Targeted Drug Intervention in Men at Risk of Progression on Active Surveillance for Early Prostate Cancer: A Randomised Trial - Therapeutics in Active Prostate Cancer Surveillance (TAPS02).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- MRI defined tumour volume
研究概览
简要总结
This is a phase 2, randomised, multicentre, double-blind, placebo-controlled trial investigating the use of short term androgen deprivation therapy in the form of apalutamide (Erleada) in men on active surveillance for 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Apalutamide 6 months
Participants will receive apalutamide 240 mg (4 x 60 mg tablets) orally once a day for up to 6 months.
干预措施: Apalutamide Oral Tablet [Erleada] (Drug)
Apalutamide 3 months + Placebo 3 months
Participants will receive apalutamide 240mg (4 x 60 mg tablets) orally once a day for up to 3 months followed by placebo to match apalutamide (4 tablets) orally once a day for up to 3 months.
干预措施: Apalutamide Oral Tablet [Erleada] (Drug)
Apalutamide 3 months + Placebo 3 months
Participants will receive apalutamide 240mg (4 x 60 mg tablets) orally once a day for up to 3 months followed by placebo to match apalutamide (4 tablets) orally once a day for up to 3 months.
干预措施: Placebo (Drug)
Placebo 6 months
Participants will receive placebo to match apalutamide (4 tablets) orally once a day for up to 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
MRI defined tumour volume
时间窗: 12 months after end of treatment
To determine whether there is a reduction in MRI defined tumour volume at 12 months post treatment in at least 50% of the treated cohort in either treatment arm compared to the baseline measurement.
次要结局
- Reported adverse events(Reported from the point of obtaining informed consent until the safety FU visit (30-45 days post-treatment))
- Patient-reported outcomes EORTC QLQ-C30(Cumulative until 12 months after end of treatment)
- Patient-reported outcomes EQ-5D-5L(Cumulative until 12 months after end of treatment)
- Cumulative rate of progression (any progression)(3 years after completion of treatment)
- Cumulative rate of progression to any prostate cancer treatment (for any cause)(3 years after completion of treatment)
研究者
Vincent Gnanapragasam
Professor of Urology and Honorary Consultant Urologist
Cambridge University Hospitals NHS Foundation Trust