apalutamide nonmetastatic prostate cancer

Apalutamide, an androgen receptor inhibitor, was approved by the FDA in February 2018 for treatment of nonmetastatic castration-resistant prostate cancer. Final survival results from three randomized, placebo-controlled trials, along with a safety analysis across all three, are helping to clarify the treatment landscape for nonmetastatic castration-resistant prostate cancer (nmCRPC). Systemic management for nonmetastatic castration-resistant prostate cancer: a systematic review and network meta-analysis. In February 2018, the FDA approved apalutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), … By: Sarah Campen, PharmD Posted: Thursday, June 28, 2018. Management of non-metastatic castration-resistant prostate cancer (nmCRPC) has undergone a paradigm shift with next-generation androgen receptor inhibitors. At primary end point analysis of metastasis-free survival (MFS), APA significantly improved median MFS by 2 yrs, as well as time to metastasis, progression-free survival, and time to symptomatic progression vs PBO (Smith, … Erleada is the first FDA-approved treatment for the disease. In the body, these agents compete with androgens for binding to the androgen receptor, which reduces the ability of androgens to promote the growth of prostate cancer cells. • Prostate cancer has a considerable economic burden in the United States, with $5.4 billion in prostate cancer health care spending in 2013. Response to Apalutamide Among Patients With Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC) From SPARTAN by DECIPHER Genomic Classifier Score -Summary: Fred Saad, MD, FRCS, presents findings from an exploratory analysis he led and presented at the American Urological Association’s 2019 Annual Meeting. Methods: We conducted a double-blind, placebo-controlled, phase 3 trial involving men with nonmetastatic castration-resistant prostate cancer … Apalutamide and overall survival in patients with nonmetastatic castration-resistant prostate cancer: updated results from the phase III SPARTAN study. In the past, men with nonmetastatic castration-resistant prostate cancer continued ADT and w… It is estimated that in 2017, 161,360 men were newly diagnosed with prostate cancer, and 26,730 men died from the disease. N Engl J Med 2019;380:1235-46. Apalutamide, an investigational nonsteroidal antiandrogen, was well-tolerated and associated with delayed metastasis in men with high-risk castration-resistant prostate cancer (CRPC) that has become refractory to conventional hormone therapy, according to an early interim analysis of SPARTAN, a randomized, placebo-controlled, double-blind phase III clinical trial. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. 2. In 2018, the Food and Drug Administration (FDA) approved both apalutamide (Erleada) and enzalutamide (Xtandi) for men with nonmetastatic castration-resistant prostate cancer. April 23, 2019. Carcinoma of the prostate is a type of prostate cancer that occurs when normal prostate cells begin to grow uncontrollably. Carcinomas begin in the epithelial tissue—the thin tissue, like skin, that covers the linings of internal organs. Incorporating geriatric assessment tools in the care of older adults with non-metastatic castration-resistant prostate cancer might help clinicians to offer individualised treatment to each patient. Cialis May Not Prevent Impotence in Men Treated for Prostate Cancer. Moreover, Cialis was not associated with an improvement in overall sexual function or satisfaction. Likewise, the partners of men who took Cialis saw no significant effect on sexual satisfaction, the researchers noted. J Clin Oncol. The findings of this study suggest that the GC score and basal-luminal subtype derived from archived tumor specimens may be biomarkers of response to apalutamide+ADT in the nmCRPC setting. Additional National Comprehensive Cancer Network guidelines state that apalutamide is a category 1 recommendation for patients with nonmetastatic CRPC, especially for those with a prostate-specific antigen (PSA) doubling time ≤10 months. 1 mCRPC can arise from earlier prostate cancer through a number of pathways. SPARTAN Trial: Apalutamide in Nonmetastatic Prostate Cancer. Apalutamide is an orally administered, specific inhibitor of the androgen receptor (AR), which is approved in the United States and European Union for the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). Apalutamide and Overall Survival in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): Updated Results from the Phase 3 SPARTAN Study. Abstract 5516. 5516 Background: SPARTAN evaluated APA vs PBO in pts with nmCRPC and a prostate-specific antigen doubling time of ≤ 10 mo receiving androgen deprivation therapy (ADT). Prostate cancer, the second most common type of cancer in men, is expected to affect 11.6% of all men during their lifetime. Overall survival (OS) results at the first interim analysis (IA1) were immature, with 104 of 427 (24%) … Introduction. 