安斯泰来和Medivation启动Xtandi III期PROSPER试验

安斯泰来（Astellas）和Medivation公司12月3日联合宣布，启动前列腺癌药物Xtandi（enzalutamide）的一项全球性III期临床试验（PROSPER），该项研究将评估enzalutamide用于治疗非转移性（non-metastatic，通常称为M0）去势抵抗性前列腺癌（CRPC）的疗效和安全性。目前，在美国，还没有专门批准用于治疗非转移性CRPC的处方药。

PROSPER是一项随机、双盲、安慰剂对照、多国III期临床试验，计划在美国、加拿大、欧洲、南非、亚太地区的站点招募约1500例非转移性CRPC患者。

该项研究将招募一组高风险的前列腺癌亚组群体，这些患者的癌症经雄激素剥夺疗法治疗后病情恶化，这些患者为无症状患者，同时既往不存在或目前不存在癌症转移的证据。

该项研究的主要终点是无转移生存率，将评估每日一次口服剂量160mg enzalutamide联合雄激素剥夺疗法，相对于安慰剂+雄激素剥夺疗法的疗效和安全性。

关于Xtandi（enzalutamide）：

Enzalutamide是一种新颖的、每日一次的口服雄激素受体信号传导抑制剂，该药能够抑制雄激素受体信号传导通路中的多个步骤，已被证明能够降低癌细胞的生长，并能诱导肿瘤细胞死亡。

enzalutamide已于2012年8月获FDA批准用于既往接受过多西紫杉醇疗法的转移性阉割性前列腺癌（mCRPC）患者的治疗。

英文原文：Medivation and Astellas Initiate Phase 3 Study of Enzalutamide in Non-Metastatic Castration-Resistant Prostate Cancer

SAN FRANCISCO, CA and TOKYO, JAPAN -- (Marketwired) -- 12/03/13 -- Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TOKYO: 4503) announced enrollment of the first patient in a global Phase 3 clinical trial, known as PROSPER, which will evaluate the safety and efficacy of enzalutamide in patients with non-metastatic (often referred to as M0) castration-resistant prostate cancer (CRPC). Currently no prescription medicine is specifically approved for the treatment of patients with non-metastatic CRPC in the United States.

"PROSPER targets an important patient population as we and Astellas look to advance the development of enzalutamide further upstream in the prostate cancer treatment paradigm," said David Hung, M.D., president and chief executive officer of Medivation, Inc. "The initiation of this trial underscores our commitment to develop enzalutamide as a potential treatment for those touched by this disease."

About PROSPER

The Phase 3 randomized, double-blind, placebo-controlled, multi-national trial plans to enroll approximately 1,500 patients with non-metastatic castration-resistant prostate cancer at sites in the United States, Canada, Europe, South America and the Asia Pacific region. PROSPER will enroll a high-risk subgroup of patients with prostate cancer who are progressing despite androgen deprivation therapy, but who are asymptomatic with no prior or present evidence of metastatic disease. The primary endpoint of the trial is metastasis-free survival. The trial will evaluate enzalutamide at a dose of 160 mg to be taken orally once daily versus placebo, plus androgen deprivation therapy. Information about patient eligibility and enrollment can be obtained by calling the PROSPER hotline toll-free at 855-977-3825.

About Enzalutamide

Enzalutamide is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. Enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA.

About XTANDI? (enzalutamide) capsules
XTANDI was approved by the U.S. Food and Drug Administration on August 31, 2012 and is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel.