A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 58
- 主要终点
- Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL
研究概览
简要总结
The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.
详细描述
This was an open-label, randomized, parallel-arm, multicenter study to determine if degarelix intermittent therapy was non-inferior to continuous androgen deprivation therapy (combination of treatment groups receiving continuous degarelix and leuprolide therapy, respectively) in maintaining PSA levels at ≤ 4.0 ng/mL at 14 months.
The study consisted of two phases, Phase A and B. During Phase A, patients in the degarelix intermittent and degarelix continuous arms received 7 months of therapy with degarelix one-month depot formulation and patients in the leuprolide continuous arm received leuprolide one-month depot injection (7.5 mg) followed by two 3-month depot (22.5 mg) injections. After 7 months of treatment, patients with a PSA ≤2 ng/mL continued into Phase B.
During Phase B, patients in the degarelix intermittent arm had a 7-month off-treatment period. Patients randomized to the degarelix continuous arm and the leuprolide continuous arm continued to receive degarelix or leuprolide depot as in Phase A for the remainder of the 14 months.
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
- •18 years or older.
- •Raising PSA after prior treatment failure of localized prostate cancer.
- •Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy.
- •Has a screening testosterone within normal range (≥1.5 ng/mL).
- •Has Eastern Cooperative Oncology Group score of ≤
- •Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs.
- •Life expectancy of at least 15 months.
排除标准
- •Taken hormone therapy in the last 6 months prior to entering this study.
- •Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial.
- •Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- •Has hypersensitivity towards any component of the study drug.
- •Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin within the last five years.
- •Has abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial.
- •Has a clinically significant medical condition (other than prostate cancer) including but not limited to; renal, haematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
- •Has an intellectual incapacity or language barriers precluding adequate understanding or co-operation.
- •Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial.
- •Has received ketoconazole or diflucan in the last 28 days preceding the Screening Visit.
- •Has previously participated in any Degarelix trial.
- •Is part of an ongoing trial.
研究组 & 干预措施
DI (Degarelix Intermittent)
Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
干预措施: Degarelix (Drug)
DC (Degarelix Continuous)
Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall
干预措施: Degarelix (Drug)
LC (Leuprolide Continuous)
Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer's labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
干预措施: Leuprolide (Drug)
结局指标
主要结局
Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL
时间窗: At 14 month
Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.
次要结局
- Absolute Change From Baseline in Serum PSA Levels(Phase A Visit 1-8 and Phase B Visit 9-15.)
- Percent Change From Baseline in Serum PSA Levels(Phase A Visit 1-8 and Phase B Visit 9-15.)
- Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being(During 14 months)
- Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being(During 14 months)
- Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being(During 14 months)
- Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being(During 14 months)
- Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns(During 14 months)
- Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score(During 14 months)
- Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive(During 14 months)
- Change From Baseline in Sexual Function as Assessed by the SFI: Erection(During 14 months)
- Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation(During 14 months)
- Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment(During 14 months)
- Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life(During 14 months)
- Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score(During 14 months)
- Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL(At 14 months)
- Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group(During Phase B)
- Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level(During Phase B)
- Absolute Change From Baseline in Serum Testosterone Levels(Phase A Visit 1-8 and Phase B Visit 9-15.)
- Percent Change From Baseline in Serum Testosterone Levels(Phase A Visit 1-8 and Phase B Visit 9-15.)