A Randomized, Open-label, Phase 2 Study Of Mdv3100 As A Neoadjuvant Therapy For Patients Undergoing Prostatectomy For Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 52
- 主要终点
- Pathologic Complete Response Rate
研究概览
简要总结
The purpose of this study is to determine if enzalutamide is an effective therapy in treating localized prostate cancer prior to prostatectomy.
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
- None
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
- •Willing to provide informed consent
- •18 years of age or older
- •Histologically confirmed adenocarcinoma of the prostate
- •Must be a candidate for radical prostatectomy and considered surgically resectable
排除标准
- •Stage T4 prostate cancer by clinical or radiologic evaluation
- •Treatment with an investigational agent within 4 weeks prior to randomization
- •Received therapy for other neoplastic disorders within 5 years
- •Hypogonadism or severe androgen deficiency
研究组 & 干预措施
Enzalutamide & Leuprolide & Dutasteride
Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
干预措施: Dutasteride (Drug)
Enzalutamide alone
Enzalutamide 160 mg, orally, once daily
干预措施: Enzalutamide (Drug)
Enzalutamide & Leuprolide & Dutasteride
Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
干预措施: Enzalutamide (Drug)
Enzalutamide & Leuprolide & Dutasteride
Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
干预措施: Leuprolide (Drug)
结局指标
主要结局
Pathologic Complete Response Rate
时间窗: Day 180
Pathologic complete response rate was defined as percentage of participants with pathologic complete response. Pathologic complete response rate following triplet therapy (enzalutamide in combination with leuprolide and dutasteride) and enzalutamide alone when administered as neoadjuvant therapy for 180 days prior to prostatectomy in participants with localized prostate cancer. Pathologic complete response was defined as the absence of morphologically identifiable carcinoma in the prostatectomy specimen, as assessed by the local and central pathologist.
次要结局
- Percentage of Participants With Extracapsular Extension: Central Review(Day 180)
- Percentage of Participants With Positive Surgical Margins(Day 180)
- Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Summary Score(Day 180)
- Pharmacodynamic Effects: Assessment of Mitotic Index(Day 180)
- Serum Testosterone: Baseline(Baseline)
- Serum Testosterone: Day 180(Day 180)
- Percentage of Participants With Extracapsular Extension: Local Review(Day 180)
- Percentage of Participants With Positive Lymph Nodes(Day 180)
- Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Bother Subscale Score(Day 180)
- Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Role-Emotional Domain Score(Day 180)
- Pharmacodynamic Effects: Tissue Dihydrotestosterone (DHT)(Day 180)
- Percentage of Participants With Positive Seminal Vesicles(Day 180)
- Prostate-Specific Antigen (PSA) Nadir(Day 195)
- Percentage of Participants With Reduction in Prostate-Specific Antigen (PSA)(Day 195)
- Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Function Subscale Score(Day 180)
- Pharmacodynamic Effects: Assessment of Apoptosis(Day 180)
- Pharmacodynamic Effects: Assessment of Androgen Receptor Signaling as Measured by Intensity of Androgen Receptor Immunohistochemical (IHC) Staining(Day 180)
- Serum Dihydrotestosterone (DHT): Baseline(Baseline)
- Serum Dihydrotestosterone (DHT): Day 180(Day 180)
- Time to Prostate-Specific Antigen (PSA) Nadir(Day 195)
- Health-Related Quality of Life (HRQoL): Number of Participants With The Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Summary Score(Day 180)
- Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Function Subscale Score(Day 180)
- Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Bother Subscale Score(Day 180)
- Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Physical Functioning Domain Score(Day 180)
- Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 General Health Domain Score(Day 180)
- Number of Participants With Adverse Events (AEs) That Led to Dose Interruption, Dose Reduction, and Study Drug Discontinuation(From baseline up to 210 days)
- Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Mental Component Summary(Day 180)
- Pharmacodynamic Effects: Tissue Testosterone(Day 180)
- Change From Baseline in Serum Dihydrotestosterone (DHT) at Day 180(Day 180)
- Change From Baseline in Serum Testosterone at Day 180(Day 180)