A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 711
- 试验地点
- 70
- 主要终点
- Disease free survival defined as the time from randomization until the date of the first failure event will be compared for the ProstAtak® arm versus the placebo control arm. The analyses will be based on the intent to treat population.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.
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
ProstAtak®
Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT
干预措施: Aglatimagene besadenovec + valacyclovir (Biological)
Control
Placebo + valacyclovir + radiation therapy +/- ADT
干预措施: Placebo + valacyclovir (Biological)
结局指标
主要结局
Disease free survival defined as the time from randomization until the date of the first failure event will be compared for the ProstAtak® arm versus the placebo control arm. The analyses will be based on the intent to treat population.
时间窗: Assessed at each visit every 6 months through year 5 until event occurs.
次要结局
- Prostate cancer specific survival and overall survival will be compared for the ProstAtak® arm versus the placebo control arm.(Assessed at each visit every 6 months through year 5 after which long-term follow up of general health status will continue yearly.)
- PSA nadir will be compared for the ProstAtak® arm versus the placebo control arm.(Assessed at each visit every 6 months through year 5.)
- Patient reported Health Related Quality of Life outcomes will be collected using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. The change in QOL over time will be compared for the ProstAtak® arm versus the placebo control arm.(Assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation.)
- The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase (until the completion of radiation). Data on late effects will be collected after radiation completion.(Assessed at each visit and continuously throughout the study.)