A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 187
- 试验地点
- 23
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. CAN-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. CAN-2409 has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that CAN-2409 can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the CAN-2409 or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.
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
CAN-2409
Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir
干预措施: aglatimagene besadenovec (Biological)
CAN-2409
Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir
干预措施: valacyclovir (Drug)
Placebo
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
干预措施: placebo (Biological)
Placebo
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
干预措施: valacyclovir (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Baseline to study completion, approximately 5 years
Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer
次要结局
- Negative biopsy rate at 1-year landmark(1 year)
- Percentage of patients with adverse events(30 days after last dose of study drug)