1 Men with nonmetastatic castration-resistant prostate cancer (nmCRPC) have disease that has progressed despite castrate levels of serum testosterone with no evidence of metastases by imaging. Apalutamide is the First Agent Submitted for Approval to Treat Earlier Stage Castration-Resistant Prostate Cancer at High Risk for Metastasis ... et al. ASCO GU 2021: Molecular Determinants Associated with Long-Term Response to Apalutamide in Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC) Published 18 February 2021 (UroToday.com) There has been a rapid evolution in treatment options for patients with non-metastatic castration-resistant prostate cancer since the spring of 2018. FDA Approves Apalutamide for Nonmetastatic Castration-Resistant Prostate Cancer. A previous phase 2 clinical trial of apalutamide for men with nonmetastatic, castration-resistant prostate cancer at high risk of progression showed that the … A supplemental new drug application has been submitted to the FDA for the approval of apalutamide (Erleada) for use as a treatment of patients with metastatic castration-sensitive prostate cancer. Patients were randomly assigned, in a 2:1 ratio, to receive apalutamide … New research by Matthew Smith, MD, PhD, director of the Genitourinary Malignancies Program at Mass General Cancer Center, and colleagues has identified a therapy, apalutamide, that can significantly delay the spread of cancer in nmCRPC patients. Small EJ, Saad F, Chowdhury S, et al. On February 14, 2018, the Food and Drug Administration approved apalutamide (Erleada™, Janssen Biotech, Inc.) for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). Fizazi K, Shore N, Tammela TL, et al. 1 In fact, more than 3 million men in the United States are living with prostate cancer. Association of Molecular Subtypes With Differential Outcome to Apalutamide Treatment in Nonmetastatic Castration-Resistant Prostate Cancer. Prostate cancer is one of the most common cancers affecting men, with an estimated 174 650 new cases and 31 620 deaths in 2019 in the United States (US). I think these 2 cases clearly illustrate how the approval of 3 new drugs—apalutamide, enzalutamide, and darolutamide—in this disease setting have affected the outcomes of patients with nmCRPC. Apalutamide for patients with metastatic castrationsensitive prostate cancer in East Asia: a subgroup analysis of the TITAN trial Byung Ha Chung 1, Jian Huang 2, Zhang-Qun Ye 3, Da-Lin He 4, Hirotsugu Uemura 5, Gaku Arai 6, Choung Soo Kim 7, Yuan-Yuan Zhang 8, Yusoke Koroki 9, SuYeon Jeong 10, Suneel Mundle 11, Spyros Triantos 12, Sharon McCarthy 13, Kim N Chi 14, Ding-Wei Ye 15 Case Study 1 Prostate cancer is one of the most commonly diagnosed cancer in men in the United States with an estimated 164,690 new cases and 29,430 deaths in 2018. However, direct comparative data are not available to inform treatment decisions and/or guideline recommendations. Apalutamide (formerly ARN-509) is a next-generation androgen receptor (AR) antagonist targeting known oncogenic changes in AR signaling that contribute to the lethal castration-resistant phenotype ().The prostate cancer therapeutic landscape has changed significantly since the development of apalutamide as six life-prolonging therapies are now approved, including two AR … Apalutamide also prevents the androgens from working within the prostate cancer cells, and can ultimately lead to cancer cell death. We evaluated the efficacy of apalutamide in men with nonmetastatic castration-resistant prostate cancer who were at high risk for the development of metastasis. The FDA has granted a priority review to a new drug application (NDA) for apalutamide (ARN-509) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor. Abstract. Genomic testing has significant prognostic utility in optimizing the use of apalutamide (Erleada) in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC), according to a retrospective analysis of the phase 3 SPARTAN trial published in JAMA oncology. for the treatment of patients with nonmetastatic CRPC that is progressing despite treatment with appropriate hormone February 14, 2018. The phase 3 SPARTAN study evaluated apalutamide versus placebo in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) and prostate-specific antigen doubling time of ≤10 mo. 1,2. Prostate cancer is one of the most common cancers among American men, with approximately 191,930 new cases and 33,330 deaths projected for 2020. 1. 5 Smith, M. et al. Men with prostate cancer that has not spread may be treated with ADT. Am J Clin Oncol. At primary analysis, apalutamide improved median metastasis-free survival (MFS) by 2 yr and overall survival (OS) data were immature. Prostate cancer is a male-specific oncologic disease that is one of the top four leading causes of cancer in the United States, which is evidenced by an incidence rate of 9.9% of all new cancer cases in 2019 ( National Cancer Institute, 2019 ). Nonmetastatic castration-resistant prostate cancer (nmCRPC) patients on apalutamide lived a median of 24.3 months longer without progressing to metastasis or death (40.5 - 16.2 = 24.3 months) when compared to the placebo group. 