Randomized, Multicentre Efficacy and Safety Study Comparing 10 Mons vs 4 Mons Degarelix Therapy in Prolonging the Off Treatment Interval in Men With Localized Prostate Cancer Receiving Intermittent ADT for Biochemical Recurrence Following Radical Local Therapy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 144
- 试验地点
- 15
- 主要终点
- serum PSA
研究概览
简要总结
Men with localized prostate cancer requiring intermittent androgen deprivation therapy for biochemical recurrence following radical therapy will be asked to participate in a phase 4 safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix (Firmagon®) therapy with the endpoint of prolonging the off treatment interval.
详细描述
This is an open-label, multi-centre, randomised trial with subjects receiving subcutaneous (s.c.) monthly injections of degarelix depot. All patients will be treated with a one-month starting dose of 240mg on Day 0. Subjects are then randomized to receive either nine or three maintenance doses of one month duration. The primary objective is to determine the effect of degarelix therapy on the length of the off treatment interval (defined as serum Prostate-specific antigen (PSA) increasing to 5 ng/ml) following completion of the androgen deprivation therapy. The trial will also assess the effect of degarelix therapy on PSA kinetics (specifically PSA doubling time), PSA nadir, and effect on quality of life as well as other measures. The efficacy and safety of these two treatments will also be reported.
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 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated
- •PSA level meeting both of these criteria:
- •PSA level of ≥ 5 ng/mL.
- •For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir.
- •screening serum testosterone level above the lower limit of normal range defined as >2.2 ng/mL.
排除标准
- •Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation)
- •Has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening
研究组 & 干预措施
10 month degarelix therapy
干预措施: degarelix (Drug)
4 month degarelix therapy arm
干预措施: degarelix (Drug)
结局指标
主要结局
serum PSA
时间窗: approximately 15 months
The study will compare the length of the off treatment interval (in months) of subjects in the 4 month arm vs those in the 10 month arm. The off treatment interval is defined as the time from PSA nadir following completion of hormone therapy in both arms until the time PSA reaches 5.0ng/ml
次要结局
- serum PSA(at 4 months (4 mon arm) or 10 montths (10 mon arm))