The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score at 12 Months
研究概览
简要总结
The proposed clinical trial will study the effects of 12 months of therapy with ARN-509 alone, or in combination with an LHRH agonist (LHRHa), each compared with LHRHa alone, in men with a rapidly rising serum PSA after prior definitive local therapy for prostate cancer. The endpoints selected reflect measurable short term effects of androgen deprivation therapy (ADT), including quality of life and several metabolic parameters. In addition, the relative effect of each treatment strategy on PSA suppression as well as testosterone recovery (and subsequent PSA progression) after 12 months of therapy will be evaluated.
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
- •Histologically proven adenocarcinoma of the prostate
- •Rising PSA after prior definitive local therapy (radical prostatectomy, external beam radiation, or brachytherapy) or combination of radical prostatectomy and radiotherapy with curative intent
- •PSA doubling time less than or equal to 12 months
- •No evidence of metastatic disease on imaging by whole body bone scan and computerized tomography (CT) or Magnetic Resonance Imaging (MRI) of the abdomen/pelvis within 6 weeks prior to randomization
- •Minimum PSA 1.0 ng/mL if prior radical prostatectomy +/- adjuvant or salvage radiation; nadir + 2.0 ng/mL if prior RT without prior radical prostatectomy
- •Prior androgen deprivation therapy (ADT) allowed if last dose was greater than (>) 6 months prior to randomization
- •No prior androgen deprivation therapy (ADT) or anti-androgen for biochemical relapse
- •Serum testosterone > 150 ng/dL at study entry
- •No history of seizures or medical conditions which may lower seizure threshold
排除标准
- •Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) within 6 weeks prior to randomization
- •Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 6 weeks prior to randomization
- •Prior bilateral orchiectomy
- •Prior treatment with ADT for biochemically relapsed prostate cancer. Prior ADT as neo-adjuvant, concurrent, and/or adjuvant treatment following salvage radiation therapy or prostatectomy for biochemically relapsed disease is allowed provided last dose of ADT is greater than (>) 6 months prior to randomization and the Screening serum testosterone level is greater than or equal to (≥)150 ng/dL
- •Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at randomization
- •Any history of seizures or medical condition which lowers seizure threshold
研究组 & 干预措施
ARN-509
ARN-509 Tablets, 240 mg/day administered orally
干预措施: ARN-509 (Drug)
LHRH agonist + ARN-509
Choice of LHRHa per investigator discretion/site practice guidelines (e.g, Eligard®, Zoladex®, Lupron Depot®, Trelstar®) and ARN-509 Tablets, 240 mg/day administered orally
干预措施: ARN-509 (Drug)
LHRH agonist + ARN-509
Choice of LHRHa per investigator discretion/site practice guidelines (e.g, Eligard®, Zoladex®, Lupron Depot®, Trelstar®) and ARN-509 Tablets, 240 mg/day administered orally
干预措施: LHRH Agonist (Drug)
LHRH agonist
Choice of LHRHa per investigator discretion/site practice guidelines (e.g., Eligard®, Zoladex®, Lupron Depot®, Trelstar®).
干预措施: LHRH Agonist (Drug)
结局指标
主要结局
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score at 12 Months
时间窗: Baseline, at 12 months
FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACT-General (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.
次要结局
- Change From Baseline in FACT-P Total Score at 3 and 24 Months(Baseline, at 3 and 24 months)
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score at 3, 12 and 24 Months(Baseline, at 3, 12 and 24 months)
- Change From Baseline in EORTC Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Score at 3, 12 and 24 Months(Baseline, at 3, 12 and 24 months)
- Change From Baseline in Sexual Health Inventory for Men (SHIM) Total Score at 3, 12, 24 Months(Baseline, at 3, 12, 24 months)
- Time to Prostate Specific Antigen (PSA) Progression Based on Modified Prostate Cancer Clinical Trials Working Group (PCWG2) Criteria(Up to 24 months)
- Percentage of Participants Without PSA or Radiographic Progression and With Recovery of Serum Testosterone(Up to 24 months)
- Percentage of Participants With a Serum PSA Less Than 0.2 ng/mL(From 7 to 24 months)
- Change From Baseline in Body Mass Index (BMI)(Baseline, Day 1 (Cycle 1), Day 28 (Cycle 1, 2, 4, 5, 7, 8, 10 and 11), Day 35 (Cycle 3, 6, 9 and 12) and endpoint (up to 24 months))
- Change From Baseline in Fasting Plasma Glucose(Baseline, Day 35 (Cycle 3, 6, 9 and 12))
- Change From Baseline in Glycated Hemoglobin (HbA1C)(Baseline, Day 35 (Cycle 3, 6, 9 and 12))
- Change From Baseline in Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and Triglycerides(Baseline, Day 35 (Cycle 3, 6, 9 and 12))
- Change From Baseline in Bone Mineral Density (BMD)(Baseline, Cycle 12 Day 35)
- Median Time to Serum Testosterone Recovery to Greater Than (>) 50 ng/dL (Non-castrate) and > 150 ng/dL(Month 13 to Month 24)
- Change From Baseline in Serum Dihydrotestosterone (DHT) Levels(Baseline, Day 35 (Cycle 6 and Cycle 12))
- Change From Baseline in Estradiol Levels(Baseline, Day 35 (Cycle 6 and Cycle 12))
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)(From date of 1st dose of study drug to date of last dose of study drug plus 30 days (up to 6 years))