type failed to demonstrate any positive association between 5α-reductase inhibitor and depression. Nearly identical results were observed in the α1-adrenergic receptor antagonist analysis (SR 0.87, 95% CI 0.84-0.90).Initiation of a 5α-reductase inhibitor was not associated with increased risk of depression. Our findings support the hypothesis that depression is more likely attributable to underlying benign prostatic hyperplasia and associated lower urinary tract symptoms than 5α-reductase inhibitor exposure.

5α-Reductase inhibitors reduced the risk of prostate cancer in 25% in 2 randomized trials but increased the risk of Gleason 8-10 at biopsy. One explanation is that 5α-reductase inhibitors induce morphological changes in prostate cancer cells similar to higher Gleason grades but without its adverse biology. We compared risk of prostate cancer death between men on 5α-reductase inhibitors and men not on 5α-reductase inhibitors before prostate cancer diagnosis in each Gleason Grade Group.Prostate Cancer data Base Sweden consists of linkages between the National Prostate Cancer Register, the Prescribed Drug Registry and the Cause of Death Registry. Of 89,227 men diagnosed with prostate cancer between July 2007 and December 2016, 5,816 had been on 5α-reductase inhibitors for more than 180 days before the date of diagnosis. Followup ended in December 2018. A Cox proportional hazard model was used to assess hazard ratio for prostate cancer death. Adjustments for age, comorbidity, education and curative treatment were made. Men with high risk cancer were stratified according to Gleason Grade Group.In men with high risk cancer the risk of prostate cancer death was similar among 5α-reductase inhibitor users and nonusers, with Gleason Grade Group 1 HR 1.02 (95% CI 0.53-1.95), Gleason Grade Group 2 HR 1.04 (95% CI 0.65-1.69), Gleason Grade Group 3 HR 1.27 (95% CI 0.89-1.80), Gleason Grade Group 4 HR 0.95 (95% CI 0.76-1.18) and Gleason Grade Group 5 HR 0.99 (95% CI 0.83-1.19), for 5α-reductase inhibitor users vs nonusers.We found no evidence that 5α-reductase inhibitors affect Gleason grading as no difference in mortality was observed among 5α-reductase inhibitor users and nonusers in each Gleason group.