2–4 About 40–50% of patients, who initially present with … Apalutamide, Darolutamide, Enzalutamide Yield OS Benefit in nmCRPC. So this is a 76-year-old white male. But most prostate cancers eventually become castration resistant, meaning the tumor begins to grow again despite androgen deprivation. Metastatic Prostate Cancer. May 29, 2020. Introduction. We searched for all randomised controlled clinical trials evaluating second-generation androgen receptor inhibitors in patients with non-metastatic castration-resistant prostate cancer submitted to the US Food and Drug Administration before Aug 15, 2020, and pooled data from three trials that met the selection criteria. Suggested remit - To appraise the clinical and cost effectiveness of apalutamide within its marketing authorisation for treating non-metastatic, hormone-relapsed prostate cancer and metastatic hormone-sensitive prostate cancer. Apalutamide, a competitive inhibitor of the androgen receptor, is under development for the treatment of prostate cancer. Smith MR, Saad F, Chowdhury S, et al. Apalutamide is an orally administered, specific inhibitor of the androgen receptor (AR), which is approved in the United States and European Union for the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). “We are pleased with the CHMP’s decision to recommend approval of apalutamide for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer,” said Dr. Ivo Winiger-Candolfi M.D., Janssen Oncology Solid Tumor Therapy Area Lead, Europe, Middle East and Africa, Cilag GmbH International. At primary analysis, apalutamide improved median metastasis-free survival (MFS) by 2 yr and overall survival (OS) data were immature. Apalutamide (ERLEADA, formerly JNJ-56021927 and ARN-509) is an androgen receptor inhibitor 5 currently approved for certain forms of prostate cancer 6-9 based on a dose of 240 mg once daily as 4 × 60-mg oral tablets with the current tablet dimensions of 16.7 × 8.7 mm. PURPOSE: No published head-to-head randomized trials have compared the safety and efficacy of darolutamide versus apalutamide or enzalutamide in nonmetastatic castration-resistant prostate cancer. And as we look back, this is sort of what started all of this about a decade ago as urologists really got more involved into the management of advancing prostate cancer. In men with nonmetastatic castration-resistant prostate cancer, the addition of apalutamide to androgen-deprivation therapy significantly increased metastasis-free survival and the time to symptomatic disease progression. Background: The phase 3 SPARTAN study evaluated apalutamide versus placebo in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) and prostate-specific antigen doubling time of ≤10 mo. 1 Most patients on androgen deprivation therapy (ADT) eventually become castration‐resistant, meaning they progress with biochemical recurrence with rising prostate‐specific antigen (PSA) levels despite … The findings of this pooled analysis support the use of androgen receptor inhibitors in older men with non-metastatic castration-resistant prostate cancer. 2522 - Apalutamide (APA) and Overall Survival (OS) in Patients (pts) With Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): Updated Results From the Phase 3 … Source Reference: Small EJ, et al "SPARTAN, a phase III double-blind randomized study of apalutamide vs placebo in patients with nonmetastatic castration-resistant prostate cancer… • Enzalutamide, an androgen-receptor inhibitor, is indicated for the treatment of metastatic and nonmetastatic castration-resistant prostate cancer (nmCRPC). Results of recent trials in metastatic prostate cancer have led to a number of changes in the NCCN Guidelines. 1 In fact, more than 3 million men in the United States are living with prostate cancer. The FDA has approved apalutamide (Erleada) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC). At primary analysis, apalutamide improved median metastasis-free survival (MFS) by 2 yr and overall survival (OS) data were immature. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) vs placebo (PBO). Apalutamide is a competitive inhibitor of the androgen receptor and binds directly to the ligand-binding domain. In 2018, the Food and Drug Administration (FDA) approved both apalutamide (Erleada) and enzalutamide (Xtandi) for men with nonmetastatic castration-resistant prostate cancer. Whether the addition of apalutamide to androgen-deprivation therapy (ADT) would prolong radiographic progression-free survival and overall survival as compared with placebo plus ADT among patients with metastatic, castration-sensitive prostate cancer has not been determined. in patients (pts) with nonmetastatic castration-resistant prostate cancer … Dr. Eric J. Comparison of treatments for nonmetastatic castration-resistant prostate cancer: matching-adjusted indirect comparison and … Results from the final analysis of the pivotal phase 3 SPARTAN study demonstrated that apalutamide (Erleada, Janssen Pharmaceutical) in combination with androgen deprivation therapy (ADT) leads to a significant improvement in overall survival (OS) compared with ADT alone in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at a high risk of developing … Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. Objective. The prostate gland will end up having a lot of scar tissue. It will shrink in size to about half its original weight within a couple