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临床试验/NCT02003924
NCT02003924已完成3 期

PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER

Pfizer760 个研究点 分布在 3 个国家目标入组 1,401 人开始时间: 2013年10月31日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Pfizer
入组人数
1,401
试验地点
760
主要终点
Metastasis Free Survival (MFS)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
Male
接受健康志愿者
否

入选标准

  • •Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
  • •Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
  • •Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
  • •Progressive disease on androgen deprivation therapy at enrollment;
  • •PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
  • •PSA doubling time ≤ 10 months;
  • •No prior or present evidence of metastatic disease;
  • •Asymptomatic prostate cancer;
  • •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • •Estimated life expectancy ≥ 12 months.

排除标准

  • •Prior cytotoxic chemotherapy;
  • •Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
  • •Known or suspected brain metastasis or active leptomeningeal disease;
  • •History of another invasive cancer within 3 years of randomization;
  • •Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;
  • •Total bilirubin ≥ 1.5 times the upper limit of normal;
  • •Creatinine > 2 mg/dL (177 µmol/L) at screening;
  • •Albumin < 3.0 g/dL (30 g/L) at screening;
  • •History of seizure or any condition that may predispose to seizure;
  • •Clinically significant cardiovascular disease;
  • •Gastrointestinal disorder affecting absorption;
  • •Major surgery within 4 weeks of randomization;
  • •Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
  • •Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.

研究组 & 干预措施

Placebo

Sham Comparator

Sugar pill manufactured to mimic enzalutamide 40 mg capsule

干预措施: Placebo (Drug)

Enzalutamide

Experimental

160 mg by mouth once daily

干预措施: Enzalutamide (Drug)

结局指标

主要结局

Metastasis Free Survival (MFS)

时间窗: From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

MFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review \[BICR\]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,\[RECIST 1.1\])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates.

次要结局

  • Time to Prostate-Specific Antigen (PSA) Progression(From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))
  • Time to First Use of New Antineoplastic Therapy(From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))
  • Overall Survival(From randomization until death (up to a maximum of 68.8 months))
  • Time to Pain Progression(From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))
  • Time to First Use of Cytotoxic Chemotherapy(From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))
  • Chemotherapy-Free Disease Specific Survival(From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))
  • Chemotherapy-Free Survival(From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))
  • Percentage of Participants With Prostate Specific Antigen (PSA) Response(From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))
  • Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 50(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 51(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS)(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 39(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 40(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 41(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 43(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 44(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 45(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 46(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 47(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 48(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 49(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 52(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 53(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 54(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 55(Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177)
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))
  • Number of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0(From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))
  • Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)(From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))
  • Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology(From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))
  • Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Chemistry(From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))
  • Number of Participants With Clinically Significant Vital Signs(From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months))

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (760)

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