Prostvac in Patients With Biochemically Recurrent Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 5
- 主要终点
- Tumor Growth Rate as Measured by Prostate-specific Antigen (PSA) Rise After 6 Months When PROSTVAC is Initiated Compared to a Group on Surveillance for 6 Months
研究概览
简要总结
Background:
Some people who have been treated for prostate cancer still have high prostate-specific antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers think the immune system can be taught to fight and kill cancer cells. They think an immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type of prostate cancer.
Objective:
To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting surveillance alone.
Eligibility:
Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Bone scan
Computed tomography (CT) scan, or magnetic resonance imaging (MRI) and positron emission tomography (PET) scan: They lie in a machine that takes pictures of the body.
Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.
Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will have surveillance for 6 months followed by prostvac for 6 months.
During the prostvac period, participants will get prostvac as a shot under the skin on weeks 1, 3, and 5, and then monthly for a total of 5 months.
Participants will have follow-up visits at least every month until they recover from prostvac side effects or their cancer worsens. Visits may include repeats of screening tests.
Participants will be followed for up to 15 years. They will have a physical exam every year for the first 5 years. They will have phone calls once a year.
详细描述
BACKGROUND
- Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy (biochemically recurrent prostate cancer). The primary goal in these patients is to prevent morbidity from their cancer and to do so with limited toxicity.
- Prostvac (Prostvac; developed by the National Cancer Institute [NCI] and licensed to BN Immunotherapeutics, Mountain View, CA) is a novel candidate prostate cancer immunotherapy for the treatment of prostate cancer. It is a viral vector based therapeutic cancer vaccine that is administered via subcutaneous injections. In a randomized controlled Phase 2 trial, Prostvac therapy was associated with a prolongation of survival in men with metastatic castrate-resistant prostate cancer. A phase III trial recently completed accrual of patients in this same population.
- There is also rationale to use therapeutic cancer vaccines such as Prostvac in earlier stage prostate cancer patients to maximize the potential therapeutic effect of immune stimulating therapy.
- Analysis of previous trials using therapeutic cancer vaccines alone suggests that such therapies may alter tumor growth rate.
OBJECTIVE
Primary Objective:
-Determine if the therapeutic cancer vaccine prostvac can decrease tumor growth rate as measured by prostate-specific antigen (PSA) rise after 6 months compared to a group getting surveillance alone.
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 100 Years（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
结局指标
主要结局
Tumor Growth Rate as Measured by Prostate-specific Antigen (PSA) Rise After 6 Months When PROSTVAC is Initiated Compared to a Group on Surveillance for 6 Months
时间窗: 6 months
Tumor growth rate was measured using the equation PSA (log growth rate) +/- SE (standard error).
次要结局
- Effects of Vaccine on Prostate-specific Antigen (PSA) Growth Rate When PROSTVAC is Initiated After 6 Months on Surveillance(After the participants in the Arm/Group "B/ Delayed PROSTVAC Treatment" received treatment for 6 months after their 6 month surveillance (e.g., 12 months total).)
- Number of Participants With Prostate-specific Antigen (PSA) Specific T-Cells at Baseline and 6 Months(Baseline and 6 months)
研究者
Ravi A. Madan, M.D.
Principal Investigator
National Cancer Institute (NCI)