Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Two Year Progression-free Survival
研究概览
简要总结
The purpose of this study is to describe the 2 year progression-free survival in men with recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard androgen-deprivation therapy (ADT) with salvage radiation therapy. Eligible men will have recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of 0.2 - 4 in the absence of metastatic disease on CT and bone scans. In addition to standard ADT and radiation therapy, research participants will take enzalutamide once daily for six months. It is primarily hypothesized the 2 year PFS rate will be improved with the combined therapy compared to the historical control data in a similar patients setting.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of prostate adenocarcinoma. Variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate, are not permitted.
- •Gleason sum of 7, 8, 9, or 10 at the time of prostatectomy.
- •PSA relapse within 4 years of prostatectomy defined by persistently detectable or rising PSA after surgery.
- •Evidence of disease recurrence or progression as evidenced by a PSA > 0.
- •This requires 2 consecutive rises in PSA, at least 1 week apart, over the post-prostatectomy nadir or one PSA value above 0.20 ng/mL if the patient failed to achieve a post-prostatectomy nadir of < 0.2 ng/mL.
- •Age ≥ 18 years
- •Karnofsky performance status ≥ 70
- •Adequate laboratory parameters
- •Adequate bone marrow function: ANC ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hb >9g/dL
- •AST/SGOT and ALT/SGPT ≤ 2.5 x Institutional Upper Limit of Normal (ULN)
- •Serum bilirubin ≤ 1.5 x Institutional ULN
- •Serum creatinine ≤ 1.5 x Institutional ULN or 24-hour clearance ≥ 50 mL/min
- •A minimum of 4 weeks from any major surgery prior to registration.
- •Ability to swallow, retain, and absorb oral medication.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Must use a condom if having sex with a pregnant woman.
- •Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration.
排除标准
- •Radiographic evidence of metastatic disease. Patients with node-positive disease (<2 positive nodes) at the time of radical prostatectomy are eligible. Patients with pelvic nodes up to 2 cm by short axis at the time of screening are eligible. Patients with any enlarged lymph nodes in the retroperitoneum or above the aortic bifurcation or with pelvic nodes ≥ 2 cm must be excluded.
- •PSA > 4.0 ng/mL.
- •Testosterone level ≤ 100 ng/dL.
- •More than 1 month of prior hormone exposure or hormone exposure within 30 days of registration. Prior enzalutamide, ketoconazole, abiraterone, or TAK700 prohibited. Prior 5α reductase inhibitors are allowed.
- •Prior immunotherapy including sipuleucel-T.
- •Prior systemic chemotherapy (docetaxel, cabazitaxel, estramustine, other cytotoxic agents)
- •History of solid organ or stem cell transplantation.
- •History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, prior head or traumatic brain injury with loss of consciousness, prior or current space-occupying lesion in the brain). Also, history of loss of consciousness or transient ischemic attack within 12 months of Day 1 visit.
- •Known or suspected brain metastasis or active leptomeningeal disease.
- •Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of enzalutamide or increase the risk of radiation (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndromes, prior small bowel resection, or inflammatory bowel disease).
- •Patients who have received prior prostate or pelvic radiotherapy, including external beam or brachytherapy.
- •Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy prior to registration.
- •Patients unable or unwilling to abide by the study protocol or cooperate fully with the investigator.
研究组 & 干预措施
Enzalutamide
Enzalutamide, Androgen Deprivation, and Radiation Therapy
干预措施: enzalutamide (Drug)
Enzalutamide
Enzalutamide, Androgen Deprivation, and Radiation Therapy
干预措施: Androgen Deprivation (Drug)
Enzalutamide
Enzalutamide, Androgen Deprivation, and Radiation Therapy
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Two Year Progression-free Survival
时间窗: 2 years
Percentage of patients surviving 2 years from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks OR evidence of clinical progression or initiation of systemic therapy for progressive disease
次要结局
- PSA Less Than 0.1(every year, up to 3 years)
- Three Year Progression-free Survival(3 years)
- Biochemical Progression-free Survival(3 years)
- PSA Nadir(8 weeks)
- Time to Testosterone Recovery(3 years)
- Number of Patients With Adverse Events Related to Combination Enzalutamide, ADT, and XRT(3 years)