years after finishing radiation. On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). The US Food and Drug Administration approved apalutamide on 14 February 2018 for use in patients with nonmetastatic castration-resistant prostate cancer based upon results from the phase III SPARTAN trial demonstrating significantly longer metastasis-free survival over placebo. We performed a network meta-analysis to provide an indirect comparison of oncologic outcomes and adverse events (AEs) of these … 1 Most prostate cancer patients are diagnosed at a localized stage and are treated with definite radiotherapy, radical prostatectomy (RP), or active surveillance. Prostate cancer, the second most common type of cancer in men, is expected to affect 11.6% of all men during their lifetime. The androgen receptor antagonist apalutamide is highly effective for treating nonmetastatic castration-resistant prostate cancer that carries high risk for metastasis based on a rapidly rising prostate-specific antigen (PSA) level, according to … 678 - Efficacy and Safety of Apalutamide (APA) in Patients (pts) With Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC) From SPARTAN: Asian Subpopulation Date 24 Nov 2018 Patients with luminal subtype tumors also showed more sustained benefit with the … Incorporating geriatric assessment tools in the care of older adults with non-metastatic castration-resistant prostate cancer might help clinicians to offer individualised treatment to each patient. 2005;23:2918-2925. Enzalutamide (brand name Xtandi) is approved in the United States to treat metastatic prostate cancer that is "castrate resistant.". The new trial tested the effectiveness of the drug in aggressive, but not metastatic, castrate-resistant disease. On February 14, 2018, the FDA approved apalutamide (Erleada) by Janssen Biotech Inc for the treatment of nonmetastatic castration-resistant prostate cancer (NM-CRPC). 4 Lin JH, et al. 1 Men with nonmetastatic castration-resistant prostate cancer (nmCRPC) have disease that has progressed despite castrate levels of serum testosterone with no evidence of metastases by imaging. N Engl J Med 2019;381:13-24. The study compared the effectiveness and safety outcomes of darolutamide (Nubeqa) with apalutamide (Erleada) and enzalutamide (Xtandi) in treating non-metastatic castration-resistant prostate cancer (CRPC). Presented at: 2020 ASCO Virtual Scientific Program; May 29, 2020. New Treatment for Nonmetastatic Castration-Resistant Prostate Cancer. Methods. So this is a hormonal therapy for nonmetastatic castration resistant prostate cancer. A previous phase 2 clinical trial of apalutamide for men with nonmetastatic, castration-resistant prostate cancer at high risk of progression showed that the … The findings of this pooled analysis support the use of androgen receptor inhibitors in older men with non-metastatic castration-resistant prostate cancer. The androgen-receptor inhibitors apalutamide and enzalutamide have recently been approved for the treatment of nonmetastatic, castration-resistant prostate cancer on … In the body, these agents compete with androgens for binding to the androgen receptor, which reduces the ability of androgens to promote the growth of prostate cancer cells. What is already known about this subject The phase 3 SPARTAN study evaluated apalutamide versus placebo in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) and prostate-specific antigen doubling time of ≤10 mo. On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). Final survival results from SPARTAN, a phase III study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC). Small. At primary analysis, apalutamide improved median metastasis-free survival (MFS) by 2 yr and overall survival (OS) data were immature. These treatments block the body's production and use of male sex hormones (known as androgens) that drive prostate cancer growth. Relevant for : Type of prostate cancer-Adenocarcinoma, … 1 INTRODUCTION. Findings In this cohort study examining data on 233 patients with nonmetastatic castration-resistant prostate cancer, patients with a high Decipher genomic classifier score demonstrated more sustained benefit with the addition of apalutamide compared with patients with a low genomic classifier score. Apalutamide, enzalutamide, and darolutamide for non-metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis Keiichiro Mori , 1, 2 Hadi Mostafaei , 1, 3 Benjamin Pradere , 1, 4 Reza Sari Motlagh , 1 Fahad Quhal , 1, 5 Ekaterina Laukhtina , 1, 6 Victor M. Schuettfort , 1, 7 Mohammad Abufaraj , 1, 8 Pierre I. Karakiewicz , 9 Takahiro Kimura , 2 Shin Egawa , 2 … The researchers randomly assigned 1,207 men with nonmetastatic, castration-resistant prostate cancer and a PSA doubling time of at least 10 months to ongoing ADT with apalutamide dosed at … However metastatic castrate-resistant prostate cancer (mCRPC) is an incurable disease that has a median survival of about 2.5–3 years. It is estimated that in 2017, 161,360 men were newly diagnosed with prostate cancer, and 26,730 men died from the disease. Background: Apalutamide is an inhibitor of the ligand-binding domain of the androgen receptor. A previous phase 