Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to Progression
研究概览
简要总结
In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically to the concurrently administered immunotherapy Sipuleucel-T and thereby significantly improve the treatment outcome for metastatic castrate resistant prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR are FDA approved therapeutic cancer treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven prostate cancer
- •Patient must currently be on androgen deprivation or anti-androgen therapy with castrate levels of testosterone (< 50ng/dl). Medical castration should continue until disease progression
- •Radiographic evidence of metastatic disease documented with bone scan or CT scan. Patients with any number of metastatic site are allowed to enroll. However, only up to six sites will be selected for SBRT treatment, at the discretion of the treating radiation oncologist.
- •PSA ≥ 5 ng/ml
- •Asymptomatic or minimally symptomatic patients
- •Visual Analog Scale (VAS) ≤ 4;vNo narcotic use in the last 21 days
- •Adequate hematologic, renal, and liver function
- •Previous treatment with surgery, radiation or hormonal therapy is allowed.
- •Performance status ECOG 0 or
- •Life expectancy of at least 6 months
- •Negative serology tests for human immunodeficiency virus (HIV) 1 and 2, human T cell lymphotropic virus (HTLV)-1, Hepatitis B and C.
- •Age ≥ 18 years.
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Subjects must not have had more than two different regiments of chemotherapy previously or any chemotherapy within the past three months.
- •Subjects may not be receiving any other investigational agents for the treatment of prostate cancer.
- •Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •Subjects with malignant pleural effusions and malignant ascites
- •Systemic corticosteroid use within past 28 days. Use of inhaled, intranasal, and topical steroids is acceptable.
- •Systemic immunosuppressive therapy in the past 28 days.
- •Use of any of the following within the past 28 days: Megestrol acetate (Megace®), diethyl stilbestrol (DES), or cyproterone acetate, Ketoconazole, high dose calcitriol [1,25(OH)2VitD] (i.e., > 7.0 μg/week).
- •Inability to tolerate contrast dye for baseline CT imaging.
- •Initiation or discontinuation of biphosphonate use within past 28 days.
- •Subjects with pathologic long-bone fractures
- •Subjects with spinal cord compression
- •Paget's disease of bone.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
arm one
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR)
干预措施: Sipuleucel-T (Drug)
arm one
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR)
干预措施: Stereotactic Ablative Body Radiation (Radiation)
结局指标
主要结局
Time to Progression
时间窗: 4 years
To evaluate the improvement in the time to progression (TTP) of metastatic prostate cancer after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Progression will be evaluated in this study using the modified new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Committee \[JNCI 92(3):205-216, 2000\] with modifications suggested by PCWG2 \[49\] recommendations and as used in the Phase III clinical trial by Kantoff et. al.\[10\]. Changes in only the largest diameter (one-dimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria as outlined in http://www.recist.com/.
次要结局
- Overall Survival (OS)(60 months)
- Progression Free Survival (PFS)(4 years)
- Biochemical Progression Free Survival (bPFS)(4 years)
- Immune Response(6 week)
- Prostate Cancer-specific Survival (PCaSS)(4 years)
- Adverse Events(60 months)
- Cost Effectiveness and Health-related Quality Adjusted Life(4 years)
研究者
Raquibul Hannan
Principal Investigator
University of Texas Southwestern Medical Center