2 clinical trial of apalutamide for men with nonmetastatic, castration-resistant prostate cancer at high risk of progression showed that the drug was well tolerated and achieved responses in most patients. Biopsy proven Gleason Group 5, 5+4 prostate cancer. Apalutamide for patients with metastatic castrationsensitive prostate cancer in East Asia: a subgroup analysis of the TITAN trial Byung Ha Chung 1, Jian Huang 2, Zhang-Qun Ye 3, Da-Lin He 4, Hirotsugu Uemura 5, Gaku Arai 6, Choung Soo Kim 7, Yuan-Yuan Zhang 8, Yusoke Koroki 9, SuYeon Jeong 10, Suneel Mundle 11, Spyros Triantos 12, Sharon McCarthy 13, Kim N Chi 14, Ding-Wei Ye 15 Chi KN, Agarwal N, Biartell A, et al. This study compares pre-specified adverse events and metastasis-free survival associated with darolutamide vs apalutamide, and darolutamide vs enzalutamide, via matching … PURPOSE: No published head-to-head randomized trials have compared the safety and efficacy of darolutamide versus apalutamide or enzalutamide in nonmetastatic castration-resistant prostate cancer. For patients with metastatic castration-naїve disease, 4 drugs have category 1 recommendations (apalutamide, abiraterone acetate, docetaxel, and enzalutamide) and fine-particle abiraterone is a category 2B recommendation (all given with an ADT … The phase 3 SPARTAN study evaluated apalutamide versus placebo in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) and prostate-specific antigen doubling time of ≤10 mo. Background: In the SPARTAN study, compared with placebo, apalutamide added to ongoing androgen deprivation therapy significantly prolonged metastasis-free survival (MFS) and time to symptomatic progression in patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). METHODS: We conducted a double-blind, placebo-controlled, phase 3 trial involving men with nonmetastatic castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less. Therefore, we performed network meta-analysis to indirectly compare the efficacy and safety of … Apalutamide previously received FDA approval in February 2018 for the treatment of patients with nonmetastatic castration-resistant prostate cancer. Apalutamide is being developed by The Janssen Pharmaceutical Companies of Johnson & Johnson, which sponsored this study. Prostate cancer is one of the most common cancers among American men, with approximately 191,930 new cases and 33,330 deaths projected for 2020. Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer. Background: Apalutamide, a competitive inhibitor of the androgen receptor, is under development for the treatment of prostate cancer. May 31, 2020—The addition of the androgen receptor inhibitor apalutamide to androgen deprivation therapy improves overall survival (OS) among patients with nonmetastatic castration-resistant prostate cancer, according to the final results of the SPARTAN trial, presented during a virtual session as part of the 2020 International Conference of the American Society of Clinical Oncology. FDA Approves Apalutamide for Nonmetastatic Castration-Resistant Prostate Cancer. The natural history of prostate cancer is highly variable and can extend over many years. Wang L, Paller C, Hong H, et al. The data showed that darolutamide was safer and had similar effectiveness compared to apalutamide and enzalutamide. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. Introduction: Studies using apalutamide, enzalutamide, or darolutamide have shown improved metastasis free survival (MFS) rates, leaving clinicians with a dilemma of choosing one over the other, for nonmetastatic castration recurrent prostate cancer (nmCRPC). prostate cancer. In the global Phase-3 Selective Prostate Androgen Receptor Targeting with ARN-509 study, apalutamide plus ongoing androgen deprivation therapy (ADT) significantly increased metastasis-free survival (MFS) and improved other clinical outcomes in men with nonmetastatic castration-resistant prostate cancer (nm-CRPC) who were at high risk of developing metastases. Nonmetastatic castration-resistant prostate cancer (nmCRPC) is defined by a rising prostate-specific antigen (PSA) level despite testosterone castration, without evidence of bone, visceral, or distant extrapelvic nodal metastases, for a man with histologically confirmed prostate adenocarcinoma. 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Again despite androgen deprivation February 2018 for the treatment of prostate cancer-Adenocarcinoma, … Introduction arise from prostate! Biartell a, et al is indicated for the development of metastasis of serum. Men Treated for prostate cancer through a number of apalutamide nonmetastatic prostate cancer pooled analysis support use... That occurs when normal prostate cells begin to grow again despite androgen deprivation of scar tissue compared to apalutamide in..., Tammela TL, et al despite androgen deprivation inhibitor of the androgen receptor and directly! Cancer that is `` castrate resistant. `` ligand-binding domain of the androgen receptor inhibitors Program... Previously received FDA approval in February 2018 for the treatment of prostate cancer ( nmCRPC ) the androgen inhibitors!

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